Speaker Biographies

Circulating Tumor Cells

Georg Bauer, PhD, Senior Vice President, Development, STRATEC Consumables GmbH

Georg Bauer has a Chemistry background, with specific expertise in industrial technologies needed for medical applications. As a PhD (University of Vienna), he was able to improve and patent novel surface analytical tests that enabled label-less detection of analytes. As a head of R&D (STRATEC Consumables), he establishes ways to create a faster and smooth transfer from research to mass manufacturing.

Richard J. Cote, MD, FRCPath, FCAP, Professor, Joseph R. Coulter Jr. Chair, Pathology & Laboratory Medicine; Professor, Biochemistry and Molecular Biology; Chief of Pathology, Jackson Memorial Hospital

Dr. Cote obtained degrees in chemistry and biology at the University of California at Irvine and received his medical degree from the University of Chicago - Pritzker School of Medicine. He completed his residency at New York Hospital - Cornell University Medical College. His training included a clinical fellowship in pathology at Memorial Sloan-Kettering Cancer Center, a research fellowship in Human Tumor Immunology at Memorial Sloan-Kettering Cancer Center and a fellowship in Molecular Pathology at New York University School of Medicine. Prior to joining the University of Miami in 2009, he was Professor, Department of Pathology; Professor, Department of Urology; Director, Genitourinary Cancer Program; Director, Laboratory of Immunology and Molecular Pathology; and Director of the USC Biomedical Nanoscience Initiative at the University of Southern California Keck School of Medicine. Dr. Cote’s research is focused on the elucidation of cellular and molecular pathways of tumor progression and response to therapy. He has special interests in micrometastases and circulating tumor cell (CTC) detection and characterization, the pathology of breast and genitourinary tumors and technology development. Most recently, he and his colleagues at the University of Southern California, Caltech and UC Berkeley have developed nanoscale technologies for cancer diagnostic applications, including bionanosensors for the detection of serum tumor markers, and technologies for the capture and characterization of circulating tumor cells. As a result of these efforts, he established the Biomedical Nanoscience Program at USC and the Dr. John T. Macdonald Biomedical Nanotechnology Institute at the University of Miami for the development of novel diagnostic platforms and targeted therapeutics. He has led three of the largest clinical trials in breast, lung and bladder cancer, which were based on discoveries from his research. Dr. Cote is the author of over 300 publications and participates on numerous scientific advisory boards for both academic and industry related institutions. He is the founder of several technology-based companies, including Impath, Inc., Clarient, Filtini and Sensitini.

Massimo Cristofanilli, MD, FACP, Professor, Medicine; Associate Director, Translational Research and Precision Medicine; Director, OncoSET Precision Medicine Program, Medicine-Hematology and Oncology, Robert H. Lurie Comprehensive Cancer Center, Feinberg School of Medicine, Northwestern University, Chicago

Dr. Cristofanilli is physician-scientist with focus on the development of diagnostics and therapeutic in metastatic breast cancer (MBC) and inflammatory breast cancer (IBC). His primary research focus has been in the detection, characterization and possible therapeutic targeting of occult (microscopic) disease in breast cancer leading to the development of new enrichment methods. His initial work using a novel immunomagnetic-based technology (CellSearch™) led to a pivotal trial which successfully demonstrated the detection and prognostic value of circulating tumor cells (CTCs) in the peripheral blood of patients with metastatic breast cancer (MBC). He has extended his interest to other blood-based molecular diagnostics including blood-based NGS (CTCs and ctDNA) applied to clinical research and clinical care.

Zigang Dong, PhD, Executive Director & Professor, Cellular & Molecular Biology, The Hormel Institute, University of Minnesota

Dr. Zigang Dong is Executive Director, Hormel/Knowlton Professor, and I. J. Holton Professor of The Hormel Institute, University of Minnesota (UMN). In 2006, he received the UMN McKnight Presidential Professorship in Cancer Prevention, one of the highest honors bestowed by the University. He is one of a very few professors holding 3 endowed professorships simultaneously at UMN. Dr. Dong is a world leader in cancer prevention and molecular carcinogenesis. Under Dong’s leadership, research funding granted to The Hormel Institute has doubled twice in the last six years. To recognize his achievement, a $30 million expansion of The Hormel Institute, University of Minnesota was completed in 2008 to house the research teams of Dr. Dong and 14 other research groups. In 2015, The Hormel Foundation and the State of Minnesota awarded another $60 million to assist him in building a world-renowned first class research facility focusing on cancer research. In a collaborative project with the Henan Provence of China and The Hormel Foundation, The US-China (Henan) Hormel Cancer Institute opened December 1, 2014. This new institute will be funded with $10 million each year for the next 10 years. Dr. Dong serves as Director of both Hormel Institutes.

Chwee Teck Lim, PhD, Professor, Mechanobiology Institute, National University of Singapore

Professor Lim is the inaugural NUSS Professor at the Department of Biomedical Engineering, a Principal Investigator at the Mechanobiology Institute as well as a Faculty Fellow of the Singapore-MIT Alliance for Research & Technology. He is founding member of the Department of Biomedical Engineering, the university’s Nanoscience and Nanotechnology Initiative as well as the university’s Centre for Advanced 2D Materials. Prof Lim’s research interests are interdisciplinary, and they include the mechanobiology of human diseases such as malaria and cancer, development of microfluidic technologies for disease detection, diagnosis and precision therapy and flexible wearable technologies for healthcare applications. He has authored over 350 peer-reviewed journal papers and delivered more than 350 plenary/keynote/invited talks. He is an elected Fellow of the American Institute for Medical and Biological Engineering (AIMBE), International Academy of Medical and Biological Engineering (IAMBE) and the Academy of Engineering, Singapore. He is also an elected member of the World Council of Biomechanics. He currently sits on the editorial boards of more than 20 international journals. Prof Lim has co-founded one incubator and five startups which are commercializing technologies developed in his lab. He and his team have garnered more than 70 research awards and honors including Winner of IDTechEx Launchpad 2017, International Precision Medicine Conference Prize 2017, ASEAN Outstanding Engineering Achievement Award and Asian Scientists 100 in 2016, Vladimir K. Zworykin Award in 2015, University’s Outstanding Researcher Award and Outstanding Innovator Award in 2014, the Credit Suisse Technopreneur of the Year Award, Wall Street Journal Asian Innovation Award (Gold) in 2012, President’s Technology Award in 2011 and the IES Prestigious Engineering Achievement Award in 2010 among others. His research was cited by the MIT Technology Review magazine as one of the top ten emerging technologies of 2006 that will “have a significant impact on business, medicine or culture.”

Dario Marchetti, PhD, Director, Biomarker Program, Methodist Hospital, Biomarker Program, Houston Methodist Research Institute

Dario Marchetti, PhD, tumor and molecular biologist, is the Director of the Biomarker Research Program, Professor of the Institute of Academic Medicine at Houston Methodist Research Institute and Visiting Professor of Molecular & Cellular Biology at Baylor College of Medicine. Dr. Marchetti is an international recognized expert and authority in the field of patient-isolated CTCs as clinically useful tools to combat cancer metastasis for improved patient outcome. With keen insights into the biology of brain metastasis, he pioneered models for discoveries of molecular determinants underlying brain metastasis and biomarker properties of brain-homing CTCs (Science Transl. Medicine, 2013), and/or brain-associated CTCs (Nature Communications, 2017). As a consummate scientist, Dr. Marchetti’s bibliography include 184 publications of which 79 are in peer-reviewed journals in the fields of neuroscience and oncology. He has received numerous awards and secured uninterrupted funding for 27 years by receiving grants from federal, state, institutional and private Agencies. He is a reviewer for the most prominent journals in cancer research and sits on editorial boards of multiple cancer journals. Dr. Marchetti graduated from the University of Pavia, Italy in 1979. He worked as postdoctoral fellow at the University of Illinois, Chicago (1980-1982), University of Texas Medical Branch – Galveston (Texas) (1984-1986). He then became a research scientist at the University of Texas Health Science Center-Houston (1986-1991), Research Associate and later Instructor at UT MD Anderson Cancer Center (1992-1999), Assistant Professor at UT-Houston (1999-2001), and Associate Professor and later Professor (with tenure) at LSU-Baton Rouge, Louisiana (2002-2007), endowed “Jack. L. Titus” Professor at Baylor College of Medicine (2008-2015; now Visiting Professor) prior to joining the faculty at Methodist Hospital Research Institute.

David T. Miyamoto, MD, PhD, Assistant Professor, Radiation Oncology, Harvard Medical School, Center for Cancer Research, Massachusetts General Hospital

David Miyamoto, MD, PhD is an Assistant Professor of Radiation Oncology at Harvard Medical School, an attending radiation oncologist at the Massachusetts General Hospital (MGH), and a physician scientist in the MGH Center for Cancer Research. Dr. Miyamoto received his undergraduate degree in Chemistry from Harvard College, MD from Harvard Medical School, and PhD in Cell Biology from Harvard University. He completed an internship in Internal Medicine at the Brigham & Women's Hospital, and his residency in radiation oncology in the Harvard Radiation Oncology Program. Dr. Miyamoto is a board-certified radiation oncologist specializing in genitourinary malignancies who sees patients in the Bertucci Center for Genitourinary Cancers at the MGH Cancer Center and the MGH Department of Radiation Oncology. His research efforts focus on the development of novel biomarkers to guide prostate cancer therapy, and the development of sensitive microfluidic platforms for the molecular analysis of circulating tumor cells (CTCs). He has authored and co-authored more than 30 publications in peer-reviewed scientific journals including Science, Cell, and Cancer Discovery. His research has been supported by the Prostate Cancer Foundation, Department of Defense, National Cancer Institute, and the Dana Farber/Harvard Cancer Center.

Rolf Muller, PhD, CEO, BioFluidica Inc.

Rolf Muller obtained his Ph.D. in biochemistry from the Pasteur Institute Paris, France. Prior to joining BioFluidica he was the Founder and President of Biomatrica, which he developed from an idea to be a global leader in biopreservation technologies for diagnostic and health care companies. Over the last 16 years he has been involved in analyzing markets and developing strategies to position biotechnologies to maximize value.

Sunitha Nagrath, PhD, Associate Professor, Chemical Engineering, University of Michigan

Dr. Nagrath’s research goal is to bring the next generation of engineering tools to patient care, especially in cancer. Her major focus of research is to develop advanced MEMS tools for understanding cell trafficking in cancer through isolation, characterization and study of circulating cell in peripheral blood of cancer patients. Dr. Nagrath’s research on isolating and studying rare cells from cancer patients. She would like to focus her lab’s efforts on designing and developing smart chips using microfluidics and nanotechnology to make impact in medicine and life sciences. Her goal is to create cutting edge engineering solutions for clinical medicine with novel translational biomedical research tools. She strongly believes in building a team where engineers, biologists and clinicians will come together to solve the complex problems with better approaches.

Costanza Paoletti, MD, Research Investigator, Internal Medicine, Hematology Oncology, University of Michigan Comprehensive Cancer Center

Dr. Costanza Paoletti received her MD and her clinical training in Medical Oncology from the University of Florence (Italy). In 2010, Dr. Paoletti served as a Post-doctoral Research Fellow in Dr. D.F. Hayes’ laboratory of at the University of Michigan Comprehensive Cancer Center (UM CCC). During this time, her focus included pre-clinical and pilot clinical studies of the utility of monitoring circulating tumor cells (CTC) number and phenotype.

Steven A. Soper, PhD, Foundation Distinguished Professor, Chemistry, Mechanical Engineering, Cancer Biology, and Bioengineering, University of Kansas

Prof. Soper is currently a Foundation Distinguished Professor in Chemistry and Mechanical Engineering at the University of Kansas, Lawrence, KS. Prof. Soper also holds an appointment at Ulsan National Institute of Science and Technology in Ulsan, South Korea, where he is a World Class University Professor. Prof. Soper is the Director of the Center of BioModular Multi-Scale Systems for Precision Medicine, which has as its primary charge to develop transformative tools for making health-related measurements from rare disease markers, such as liquid biopsy markers. This Center has recently been awarded funding from the National Institutes of Health as part of their Biotechnology Resource Center Program (funded through the National Institute of Biomedical Imaging and Bioengineering). Prof. Soper has secured extramural funding totaling >$90M and has published over 345 manuscripts and is the author of 14 patents. He is also the founder of a startup company, BioFluidica, which is marketing devices for the isolation and enumeration of circulating tumor cells.

Lynn R. Sorbara, PhD, Program Director, Cancer Biomarker Research Group, National Cancer Institute

Dr. Lynn Sorbara earned her PhD from Albert Einstein College of Medicine in 1986. Her thesis research was in the areas of the mechanism of action of the drug, Taxol, and of multidrug resistance. After postdoctoral fellowships at the Rockefeller University and the Mount Sinai College of Medicine in Manhattan, she came to the NIH as a Senior Staff Fellow in the Diabetes Branch of NIDDK. From 1996 to 2007, she was the Technical Supervisor and Clinical Staff Scientist for the Molecular Diagnostics Unit of the Laboratory of Pathology at NCI. As the Technical Supervisor, she was responsible for the development, validation, and quality assurance for all the diagnostic tests performed in this College of American Pathologists and CLIA certified laboratory. Since 2007, she has been a Program Director for the Cancer Biomarkers Research Group in the Division of Cancer Prevention of NCI. In her current role, she oversees and manages cooperative agreement grants for the Biomarker Reference Laboratories and is the co-coordinator of the Lung Collaborative Group for the Early Detection Research Network. She is the lead Program Director for the Cancer Prevention R03 Small Grants Program for DCP as well as a Program Representative for the Innovative Molecular Technologies Analysis and the SBIR Programs. She has a strong interest in developing Standard Operating Procedures for biomarker discovery/validation, and diagnostic assay development. Her grant portfolio includes biomarkers for early detection of hematopoietic malignancies, lung and upper aerodigestive cancers, new technologies and diagnostics tools for cancer research.

Shannon N. Tessier, PhD, Instructor, Center for Engineering in Medicine, Department of Surgery, Massachusetts General Hospital, Harvard Medical School

Dr. Tessier received her PhD in molecular biology and biochemistry from Carleton University where she applied cutting edge molecular technology to delineate signaling pathways which allow animals to enter a state of suspended animation. Since these organisms withstand stressors known to be experienced during biopreservation of human cells, tissues and organs, a natural transition during her postdoctoral fellowship was to translate these lessons from nature to human biologics. As a postdoctoral fellow, Dr. Tessier expanded her skillset into the field of biomedical engineering by joining the Center for Engineering in Medicine at the Massachusetts General Hospital (MGH) and Harvard Medical School (HMS). Recently, Dr. Tessier was promoted to Instructor in Surgery at MGH and HMS. Here, Dr. Tessier is leading the development of novel preservation methods for the limitation of ex vivo organ injury destined for transplantation, creating new strategies for the stabilization of biologics for molecular diagnostics, and testing new compounds for applications in cryopreservation of primary cells for therapeutics. A common theme across these projects is the control of biological time and promoting the broad dissemination of life-saving technology.

Siva A. Vanapalli, PhD, Professor, Chemical Engineering, Texas Tech University

Prof. Siva Vanapalli is a Professor in Chemical Engineering at Texas Tech University. He obtained his B.Tech from IIT Kharagpur and PhD from the University of Michigan. He is currently the holder of the Bill Sanderson and the Ed & Linda Whitracre Faculty Fellowships at Texas Tech. His research interests are in the areas of microfluidics, complex fluids, cancer, healthy aging and technology development. He received the CAREER Award from the National Science Foundation and the Rising Star Award from the Cell & Molecular Bioengineering Group of Biomedical Engineering Society. He has published over 50 research papers and developed several patent-pending microfluidic technologies. His laboratory is currently supported by grants from NSF, NIH and NASA.

Min Yu, MD, PhD, Assistant Professor, Stem Cell Biology and Regenerative Medicine Member, Norris Comprehensive Cancer Center, Keck School of Medicine, University of Southern California

Min Yu, MD, PhD, received her medical degree from China and PhD in genetics from Stony Brook University and Cold Spring Harbor Laboratory (CSHL). She pursued postdoctoral training with Dr. Daniel Haber at Massachusetts General Hospital, Harvard Medical School, where she characterized circulating tumor cells isolated from the peripheral blood of cancer patients. Dr. Yu joined the Department of Stem Cell Biology and Regenerative Medicine and the USC Norris Comprehensive Cancer Center as an assistant professor in 2014, and her lab focuses on the mechanisms of cancer metastasis. In addition to the NIH Director’s New Innovator Award, she received the NCI career transition (K22) award, the STOP CANCER Research Career Development Award, the Pew-Stewart Scholar for Cancer Research award, and the Donald E. & Delia B. Baxter faculty fellowship.

Youli Zu, MD, PhD, Professor and Endowed Chair in Pathology; Chief, Hematopathology Section; Director, Cancer Pathology Research Lab, Pathology and Genomic Medicine, Houston Methodist Hospital

After obtaining his MD and PhD degrees, Dr. Zu attended the University of Connecticut Health Center as a postdoctoral fellow and later remained there as an assistant professor. He then spent four years in pathology residency training at New York University, followed by a two-year hematopathology fellowship at the National Cancer Institute of the National Institutes of Health. Dr. Zu joined the Department of Pathology and Genomic Medicine at Houston Methodist Hospital in 2004, where he currently serves as the Medical Director of the Hematopathology Section. He is also Professor of Pathology and Laboratory Medicine at the Weill Cornell Medical College of Cornell University. In addition to his clinical responsibilities, Dr. Zu is also the Director of the Cancer Pathology research laboratory at the Houston Methodist Research Institute. These combined positions enable him to address clinically-driven questions. As a physician-scientist, Dr. Zu has pioneered the translation of the oligonucleotide aptamers and nanotechnology into clinical applications, and his research is currently funded by multiple NIH and CPRIT grants.

Biomarkers for Cancer Immunotherapy and Combinations

Neeraj Adya, PhD, Director, Pharmacodiagnostics Translational Medicine, Bristol-Myers Squibb

Neeraj Adya has over 17 years of expertise in the In Vitro Diagnostics (IVD) medical device industry, specifically in developing and supporting diagnostic assays. He is currently at Bristol-Myers Squibb (BMS) as a Pharmacodiagnostics (PDx) Lead, enabling development of Companion/Complementary diagnostics in various therapeutic areas, including Oncology, Cardiovascular, and Fibrosis. In this role, Neeraj provides PDx leadership for complementary and companion diagnostic activities, facilitating delivery of all diagnostics by working with external diagnostic business partners. Prior to that, he was at Abbott Laboratories for over 15 years where he led cross-functional teams to develop blood screening diagnostics products for infectious diseases as well as development of assays intended as companion diagnostic (CDx) with multiple Pharma partners. Neeraj Adya received his PhD in Molecular Biology from Case Western Reserve University for work on genetic mechanisms of HTLV-1 carcinogenesis in Adult T-Cell Leukemia. Subsequently, as a Postdoctoral Research Fellow at the National Human Genome Research Institute in NIH, he examined the role of chromosomal rearrangements in Acute Myeloid Leukemia and molecular mechanisms of hematopoietic development.

Deepti Aurora-Garg, PhD, Director Companion Diagnostics, Translational Medicine, Merck&Co.

Deepti has a PhD in Molecular Biology and Immunology from Indiana University and post-doctoral training in infectious diseases from Children’s Hospital Boston. She has spent over 10 years developing diagnostics in infectious diseases, transplantation and oncology. She is currently the Director of Companion Diagnostics at Merck and Co. overseeing the development of IHC and genomic biomarkers in Keytruda

Meghna Das Thakur, PhD, Biomarker Scientist, Oncology Biomarker Development, Genentech

Meghna Das Thakur received her PhD from Washington University in St Louis in 2010 in Gregory Longmore's lab where she studied the Role of Ajuba LIM proteins as negative regulators of the Hippo growth-signaling pathway. Meghna then moved to California and did a joint research project at Novartis Institute for BioMedical Research and UCSF as a Presidential Posdoctoral candidate where she generated preclinical melanoma models to study acquired resistance to BRAF and MEK inhibitors, and developed methods of forestalling the onset of resistance by altering dosing regimens which has since been tested in the clinic. In 2013 she took on a Scientist role in Novartis where she led efforts to build GEMM and Patient Derived Xenografts models to generate clinically relevant resistance to targeted therapies. Meghna Das Thakur has been a part of Genentech’s Oncology Biomarkers group since May 2014 and has been the Biomarker lead for the Innovative Pediatric Oncology Drug Development (IPODD) program. In this role, she worked towards building an internal knowledge base for pediatric diseases through collaborations and leveraging past (Avastin) and ongoing (Cancer Immunotherapy and Targeted inhibitor) pediatric trials to develop and execute comprehensive biomarker strategies that are specific to pediatric diseases. Since then Meghna worked on the Cancer immunotherapy combination Ph1b trials which led to ongoing registrational trials in CRC and melanoma. In addition, she was on a Phase 1b combination clinical trials platform where her focus was on GI disease area strategies with a goal to propose novel immunotherapy combinations. To this end, beyond her biomarker work on trials she has been working on CRC, Gastric Cancer and Pancreatic Cancer datasets from internal trials and through external collaborations allowing her to dissect their disease biology and help inform new combinations in these hard to treat indications. In the last year and a half, Meghna has been leading the Biomarker efforts for a Molecule called CEA-TCB that binds T-cells and tumour cells simultaneously. CEA-TCB was studied in patients with carcinoembryonic antigen (CEA)-positive solid tumours, including microsatellite stable (MSS) metastatic colorectal cancers (mCRC) that overexpress CEA. She is now researching predictive biomarkers and the pharmacodynamics of this drug in ongoing clinical trials.

Sam M. Hanash, MD, PhD, Professor, Molecular Pathology, Division of Pathology Lab Medicine, The University of Texas MD Anderson Cancer Center

No biography available

J. Joseph Melenhorst, PhD, Director, Product Development & Correlative Sciences Laboratories (PDCS); Adjunct Associate Professor, Center for Cellular Immunotherapies, University of Pennsylvania

Dr. J. Joseph Melenhorst is the Director of Product Development & Correlative Sciences (PDCS) at the Center for Cellular Immunotherapies (CCI), and Adjunct Associate Professor of Pathology and Laboratory Medicine, University of Pennsylvania (UPenn). After he obtained is MSc degree at the University of Nijmegen, Netherlands, and PhD degree at the University of Leiden, Netherlands, he did his post-doctoral research at the National Institutes of Health in Bethesda, Maryland, studying the biology of bone marrow failure syndromes, leukemia and graft-versus host immunology, and adoptive cell therapy. Dr. Melenhorst was recruited to the University of Pennsylvania in 2012. The focus of his laboratory is to understand and improve the efficacy and safety of cellular immunotherapy through biomarker, mechanistic, and product development studies. His laboratory has uncovered key biomarkers of a chimeric antigen receptor (CAR) T cell therapy-associated toxicity, cytokine release syndrome (CRS), and developed predictive monitoring tools for CRS in leukemia 1. He furthermore identified the critical parameters determining success in CAR T cell therapies in leukemia 2 (and manuscripts under revision). Lastly, his efforts include the development of a universal, streamlined, cost-effective and potent manufacturing process for T cell engineering and some of his insight has already been translated into clinical practice.

Iulian Pruteanu-Malinici, PhD, Biostatistics, Investigator II, Lab Head, Novartis Institutes for BioMedical Research (NIBR)

I have a PhD in Bayesian statistics and machine learning from Duke University. I am currently working at Novartis, as an Investigator with a leading role across statistical efforts in CAR-T cell therapies. We apply bioinformatics models to improve upon and characterize patient cells in CAR-T trials. Besides using flow cytometry we are also working with other cytometry techniques for improved throughput and higher data dimensionality.

Jaime Rodriguez-Canales, MD, FEBP, Senior Pathologist Translational Pathology Laboratory, MedImmune

Dr. Jaime Rodriguez-Canales obtained his MD degree and Anatomic Pathology board certification at the Pontifical Catholic University of Chile (Santiago, Chile) and the European Board of Pathology (Utrecht, Netherlands). He was trained in oncologic surgical pathology during a 3-year fellowship under the direction of Dr. Juan Rosai (Italy). Dr. Rodriguez-Canales was postdoc and research fellow at the Laboratory of Pathology at NCI, NIH (Bethesda, MD), and research scientist in Dr. Ignacio Wistuba’s lab, at MD Anderson Cancer Center (Houston, TX). From 2013 to 2017, Dr. Rodriguez-Canales was Assistant Professor and Director of the IHC & Digital Pathology Lab at the Department of Translational Molecular Pathology at the MD Anderson Cancer Center. In August 2017, he joined the Laboratory of Pathology at MedImmune (Gaithersburg, MD). Dr. Rodriguez-Canales has contributed to over 118 peer-reviewed publications including journals such as Lancet Oncology, Nature and pathology journals, a patent application, and several abstracts and presentations at diverse meetings including USCAP, AACR and WCLC/IASLC. His experience includes human oncologic pathology, lung cancer, basic mouse model and PDX histopathology, laser capture microdissection, immunohistochemistry, RNAscope, multiplex immunofluorescence using PerkinElmer Vectra/Polaris, validation of biomarkers in tissue specimens, and more recently immuno-oncology from the pathologist’s perspective.

Alex Reuben, PhD, Assistant Professor, Thoracic Head and Neck Medical Oncology, University of Texas MD Anderson Cancer Center

Dr. Reuben obtained his PhD at the University of Montreal, Canada where he studied antigen presentation. Since 2014, he has worked at MD Anderson performing translational melanoma and lung cancer research. His focus has been identifying biomarkers of response and resistance to checkpoint blockade immunotherapy. Most recently, Dr. Reuben has worked on characterizing the T cell repertoire in the context of non-small cell lung cancer

Aaron J. Schetter, PhD, Scientific Reviewer, Division of Molecular Genetics and Pathology, CDRH, FDA

No biography available

Devon J. Shedlock, PhD, Vice President, Preclinical Development, Poseida Therapeutics

Dr. Shedlock is VP of Preclinical Development at Poseida Therapeutics. He has extensive experience in the field of T cell immunology and was formerly an Adjunct Assistant Professor of Pathology & Laboratory Medicine at the Perelman School of Medicine and the Associate Director of the T-Cell Engineering Laboratory as part of the Translational Research Program (TRP) at the University of Pennsylvania. Prior to his work developing engineered T lymphocyte-based therapies for treating cancer, he developed DNA vaccines against the human herpes viruses and a vaccine for Ebola, now in clinical trials. He also established numerous animal models for evaluation of immunogenicity and efficacy of vaccines, molecular adjuvants, genetic optimization strategies, and advanced delivery technologies. Before this he studied the mechanisms of antibody-mediated neutralization of Ebola as a Postdoctoral Fellow at the Vaccine Research Center, National Institutes of Health.

Katie Streicher, PhD, Associate Director, Translational Medicine, Medimmune

No biography available

Janis M. Taube, MD, Director, Dermatopathology Division and Fellowship, Associate Professor of Dermatology, Pathology, and Oncology, Johns Hopkins University

Dr. Janis Taube is an associate professor of dermatology and pathology at the Johns Hopkins University School of Medicine and a member of the Johns Hopkins Kimmel Cancer Center. Her area of clinical expertise is dermatopathology. Dr. Taube serves as the Director of the Division of Dermatopathology and as the Assistant Director of the Dermatoimmunology Laboratory at the School of Medicine.Dr. Taube received her undergraduate degree in engineering from Duke University. She earned her MD from Tulane University and her M.Sc. in molecular medicine from University College London. She completed her residency in pathology at Johns Hopkins where she also served as the chief resident, before undertaking a dermatopathology fellowship at Stanford University. In 2009, Dr. Taube returned to Johns Hopkins for her certification in the Melanoma Clinic. She is one of the lead scientific researchers in the Department of Dermatology at Johns Hopkins. Her research is related to the study of the B7-H1 molecule. Dr. Taube and her team are seeking to identify the signaling mechanisms behind B7-H1 expression. She is a member of the College of American Pathologists, United States and Canadian Academy of Pathology, American Society of Dermatopathology and Dermatology Foundation.

Ignacio I. Wistuba, MD, Professor & Chair, Department of Translational Molecular Pathology, Anderson Clinical Faculty Chair for Cancer Treatment and Research, UT MD Anderson Cancer Center

Ignacio I. Wistuba, MD, is Professor and Chair of the Department of Translational Molecular Pathology, with a joint appointment in Thoracic/Head and Neck Medical Oncology at MD Anderson Cancer Center in Houston, TX. He is director of the MD Anderson CCSG-funded Institutional Tissue Bank (ITB) and Research Histology Cores, director of the ECOG-ACRIN Central Biorepository and Pathology Facility, and co-leader of the MD Anderson APOLLO Moon Shot Platform. He is a surgical and molecular pathology specialist with a strong record of scientific achievement in lung cancer with over 450 peer-reviewed papers and several book chapters. His research interests include the elucidation of the molecular abnormalities involved in the pathogenesis and progression of lung cancer, and the identification of novel molecular targets and validation of biomarkers for targeted therapy. At MD Anderson Cancer Center, Dr. Wistuba oversees biomarker studies for lung cancer and other solid tumors therapeutic clinical trials, particularly on immunotherapy. Additionally, he currently serves as the pathologist of the Lung Cancer Committee of SWOG, the Lung Cancer Mutation Consortium (LCMC), and member of the Pathology Panel of the International Association for the Study of Lung Cancer (IASLC). He serves as senior editor of Cancer Prevention Research (AACR) and Annals of Oncology (ESMO), and is member of editorial board of Clinical Cancer Research and other journals.

Roman Yelensky, PhD, Executive Vice President and Chief Technology Officer, Sequencing and Bioinformatics, Gritstone Oncology

Dr. Roman Yelensky serves as chief technology officer and is responsible for overseeing the Company’s genomics, proteomics and informatics programs. He joined Gritstone at its inception in October 2015 as executive vice president of sequencing and bioinformatics. Prior to that, he was vice president of biomarker and companion diagnostic development at Foundation Medicine, which he joined at its inception. While at Foundation Medicine, he co-led sequence data analysis for FoundationOne™ and led validation studies supporting clinical laboratory accreditation and testing of more than 100,000 patients. Dr. Yelensky established Foundation Medicine’s FDA-regulated products program, leading to the FDA approval of FoundationFocus CDxBRCA, the first NGS-based companion diagnostic. He also contributed to key national initiatives on the clinical implementation of next-generation sequencing (NGS), leading the diagnostic implementation of Lung-MAP, a first-of-its-kind NCI-sponsored trial matching lung cancer patients to investigational treatments using comprehensive genomic testing. Prior to Foundation Medicine, Dr. Yelensky was a senior scientist in biomarker development at Novartis. He has co-authored more than 75 manuscripts on bioinformatics, statistical genetics, NGS biomarker and assay development and cancer genomics. He earned an M.S. in computer science from Stanford University and a PhD in bioinformatics and integrative genomics from the Harvard-MIT Division of Health Sciences and Technology.

Molecular Diagnostics for Infectious Disease

Esther Babady, PhD, Director, Clinical Microbiology Operations, Memorial Sloan Kettering Cancer Center

Esther Babady, PhD, is the Director of Clinical Operations for the Microbiology Laboratory Service, Director of the CPEP Clinical Microbiology Fellowship program and an associate professor in the Department of Laboratory Medicine at Memorial Sloan-Kettering Cancer (MSKCC) in New York City. She received her PhD in Biochemistry and Molecular Biology and completed a post-doctoral CPEP fellowship in Clinical Microbiology both at the Mayo Clinic in Rochester, MN before joining MSKCC. She is board certified by the American Board of Medical Microbiology and serves on the editorial boards of the Journal of Clinical Microbiology and Journal of Molecular Diagnostics. Her research interests include rapid diagnosis of infections in immunocompromised hosts, the development and evaluation of the clinical utility of molecular microbiology assays.

Tim Blauwkamp, PhD, CSO, Karius

Dr. Tim Blauwkamp is co-founder and Chief Scientific Officer of Karius, a life science company transforming infectious disease diagnostics with genomics. Tim is a biomedical scientist with 15 years experience managing research in molecular biology, regenerative medicine, and next-generation sequencing, He has a PhD in biological chemistry from U. Michigan for studies in microbial physiology and completed postdoctoral work at Stanford University. He was Head of Molecular Biology at Moleculo, acquired by Illumina.

Charles Chiu, MD, PhD, Associate Professor, Laboratory Medicine and Medicine/Infectious Diseases, Director, UCSF-Abbott Viral Diagnostics and Discovery Center, Associate Director, UCSF Clinical Microbiology Laboratory, UCSF School of Medicine

Charles Chiu, MD/PhD is Associate Professor of Laboratory Medicine and Medicine, Division of Infectious Diseases at University of California, San Francisco, Director of the UCSF-Abbott Viral Diagnostics and Discovery Center (VDDC), and Associate Director of the UCSF Clinical Microbiology Laboratory. He is the principal investigator of the nationwide, multi-site “Precision Diagnosis of Acute Infectious Diseases” study (June 2016 – July 2017) to investigate the clinical impact and cost-effectiveness of a validated metagenomic next-generation sequencing assay for diagnosis of encephalitis and meningitis in hospitalized patients. Chiu currently heads a translational research laboratory focused on next-generation sequencing assay development for infectious disease diagnostics, investigation of emerging pathogens, including Borrelia burgdorferi (Lyme disease), Ebola virus, enterovirus D68, and Zika virus, and clinical / public health applications of new diagnostic technologies such as nanopore sequencing. His work is supported by funding from the National Institutes of Health (NIH), Abbott Laboratories, Department of Defense, NASA/Translational Research Institute philanthropic grants (Sandler, Bowes, and Schwab Foundations), and the California Initiative to Advance Precision Medicine. Dr. Chiu has authored more than 70 peer-reviewed publications, holds over 15 patents and patent applications, and serves on the scientific advisory board for Therabio, Inc.

Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and Virology, Children’s Hospital Los Angeles; Assistant Professor, Pathology and Laboratory Medicine, Keck School of Medicine, University of Southern California

Jennifer Dien Bard, PhD, D(ABMM), is the Director of the Cinical Microbiology and Virology laboratories at Children’s Hospital Los Angeles (CHLA) and Associate Professor of Clinical Pathology at the University of Southern California Keck School of Medicine. She is a Diplomate of the American Board of Medical Microbiology and has extensive experience in diagnostic microbiology. Her current research interests include the development and utilization of rapid laboratory diagnostics and their subsequent impact on patient management.

Eric F. Donaldson, PhD, Clinical Virology Reviewer, Co-Chair of the FDA Genomics Working Group Division of Antiviral Products, Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration

Eric F. Donaldson, Ph.D. is a Clinical Virology reviewer in the Division of Antiviral Products (CDER/OND/OAP) and currently serves as a co-chair and CDER representative on the FDA Genomics Working Group. Dr. Donaldson gained expertise in High Throughput Sequencing (HTS) as a member of the faculty in the Department of Epidemiology at the University of North Carolina where he used this technology to identify novel coronaviruses in bats, to study the evolution of norovirus infection in immunocompromised patients, to sequence a simian hemorrhagic fever virus genome, to identify novel hemorrhagic viruses in baboons, and to identify pathogens present in fatal human respiratory infections of unknown etiology. This work allowed Dr. Donaldson to gain experience with the entire process of obtaining sequence samples, preparing them for sequencing using multiple HTS platforms, and analyzing the complex data sets generated from this emerging technology. Since joining the FDA in 2012, Dr. Donaldson has led the effort in developing a HTS analysis pipeline and review procedures for analyzing antiviral drug resistance data for the Division of Antiviral Products.

Michael Klepser, PharmD, FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy

Dr. Klepser received his Doctor of Pharmacy from the University of Michigan College of Pharmacy in 1992. He has completed a pharmacy practice residency at Detroit Receiving Hospital and University Health Center and a fellowship in infectious diseases at Hartford Hospital in Hartford, Connecticut. Dr. Klepser has been a Professor of Pharmacy at Ferris State University since 2001. Prior to joining Ferris, he was an Associate Professor at the University of Iowa College of Pharmacy (1995-2001). Dr. Klepser’s research interests include use of point-of-care tests in community pharmacies and community-based antimicrobial stewardship. He has published extensively on these topics and has more than 130 peer-reviewed manuscripts to his credit. Dr. Klepser is a founder and content advisor for the “Community Pharmacy-Based Point-of-Care Testing” certificate program. Dr. Klepser is active in several professional organizations including the Society of Infectious Diseases Pharmacists, the American College of Clinical Pharmacy, and the Infectious Diseases Society of America.

Jason Kralj, PhD, Staff Scientist, Complex Microbial Systems Group, Biosystems and Biomaterials Division, Material Measurements Laboratory, NIST

Jason Kralj is the co-leader of NIST’s sequencing-based pathogen detection, focusing on developing standard methods and materials to address mixtures of microbes. Through interactions with government, academic, and private entities, the NIST team seeks to address the current challenges facing development of sequencing-based metagenomics analyses and expedite commercialization of the technologies. Dr. Kralj also has extensive experience in microfluidic-based technologies for chemical and biological applications.

Nathan Ledeboer, PhD, Associate Professor of Pathology and Medical Director, Medical College of Wisconsin

Dr. Ledeboer received his B.A. Degree from Dordt College in 2000 and his PhD Degree in Microbiology from the University of Iowa in 2005. Following two years of fellowship training in clinical and public health microbiology at Washington University School of Medicine in Saint Louis, MO, he became an Assistant Professor of Pathology at the Medical College of Wisconsin and Medical Director of Clinical Microbiology and Molecular Diagnostics at Froedtert Hospital and Dynacare Laboratories in Milwaukee, WI where he has remained for more than 5 years. In addition to his service activities as director of clinical microbiology and molecular diagnostics at a large academic medical center, Dr. Ledeboer continues to develop his research career. His research endeavors, particularly in the area developing diagnostic tools for infectious diseases, have led to numerous publications in peer-reviewed journals. He has been Chairman of Public and Professional Affairs for the South Central Association for Clinical Microbiology and served on the American Society for Microbiology’s Clinical Microbiology Task Force. Dr. Ledeboer is currently a member of the American Board of Medical Microbiology Exam committee, a member of the Committee on Postgraduate Educational Programs through the American Society for Microbiology, and is the microbiology scientific program chair for The Association for Mass Spectrometry: Applications to the Clinical Laboratory. He is currently a member of the editorial board of the Journal of Clinical Microbiology and serves as an ad hoc reviewer for numerous other journals in infectious diseases and clinical microbiology. He has delivered nearly 100 invited lectures in various medical-scientific educational forums worldwide and has served as an investigator on more than 75 funded research projects. In 2011, he received the distinguished Siemens Young Investigator Award from the American Society for Microbiology.

Larissa May, MD, MSPH, MSHS, Professor, Emergency Medicine; Director, Emergency Department Antibiotic Stewardship, University of California Davis

Larissa May, MD, MSPH, MSHS - Dr. Larissa May is Professor of Emergency Medicine and Director of Emergency Department Antibiotic Stewardship at the University of California-Davis. She is a national expert in antibiotic stewardship in the emergency department (ED). Dr. May received her MD, her MSPH in Public Health Microbiology and Emerging Infectious Diseases, and her MSHS in Clinical and Translational Research from The George Washington University. Dr. May’s research interests center on clinical infectious disease epidemiology and management, with a particular focus on the application of rapid molecular diagnostic assays to improve antibiotic stewardship in the ED. Dr. May has served as an investigator on several federally-funded and industry-sponsored trials evaluating new molecular assays in the ED. She has published over 60 peer-reviewed articles. She has also served on committees and task forces for the Centers for Disease Control and Prevention and professional organizations including the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America and is a member of the Diagnostics Subcommittee of the Antibacterial Resistance Leadership Group funded by the National Institutes of Health.

Kevin Messacar, MD, Assistant Professor of Pediatrics, University of Colorado/Children’s Hospital Colorado, Section of Infectious Diseases

Dr. Messacar's research interests focus on improving the use of diagnostic tests for infectious diseases with a focus on central nervous system infections. He is interested in the process of selecting, implementing, and evaluating newly emerging rapid diagnostic technologies using concepts of diagnostic and antimicrobial stewardship. After joining the University of Colorado faculty in 2014, Dr. Messacar received a Children's Hospital Colorado Research Institute Research Scholars Award for his study of real-time antimicrobial stewardship decision support for rapid diagnostics in children with bloodstream infections. His current efforts include evaluating the clinical impact of rapid multiplex PCR panels and metagenomic sequencing of cerebrospinal fluid on children with suspected meningitis and encephalitis.

Timothy D. Minogue, PhD, Chief, Molecular Diagnostics Department, Diagnostic Systems Division, USAMRIID

Timothy Minogue, PhD, has more than 10 years of experience in Diagnostics and more than 15 years in the Genomics fields in both the applied and basic research. Dr. Minogue obtained his PhD at the University of Connecticut (2005) in the field of Bacterial Molecular Genetics studying quorum sensing in plant pathogens. He finished a postdoctoral fellowship at the Institute for Genomic Research, before becoming a team leader at the J. Craig Venter Institute focused on biodefense genomic research and applications. Currently, Dr. Minogue is the Department Chief for the Molecular Diagnostics Department at USAMRIID where his research focus is development of novel diagnostics solutions for biowarfare agents. Diagnostic assays such as the currently fielded EUA Ebola assay and next generation sequencing assays for viral hemorrhagic fevers are examples of direct products from his lab.

Christopher Polage, MD, MAS, Medical Director, Duke University Health Systems Clinical Microbiology Laboratory; Associate Processor, Duke University Medical Center

Dr. Polage is the medical director of the clinical microbiology laboratory for the Duke University Health System and an expert in Clostridium difficile diagnostic testing. In 2016, Dr. Polage received a Distinguished Clinical Research Achievement Award from the Clinical Research Forum for his research into the clinical outcomes of hospitalized patients tested for C. difficile infection.

Gary W. Procop, MD, Director, Molecular Microbiology, Parasitology, Virology Laboratories; Co-Chair, Enterprise Laboratory Stewardship Committee, Medical Operations; Processor of Pathology, Cleveland Clinic Lerner College of Medicine, Cleveland Clinic

Gary W. Procop, MD, MS is Medical Director and Co-Chair of the Enterprise Laboratory Stewardship Committee. He is the Director of Molecular Microbiology, Virology, Mycology and Parasitology at the Cleveland Clinic. He is past Chair of the Departments of Clinical Pathology and Molecular Pathology, and past Section Head for Clinical and Molecular Microbiology. He completed a Bachelor of Science at Eastern Michigan University, followed by an MD and MS at Marshall University School of Medicine. Residency training in Anatomic and Clinical Pathology training was completed at Duke University Medical Center and a Clinical Microbiology Fellowship at the Mayo Clinic. He is a diplomat of the American Board of Pathology in Anatomic and Clinical Pathology, and Medical Microbiology. He is a Fellow of the American Academy of Microbiology, the College of American Pathologists, the American Society for Clinical Pathology, the Infectious Diseases Society of America, and the Royal Society of Tropical Medicine and Hygiene. He has given more than 615 scientific presentations, and has 204 published manuscripts, 49 chapters, and three books to his credit. He is the incoming Chair of the Committee on Continuing Certification of the American Board of Medical Specialties. He is a Past President and a Trustee of the American Board of Pathology, and Chair of the Microbiology Test Development Committee for the Board. He is the Chair of the Antifungal Subcommittee of the Clinical Laboratory Standards Institute. He is also a Member of the Council on Scientific Affairs and Quality Practices Committee for the College of American Pathologists (CAP). He is also a Member of the Effective Test Utilization Subcommittee of the Commission on Science, Technology & Policy for the American Society for Clinical Pathology. He has served as a Member of the NGS Coalition and Conferences Committee for the American Society for Microbiology. He has also served as the Chair and Advisor of the Microbiology Resource Committee for the CAP. Major recognitions include the ASM BD Award for Research in Clinical Microbiology, the CAP Distinguished Patient Care Award and the ASCP Mastership Designation. His primary interests are developing and promoting best practices in laboratory testing, the practical applications of molecular diagnostic methods for the diagnosis and treatment of infections; infectious disease pathology; mycology and parasitology.

Heike Sichtig, PhD, Principal Investigator and Team Lead, Microbiology Devices, Center for Devices (CDRH), FDA

Dr. Heike Sichtig is a principal investigator and lead technical regulatory scientist in FDA’s Office of In Vitro Diagnostics and Radiological Health in the Division of Microbiology Devices. She is leading the highly collaborative effort on developing FDA-ARGOS (formerly MicroDB): FDA dAtabase for Regulatory Grade micrObial Sequences. She joined the Division of Microbiology Devices in 2012 and is primarily focusing on enabling next generation sequencing (NGS) based technologies for clinical diagnostics. She is part of a multidisciplinary team that is developing and implementing the concepts for validation and evaluation of NGS-based microbiological diagnostic devices. Dr. Sichtig obtained a B.S. / M.S. in Computer Science/Statistics from Kean University in 2002 and 2003, and a PhD in Biomedical Engineering from Binghamton University in 2009. She did her postdoctoral training at the University of Florida/Genetics Institute in Gainesville FL in pathogen signatures, transcriptional regulation and epigenetics. Dr. Sichtig received the Commissioners’ Special Citation award in 2014 and several others related to FDA review work.

Tom Slezak, Distinguished Member of the Technical Staff, Global Security Program, Lawrence Livermore National Lab

No biography available

Ephraim L. Tsalik, MD, MHS, PhD, Associate Professor, Medicine, Duke University School of Medicine; Founder, Predigen, Inc.

Ephraim Tsalik is an Associate Professor in the Department of Medicine and the Department of Molecular Genetics & Microbiology. He also holds an appointment in the Emergency Department Service at the Durham VA Health Care System. He earned his M.D. and Ph.D. from Columbia University followed by residency and fellowship training at Duke University. He also obtained a Masters in Health Services with a focus on Clinical Research. Through the Duke Center for Applied Genomics & Precision Medicine, Dr. Tsalik leads multiple translational research programs focused on the study of host-pathogen interactions using genomic medicine technologies. This information serves as a resource to develop novel diagnostic strategies, which Dr. Tsalik is pursuing through his company, Predigen, Inc.

Guiqing (Hank) Wang, MD, PhD, Chief of Labs, Pathology and Clinical Laboratories, Westchester Medical Center & New York Medical College

Dr. Wang is Chief, Laboratory Services, for Microbiology, Virology, and Molecular Diagnostics in the Department of Pathology at Westchester Medical Center and Associate Prof. of Pathology at New York Medical College. He is board-certified in clinical microbiology and molecular diagnostics by the American Board of Medical Microbiology and the American Board of Clinical Chemistry. Dr. Wang has diverse education and training in clinical medicine, epidemiology and medical microbiology. He completed an accredited fellowship in clinical and public health microbiology at University of California, Los Angeles Medical Center. At Westchester Medical Center, Dr. Wang provides mainly clinical diagnostic services in microbiology and molecular diagnostics. In addition, he has been serving as principal investigator of multiple research projects. The areas of his interest include diagnosis and mechanism studies of emerging tick-borne diseases, antimicrobial resistance and applications of next-generation sequencing in diagnostic microbiology and molecular epidemiology. He has published more than 70 peer-reviewed papers on these subjects.

Commercializing Molecular Diagnostics in Pharma, Healthcare and the Clinic

Jason Bhan, MD, CMO and Co-Founder, Prognos

Jason Bhan, MD, is a Family Physician and serves as the CMO at Prognos. He is regarded as a national expert in the applications of technology to healthcare and medicine, a topic on which he speaks regularly at institutions and conferences, such as Health 2.0, mHealth, New York’s eHealth Collaborative, and Health Datapalooza. He also has done extensive strategy consulting with pharmaceutical companies. From 2007-2010, Dr. Bhan worked with Clinovations and managed several large hospital system EHR implementations, outcomes measurements and data analysis. Dr. Bhan obtained his Doctor of Medicine at the University of Miami School of Medicine and he is board certified in Family Medicine.

Timothy Cannon, MD, Inova Schar Cancer Insititute; Assistant Professor, Virginia Commonwealth University

Dr. Cannon is a specialty care physician board certified in medical oncology. He has a special interest in the management of gastrointestinal malignancies. Dr. Cannon is the clinical director and moderator of the weekly molecular tumor board at Inova, which matches patients with targeted therapies based on molecular diagnostics. He is very interested in national cooperative group clinical trials and is a member of the NRG colorectal and non-colorectal clinical trials committee. He is the site principal investigator for multiple clinical trials in immunotherapy. Dr. Cannon was the chief fellow of hematology/oncology at New York University (NYU). He was voted fellow of the year at NYU during each of his last two years there. He received a “best doctor” award by Northern Virginia magazine in 2015. Dr. Cannon currently serves as an assistant professor in the Department of Internal Medicine at Virginia Commonwealth University School of Medicine.

Joseph Chin, MD, Deputy Director, Coverage & Analysis Group, US Dept of Health & Human Services, Centers for Medicare & Medicaid Services

Joseph Chin is the Deputy Director of the Coverage and Analysis Group (CAG) in the Center for Clinical Standards and Quality at the Centers for Medicare and Medicaid Services (CMS). He joined CMS in 1992 as a medical officer in the quality improvement component and transitioned to CAG in 1999, focusing on systematic evidence reviews, Medicare translational science and preventive services. Prior to joining CMS, Dr. Chin practiced full time in occupational and ambulatory medicine. He is board certified in preventive medicine, completed his MD, MS in epidemiology and residency at the University of Maryland School of Medicine, and maintains a primary care practice in Maryland.

John Deeken, MD, COO, Inova Translational Medicine Institute, Senior Vice President, Inova Health System; Associate Professor, Virginia Commonwealth University

Dr. Deeken is the Chief Operating Officer of the Inova Translational Medicine Institute, an 85-person lab and translational research organization focused on genomic research. He is a practicing medical oncologist with a clinical focus on the treatment of patients with head and neck cancer. His research areas of interest include using genomics to personalize cancer therapy, as well as in developing new targeted drugs to treat patients with refractory cancers. He also is a Senior Vice President for the Inova Health System. Dr. Deeken joined Inova 2013 with over 12 years of clinical experience in internal medicine and medical oncology. He served as Associate Director for Clinical Research for Inova Schar Cancer Institute, working with leadership to develop and manage the cancer center clinical trial infrastructure and develop outside collaborations for early phase clinical trials. He was also Medical Director for Medical Oncology for Inova, which including recruiting a practice of employed physicians. Under his leadership the Medical Oncology group grew from 1 to 22 total physicians. Dr. Deeken served on the national Head and Neck Cancer Scientific Committee for the American Society of Clinical Oncology (ASCO). He is currently a member of ASCO’s Government Relations Committee. Prior to joining Inova, he was director of the Head and Neck Medical Oncology Program at the Lombardi Cancer Center at Georgetown University and was regional director for medical oncology for Medstar Health. He is an associate professor at Virginia Commonwealth University.

Eric F. Donaldson, PhD, Clinical Virology Reviewer, Co-Chair of the FDA Genomics Working Group Division of Antiviral Products, Office of Antimicrobial Products, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration

Eric F. Donaldson, Ph.D. is a Clinical Virology reviewer in the Division of Antiviral Products (CDER/OND/OAP) and currently serves as a co-chair and CDER representative on the FDA Genomics Working Group. Dr. Donaldson gained expertise in High Throughput Sequencing (HTS) as a member of the faculty in the Department of Epidemiology at the University of North Carolina where he used this technology to identify novel coronaviruses in bats, to study the evolution of norovirus infection in immunocompromised patients, to sequence a simian hemorrhagic fever virus genome, to identify novel hemorrhagic viruses in baboons, and to identify pathogens present in fatal human respiratory infections of unknown etiology. This work allowed Dr. Donaldson to gain experience with the entire process of obtaining sequence samples, preparing them for sequencing using multiple HTS platforms, and analyzing the complex data sets generated from this emerging technology. Since joining the FDA in 2012, Dr. Donaldson has led the effort in developing a HTS analysis pipeline and review procedures for analyzing antiviral drug resistance data for the Division of Antiviral Products.

Bob Kain, CEO and Co-Founder, Luna DNA

Bob Kain is a renowned pioneer in genomics. At Illumina, Bob led the invention of the modern, high throughput genome sequencer that brought the cost from millions of dollars down to less than $1,000. He joined Illumina pre-IPO in 1999 and retired in 2014, as the Chief Engineering Officer. Bob is lead inventor on 28 U.S. patents that led to the breakthroughs that have revolutionized genome sequencing. Prior to joining Illumina, Bob was the Director of the Microarray Business Unit at Molecular Dynamics. He is also on the Scientific Advisory Boards of Dovetail Genomics, Singular Genomics, and Edenroc Biosecurity, and is the co-founder of Revere Biosensor. Additionally, he is the co-founder and chairman of the board of a successful health & fitness business, Mesa Rim Climbing and Fitness Center, with multiple locations in San Diego and Reno, Nevada. Bob received a BS in Physics from San Diego State University and an MBA from Saint Mary’s College of California.

Harry Glorikian, MBA, Healthcare Consultant

Mr. Glorikian has more than 20 years of experience in the health care and life science industries. He has deep commercial background in diagnostics, molecular biology, proteomics, cellular biology and biodefense. His unique understanding of technologies, operations and strategy from both customer and industry player perspectives has shaped a sophisticated framework and proprietary analytic tools. He holds a Bachelor's Degree in Business Administration from Boston University, a Masters of Business Administration from the Boston University, and a BA in General Biology from San Francisco State University.

Stuart Goldberg, MD, CSO, COTA Inc

Stuart Goldberg, MD is CSO at Cota, Inc. and Associate Clinical Professor of Medicine at Rutgers: The New Jersey Medical School. He also maintains an active clinical practice in the Division of Leukemia at the John Theurer Cancer Center. Dr. Goldberg obtained his medical degree at the Milton Hershey Medical Center of Pennsylvania State University. After completing internal medical residency and hematology-oncology fellowships at George Washington University Medical Center, he served as a BMT fellow at the Mayo Clinic and Associate Director of the BMT Program at Temple University. Dr. Goldberg’s clinical research has focused on new treatment strategies for patients with chronic myelogenous leukemia and myelodysplastic syndromes.

Robert Havasy, MS, Senior Director, HIS, HIMSS North America

Rob Havasy is Senior Director, Health Information Systems at HIMSS: a global, cause-based, not-for-profit organization focused on better health through information and technology. In this role, Rob focuses on connected health, care coordination and the use of health IT in the long-term post-acute care arena. Rob joined the HIMSS family in 2014 as Vice President of the Personal Connected Health Alliance where he led the Alliance’s Continua interoperability initiative. In 2016, Rob joined HIMSS North America to leverage his background in connected health, interoperability, remote patient monitoring, and telemedicine and serve as the liaison to HIMSS’ Connected Health Committee and Community.

Before joining HIMSS/PCH Alliance, Rob was a Corporate Team Lead at Partners HealthCare’s Center for Connected Health, where he worked to design and implement systems for gathering and integrating patient-generated health data into clinical workflows. Rob holds an MS in Health and Medical Informatics from Brandeis University and a BS in Environmental Science from Keene State College. Rob resides with his family in central Massachusetts.

Debra G.B. Leonard, MD, PhD, Chair, Pathology and Laboratory Medicine, The University of Vermont Health Network and the Robert Larner, MD College of Medicine, University of Vermont

Debra G. B. Leonard, MD, PhD, is Professor and Chair of the Department of Pathology and Laboratory Medicine at the University of Vermont Health Network and the Robert Larner, MD College of Medicine at the University of Vermont since April 2013. Dr. Leonard is a leading expert in molecular pathology and genomic medicine, and is developing a Genomic Medicine Program for cancer, pharmacogenomics and inherited disorders for Vermont and northern New York State. Dr. Leonard did her undergraduate education at Smith College and her medical and scientific training at New York University. Dr. Leonard is certified by the American Board of Pathology in Anatomic Pathology, and by the American Boards of Pathology and Medical Genetics in Molecular Genetic Pathology. She has been on the faculty at Case Western Reserve University School of Medicine, the University of Pennsylvania School of Medicine, and Weill Cornell Medical College. She currently is a member of the Roundtable on Genomics and Precision Health of the National Academies of Sciences, Engineering and Medicine. Dr. Leonard received the Association for Molecular Pathology Leadership Award in 2009 and the College of American Pathologists’ Lifetime Achievement Award in 2015. She is editor of two molecular pathology textbooks and has published over 80 peer-reviewed articles, book chapters and reviews.

Stephen E. Lincoln, Senior Vice President, InVitae

Steve has over 25 years of experience in Genomics and Bioinformatics. He was previously Vice President of Scientific Applications at Complete Genomics, where his team worked with CG’s customers to help interpret thousands of whole human genome sequences. Prior to that Steve was Vice President of Informatics for Affymetrix, responsible for diagnostic and research-use microarray data analysis software, and he was Vice President of Bioinformatics for Incyte Genomics during the race to discover and sequence most of the human genes, particularly those of therapeutic and diagnostic relevance. Steve’s academic background includes 7 years with Eric Lander at the Whitehead Institute and MIT during the initial phases of the human genome project.

Donna Messner, Senior Vice President, Center for Medical Technology Policy

Donna A. Messner, PhD, is the Senior Vice President at the Center for Medical Technology Policy (CMTP) where she oversees programs for research and stakeholder engagement to reduce barriers to clinical evidence development that is patient-centered, stakeholder-informed, and relevant to real-world decision-making. Dr. Messner leads the Green Park Collaborative (GPC), which is a multi-stakeholder forum to develop condition- and technology-specific study design recommendations for the generation of evidence needed to inform both clinical and payment decisions. With GPC, she has spearheaded a number of major initiatives, including the development of methods recommendations for determining the optimal sequence of cancer therapies for patients with metastatic/advanced cancer. She also leads a program to engage major health plans and other stakeholders to establish a framework for covering next-generation sequencing (NGS) testing in clinical oncology – and do so concurrently with creating strategies to reduce uncertainties associated with clinical use of NGS. Dr. Messner holds a PhD and MSc (with distinction) in Science and Technology Studies from the University of Edinburgh, UK, an MA from George Mason University, and an undergraduate degree in chemistry from Virginia Tech. She was previously a research fellow in the Penn Center for the Integration of Genetic Health Care Technologies in the University of Pennsylvania’s Division of Medical Genetics; the Gordon Cain Fellow in Technology, Policy, and Entrepreneurship at the Chemical Heritage Foundation in Philadelphia; a visiting doctoral scholar in the School of Policy, Georgia Institute of Technology; and a long-time chemical laboratory director and senior project scientist.

Timothy D. Minogue, PhD, Chief, Molecular Diagnostics Department, Diagnostic Systems Division, USAMRIID

Timothy Minogue, PhD, has more than 10 years of experience in Diagnostics and more than 15 years in the Genomics fields in both the applied and basic research. Dr. Minogue obtained his PhD at the University of Connecticut (2005) in the field of Bacterial Molecular Genetics studying quorum sensing in plant pathogens. He finished a postdoctoral fellowship at the Institute for Genomic Research, before becoming a team leader at the J. Craig Venter Institute focused on biodefense genomic research and applications. Currently, Dr. Minogue is the Department Chief for the Molecular Diagnostics Department at USAMRIID where his research focus is development of novel diagnostics solutions for biowarfare agents. Diagnostic assays such as the currently fielded EUA Ebola assay and next generation sequencing assays for viral hemorrhagic fevers are examples of direct products from his lab.

Niven R. Narain, Co-Founder, President & CEO, Berg Pharma

Niven R. Narain is Co-founder, President & CEO of Berg, a Boston-based biopharma company driving the next generation of drugs and diagnostics by combining patient-driven biology and AI to unravel actionable disease insight. He has overseen development of Berg’s clinical stage assets and pipeline and forged strategic partners with industry, academia, and US and UK governments. Narain is an industry thought leader on precision medicine and drug development, and is the inventor of Berg’s flagship Interrogative Biology® platform that created and guided a deep pipeline of products in oncology, diabetes, and CNS diseases, namely BPM 31510 in Phase II trials for cancer. Narain speaks at many international meetings on medicine and technology, and his research has been published in Nature Medicine and Cell among others with leading collaborators from academia, NIH, and DoD. He serves on the NASA/Gene Lab Steering Committee and works closely with DoD leadership on breast and prostate cancer initiatives. Narain is an inventor on a patent portfolio of over 550 pending patent applications and over 100 issued patents in the US and internationally, covering multiple disease areas and AI-based technologies. He received his BS/BA in Biochemistry and Philosophy from St. John’s University, NY, obtained PhD training in cancer biology and performed clinical dermatology research at the University of Miami Miller School of Medicine where he served as Director of Cutaneous Oncology Research before moving to Boston.

Gary W. Procop, MD, Director, Molecular Microbiology, Parasitology, Virology Laboratories; Co-Chair, Enterprise Laboratory Stewardship Committee, Medical Operations; Processor of Pathology, Cleveland Clinic Lerner College of Medicine, Cleveland Clinic

Gary W. Procop, MD, MS is Medical Director and Co-Chair of the Enterprise Laboratory Stewardship Committee. He is the Director of Molecular Microbiology, Virology, Mycology and Parasitology at the Cleveland Clinic. He is past Chair of the Departments of Clinical Pathology and Molecular Pathology, and past Section Head for Clinical and Molecular Microbiology. He completed a Bachelor of Science at Eastern Michigan University, followed by an MD and MS at Marshall University School of Medicine. Residency training in Anatomic and Clinical Pathology training was completed at Duke University Medical Center and a Clinical Microbiology Fellowship at the Mayo Clinic. He is a diplomat of the American Board of Pathology in Anatomic and Clinical Pathology, and Medical Microbiology. He is a Fellow of the American Academy of Microbiology, the College of American Pathologists, the American Society for Clinical Pathology, the Infectious Diseases Society of America, and the Royal Society of Tropical Medicine and Hygiene. He has given more than 615 scientific presentations, and has 204 published manuscripts, 49 chapters, and three books to his credit. He is the incoming Chair of the Committee on Continuing Certification of the American Board of Medical Specialties. He is a Past President and a Trustee of the American Board of Pathology, and Chair of the Microbiology Test Development Committee for the Board. He is the Chair of the Antifungal Subcommittee of the Clinical Laboratory Standards Institute. He is also a Member of the Council on Scientific Affairs and Quality Practices Committee for the College of American Pathologists (CAP). He is also a Member of the Effective Test Utilization Subcommittee of the Commission on Science, Technology & Policy for the American Society for Clinical Pathology. He has served as a Member of the NGS Coalition and Conferences Committee for the American Society for Microbiology. He has also served as the Chair and Advisor of the Microbiology Resource Committee for the CAP. Major recognitions include the ASM BD Award for Research in Clinical Microbiology, the CAP Distinguished Patient Care Award and the ASCP Mastership Designation. His primary interests are developing and promoting best practices in laboratory testing, the practical applications of molecular diagnostic methods for the diagnosis and treatment of infections; infectious disease pathology; mycology and parasitology.

Heike Sichtig, PhD, Principal Investigator and Team Lead, Microbiology Devices, Center for Devices (CDRH), FDA

Dr. Heike Sichtig is a principal investigator and lead technical regulatory scientist in FDA’s Office of In Vitro Diagnostics and Radiological Health in the Division of Microbiology Devices. She is leading the highly collaborative effort on developing FDA-ARGOS (formerly MicroDB): FDA dAtabase for Regulatory Grade micrObial Sequences. She joined the Division of Microbiology Devices in 2012 and is primarily focusing on enabling next generation sequencing (NGS) based technologies for clinical diagnostics. She is part of a multidisciplinary team that is developing and implementing the concepts for validation and evaluation of NGS-based microbiological diagnostic devices. Dr. Sichtig obtained a B.S. / M.S. in Computer Science/Statistics from Kean University in 2002 and 2003, and a PhD in Biomedical Engineering from Binghamton University in 2009. She did her postdoctoral training at the University of Florida/Genetics Institute in Gainesville FL in pathogen signatures, transcriptional regulation and epigenetics. Dr. Sichtig received the Commissioners’ Special Citation award in 2014 and several others related to FDA review work.

Tom Slezak, PhD, Distinguished Member of the Technical Staff, Global Security Program, Lawrence Livermore National Lab

No biography available

Christopher Williams, Vice President, Business Development, Multiple Myeloma Research Foundation

Christopher Williams was named Vice President of Business Development at the MMRF in 2017, and is responsible for business development, partnership and joint venture efforts for the foundation. He is a business development leader with a strong scientific background, specializing in the pharmaceutical and diagnostics space. Most recently he served as the Vice President of Business Development at WaveSense where he was in charge of their US commercialization strategy and product expansion, as well as, being responsible for overseeing their strategic partner relationships. Previously, Chris was Vice President of Business Development at SkylineDx providing commercialization strategy for their oncology portfolio. With PerkinElmer, as the Market Segment Leader in Oncology he had responsibility for their cancer diagnostic products including strategy, launch activities, external presentations and marketing execution. While at Millennium Pharmaceuticals Chris held roles in the Protein Science, Technology Development and Proteomics groups. Chris holds graduate and post-graduate degrees in Microbiology/Molecular Biology and Protein Biochemistry from Clemson University.

Enabling Point-of-Care Diagnostics

Timothy Amukele, MD, PhD, Assistant Professor of Pathology, Johns Hopkins University School of Medicine

Dr. Timothy Amukele is an Assistant professor in the Department of Pathology at the Johns Hopkins School of Medicine, the Director of Clinical Laboratories at Johns Hopkins Bayview Hospital and the President of Pathologist’s Overseas – a non-governmental organization dedicated to improving laboratory services in low- and middle-income countries. He has pioneered the use of unmanned aerial systems (colloquially known as drones) to move medical samples.

Haim H. Bau, PhD, Professor, Mechanical Engineering and Applied Mechanics, University of Pennsylvania

Haim H. Bau is a professor of Mechanical Engineering and Applied Mechanics at the University of Pennsylvania. He received his PhD from Cornell University (1980) and his undergraduate degree from the Technion Israeli Institute of Technology. His research focuses on micro and nano fluidics with applications to point of care diagnostics, C. elegans phenotyping, and single cell studies. He has published over 180 archival papers and numerous conference proceedings.

Herbert S. Bresler, PhD, Senior Research Leader, Health Business Unit, Battelle

Dr. Bresler is the Senior Research Leader for Battelle’s Medical Device business. He has over 25 years of interdisciplinary innovation, strategy development and execution, working across traditional boundaries to identify opportunities and build relationships in medical and life science market areas. He serves as lead or consulting scientist on projects in which the device and the biology are closely connected. He has created the strategic vision, built effective research and development teams, and executed several innovative medical and diagnostic products. Dr. Bresler’s scientific leadership, innovation and program management experience in health and life science-related disciplines includes development of a system to detect circulating tumor cells, creation of new approaches for manufacturing cell-based products, and development of new systems approaches for the delivery of protein drugs. He is currently Principal Investigator on two projects: 1) a DARPA-funded effort to develop a dialysis-like therapeutic system for the treatment of sepsis; and 2) a Battelle-funded project to restore motor control to the hand and lower arm of a quadriplegic using a combination of sensor array implanted into the motor cortex, a computer interface to decode and re-encode brain signals for motor stimulation, and a multi-electrode cuff on the subject’s arm to provide muscle stimulation. Dr. Bresler’s other direct responsibilities include strategy development, management of the business’ Intellectual Property portfolio and Independent Research and Development activities.

William Clarke, PhD, MBA, DABCC, Associate Professor of Pathology, Johns Hopkins University School of Medicine

Dr. Clarke received his PhD in Analytical Chemistry from the University of Nebraska in Lincoln in 2000, followed by a post-doctoral fellowship in Clinical Chemistry at the Johns Hopkins School of Medicine, ending in 2002. In addition, he received an MBA focused on medical services management from the Carey School of Business at Johns Hopkins in 2007. Following his post-doctoral fellowship, he remained at Johns Hopkins, where he is an Associate Professor in the Department of Pathology, as well as the director of both Point-of-Care Testing and Clinical Toxicology for the hospital. Dr. Clarke is board certified in Clinical Chemistry by the American Board of Clinical Chemistry, and is a Fellow of the American Association for Clinical Chemistry. His research interests include clinical mass spectrometry, method development and evaluation for therapeutic drug monitoring, clinical toxicology, point-of-care testing, and development/validation of biomarkers for use in drug management. Dr. Clarke has published as author or co-author over 100 peer-reviewed manuscripts or book chapters, is the Editor of textbook Contemporary Practice in Clinical Chemistry, and is the Editor-in-Chief of the journal Practical Laboratory Medicine.

Don L. DeVoe, Professor, Mechanical Engineering, University of Maryland, College Park

No biography available

Karen W. Dyer, MT(ASCP), DLM, Director, Division of Clinical Laboratory Improvement and Quality, Centers for Medicare & Medicaid Services

Karen Dyer is the Director of the CLIA program at the Centers for Medicare & Medicaid Services (CMS), Baltimore, Maryland. She is a registered Medical Technologist with certification in Laboratory Management. She received a BA degree from the University of Maryland Baltimore County in Health Science and Policy. She is the CLIA subject matter expert on Electronic Health Records and the Patient Access regulation and also serves as a member of the CLSI Consensus Council. Prior to joining the CLIA program at CMS, Karen was employed by the Johns Hopkins Hospital Medical Laboratories, as an Affiliate Laboratory Supervisor and Point of Care Testing Coordinator.

Gerald J. Kost, MD, PhD, MS, FAACC, Director, Point-of-Care Testing Center for Teaching and Research (POCT•CTR), Emeritus Professor, School of Medicine, University of California, Davis

Dr. Kost studied Engineering at Stanford University (BS, 1967) and in Venezuela, then received the Master’s degree in Engineering-Economic Systems (EEP) from Stanford prior to entering Medical Scientist MD-PhD training at the University of California (UC). He received his PhD in Bioengineering (NIH Bioengineering Traineeship) from UC San Diego and his MD from UC San Francisco. He was elected to Mu Alpha Theta (mathematics), Phi Kappa Phi (scholarship), and Sigma Xi (science) Honor Societies. Dr. Kost’s clinical residency included Internal Medicine and Neurology at UCLA, and Laboratory Medicine at the University of Washington, Seattle, where he was Chief Resident and a postdoctoral researcher with Dr. Jim Bassingwaighte in Bioengineering. Dr. Kost was boarded in Clinical Pathology by the American Board of Pathology. At UC Davis for nearly 30 years, Dr. Kost is Director of Point-of-Care Testing and Clinical Chemistry for the UCD Health System. He is a tenured Professor in the Department of Pathology and Laboratory Medicine, the Quality Program Chair, and faculty in Biomedical Engineering and Comparative Pathology.

Hayden Huang, Senior Engineer, Center for Science, Technology and Engineering, Government Accountability Office

Hayden Huang is a biomedical engineer working at the Government Accountability Office. He covers issues related to health care and technology to help inform policy officials. He previously worked on projects reviewing the performance of the BioWatch system, the Internet of Things, and the Zika Outbreaks.

Kent Lewandrowski, MD, Associate Chief of Pathology, Director, Pathology Laboratories and Molecular Medicine, Massachusetts General Hospital; Professor, Pathology, Harvard Medical School

Kent Lewandrowski, MD is the Director of Pathology Laboratories and Molecular Medicine and Associate Chief of Pathology at the Massachusetts General Hospital. He is also director of the hospital point-of-care program and the Quality Chair of the Department of Pathology. He is a Professor at Harvard Medical School with research interests in the evaluation of point-of-care technologies and outcomes studies concerning implementation of point-of-care testing. Dr. Lewandrowski was trained in anatomic and clinical pathology at the Massachusetts General Hospital and has been on the staff of the department of Pathology since 1991. He is also editor in chief of the medical journal "Point of Care: The Journal of Near Patient Testing Technologies.

James H. Nichols, PhD, DABCC, FACB, Professor, Pathology, Microbiology and Immunology; Medical Director, Clinical Chemistry; Medical Director, POCT, Vanderbilt University School of Medicine

James H. Nichols, PhD, DABCC, FACB is a Professor of Pathology, Microbiology, and Immunology, Medical Director of Clinical Chemistry and Point-of-Care Testing at Vanderbilt University School of Medicine. Dr. Nichols received his BA in General Biology/Premedicine from Revelle College, University of California at San Diego. He went on to complete a Masters and Doctorate in Biochemistry from the University of Illinois, Urbana-Champaign. Jim was a fellow in the Postdoctoral Training Program in Clinical Chemistry at the Mayo Clinic, Rochester, MN. He is board certified in both Clinical Chemistry and Toxicological Chemistry by the American Board of Clinical Chemistry. Dr. Nichols spent several years as Associate Director of Clinical Chemistry, Director of Point-of-Care Testing, and an Associate Professor of Pathology at Johns Hopkins Medical Institutions. Jim later served as Medical Director of Clinical Chemistry for Baystate Health in Springfield, MA and was a Professor of Pathology at Tufts University School of Medicine. Dr. Nichols’ research interests span evidence-based medicine, information management, laboratory automation, point-of-care testing and toxicology.

Angelika Niemz, PhD, Arnold and Mabel Beckman Professor, Keck Graduate Institute

Angelika Niemz received her undergraduate degree in chemistry in 1992 at the University of Konstanz (Germany), and her PhD in biophysical chemistry in 1999 at the University of Massachusetts (Amherst). After a postdoc in chemical engineering at the California Institute of Technology, she joined Keck Graduate Institute in 2002, where she is now the Arnold and Mable Beckman Professor. In 2009, she worked during a 6-month sabbatical for Roche Molecular Diagnostics. From 2009-2014, she served as Director of Research at Keck Graduate Institute. Her current research focuses on developing assays and devices for near patient infectious disease diagnosis via nucleic acid testing. She teaches courses on medical diagnostics, high throughput technologies for biomarker and drug discovery, and instrumentation development.

Ann M. Sakaguchi, MPH, PhD, Specialist, Director, Pacific Emergency Management, Preparedness, Response, Information Network and Training Services (Pacific EMPRINTS), National Disaster Life Support Regional Training Center-Pacific, Anthropology, University of Hawaii, College of Social Sciences

Dr. Ann Sakaguchi is a tenured faculty member in the Department of Anthropology at the University of Hawaii ‘s flagship Manoa campus and the Director of the Pacific Emergency Management, Preparedness and Response Information Network and Training Services (Pacific EMPRINTS) and the National Disaster Life Support Regional Training Center-Pacific (NDLS RTC-Pacific). Pacific EMPRINTS was established with funding from the U.S. Department of Health and Human Services in 2005 and is a continuing education program that addresses CBRNE events and other public health threats, such as but not limited to pandemic influenzas. It currently offers approximately 100 online and 80 +face-to-face courses with total course enrollments exceeding 90,000, with participants from all 50 U.S. states and territories and more than 110 countries globally. Since 2007, Pacific EMPRINTS offers Basic Disaster Life Support and Advanced Disaster Life Support courses to health professionals in Hawaii and the Pacific Islands as a Regional Training Center of the National Disaster Life Support Foundation’s training network.

Peter Tobin, PhD, Chemist, Division of Program Operations and Management, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, Food and Drug Administration

No biography available

Paul Yager, PhD, Professor, Bioengineering, University of Washington

Paul Yager, a native of Manhattan, received his AB in Biochemistry from Princeton in 1975, and a PhD in Chemistry from the University of Oregon in 1980, specializing in vibrational spectroscopy of biomolecules. After an NRC Fellowship at the Naval Research Laboratory (1980-1982), he joined the NRL staff as a Research Chemist. He moved to the Center (now Department) of Bioengineering at the University of Washington as Associate Professor in 1987, advancing to Professor in 1995; he served as Chair of the department from 2007 to 2013. Initially working on both self-organizing lipid microstructure and optically-based biomedical sensors, since 1992 his lab has focused primarily on development of microfluidics for the analysis of biological fluids for use in low-cost point-of-care biomedical diagnostics for the developed and developing worlds. From 2005-2010, a team led by Yager was supported by the Bill & Melinda Gates Foundation to develop a low-cost rugged point-of-care system for pathogen identification. Since 2008, most lab activity (with several close partners) has focused on developing two-dimensional porous networks for ultra-low-cost instrument-free pathogen identification for human diagnosis. Readout is often coupled with cell phones for quantitative analysis and data transmission; this has been under support of NIH, NSF, DARPA and DTRA. He has authored >150 publications in refereed journals, and 40 issued patents.

Clinical Application of Cell-Free DNA

Kelly Bolton, MD, Hematology-Oncology Fellow, Department of Medicine, Memorial Sloan Kettering

Kelly Bolton is a third year Medical Oncology Fellow at Memorial Sloan Kettering. Dr. Bolton attended medical school at UCLA School of Medicine and completed a residency in Internal Medicine at Weill-Cornell Medical College-NYP. She has a MPhil in Epidemiology and Public Health and a PhD in Genetic Epidemiology from the University of Cambridge. At Memorial Sloan Kettering, she is mentored by Dr. Elli Papaemmanuil. Dr. Bolton’s research focuses on the use of blood-based genomic screens for early detection of malignancies and pre-malignant states.

Dipanjan Chowdhury, PhD, Chief of the Division of Radiation and Genomic Stability, Department of Radiation Oncology, Dana-Farber Cancer Institute; Associate Professor, Harvard Medical School; Associate Member, Broad Institute of Harvard & MIT

Dipanjan Chowdhury, PhD, is chief of the Division of Radiation and Cancer Biology in the Department of Radiation Oncology at Dana-Farber. Chowdhury an associate professor of Medicine at Harvard Medical School, a member of the Division of DNA Repair and Genomic Stability in the Department of Radiation Oncology at Dana-Farber Cancer Institute and associate member of the Broad Institute of Harvard & MIT. He is also an affiliate faculty member of the Department of Biochemistry and Molecular Pharmacology and the Department of Immunology at Harvard Medical School. Chowdhury’s research focuses on deciphering cellular response to DNA damage, particularly DNA double strand breaks, with the goals of generating strategies for personalized radio and chemotherapy, and countering accidental radiation exposure. His studies were the first to show that microRNAs can functionally impact the efficacy of DNA repair in tumor cells, and influence specific DNA repair pathways. His laboratory investigates fundamental questions which have recently led to the discovery of an uncharacterized RNA binding protein that profoundly impacts DNA repair. On the translation research side, the Chowdhury laboratory has developed a platform to use serum microRNAs as non-invasive biomarkers for various pathological conditions.

Maximilian Diehn, MD, PhD, Assistant Professor, Radiation Oncology, Stanford Cancer Institute, Institute for Stem Cell Biology & Regenerative Medicine, Stanford University

Max Diehn, MD, PhD is an Assistant Professor of Radiation Oncology at Stanford University. He has co-appointments in the Stanford Cancer Institute and Institute for Stem Cell Biology and Regenerative Medicine. Dr. Diehn trained at Harvard University and Stanford University and has a background in genomics and stem cell biology. He is also a board-certified Radiation Oncologist and specializes in treatment of lung cancer. Dr. Diehn’s research programs spans basic, translational, and clinical studies. He has made significant contributions in number of areas, including in cancer stem cell biology and cancer genomics. His group recently developed a next generation sequencing-based method for detection of circulating tumor DNA called CAPP-Seq. Further development and clinical application of this approach are major ongoing research efforts in his laboratory.

Shumei Kato, MD, Assistant Clinical Professor, Hematology & Oncology, Center for Personalized Cancer Therapy, UC San Diego Moores Cancer Center

Dr. Shumei Kato is Assistant Clinical Professor at the Experimental Therapeutics program, UCSD Moores Cancer Center. Dr. Kato’s research interest has been the identification of molecular targets among patients with diverse cancers, as well as to identify the response/resistance mechanism from targeted and/or immunotherapeutic agents, that may be transformed into patient care.

Nefize Sertac Kip, MD, PhD, Associate Professor, Molecular Oncology, Icahn School of Medicine, Mount Sinai

Nefize Sertac Kip, MD, PhD, upon completion of her medical and PhD degree in Turkey, has come to the U.S. to be involved in basic research at Mayo Clinic, Rochester MN, where she has completed her residency and fellowship trainings in Anatomic and Clinical Pathology, and Molecular Genetics Pathology, respectively. Dr. Kip, who is board-certified in these areas, is currently an associate professor at Icahn School of Medicine, Mount Sinai, NY and practices as a Director of Oncology at Sema4 in CT, which is a venture of Mount Sinai involved in NGS-based testing for cancer, inherited disorders and NIPT screening.

Scott Kopetz, MD, PhD, FACP, Associate Professor, Gastrointestinal Medical Oncology, University of Texas MD Anderson Cancer Center

Dr. Scott Kopetz received his medical degree from Johns Hopkins School of Medicine after an undergraduate degree in Electrical and Biomedical Engineering at Vanderbilt University. He obtained his residency training in Internal Medicine at Duke University Medical Center, followed by a medical oncology fellowship at M. D. Anderson Cancer Center. He subsequently completed a PhD at MD Anderson in cancer biology with thesis focus on mechanisms of chemotherapy resistance in colorectal cancer. Dr. Kopetz is currently Deputy Chair of the Department of Gastrointestinal Medical Oncology and Program Leader of the GI Program of the Cancer Center Support Grant at UTMDACC. Dr. Kopetz is well versed in multidisciplinary care of and translational research for GI cancer patients. His laboratory is funded by multiple NIH-funded grants, including 3 current R01 grants. He serves as chair of the Colon Cancer Task Force, and is Vice-Chair for Colon Cancer in the NSABP/RTG/GOG (NRG) Cooperative Group. Dr. Kopetz is a leader of the GI Cancer Center Support Grant at MD Anderson and the Colorectal Cancer Moonshot, a multi- disciplinary effort to improve the survival of this disease beyond incremental advances. He has authored over 200 peer-reviewed articles in respected scientific journals such as Nature Medicine, Journal of Clinical Oncology, Lancet, Nature Reviews Cancer, Cancer Research, Lancet Oncology, Clinical Cancer Research, and JAMA, and is a senior editor for Clinical Cancer Research, and editorial board member on Journal of Clinical Oncology and JNCI. Dr. Kopetz has developed a translational and clinical trial program in BRAF-mutated colorectal cancer, which has resulted in addition of combination therapy with a BRAF inhibitor to the current treatment guidelines. He also co-led the clinical trial resulting in the FDA-approval of nivolumab for mismatch repair deficient tumors. He also is an innovator in the development and implementation of circulating tumor DNA into clinical management, including interrogation of mechanisms of resistance, evaluation of minimal residual disease, and integration into clinical trial designs. Further research efforts include the development of the Consensus Molecular Subtypes, an RNA- based methodology for CRC classification that is now being widely integrated in retrospective and clinical trial efforts.

Anne Marie O’Broin-Lennon, MD, PhD, Director, Multidisciplinary Pancreatic Cyst Program; Associate Professor of Medicine, Johns Hopkins University

Dr. Anne Marie Lennon is an Associate Professor of Gastroenterology at The Johns Hopkins University School of Medicine in Baltimore, Maryland USA. She is the founder and Director of the Multidisciplinary Pancreatic Cyst Clinic at Johns Hopkins University. After receiving a medical degree from the Royal College of Surgeons in Ireland, and a PhD from University College Dublin, Dr. Lennon continued her residency training in internal medicine at the Mater Hospital, Dublin and the Cleveland Clinic, Cleveland, Ohio. She then completed a Fellowship in Gastroenterology in Edinburgh, United Kingdom, followed by a two-year Advanced Endoscopy Fellowship in endoscopic ultrasound and ERCP at Johns Hopkins. She joined the faculty at Johns Hopkins in 2010. Dr. Lennon specializes in caring for patients with pre-cancerous lesions of the pancreas or pancreatic cancer. Dr. Lennon is accredited in General Internal Medicine and astroenterology certified by the Joint Royal Colleges of Physicians Training Board (JRCPTB) of the United Kingdom. She is a Fellow of the American Society of Gastrointestinal Endoscopy and a Fellow of the Royal College of Physicians of Ireland. She has authored over 70 peer-reviewed papers, 21 book chapters and is the co-editor of the textbook Gastrointestinal Endoscopy in Practice. She has given multiple talks at national and international meetings on the management of patients with pancreatic cysts. Dr. Lennon's research is centered on developing better tools, and improving care for patients with pancreatic cysts.

Nickolas Papadopoulos, PhD, Professor, Oncology and Pathology; Director, Translational Genetics, Ludwig Center for Cancer Genetics & Therapeutics, Sidney Kimmel Comprehensive Cancer Center, The Johns Hopkins Institutions

Dr. Nickolas Papadopoulos is internationally known as a co‐discoverer of the genetic basis of the predisposition to hereditary nonpolyposis colon cancer (HNPCC), one of the most common hereditary forms of cancer, earlier in his career. He is known for the development of diagnostic tests and he is considered an expert in cancer genetics and diagnostics. He was part of the interdisciplinary team that was first to sequence all of the protein coding genes, determine genetic alterations and construct expression profiles in multiple tumors of different cancer types. Currently, he is focused on translating the genetic information derived from cancer genome analyses to clinical applications in early detection, diagnosis and monitoring of cancer. He is a co-developer of sensitive methods for the detection of tumor DNA in liquid biopsy. He is also the co-founder of two companies that develop diagnostics for cancer.

Abhijit Patel, MD, PhD, Associate Professor, Therapeutic Radiology, Yale University School of Medicine

Abhijit Patel’s research group at Yale University is working to develop and clinically validate novel noninvasive DNA- and RNA-based cancer diagnostics. He is an Associate Professor of Therapeutic Radiology at the Yale University School of Medicine. He completed residency training in radiation oncology at Harvard University, medical internship at Memorial Sloan-Kettering Cancer Center, and obtained his MD and PhD degrees at Yale University. His scientific background is in the field of nucleic acid biochemistry, having performed his PhD and postdoctoral training with Drs. Joan Steitz and Jack Szostak. As a physician-scientist, he also maintains an active clinical radiation oncology practice.

Cloud Paweletz, PhD, Head, Translational Research Laboratory, Belfer Center for Applied Cancer Science, Dana Farber Cancer Institute

Dr. Paweletz has industry expertise in drug discovery, biomarker development and licensing in Oncology and led efforts of early drug development teams. He is currently Head of the Translational Research Laboratory at the Dana Farber Cancer Institute focusing on blood-based analyses and blood-based biomarkers to better understand, evaluate and validate new cancer treatments using industry-grade assays in active clinical trials. He joined the Belfer Institute from Merck & Co., Inc., where he most recently served as Principal scientist, externalization lead, and Proteomics Site Lead for the Department of Molecular Biomarkers at the Merck Research Laboratory in Boston. At Merck, Dr. Paweletz successfully built platforms to look at disease biomarkers in body fluids and oversaw research activities spanning the spectrum from early-stage discovery to the clinic. Prior to that, he was a postdoctoral fellow in the Department of Physiology at the Uniformed Services University School of Medicine in Bethesda, Maryland and a research fellow in the Laboratory of Pathology at the National Cancer Institute, National Institutes of Health (NIH). Drt. Paweletz serves on the Scientific Advisory Board of DropWorks with the goal to bring ‘liquid biopsies’ into community hospitals.

Valerie Taly, PhD, CNRS Research Director (Dr2), Group Leader, Co-Director Ediag Platform, UFR Des Sciences Fondamentales Et Biomedicales, France

V. Taly is a CNRS research director and group leader of the Translational Research and Microfluidics team within the clinical oncology research unit headed by Prof. P. Laurent-Puig in university Paris Descartes. Her team performs interdisciplinary researches aiming at developing and validating microfluidic tools for cancer research in close collaboration with clinicians and researchers in oncology and toxicology. Since 2008, she developed droplet-based digital procedures for Cancer diagnosis. Recently, her research has been dedicated to the clinical validation of droplet-based microfluidics for the non-invasive detection of Cancer biomarkers, the highlighting of new Cancer Biomarkers and the development of original tools and procedures for their detection with applications in personalized medicine, cancer recurrence detection and cancer diagnostics.

Ahmet Zehir, PhD, Director, Clinical Bioinformatics, Assistant Attending, Pathology, Memorial Sloan Kettering Cancer Center

Ahmet Zehir PhD is currently the Director of Clinical Bioinformatics in the Molecular Diagnostics Service in the Department of Pathology at MSKCC. He leads a large team of computational biologists and software engineers, responsible from overseeing development of Next-Generation Sequencing (NGS) data analysis pipelines and clinical validation of NGS assays. His team also develops software solutions for the molecular laboratory which helps with automated data analysis of test results, automatic report generation and sharing the reports within the hospital systems with the clinicians and researchers. His current research interests are focused on two main areas: discovery and characterization of clonal hematopoiesis in patients with advanced disease; discovery of genetic biomarkers related to cancer initiation and progression.

Kang Zhang, MD, PhD, Professor, Human Genetics and Nano-Engineering; Founding Director, Institute for Genomic Medicine, University of California, San Diego

Dr. Zhang obtained his MD with Magna Cum Laude honors from Harvard Medical School and MIT joint MD program and his PhD in genetics from Harvard University. He did his postdoctoral training also at Harvard. His research has been extensively covered by prominent news media including New York Times, Wall Street Journal, The Guardian, LA Times, Xinhua News Agency, NBC, CBS, ABC, BBC, and CCTV.

Precision Medicine

Lynn G. Dressler, PhD, Director, Personalized Medicine and Pharmacogenomics, Mission Health

From 2013-2018, Dr. Dressler developed and implemented the first Personalized Medicine and Pharmacogenomics Program (PMP) at Mission Health, a rural community health system in western North Carolina. Formerly a faculty member in the Schools of Medicine and Pharmacy at the University of North Carolina at Chapel Hill, and a founding member of the UNC Institute for Pharmacogenomics and Individualized Therapy, Dressler’s 30 year career spans translational laboratory research in cancer, health policy research and the ethical ,legal, and social implications (ELSI) of genomic medicine At UNC, her laboratory conducted the research study that directly led to the FDA approval of the HER2 FISH assay (PathVYsion ™), one of the first pharmacogenomic tests in solid tumors. At Mission, Dressler has implemented a clinical and research program in Personalized Medicine for cancer and non-cancer patients. In cancer patients, the program helps to meet/exceed national guidelines for tumor marker testing to predict response to drugs for targeted and immunotherapy approaches. In non-cancer patients, the program has implemented education, training, and clinical decision support for FDA designated black box drugs and conducted several demonstration projects bringing pharmacogenetics to primary care and specialty practices. In North Carolina, nearly 10 years prior to GINA, (Genetic Information Non Discrimination Act, Federal Statute), Dressler worked with the North Carolina General Assembly to pass a law to prohibit discrimination by employers and health insurance providers on the basis of an individual’s genetic information. She has consulted with NIH, NCI, NHGRI and NAM and has over 100 publications in related fields.

Ron Kamienchick, MBA, Senior Director, Diagnostics and Personalized Medicine, Digital Health, Teva Pharmaceuticals

I have been helping companies accelerate early stage innovation to global commercialization, both in a corporate as well as startup environment, linking strategy and commercial requirements with cutting-edge technologies that can revolutionize and disrupt the way medicine is practiced today. My career path has allowed me to build a diverse commercial experience in both startups (private and private-gone-public NASDAQ/TASE) and large pharma, always focused on innovative healthcare solutions which required non-traditional commercialization strategies. Solutions included molecular diagnostics (Companion Diagnostics CDx), Point-of-Care Diagnostics, AI (Machine Learning and Predictive Analytics), Digital Health, and Regenerative Medicine/Stem Cells. All roles required a deep understanding of the R&D process, the regulatory pathways, the impact on the commercial potential of the solution, and closely working with and leading cross functional teams from concept to launch, to post-launch support.

Xuefeng Liu, MD, Professor, Pathology, Georgetown University

Dr. Liu is an Associate Professor in the Department of Pathology, serves as Director of Telomeres and Cell Immortalization Program within Center for Cell Reprogramming (CCR) and Scientific Director of Conditional Reprogramming Laboratory (CRL). Dr. Liu’s research interests focus on the roles of papillomavirus oncoproteins and telomerase in cell immortalization which is a very early stage of human cancer. The E6 and E7 proteins from high risk HPVs were first identified as targeting to disruption of cell cycle controls. The simultaneous expression of E6 and E7 appears to be requisite for cervical cancer. E6 protein has the unique property of increasing cellular telomerase activity by engaging both transcriptional and post-transcriptional mechanisms and this activation has been considered a critical and rate-limiting step in the progression to malignancy. His work has defined two major cellular targets for E6 oncoprotein, Myc and hTERT, which play a critical role in cell immortalization (PNAS 2003, JBC 2005, JVI 2007 and 2008, Virology 2008, BCTR 2009). Recently, his group has discovered that the E6 protein also interacts directly with the hTERT protein (PNAS 2009) and that E6 and E7 induce immortalization through non-telomere/non-catalytic functions of hTERT (PLoS Pathogens 2013). These studies are funded by a new grant from NIH. Together with Dr. Richard Schlegel, Dr. Liu recently co-invented a new cell technology, CRC technology, which was described in the Journal of Clinical Investigation (2010), American Journal of Pathology (2012, 2013), New England Journal of Medicine (2012), PNAS (2012), PLoS ONE (2014) and Oncotarget (2014). This technology allows us to rapidly propagate patient-derived normal and tumor (diseased) cells infinitely. Importantly, he utilized this technology to identify infection of HPV 11 and an effective therapy for a patient with metastatic pulmonary tumors arising from laryngeal papillomatosis. These results represent the first successful example of individualized therapy (NEJM). Dr. Liu has trained more 50 researchers from NIH/universities - Harvard, Yale, Duke, Stanford, Arizona, Wake Forest, UNC, Thomas Jefferson, CUHK, Mayo, MD Anderson to name a few - as well as scientists at Georgetown University to use CRC technique in their research. This training also resulted in a broad spectrum of intramural and extramural collaborations.

Christine Lu, PhD, Associate Professor, Department of Population Medicine, Harvard Medical School/Harvard Pilgrim Health Care Institute

Christine Lu MSc, PhD is an Associate Professor in the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute and she co-directs the PRecisiOn Medicine Translational Research (PROMoTeR) Center. She is a pharmacist, health policy scientist and pharma. Christine Lu MSc, PhD is an Associate Professor in the Department of Population Medicine at Harvard Medical School and Harvard Pilgrim Health Care Institute and she co-directs the PRecisiOn Medicine Translational Research (PROMoTeR) Center. She is a pharmacist, health policy scientist and pharmacoepidemiologist. After receiving an MSc (Biopharmaceuticals) and a PhD in Clinical Pharmacology from the University of New South Wales, Australia, Dr. Lu completed her post-doctoral training at Harvard Medical School. Dr. Lu leads the precision medicine & policy, and precision medicine oncology portfolios in the DPM. Her program of research focuses on the policy, legal, ethical, economic and societal issues of precision medicine. These include but are not limited to (1) coverage and reimbursement of genomic testing and sequencing; (2) disparities in access to genomic testing and sequencing and outcomes, and ethical implications; (3) barriers and facilitators to the implementation of genomic testing and sequencing; and (4) clinical and economic outcomes related to the use of genomic testing and sequencing, including the impact of value-based contracts. She also conducts research to examine access and affordability issues related to gene therapies. Dr. Lu is Co-Principal Investigator of Genomics-based Technologies: Access and Reimbursement Issues. She co-leads the Genetic and Molecular Tests Data Workgroup for the Cancer Research Network that investigates the range and depth of information available within and outside the Virtual Data Warehouse on clinical cancer makers. Dr. Lu is site Principal Investigator of an NCI-funded project to examine organizational and economic barriers and facilitators to the implementation of universal Lynch Syndrome Screening across multiple healthcare systems (Study PI: Alanna Rahm, Geisinger Health). Dr. Lu is policy expert investigator of Precision Medicine Treatment (PreEMT) Model that simulates short- and long-term clinical benefits and estimates the cost-effectiveness of integrating different genome screening strategies into clinical care for healthy or high-risk newborns for heritable conditions (PI: A. Wu). Since 2003, Dr. Lu has examined access to high-cost specialty drugs and orphan drugs (i.e., biologics for rare and chronic conditions including cancer, rheumatoid arthritis, hepatitis C, and rare diseases). She is the lead investigator of an international study of managed entry agreements for such drugs. Dr. Lu is the lead of a national study examining reimbursement of direct acting antivirals for chronic hepatitis C under state Medicaid programs, and the Principal Investigator of a regional study examining approaches for managing the use of direct acting antivirals for chronic hepatitis C. Dr. Lu is an investigator of the Cancer Research Network and the Mental Health Research Network, the Health Care Systems Research Network. She also serves as a pharmacoepidemiologist for the FDA-funded Sentinel System, a congressionally mandated national medical product safety surveillance system. PRoMoTeR Rapid advances in genomic technologies and the availability of increasing amounts of genomic information influence how health care is provided. Our mission is to identify and evaluate genomics practices to improve individual and population health. We are composed of a team of multidisciplinary investigators with expertise in conducting studies of effectiveness and cost-effectiveness, health policy analysis, and pharmacoepidemiology. Existing Core Faculty: • Ann Wu (Director) • Chris Lu (Associate Director) • Marie-France Hivert • Maryam Asgari

Bernard L. Marini, PharmD, BCOP, Clinical Pharmacist Specialist, Inpatient Hematology/Oncology, Adjunct Clinical Assistant Professor, Pharmacy, University of Michigan Health System

Dr. Bernard Marini is a Clinical Pharmacist Specialist in Hematology/Oncology at the University of Michigan and an Adjunct Clinical Assistant Professor at the University of Michigan College of Pharmacy. Dr. Marini has been integral in developing the CNS Precision Medicine Tumor Board at the University of Michigan, the creation of the CNS TAP algorithm for selecting precision medicine therapies, and helping develop several rational precision medicine clinical trials for pediatric neuro-oncology patients at the institution. Dr. Marini has over 30 peer-reviewed publications primarily involving precision medicine, improving clinical outcomes for patients with acute leukemias, and immunocompromised infectious diseases.

Stuart Martin, Professor, Greenebaum Comprehensive Cancer Center, University of Maryland School of Medicine

Dr. Martin received his PhD from the University of California, San Diego, after training as a Howard Hughes undergraduate research fellow at the University of Virginia. Dr. Martin completed a Damon Runyon postdoctoral fellowship at Harvard Medical School that combined functional genomic studies with mouse models of breast tumor metastasis, under the mentorship of Dr. Phil Leder. In 2004, Dr. Martin joined the Marlene and Stewart Greenebaum Cancer Center (UMGCC) and the Department of Physiology at the University of Maryland School of Medicine. Dr. Martin is working to apply physical science and engineering approaches to study the mechanical properties of circulating tumor cells. In 2010, Dr. Martin was one of only 3 investigators in the United States recognized with an Era of Hope Scholar Award from the Congressionally-directed Medical Research Program for his innovative research on breast cancer metastasis.

Emanuel Petricoin, PhD, Co-Director, Center for Applied Proteomics and Molecular Medicine, George Mason University

Dr. Emanuel F Petricoin has been the Co-Director of the Center for Applied Proteomics and Molecular Medicine (CAPMM) at George Mason University since 2005, where he is a University Professor. Prior to this position, he served as Co-Director of the FDA-NCI Clinical ProteomicsProgram and a Senior Investigator within the Center for Biologics Evaluation and Research at the FDA from 1993-2005. Dr. Petricoin received his PhD in Microbiology from the University of Maryland in 1990. The focus of the CAPMM is the invention and use of proteomics technologies for personalized therapy, and biomarker discovery and measurement for direct clinical applications at the bedside. He is a co-founder of 4 life science companies, Theranostics Health, Inc, Ceres Nanosciences Inc., C-4 Diagnostics, Inc. and Perthera, Inc. He is a co-inventor on 40 filed and published patents, and has authored over 350 peer-reviewed publications and invited reviews. He has authored over 40 book chapters, is on the editorial board of Proteomics, Biomedical Microdevices, Proteomics- Clinical Applications, Proteomics- Protocols, Molecular Carcinogenesis, Journal of Personalized Medicine and is a Senior Editor for Cancer Epidemiology Biomarkers and Prevention Dr. Petricoin is a founding member of the Human Proteomic Organization (HUPO) as well as the US HUPO and served on the Executive Committee and Treasurer for HUPO from 2002-2004. He has received numerous awards including the University Professorship at George Mason University, the NIH Director’s Award, FDA Distinguished Scientist Award, 2015 Innovator of the Year Award, GAP50 Top Virginia Entrepreneurs, Nifty 50 Award, American Society of CytopathologyBasic Research Award, the Roche Diagnostics/CLAS Distinguished Scientist Award and the Harvard University Leading Edge Award and is s Kentucky Colonel. He is the faculty representative to the George Mason University Research Foundation and represents GMU on the Board of Directors for the Virginia Health Research Biosciences Corporation.

Clifford A. Reid, PhD, CEO, Travera

Dr. Clifford A. Reid is the founding CEO of Travera, a recent spin-out from MIT that is developing a new approach to personalized medicine for cancer. Previously, Dr. Reid was the founding Chairman, President and Chief Executive Officer of Complete Genomics (CGI), a leading developer of whole human genome DNA sequencing technologies and services. He founded CGI in 2006, took the company public in 2010 (GNOM: NASDAQ), and led the company though its acquisition by BGI in 2013. Prior to CGI he founded two enterprise software companies: Eloquent (ELOQ:NASDAQ), an internet video company which was acquired by Open Text, and Verity (VRTY:NASDAQ), an enterprise search engine company which was ultimately acquired by Hewlett-Packard. Dr. Reid is on the Visiting Committee of the Biological Engineering Department at the Massachusetts Institute of Technology (MIT), and is a member of the MIT Corporation Development Committee. He is an advisor to Warburg Pincus. He earned a B.S. in Physics from MIT, an MBA from the Harvard Business School, and a PhD in Management Science and Engineering from Stanford University.

Ana I. Robles, PhD, Staff Scientist, Laboratory of Human Carcinogenesis, National Cancer Institute

Dr. Ana Robles is a Staff Scientist at the National Cancer Institute. Her research focuses on omics-based identification and functional characterization of clinically informative biomarkers of lung cancer. Her studies are based on the integrative analysis of genomic, epigenomic and transcriptomic data of well-characterized patient populations to uncover biomarkers that aid patient stratification into risk categories, and generate hypothesis that illuminate biology. Dr. Robles completed undergraduate training in Chemistry at University of Buenos Aires, Argentina. She received her PhD in Cancer Biology from the Graduate School of Biomedical Sciences at the University of Texas, and completed postdoctoral training in the Laboratory of Human Carcinogenesis at the NCI.

Pallavi Sachdev, MPH, PhD, Director, Clinical Pharmacology and Translational Medicine, Oncology, Eisai Inc.

Dr. Pallavi Sachdev, Director, Clinical Pharmacology and Translational Medicaine, at Eisai, a human health care (hhc) company, supports the Clinical Development team in the development and execution of the clinical translational biomarker strategy across a diverse oncology pipeline. During her time at Eisai, Dr. Sachdev has increasingly focused on bridging the translational gap between the nonclinical and clinical teams and global coordination of biomarker research across all stages of clinical development (from early phase - first-in-human and proof-of-concept studies, to late stage/registrational studies). Her responsibilities include alignment of drug and diagnostic strategies to deliver tailored therapeutics. Previously, Dr. Sachdev was a scientist at The Rockefeller University focusing on cancer signaling networks, stem cell biology and systems biology. Dr. Sachdev received her PhD in Biochemistry and Molecular Biology from Mount Sinai-New York University School of Medicine and her B.S. from Cornell University. She has co-authored numerous research publications in the fields of cancer signaling networks and cancer genomics and presented at international scientific conferences focusing on precision medicine and big data.

Anthony Sireci, MD, MSc, Physician Manager, Personalized Genomic Medicine, Assistant Professor of Pathology Columbia UniversityMedical Director, Medical Affairs, Loxo Oncology 

Dr. Anthony N. Sireci presently working as an Assistant Professor of Clinical Pathology, Columbia University with research interest developing process improvement plans in the laboratory setting to help deliver higher quality and more efficient care to the patients. He was awarded PhD degree from University of Utah, Salk Lake City

Matthew A. Smith, PhD, MSPH, Research Scientist, Thoracic Oncology, Moffitt Cancer Center

Our current work involves the design and optimization of novel predictive biomarker assays in lung cancer. We have developed proximity ligation assays for EGFR and MET that measure functional association with the downstream adaptor GRB2, which is required for oncogenic signal transduction. These assays perform robustly in FFPE and provide proof-of-principle for interactome-based biomarker strategies. In studies using patient-derived xenograft models and lung cancer patient specimens, presence of these "signaling-associated complexes" is predictive of response to EGFR- and MET-targeting agents, such as cetuximab, erlotinib and crizotinib. We are currently adapting these methods for deployment in clinical pathology laboratories and are working toward a CLIA-certified assay platform with grant support from the National Cancer Institute. I currently work under the supervision of Eric Haura, MD in the Department of Thoracic Oncology at Moffitt Cancer Center. I have broad interests in precision medicine approaches in thoracic and other solid tumor malignancies.

Timothy T. Stenzel, MD, PhD, Director, Office of In Vitro Diagnostics and Radiological Health (OIR), CDRH/FDA/HHS

Tim joined the FDA in July 2018 and has an extensive background, spanning more than 20 years, in executive leadership, innovation, companion diagnostics, research and development, FDA regulations, and clinical laboratory operations. He received his M.D. and Ph.D., in Microbiology and Immunology, focusing on the Molecular Biology of DNA Replication, from Duke University after graduating with Honors in Chemistry from Grinnell College. In his last position, from 2014 to 2018, Tim served as Chief Operating Officer (COO) at Invivoscribe, focusing on Companion Diagnostics and Next Generation Sequencing/Massively Parallel Sequencing in Oncology. During his career, he has played important roles in the development and launch of more than 30 IVD products, as well as numerous unique LDT services, including the FDA approved companion diagnostic for Novartis’ drug Rydapt and the world’s first clinical microRNA assay (for pancreatic cancer detection). Other experience includes serving as Chief Scientific Officer and founder of the Molecular Diagnostics franchise at Quidel, Chief Medical Officer and Vice President of Research and Development at Asuragen, and Senior Director for Medical, Regulatory and Clinical Affairs at Abbott Molecular. Dr. Stenzel served as a Board Director at the ACMG Foundation for Genetic and Genomic Medicine from 2008 to 2013. He has served on the ACMG/CAP Biochemical and Molecular Genetics Resource Committee from 1996 to 2005, the AMP Finance Committee from 2012 to 2018, the AMP Strategic Planning Committee from 2007 to 2009, as the AMP Chair-Elect and Chair of the Solid Tumor Division from 2003 to 2004, the CAP Molecular Oncology Committee from 2013 to 2018, and as a Member of the CAP House of Delegates from 2011 to 2017. As the OIR Director, Tim will advise Center leadership on all regulatory (premarket and postmarket) in vitro diagnostic, radiological medical device, and radiation-emitting product issues that have an impact on Center and Agency level decisions, policy development, nationwide program execution and short and long-range program goals and objectives as well as provide executive leadership and scientific direction to the OIR staff.

Clinical NGS Assays: Interpretation and Clinical Utility

Michael Berger, PhD, Associate Director, Marie Josee & Henry R Kravis Center for Molecular Oncology, Memorial Sloan Kettering Cancer Center

Michael Berger, PhD, is an Associate Director of the Marie-Josée and Henry R. Kravis Center for Molecular Oncology at Memorial Sloan Kettering Cancer Center, a multidisciplinary initiative to promote precision oncology through genomic analysis to guide the diagnosis and treatment of cancer patients. He is also an Assistant Attending in the Department of Pathology and an Affiliate Member of the Human Oncology and Pathogenesis Program, with expertise in cancer genomics, computational biology, and high-throughput DNA sequencing technology. His laboratory is developing experimental and computational methods to characterize the genetic makeup of individual cancers and identify genomic biomarkers of drug response and resistance. As a Scientific Director of Clinical NGS in the Molecular Diagnostics Service, he oversees the development and bioinformatics associated with clinical next-generation sequencing assays, and he helped lead the implementation of a robust molecular profiling platform (MSK-IMPACT) and accompanying analytical framework for use in real-time patient management. He received his Bachelor’s Degree in Physics from Princeton University and his PhD in Biophysics from Harvard University.

Annerose Berndt, VP, Clinical Genomics, Clinical Genomics, UPMC

Annerose Berndt, PhD, DVM, is a Doctor of Veterinary Medicine and received her PhD in Molecular Biology. She then focused on complex genetic and genomics during her postdoctoral studies at The Jackson Laboratory. In 2010, Dr. Berndt was recruited to join the University of Pittsburgh School of Medicine and in 2014 became Vice President of Analytics at the University of Pittsburgh Medical Center (UPMC). In 2016 she took on the responsibility of Vice President for Clinical Genomic. In this role she strategized and lead the implementation of UPMC’s Genome Center, which includes a high-throughput, CLIA-certified laboratory and a cloud-based bioinformatics infrastructure.

Emily Farrow, PhD, CGC, Associate Professor, UMKC School of Medicine, Director of Laboratory, Operations Center for Pediatric Genomic Medicine, Center for Pediatric Genomic Medicine, Children’s Mercy Hospitals and Clinics

Emily Farrow is a board certified genetic counselor and the current Director of Laboratory Operations in the Center for Pediatric Genomic Medicine at Children’s Mercy Hospital. She is also an Associate Professor in the Department of Pediatrics in the UMKC School of Medicine. As a genetic counselor Emily’s research interests are in the blurring boundaries between research and clinical testing and the implementation of genomic medicine, specifically in pediatrics. She also has a research interest in applying genomics to understand bone development, in both normal and disease states.

Gail Javitt, Member of the Firm, Health Care & Life Sciences, Epstein Becker & Green, P.C.

GAIL H. JAVITT is a Member of the Firm in the Health Care and Life Sciences practice of Epstein Becker Green. Ms. Javitt provides strategic FDA regulatory advice for leading medical device, diagnostics, pharmaceutical, biological products, human cellular, and tissue-based products (HCT/Ps), and dietary supplement companies throughout the product life cycle and has successfully resolved disputes at both the pre- and post-market stage. She also has significant experience advising clinical laboratories and NGS bioinformatics tools developers on navigating regulatory requirements for NGS-based testing. Ms. Javitt has written and spoken widely on legal, ethical, and policy issues related to access to and clinical integration of genetic testing. Ms. Javitt is also a member of an NIH-funded Working Group of top legal and scientific experts working to develop consensus legal recommendations to optimize successful translation of genomics into clinical use.

Yuan Ji, PhD, DABCP, DABMGG, FACMG, Assistant Professor of Clinical Pathology/Medical Director, Pathology, ARUP Laboratories/University of Utah School of Medicine

Dr. Yuan Ji is an assistant professor at the University of Utah School of Medicine and also a Medical Director of Molecular Genetics & Genomics at ARUP Laboratories, Salt Lake City, Utah. She received her PhD in pharmacology at the Mayo Clinic in Rochester, Minnesota, where she completed research her fellowship in Pharmacogenetics and Pharmacometabolomics, a fellowship in Clinical Pharmacology, a fellowship Clinical Molecular Genetics. Dr. Ji is board certified in both American Board of Clinical Pharmacology (ABCP) and American Board of Medical Genetics and Genomics (ABMGG). This unique training background allows Dr. Ji to develop a deep focus in clinical pharmacogenomics testing, i.e., implementation, interpreting and reporting.

Lisa Kalman, PhD, Senior Advisor for Repository Science, Division of Laboratory Systems, Centers for Disease Control and Prevention

Lisa Kalman directs the Genetic Testing Reference Material Coordination Program (GeT-RM) at the Centers for Disease Control and Prevention (CDC) in Atlanta GA, USA. Dr. Kalman earned her BS degree in Biology and her PhD in Microbiology and Molecular Genetics from the University of California, Los Angeles. She also completed a postdoctoral fellowship at Stanford University in Developmental Biology and Biochemistry. As the Coordinator of the GeT-RM Program, Lisa partners with members of the genetic testing community to manage a voluntary, sustainable process to improve the quality of clinical genetic testing. The GeT-RM program helps the genetics community to identify appropriate, well characterized reference materials through coordinated information exchanges between testing laboratories and providers of reference materials. The program also initiates and coordinates the contribution, development, characterization and distribution of new reference materials for genetic testing. She is also the Science Advisor for the CDC’s Biorepository. Dr. Kalman has authored a number of guidance documents related to molecular genetic testing.

Monkol Lek, PhD, Assistant Professor, Genetics, Yale School of Medicine

Monkol received an undergraduate degree in Engineering (Computer Engineering) in 2000 at the University of New South Wales (UNSW) and then worked for IBM for 3.5 years. He returned to UNSW and completed undergraduate degrees in Science (Physiology) and Engineering (Bioinformatics) and received the University Medal in 2007. He completed his PhD (Medicine) at the University of Sydney in 2012 with the thesis topic: Functional differences between alpha-actinin-2 and alpha-actinin-3. Monkol did his post-doctoral training in Daniel MacArthur’s lab based at Massachusetts General Hospital, Harvard Medical School and the Broad Institute. He was the lead author/analyst for the Exome Aggregation Consortium (ExAC) project that was published in Nature 2016. He went on to lead the NIH funded Broad Center for Mendelian Genomics (CMG) analysis team. As lead analyst, he oversaw the analysis strategy for all major CMG collaborations and organized monthly meetings to foster sharing of new methods and analysis amongst the rare disease community. He also coordinated the data processing and preliminary analysis of NIH Gabriella Miller Kids First (GMKF) cohorts sequenced or reprocessed at the Broad Institute. Monkol has a strong passion for rare muscle disease research as a patient with Limb Girdle Muscular dystrophy (LGMD2G). During his time in the Broad Institute, he lead the exome/genome analysis of MYOSEQ (European cohort of >1000 LGMD patients) and SeqNMD (an international consortium of undiagnosed rare muscle diseases) which has resulted in novel disease gene discovery.

Christian R. Marshall, PhD, FACMG, Molecular Laboratory Director, Genome Diagnostics, The Hospital for Sick Children

Dr. Christian Marshall is a Molecular Laboratory Director in the Division of Genome Diagnostics in Department of Pediatric Laboratory Medicine at The Hospital for Sick Children (SickKids). Dr. Marshall has an academic rank of Assistant Professor in Laboratory Medicine and Pathobiology at the University of Toronto and also serves as a Scientist at SickKids Centre for Applied Genomics (TCAG). He obtained his PhD in molecular biology at Simon Fraser University in Vancouver, Canada before moving to Toronto to complete a post-doctoral fellowship in Autism genomics and Clinical Molecular Genetics and Genomics training at SickKids. Dr. Marshall’s current research focuses on the application of new sequencing technologies for identification of human genome variation and its relation to disease. Specifically, he is interested in the discovery of genomic variation associated with neurodevelopmental disorders such as autism spectrum disorder (ASD), Schizophrenia, and Attention Deficit Hyperactivity Disorder. As a principal investigator for the Centre for Genetic Medicine’s Genome Clinic, Dr. Marshall is exploring the utility of whole genome sequencing in pediatric medicine and the translation of the technology into clinical diagnostics.

Samantha J. Mentch, PhD, Bioinformatic Analyst, UPMC Genome Center

Samantha Mentch graduated from Cornell University with her PhD in Biochemistry, Cell and Molecular Biology with a Genomics Minor. Her previous work has been published in high impact journals like Nature Genetics, and involved developing NGS and mass spectrometry protocols and integrating metabolomics and genomics data to understand how diet alters the epigenetic state of normal and cancer cells. She has over 10 years of research experience on various projects and has spent the last 5 years optimizing and analyzing high throughput sequencing experiments and NGS data. She is an expert in the end-to-end NGS process from DNA extraction to variant calling and annotation. At the UPMC Genome Center, she builds, tests, optimizes, and validates the production bioinformatics pipelines, monitors sample quality, is involved in experimental design and works with customers to ensure they receive the highest quality sequencing results for their needs. Her ultimate goal is to generate the highest quality genetic data and enable precision medicine to become the future of patient care.

Jennifer J.D. Morrissette, PhD, FACMG, Scientific Director, Clinical Cancer Cytogenetics; Clinical Director, Center for Personalized Diagnostics, Department of Pathology, University of Pennsylvania

Jennifer Morrissette, PhD is the Scientific Director of the Clinical Cytogenetics Laboratory, the Clinical Director of the Center for Personalized Diagnostics (CPD) and an Assistant Professor at the University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA. She is certified in Clinical Molecular Diagnostics and Clinical Cytogenetics through the American Board of Medical Genetics and has been a clinical laboratory director for 10 years. Dr. Morrissette joined the University of Pennsylvania, Department of Pathology as the Scientific Director of Clinical Cancer Cytogenetics in 2010. Previous to the University of Pennsylvania, she was an Assistant Professor at Drexel University and Director of Clinical Cytogenetics and Molecular Genetic Diagnosis at St Christopher’s Hospital for Children. Dr. Morrissette was a founding member of the Center for Personalized Diagnostics, a joint initiative between the Department of Pathology and the Abramson Cancer Center.

Eric Rush, MD, FAAP, FACMG, Clinical Geneticist, Associate Professor of Pediatrics, Pediatrics, Children’s Mercy Kansas City

Eric Rush is a Clinical Geneticist at Children’s Mercy Hospital and The University of Kansas Medical Center and an Associate Professor of Pediatrics at the University of Missouri – Kansas City. He is board-certified in Internal Medicine, Pediatrics, and Clinical Genetics. His clinical interests are in rare bone disease, cancer genetics, cardiovascular/connective tissue genes, and molecular characterization of genetic disease. His research interests include extraskeletal manifestations of osteogenesis imperfecta and bone pathology in inborn errors of metabolism.

Avni Santani, PhD FACMG, Director - Clinical Laboratories, Strategic Partnerships and Innovation, Center for Applied Genomics, Children's Hospital of Philadelphia; Assistant Professor of Clinical Pathology, Perelman School of Medicine, University of Pennsylvania

Avni Santani, PhD, is the scientific director and has over seven years of experience in molecular diagnostic testing. She obtained her PhD at Texas A&M University and her clinical laboratory training in genetics at The Children’s hospital of Philadelphia. Dr. Santani holds specialty board certifications in Clinical Molecular Genetics and Clinical Cytogenetics. Her primary focus is on new test development and adoption of next generation sequencing technologies for diagnostic testing. Dr. Santani has experience in developing diagnostic tests for over 100 disease genes implicated in disorders such as hearing loss, epilepsy, Noonan syndrome, Rett syndrome, paraganglioma, neuroblastoma and others. Her training and experience make her an expert in a wide variety of genetic disorders, molecular biology applications and genomics.

Carol Saunders, PhD, FACMG, Clinical Laboratory Director, Professor of Pediatric Pathology, Center for Pediatric Genomic Medicine, Children’s Mercy Kansas City

Dr. Saunders is a board certified clinical molecular geneticist with a PhD in molecular genetics from the University of Kansas. She is a Professor at the University of Missouri-Kansas City School of Medicine and has directed the Clinical Molecular Genetics Laboratory at Children’s Mercy Hospital in Kansas City for 15 years. She was at the forefront of the rapid changes in the field of genetics, intimately involved in the inception of the Center for Pediatric Genomic Medicine (CPGM), which was the first genome center located in a pediatric hospital. The CPGM has lead the genomic approach for the rapid and early diagnosis of childhood diseases, and is currently one of the only U.S. laboratories performing clinical whole genome sequencing. Her research interests relate to the utility of clinical next generation sequencing, new associations of rare Mendelian pediatric diseases with genes; in particular, of neurodevelopmental and mitochondrial disorders. She is the director of the fellowship program in molecular genetics at Children’s Mercy Hospital, and pathology residency training in molecular genetics.

Wenming Xiao, PhD, Principle Investigator, Division of Bioinformatics and Biostatistics, NCTR/FDA

Dr. Xiao had advanced training in biology and computer science. He has over 20 years of experience in bioinformatics through his career in industry, academia and government agencies. Dr. Xiao has numerous publications in peer-reviewed journals such as Nature, PNAS, and N. Engl. J. Med and received NIH Director Award in 2010 in recognition to his contributions to cancer biomarkers discovery. His work in Lymphoma/Leukemia Molecular Profiling resulted in 20 gene biomarkers for Lymphoma Subtyping Test (LST), which is in Phase III global clinical validation trial, and a candidate drug, ibrutinib, which currently is in phase II clinical trial. Dr Xiao currently is a principle investigator in Food and Drug Administration (FDA) and leads an international working group, including 170+ scientists, to establish reference materials, data sets, analysis pipelines, and quality metrics for cancer mutation detection with NGS technology.

Justin Zook, PhD, Research Scientist, Genome-scale Measurements Group, National Institute of Standards and Technology (NIST)

Justin Zook is a scientist in the Genome-scale Measurements Group at the US National Institute of Standards and Technology. He co-leads the Genome in a Bottle Consortium work developing authoritatively characterized human genome reference samples, and is Chair of the Global Alliance for Genomics and Health Benchmarking Team, completing its work standardizing variant calling benchmarking methods. His recent research has focused on developing methods to integrate diverse sequencing and bioinformatics technologies to form benchmark human genome variant calls.

Stephan Zuchner, MD, PhD, Professor, Human Genetics, University of Miami

Stephan Züchner, MD, PhD, is a trained neurologist and molecular geneticist at the University of Miami Miller School of Medicine where he is a Professor of Human Genetics and Neurology and Interim Chair of the Dr. John T. Macdonald Foundation Department of Human Genetics. Dr. Züchner obtained his medical degree from RWTH Aachen University Medical School, where he also completed residencies in Neurology and Neuropathology and his ‘Dr. Med.’ degree (PhD equivalent). Dr. Züchner completed his postdoctoral studies at Duke University Medical Center in Durham, North Carolina, where he subsequently achieved Assistant Professor status. In 2007, he moved to the University of Miami as one of the founding faculty of the John P. Hussman Institute for Human Genomics. Dr. Züchner’s research interests are focused on identifying genetic variation associated with disease. His lab has identified several genes for Mendelian neurodegenerative disorders and also evaluated risk factors for complex genetic conditions, including Alzheimer disease, Parkinson disease, and obsessive-compulsive disorder. His lab is amongst the pioneering groups that have promoted genome sequencing methods for disease gene identification in humans, mice, and drosophila. He is currently pursuing large - scale exome and genome analysis in multiple neurodegenerative disorders and develops innovative new software tools that allow real time-shared analysis of large amounts of genomic data.

Single Cell Analysis

Jeffery Agar, PhD, Associate Professor, Chemistry and Chemical Biology, Bouve College Health Sciences - Center For Drug Discovery, Northeastern University

No biography available

Ziv Bar-Joseph, FORE Systems Professor of Computational Biology and Machine Learning, Computational Biology, Carnegie Mellon University

Ziv Bar-Joseph is the FORE Systems Professor of Computational Biology and Machine Learning at the School of Computer Science at Carnegie Mellon University. His work focuses on the analysis, integration and modeling of high throughput biological data and on improving algorithms for distributed computational networks by relying on our increased understanding of how biological systems operate. Dr. Bar-Joseph received his PhD from MIT in 2003. He was the recipient of the DIMACS-Celera Genomics Graduate Student Award in Computational Biology, the NSF CAREER award and Overton prize in computational biology. He is currently the director of the joint CMU-Pitt PhD program in computational biology.

Aparna B. Baxi, Graduate Student, Chemistry & Biochemistry, Anatomy and Regenerative Biology, University of Maryland–College Park, George Washington University

Aparna Baxi is a second-year graduate student at the Institute for Biomedical Sciences at the George Washington University. She works under Prof. Peter Nemes and Prof. Sally A. Moody to study developmental biology through the lens of high resolution mass spectrometry. Her current work explores proteomic changes that guide the formation of a functional nervous system. Prior to joining GWU for her graduate study, Aparna worked in the Department of Pathology at Johns Hopkins University where she studied cancer lipidomics through ambient ionization mass spectrometry. She holds an MS in Molecular Medicine from the University of Maryland, Baltimore and a bachelor of engineering (BE) in Biotechnology from the Birla Institute of Technology Mesra, India.

Suman Bose, PhD, Postdoctoral Fellow, Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology

No biography available

Minh Doan, MD, PhD, Assay Developer, Imaging Platform, Broad Institute

I've trained as a medical doctor (2004-2010) and did PhD in molecular cell biology (2010-2015) in University of Debrecen, Hungary. I then did my first postdoc in microbiology in Pasteur Institute, Paris, France for nearly 2 years, focusing on genomic interaction between the host cell and Chlamydial microbes. From 2016 until now, I join Dr. Anne Carpenter's Imaging Platform at the Broad Institute of MIT and Harvard, leading the effort to analyze Imaging flow cytometric data in clinical studies. Here we focus on developing machine learning methodology, especially deep learning, to automate the analytic processing of single cell images, from not only Imaging flow cytometry but may potentially applicable for general bioimaging.

Joshy George, PhD, Associate Director, Computational Sciences, Jackson Laboratory for Genomic Medicine

Joshy George is currently an Associate Director in the computational sciences group in the Jackson laboratory for genomic medicine in Connecticut, USA. He did his PhD in Bioinformatics from the University of Melbourne. Prior to joining the Jackson Laboratory, he has worked at the Peter MacCallum Cancer Center in Melbourne Australia and at the Genome Institute of Singapore. His primary interest is in developing principled methods that can generate biological insights from large scale genome level data.

Yuval Kluger, PhD, Associate Professor, Pathology, Yale University School of Medicine

Yuval Kluger has been working in the broad fields of bioinformatics, machine learning, and dynamics of quantum fields. His main contributions to date relate to development of spectral methods for unsupervised learning, cell specific regulatory networks, algorithms for analyzing genomics and epigenomics sequencing data, algorithms for detecting and characterizing biomarkers in high dimensional assays, and non-equilibrium quantum field theory models.

Alexander Krasnitz, PhD, Associate Professor, Simons Center for Quantitative Biology, Cold Spring Harbor Laboratory

Alex Krasnitz received a PhD degree in physics from Tel Aviv University. Having held a number of research positions in computational physics in the US and in Europe, he made a transition to computational biology and joined Cold Spring Harbor Laboratory, where he is now an associate professor at the Simons Center for Quantitative Biology. His current research focuses on computational genomics of cancer, including applications of single-cell genomics to tumor diagnostics and detection, genomics of organoid models, and immune response to cancer. His work is supported by the National Cancer Institute, the Simons Foundation and the Lustgarten Foundation.

Carsten Krieg, PhD, Assistant Professor, Microbiology & Immunology, Medical University of South Carolina

My laboratory is interested in the unbiased high dimensional analysis of the immunome in steady sate and during inflammation, such as autoimmunity and cancer. We use single cell high throughput mass cytometry and RNAseq combined with machine-learning algorithms to create a complete picture of the immune system, as we call them “immune instagrams”. In order to achieve this, we collaborate with clinicians, wet lab and computer scientists in academia and industry alike and hope to identify biomarkers and new therapeutic avenues to benefit patients.

Chang Lu, PhD, Fred W. Bull Professor, Chemical Engineering, Virginia Tech

Dr. Chang Lu is the Fred W. Bull professor of chemical engineering at Virginia Tech. Dr. Lu obtained his B.S. in Chemistry with honors from Peking University in 1998 and PhD in Chemical Engineering from University of Illinois at Urbana-Champaign in 2002. He then spent 2 years as a postdoctoral associate in Applied Physics of Cornell University. His research has been in the general area of developing microfluidic technologies for molecular/cellular manipulation and analysis, with recent focus on profiling epigenomes using tiny amounts of samples. These technologies have been useful for understanding disorders and processes such as cancer, stem cell differentiation, and brain development. His lab has published in leading journals such as Nature Methods, Nature Biomedical Engineering, Science Advances, and Nature Protocols. Dr. Lu received Wallace Coulter Foundation Early Career Award, NSF CAREER Award, and VT Dean’s award for research excellence among a number of honors.

John T. McDevitt, PhD, Chair, Department of Biomaterials, New York University College

John T. McDevitt serves as the Chair for the Department Biomaterials at New York University College of Dentistry, is a member of NYU’s Bioengineering Institute and participates as a faculty member in the NYU Department of Chemical and Biomolecular Engineering within the Tandon School of Engineering. McDevitt is a pioneer in the development of ‘programmable bio-nano-chip’ technologies. He has a strong track record of translating essential bioscience discoveries into real-world clinical practice. In this capacity, he serves as the Scientific Founder for three diagnostic companies. His most recent company, SensoDx, features a universal platform sensor technology with capacity to digitize biological signatures for a broad range of key health conditions. McDevitt and his team has raised over $45M in Federal and Foundation support. His recent research has been sponsored by major programs funded by the National Institute of Dental and Craniofacial Research (NIDCR) division of the National Institutes of Health (NIH), the Bill and Melinda Gates Foundation, Cancer Prevention Research Institute of Texas (CPRIT), the National Aeronautics and Space Administration (NASA), the Army and the United Kingdom’s Home Office Scientific Development Branch. McDevitt and his team have written more than 200 peer-reviewed scientific manuscripts and have contributed to more than 100 patents and patent applications. This work was recognized with the “2016 AACC Wallace H. Coulter Lectureship Award,” “Best of What's New Award” in the Medical Device Category for 2008 by Popular Science as well as for the “Best Scientific Advances Award” in 1998 by the Science Coalition. Dr. McDevitt’s individual honors include the Presidential Young Investigator Award, the 2010 California Polytechnic Distinguished Alumni Award and the Exxon Education Award. Over the past 7 years, Dr. McDevitt has served as the Principal Investigator for 6 major clinical trials and 2 clinical pilot studies, all involving the programmable bio-nano-chip. Through these clinical efforts, mini-sensor ensembles are being developed for major diseases in the areas of oral cancer, cardiac heart disease, trauma, drugs of abuse, ovarian cancer and prostate cancer.

Paul Smith, Chief Executive Officer, ANGLE Biosciences Inc.

Paul Smith is the CEO of ANGLE Biosciences, Inc., a subsidiary of ANGLE plc focused on the development and commercialization of multiplex biomarker tools. Most recently serving as President and CEO of Axela Inc., he has more than 35 years of experience in the life science and diagnostic instrumentation field with a diverse background in management, sales, marketing and field operations. A major focus has been commercializing new technologies through collaborative partnerships with academic, pharmaceutical and industrial clients for both established companies and start-ups.

MARIO SUVÀ is a scientist in the Department of Pathology at Massachusetts General Hospital (MGH) and at the Broad Institute of MIT and Harvard. Suvà’s expertise is in neuro-oncology, single-cell genomics and chromatin analysis. Suvà's laboratory focuses on the biology of diffuse gliomas, both in adults and children. A particular effort of the laboratory is on dissecting the heterogeneity of patient tumors and relating transcriptional and genetic programs of individual cancer cells. Suvà co-directed landmark studies characterizing glioblastoma, oligodendroglioma and astrocytoma with single-cell genomic technologies, shedding light on tumor heterogeneity, tumor classification, glioma cell lineages, cancer stem cell programs, tumor evolution and the composition of the tumor microenvironment. Suvà obtained his PhD degree in the laboratory of Ivan Stamenkovic in Lausanne, Switzerland, studying cancer stem cells in gliomas and sarcomas. He earned his MD from the University of Lausanne and his certification in Neuropathology from the Swiss Medical Association. He did his post-doctoral research at MGH and the Broad Institute with Brad Bernstein and David Louis, applying chromatin analysis and functional approaches to identify master regulators of glioma stem cell programs.

Lance U’Ren, DVM, PhD, Principal Scientist, RareCyte

Dr. U’Ren is a principal scientist at RareCyte where he leads the Immuno-Oncology applications of their technologies. He received his DVM and PhD degrees from Colorado State University where he investigated how innate immune cells promote tumor angiogenesis within the tumor microenvironment and was active in the development of a novel liposomal-based cancer vaccine platform. He did his post-doctoral training at the University of Colorado Denver and National Jewish Health where he studied T cell metabolism within the context of the tumor microenvironment.

Akos Vertes, PhD, D.Sc., Professor of Chemistry, Professor of Biochemistry and Molecular Biology, Department of Chemistry, George Washington University

Akos Vertes is a Professor of Chemistry and a Professor of Biochemistry and Molecular Biology at the George Washington University in Washington, DC. His research interests encompass the development of new analytical techniques applicable in diverse fields of chemistry, biology, and medicine. Research areas include high throughput methods in systems biology for rapid mechanism of action studies, new methods for molecular imaging of biological tissues under native conditions, and single cell and subcellular analysis. One of his major accomplishments, a new ambient ionization method called laser ablation electrospray ionization (LAESI), received several awards, including a “Top 10 Innovations of 2011” award from The Scientist magazine, and a “2012 R&D 100 Award” from the R&D Magazine. His research has been presented in over 160 peer-reviewed publications, and in two books. He is a co-inventor on 17 patents and several pending patent applications. He was elected Fellow of the National Academy of Inventors, and received the 2016 Distinguished Researcher Award at GWU, the 2012 Hillebrand Prize, and the 2007 Oscar and Shoshana Trachtenberg Prize for Scholarship. He is a Doctor of the Hungarian Academy of Sciences. He served as Visiting Faculty at the Lawrence Berkeley National Laboratory and as a Visiting Professor at the Swiss Federal Institute of Technology Zurich (ETH Zurich) in Switzerland.

Shan X. Wang, PhD, Professor, Materials Science and Engineering, and Electrical Engineering, Stanford University

Shan X. Wang currently serves as a Professor and Associate Chair of Materials Science & Engineering and jointly Professor of Electrical Engineering at Stanford University, and by courtesy, a Professor of Radiology at Stanford School of Medicine. He directs the Center for Magnetic Nanotechnology, and is a co-Principal Investigator of the Center for Cancer Nanotechnology Excellence for Translational Diagnostics (CCNE-TD) at Stanford University. He has over 270 publications, and holds 56 issued or pending patents in the areas of magnetic nanotechnology, biosensors, nanofabrication, spintronics, power management and information storage. Dr. Wang was elected a Fellow of the Institute of Electrical and Electronics Engineers (IEEE, 2009) and a Fellow of American Physical Society (APS, 2012) for his seminal contributions to magnetic materials and nanosensors. He has received numerous other awards, including most recently the Bold Epic Innovator (BEI) Award in the XPRIZE Qualcomm Tricorder Competition (April 2017). He obtained the PhD degree in electrical and computer engineering from Carnegie Mellon University, Pittsburgh, PA, USA, in 1993

Xiaodong Xiao, PhD, Director, Biologics Discovery, Biologics Lead Discovery, Bristol-Myers Squibb

No biography available

Companion and Complementary Diagnostics in Immuno-Oncology

Jeff Allen, PhD, President, CEO, Friends of Cancer Research

Jeff Allen, PhD serves as the President and CEO of Friends of Cancer Research (Friends). During the past 20 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As a thought leader on many issues related to Food and Drug Administration, regulatory strategy and healthcare policy, he is regularly published in prestigious medical journals and policy publications, and has contributed his expertise to the legislative process on multiple occasions. Recent Friends initiatives include the establishment of the new Breakthrough Therapies designation and the development of the Lung Cancer Master Protocol, a unique partnership that will accelerate and optimize clinical trial conduct for new drugs. Dr. Allen received his PhD in cell and molecular biology from Georgetown University, and holds a Bachelor of Science in Biology from Bowling Green State University.

Jonathan Baden, Director, Pharmacodiagnostics, Translational Medicine, BMS

Jon Baden joined the BMS Precision Medicine Pharmacodiagnostics team in 2017 to support Translational Medicine teams requiring Pharmacodiagnostic assay development on NGS platforms with specific focus on tumor mutational burden assays. Jon came to BMS from Janssen Pharmaceuticals where he led IVD strategies aligned with therapeutic disease areas for the development of stand-alone and companion diagnostics. At Janssen, Jon orchestrated alignment with matrix teams both with internal and external partners for the management, execution and resolution of assay process for all stages of the product development life cycle. Jon has expertise in oncology disease states, autoimmune, and infectious diseases. Jon has managed MDx teams (NGS, PCR) in exploratory through late stage assay development. Jon received his M.S. degree in Microbiology, University of Rochester Medical Center and also holds a B.S. degree in Biotechnology from Rochester Institute of Technology.

Tricia Bal, MD, MBA, Oncology Biomarker and Diagnostics Leader, Oncology Global Medical Affairs, Merck

Dr. Bal is currently a Biomarker and Diagnostics Leader at Merck and is responsible for leading and executing the Biomarker and Diagnostics Medical Affairs strategy. She entered the diagnostics industry in 2006 and has worked for Siemens Healthcare Diagnostics and Ventana Medical Systems in various roles including responsibilities and activities for ALK and PD-L1 companion/complementary diagnostics. She received her MD from University of Michigan Medical School. She completed an internship in urology at Upstate Medical Center, New York and an internship in pathology at Harbor-UCLA, California. She has also completed two postdoctoral fellowships in molecular oncology and molecular biology at the Salk Institute and University of Southern California, and has an MBA from Pepperdine University, California.

Jonathan Beer, Director, FPM Lead of Disruptive Technologies, Novartis Precision Medicine Center of Excellence

Jonathan Beer is the Director of the Disruptive Technologies Team in the Oncology Precision Medicine division of Novartis Global Drug Development where he oversees a team of scientists who identify and evaluate new and emerging diagnostic methods and vendors for potential use in clinical trials. For the past 7 years he has been a core team member of the Novartis Breast Disease Area responsible for the diagnostic strategy of clinical trials for several compounds and has contributed to multiple Investigational Device Exemption and CDx Pre-Market Approval submissions to the FDA.

René Castro, PhD, Senior Vice President, Biopharma Business Development, Foundation Medicine, Inc.

René Castro is the Senior Vice President, Biopharma Business Development at Foundation Medicine, Inc. (FMI) and has more than 15 years of experience in the healthcare and life sciences industries, focused on business and corporate development, strategy, licensing, M&A and financing transactions. At FMI, René leads the business development group which is responsible for sourcing, executing and growing partnerships with biopharmaceutical companies. Prior to joining FMI, René was a Senior Vice President at McKesson Corporation leading strategy, corporate development and M&A for its medical-surgical business. Before that, he served in senior corporate development positions at Harvard University, RaNA Therapeutics, Anza Therapeutics and Exelixis, and was a consultant to biopharmaceutical companies and venture capital firms. He also worked as an investment banker in the healthcare group at Goldman, Sachs & Co., advising clients across the healthcare industry on corporate finance matters. René earned a Bachelor’s Degree in music performance and a Ph.D. in organic chemistry from the University of Miami, an MBA from Dartmouth College, and was a post-doctoral fellow at the Scripps Research Institute.

Kenneth Emancipator, MD, Executive Medical Director and Head of Companion Diagnostics, Translational Medicine, Merck

Dr. Emancipator led the Merck team which partnered with Agilent Technologies to develop the 22C3 PD-L1 immunohistochemistry test which identifies those non-small cell lung cancer patients most likely to benefit from Keytruda® (pembrolizumab), which is the first FDA-approved companion diagnostic in cancer immunotherapy, and which enabled Keytruda to become the first immunotherapy to be approved for first-line treatment of lung cancer. He was one of six members of the Keytruda Team to receive the 2015 PhRMA Research and Hope Award for Biopharmaceutical Industry Research on behalf of Merck. His has held positions at National Institutes of Health, Cornell University Medical College, Beth Israel Medical Center (NY), and Bayer Healthcare. He is a former officer of the American Society for Clinical Pathology, and is a regular reviewer for the American Journal of Clinical Pathology. His credits include more than 100 papers and abstracts, and more than 100 extramural presentations.

Fritz Eibel, MBA, Senior Vice President, MolecularMD

Fritz Eibel brings more than two and a half decades of broad-based in vitro diagnostics and life science experience focused primarily on new and emerging growth opportunities. At MolecularMD he is responsible for the company’s marketing strategy and management, new product launch and commercialization, and development of joint ventures, affiliations and partnerships that support long-term growth.

Joseph V. Ferrara, MS, CEO, Boston Healthcare Associates

Mr. Ferrara has over 20 years of experience in life sciences consulting, working with biopharmaceutical, medical device, diagnostics, and informatics clients in market and business development strategy. Mr. Ferrara has expertise in the value of medical technology innovation, with a focus on pharmacogenomics, specialty pharmaceuticals, and novel therapeutic devices.

Alberto Gutierrez, PhD, Partner, NDA Partners LLC, Former Director, Office of In Vitro Diagnostics and Radiological Health, FDA

Alberto Gutierrez, PhD, was most recently the Director of FDA’s Office of In Vitro Diagnostic Device Evaluation and Safety. Dr. Gutierrez received a bachelor’s degree from Haverford College, and master and doctorate degrees in Chemistry from Princeton University. Dr. Gutierrez has over 10 years of experience in research in the area of structural organic and organometallic chemistry. Dr. Gutierrez joined the FDA in 1992 as researcher and reviewer in FDA’s Center for Biologics Evaluation and Research working on vaccine adjuvants and method development for determination of purity and structure of vaccine components. In 2000, he joined the Office of In Vitro Diagnostic Device Evaluation and Safety as a scientific reviewer, becoming a Team leader for Toxicology in 2003, Director of the Division of Chemistry and Toxicology Devices in 2005 and Deputy Director of the Office of In Vitro Diagnostic Devices in 2007 and Director in 2009.

Marc Ladanyi, MD, William J. Ruane Chair in Molecular Oncology, Molecular Diagnostics Service and Human Oncology & Pathogenesis Program, Memorial Sloan Kettering Cancer Center

Dr. Marc Ladanyi, a graduate of McGill University Faculty of Medicine, is the attending pathologist and chief of the Molecular Diagnostics Service at Memorial Sloan Kettering Cancer Center (MSKCC) and a professor in its Human Oncology & Pathogenesis program. He also holds the endowed William Ruane Chair in Molecular Oncology. As chief of Molecular Diagnostics Service at MSKCC, he oversees the large-scale genetic analysis of patient tumor samples based on a variety of next-generation DNA sequencing technologies, providing the foundation for MSKCC’s cutting-edge precision oncology efforts in cancer care and clinical trials. He also directs a research group that studies lung cancer, mesothelioma, and several types of pediatric and young adult sarcomas to better understand their genetic basis and to find therapeutic targets.

Theresa LaVallee, PhD, Head of Translational Medicine, The Parker Institute for Cancer Immunotherapy

Theresa LaVallee, PhD, joined the Parker Institute for Cancer Immunotherapy in 2017 as head of translational medicine and regulatory affairs. She has more than 25 years of research and industry experience, with broad knowledge of drug discovery and development. Previously, Dr. LaVallee served as Senior Vice President of Regulatory and Precision Medicine at Celldex Therapeutics and Senior Vice President of Translational Medicine and Product Development at Kolltan Pharmaceuticals. Prior to those roles, she was Senior Director Translational Medicine at MedImmune and EntreMed. In these positions, she advanced drugs in oncology, immunology and inflammation from discovery through late stage development. Dr. LaVallee has a depth of expertise in translational medicine to enable science-driven development decisions and to implement effective use of biomarker assays in clinical studies. She is author or co-author of more than 50 publications and abstracts with a focus on translational medicine approaches in clinical development. She received her doctoral degree in microbiology and molecular genetics from the University of California, Los Angeles and her bachelor’s degree in biochemistry and molecular biology from the University of California, Santa Barbara. Dr. LaVallee completed her postdoctoral research at the American Red Cross Holland Laboratory.

Caroline Popper, MD, President, Popper and Company

The president and co-founder of Popper and Company, has 25 years of hands-on global biotech/life sciences operating experience. An internist and pathologist, she combines this clinical perspective with that gained from managing a wide spectrum of healthcare and life sciences businesses in diagnostics, devices and drug discovery. Trained further in health economics and health policy, she consults frequently on issues pertaining to cost-effectiveness of new technology, impact of diagnostics on therapeutic use and impact on total cost of episode of care and how these drive reimbursement strategies. With co-founder Ken Walz she has advised many private companies in the sector on their M&A activities and led the implementation of these strategies.

Janaki Veeraraghavan, PhD, Senior Staff Fellow, FDA

No biography available

Wendy Rubinstein, MD, PhD, Division Director, Clinical Data Management and Curation, CancerLinQ, LLC, American Society of Clinical Oncology

Dr. Wendy Rubinstein is Deputy Medical Director of CancerLinQ, a not-for-profit subsidiary of the American Society of Clinical Oncology (ASCO). During her five-year tenure at the National Institutes of Health, Dr. Rubinstein was Senior Scientist, Director of the NIH Genetic Testing Registry (GTR) and Chief of Medical Genetics and Human Variation at the National Center for Biotechnology Information (NCBI) where she was responsible for GTR, ClinVar, dbSNP, dbGaP, and other flagship resources. She was a representative to the NIH-FDA-CMS Trilateral Genomic Medicine Workgroup and FDA-NIH Interagency Task Force on Laboratory Developed Tests, and received the NIH Director’s Award for developing and launching GTR. Dr. Rubinstein has 15 years’ experience directing cancer genetics programs and has been a member of three NCI-designated Comprehensive Cancer Centers. She holds dual certification in clinical genetics and clinical molecular genetics (ABMG) and is a Fellow of the American College of Medical Genetics and the American College of Physicians.

Companion Diagnostics: Strategy & Partnership

J. Carl Barrett, PhD, Vice President, Translational Sciences, Onc iMed, AstraZeneca

I am Vice President of Translational Science in the Oncology Innovative Medicines Division at AstraZeneca Pharmaceuticals. My responsibility is to develop and execute biomarker strategy and translational sciences efforts to support compound development from research through early and full development in oncology.

Joseph Chin, MD, MS, Deputy Director, Coverage and Analysis Group, Center for Clinical Standards and Quality, Centers for Medicare & Medicaid Services (CMS)

No biography available

Jason Christiansen, PhD, VP, Diagnostics, Ignyta, Inc

Jason Christiansen is the Vice President of Diagnostics for Ignyta. His teams drive the companion diagnostic strategies, test development and applications to support Ignyta’s various therapeutic pipelines. This includes testing in Ignyta’s CLIA/QSR laboratory or working to collaborate and develop different platforms among the clinical trial sites. Prior to Ignyta, Dr. Christiansen was Sr. Director of Assay Development at Genoptix/Novartis, bringing multiple testing platforms, including NGS and digital pathology, into clinical use. Earlier, he led operations and diagnostic development efforts at other biotechnology companies (i.e., HistoRx, Protedyne, Molecular Staging). He received his PhD in Biophysics from the University of California.

Mark Curran, PhD, Vice President, Companion Diagnostics, Janssen R&D

Dr. Curran is currently Vice President of Immunology at Janssen Research & Development, LLC. He leads the Companion Diagnostics and Digital Healthcare strategy for Immunology and is a Development Team leader for multiple clinical assets. Mark’s experience in drug and diagnostic development spans over 25 years in biotech, venture and pharma. Mark earned his doctorate in Human Genetics at the University of Utah, has co-authored over 50 scientific publications and holds multiple patents. He has contributed seminal discoveries in the field of heritable cardiac arrhythmias and co-developed the Familion™ diagnostic test for long QT syndrome. His primary interests are discovery of novel therapeutics, implementation of molecular diagnostics for personalized medicine and evolution of Digital Health Care and Integrated Patient Care Solutions to improve the lives of all patients living with auto-immune disease.

Nicholas Dracopoli, PhD, Senior Vice President, Translational Science, Personal Genome Diagnostics

Dr. Nicholas Dracopoli joined Personal Genome Diagnostics in January 2018. Previously he was Vice President, Head Oncology Translational Research and Oncology Diagnostics at Janssen R&D. In these roles he was responsible for biomarker discovery, development and applications for oncology products. Previously, he was Vice President of Clinical Discovery Technologies at Bristol-Myers Squibb, and prior to that spent five years in the biotechnology industry at Sequana Therapeutics. Dr Dracopoli obtained his B.Sc. and PhD degrees from the University of London, and completed post-doctoral fellowships at the Memorial Sloan-Kettering Cancer Center and the Massachusetts Institute of Technology. Subsequently, he served as an Assistant Director at the Whitehead/MIT Genome Center, and as a Section Chief at the National Center for Human Genome Research at the NIH before moving to the biotechnology industry. Dr Dracopoli has authored >80 scientific publications, and has extensive experience in the fields of genomics, molecular biology and cancer research.

Soma Ghosh, PhD, Scientific Reviewer, FDA/CDRH/OIR/DMGP

Dr. Ghosh is a regulatory reviewer in the Division of Molecular Genetics and Pathology, in CDRH’s Office of In Vitro Diagnostics and Radiological Health. In this role, she has been actively involved in reviewing pre-market submissions, including submissions on molecular devices and companion diagnostic devices. Prior to her FDA career, she was a senior research fellow at the Sidney Kimmel Comprehensive Cancer Center in Johns Hopkins Medical Institute, where she worked on developing sequencing-based assays that had a potential in supporting clinical decision making in cancer therapy and management. Dr. Ghosh also performed post-doctoral research on understanding the molecular mechanisms that regulate cellular DNA replication during animal development at the National Institutes of Health (NIH/NICHD) after completing her PhD in molecular biology at J.N.U., in New Delhi, India.

Matthew Hawryluk, PhD, Executive Vice President and Chief Business Officer, Gritstone Oncology

Dr. Matthew Hawryluk serves as executive vice president and chief business officer and leads partnering activities. Prior to Gritstone, he served as vice president of corporate and business development at Foundation Medicine, where he led the biopharmaceutical business and a team responsible for business development, strategic alliances and operations. While there, Dr. Hawryluk forged partnerships with dozens of biopharma companies, providing comprehensive genomic profiling for clinical trials, molecular information, and companion diagnostics. Previously, he held roles in business development, marketing and product management across multiple divisions of Thermo Fisher Scientific. Dr. Hawryluk earned a PhD in cell biology and protein biochemistry from the University of Pittsburgh School of Medicine, an M.B.A. at Carnegie Mellon University’s Tepper School of Business as a Swartz Entrepreneurial Fellow, and a B.S from the University of Notre Dame.

Myla Lai-Goldman, MD, Chief Executive Officer, GeneCentric Therapeutics, Incand

Dr. Lai-Goldman is the Chief Executive Officer and President of GeneCentric Therapeutics. She is also a founder and director of the Company. Dr. Lai-Goldman spent more than 18 years at Laboratory Corporation of America, Holdings (LabCorp), the last 10 years as Executive Vice President, Chief Medical Officer and Chief Scientific Officer. She served on LabCorp’s Executive and Management Committees, with strategic and operations responsibilities for 3 major genomic laboratories comprising more than 700 people. During her tenure at the Company, she led all clinical, scientific and medical activities, including the introduction of more than 400 clinical assays. Her experience includes the development of partnerships, licensing, and acquisitions. After leaving LabCorp, Dr. Lai-Goldman became a Venture Partner at Hatteras Venture Partners and is the managing partner of Personalized Science, LLC, a consulting company founded to assist customers achieve successful adoption of innovative diagnostics. Dr. Lai-Goldman received her BS from the University of Pennsylvania and MD from Columbia University College of Physicians and Surgeons. Dr. Lai-Goldman is Board-certified in anatomic and clinical pathology.

Eric Lai, PhD, Partner, Personalized Science, LLC

Dr. Eric Lai is currently a partner at Personalized Science LLC. From 2012 – 2017 he was Senior Vice President and Head of Genomic Medicine at Takeda Pharmaceutical. Before he joined Takeda, he was the SVP and Head of Research and Development at Gen-Probe (now part of Hologic Inc) from 2009 – 2012 and before that he was the VP of Pharmacogenetics at GlaxoSmithKline for over 13 years. Dr. Lai received his PhD, from Columbia University and did his post-doctoral training at Dr. Lee Hood’s laboratory at CalTech in the early days of the Human Genome Project. He was the co-scientific leader of The SNP Consortium and the Severe Adverse Reaction Consortium. For almost 20 years, Dr. Lai has focused his efforts in the clinical application of Pharmacogenomics in drug development and drug safety. In 2002, Dr. Lai discovered the association of HLA5701 to Abacavir hypersensitivity reaction and oversaw the clinical development and application of this test. The Abacavir HLA5701 discovery significantly improved the benefit-risk relationship by identifying patients at high risk for a serious drug adverse reaction and is frequently quoted in FDA guidance as one of the most important demonstration of precision medicine.

Jonathan Lim, MD, CEO, Ignyta, Inc.

Jonathan Lim, MD co-founded Ignyta, Inc. (NASDAQ: RXDX) in August 2011 as Chairman, and subsequently joined the company full-time in July 2012 as President and Chief Executive Officer. Under his leadership, the company went public in 2013, has raised over $350 million from financings and corporate transactions, and is focused on building a cancer precision medicine company aspiring to eradicate residual disease in precisely defined patient populations by 2030. Dr. Lim is also a member of the Board of Visitors of the Moores Cancer Center at the University of California, San Diego. In March 2011, Dr. Lim co-founded and most recently served as Chairman and CEO of Eclipse Therapeutics, a Biogen Idec spinout. Eclipse was successfully sold to Bionomics Ltd (ASX:BNO) in a transaction that closed in September 2012, and Dr. Lim subsequently served as a member of the Board of Directors of Bionomics for three years, until November 2015. Dr. Lim’s prior experience includes President, CEO and Director of Halozyme Therapeutics, Inc. (NASDAQ: HALO), management consulting at McKinsey & Company, NIH Postdoctoral Fellowship at Harvard/Dana Farber Cancer Institute, and two years of general surgery residency at New York Hospital-Cornell and Memorial Sloan Kettering Cancer Center.

John Lubniewski, President, COO, HTG Molecular

Mr. Lubniewski has recently served as our Chief Business Officer since April 2011. He joined HTG from Ventana, a medical diagnostics company and member of the Roche Group and global headquarters of Roche Tissue Diagnostics, or RTD. During his time at Ventana, Mr. Lubniewski served in several senior leadership roles and was responsible for marketing and global accountability for all clinical assay products. Prior to the acquisition by Roche, Mr. Lubniewski was responsible for a variety of assay and platform development and commercialization efforts across the company. Prior to Ventana, Mr. Lubniewski spent over a decade working at Corning, Inc., a manufacturing company, in a variety of roles including divisional, sector, and corporate sales, and marketing roles. Mr. Lubniewski earned a B.S. in Chemical Engineering from Clarkson University.

Brad Nohe, Head of Lupus, Global Product and Portfolio Strategy, AstraZeneca

Brad Nohe currently is Head of Lupus, Global Product and Portfolio Strategy at AstraZeneca. He is responsible for global commercialization of anifrolumab, a Phase III monoclonal antibody being studied for lupus. Previously, Brad spent 8 years at Takeda Pharmaceuticals, including playing a central role in the successful global launch of Entyvio for the treatment of ulcerative colitis and Crohn's disease. Brad also worked in biopharmaceutical commercialization at Genentech and management consulting at ZS Associates. Brad received an A.B. degree in Philosophy from the College at the University of Chicago and an M.B.A degree from the University of Chicago Graduate School of Business, where he graduated with concentrations in Strategic Management and Marketing Management.

Eric Peters, PhD, Director, Head, Companion Diagnostics, Genentech

Eric Peters is currently Director and Head of Companion Diagnostics at Genentech. His group is responsible for the development and implementation of CDx assay development strategies to further the therapeutic molecule development pipeline. His group works closely with internal and external diagnostic partners to meet co-development goals. Prior to joining Genentech in 2012, Eric was a project team leader at Illumina. While there, he led a team focused on the development of next-generation diagnostic and CDx assays and platforms. His work included leading the team responsible for the development of the first FDA-cleared NGS platform (MiSeqDx). Eric obtained a PhD in Pharmaceutical Sciences and Pharmacogenomics from the University of California at San Francisco. He subsequently completed postdoctoral training in cancer pharmacogenomics at the University of North Carolina.

Julie Ramage, National Account Director, Diagnostics, Pfizer Oncology

23 years in the lab industry in various sales leadership roles and a focus in pathology at labs such as Nichols Institute, Quest Diagnostics, US Labs, NeoGenomics, and PhenoPath. Board member and Past President of the California Clinical Lab Association. A pivot into pharma in Pfizer Oncology occurred 4 years ago when a unique position was created for providing subject matter expertise in diagnostics and testing. The position includes a focus on working with the commercial labs, community pathologists, reimbursement in diagnostics and policy expertise in the lab and diagnostic community that impacts test to treat. I’ve been actively involved in data acquisition from the commercial labs and analyzing the content along with developing and working with data work streams throughout the oncology portfolio.

Debra J. Rasmussen, Global Regulatory Affairs Diagnostic Leader, Johnson & Johnson Company

Debra J. Rasmussen supports regulatory affairs for Janssen Diagnostics. In this role, she is responsible for development of regulatory strategy, policy and registration of the in vitro diagnostic devices associated with Johnson & Johnson drug development and commercialization. For Janssen, both companion and complementary diagnostics and mobile medical applications regulatory strategy and expertise are driven by the Global Regulatory Affairs Diagnostics group. Deb’s regulatory and quality career has spanned both large and small companies and both United States and global programs. She has been in diagnostics for more than 25 years and gained her experience working at Bio-Rad Laboratories, Roche Molecular Systems, Chiron Corporation (now Novartis), Applied Imaging Corporation and Visible Genetics. She holds an M.B.A. from St. Mary’s College in Maryland and a Bachelor of Science degree in Bacteriology/Immunology from the University of California, Berkeley.

Cecilia Schott, PhD, Vice President, Precision Medicine, AstraZeneca

Cecilia Schott is VP, Precision Medicine for AstraZeneca Global Product & Portfolio Strategy. Cecilia and her team are responsible for establishing external global collaborations and partnerships for diagnostic development and commercialization alongside AstraZeneca’s portfolio. Prior to her current role Cecilia held positions Global Marketing and US Medical Affairs. Cecilia background includes roles in the biotech and device industries. Before joining AstraZeneca, she was part of Biogen’s Drug Safety and Medical Information function, and at Boston Scientific she was responsible for establishing the drug eluting stent franchise Medical Publications and Medical Information groups as part of Medical Affairs. Cecilia holds a BS in Pharmacy from University of Sao Paulo, Brazil; a Doctor of Pharmacy degree from the Massachusetts College of Pharmacy, Boston, and a MBA from Babson College, Boston.

Jorge S. Villacian, CMO, Janssen Diagnostics

Jorge Villacian is Chief Medical Officer at Janssen Diagnostics, developing diagnostic solutions spanning across companion diagnostics as well as novel diagnostics in the areas of focus for Johnson & Johnson, including infectious, metabolic, immunologic, neurologic, oncologic diseases and global public health. Previously, Jorge worked for Tibotec-Virco developing solutions to manage HIV and other infectious diseases. He established the Medical Department at Virco, including a diagnostic biostatistics and clinical virology groups as well as the management of a diagnostic laboratory performing collaborative work with multiple pharmaceutical companies for clinical development of compounds in hepatitis C and HIV. Before this, Jorge lead international clinical development studies of a new protease inhibitor for treatment of HIV with Boehringer Ingelheim.

Coverage and Reimbursement for Advanced Diagnostics

Jim Almas, MD, Medical Director, MolDX, PalmettoGBA

Dr. Almas was a Medical Officer at CMS (CAG) and now serves as the Medical Director of the MolDX Program. He is a graduate of Stanford University and received his MD from Columbia University. He is a board-certified pathologist.

Chandra Branham, Vice President, Payment and Health Care Delivery Policy, AdvaMed

Chandra Branham, J.D., joined the Advanced Medical Technology Association (AdvaMed) as Vice President, Payment and Health Care Delivery Policy, in 2011. Ms. Branham leads AdvaMed’s policy work in a number of areas, including diagnostics payment, coverage issues, and comparative effectiveness. Prior to joining AdvaMed, Ms. Branham was an associate at large D.C. law firm where she focused on healthcare regulatory and legislative issues involving Medicare coverage, coding, reimbursement and quality for providers and suppliers of Medicare items and services. Ms. Branham previously was a senior legislative analyst at the Centers for Medicare & Medicaid Services (CMS) Office of Legislation; and early in her career, served as associate director of regulatory affairs at the National Association for Home Care. Ms. Branham has a Bachelor of Science from Drexel University and a J.D. from the George Mason University School of Law.

Shivang Doshi, MSc, Director, Boston Healthcare Associates

Mr. Doshi has worked with a variety of pharmaceutical and diagnostics innovators on issues related to market access, evidence development and reimbursement strategies of novel diagnostic technologies. Mr. Doshi has specific expertise in value-based molecular assays, companion diagnostics, and informatics tools that support delivery of precision medicine. Mr. Doshi has a Master of Public Health from Harvard School of Public Health and a Master’s degree in Biotechnology from Johns Hopkins University.

Robert Dumanois, Manager, Reimbursement Strategy, Thermo Fisher Scientific

Rob has over 20 years’ experience working with payers, providers, and CLIA labs. His current role includes design and execution of reimbursement strategies for Oncomine™ Dx Target Test: the first FDA-approved next-generation sequencing (NGS) in vitro diagnostic test for non-small cell lung carcinoma (NSCLC), offering clinically actionable and analytical cancer-driver biomarker information to inform treatment decisions. This is a multi-marker companion diagnostic, developed in partnership with Pfizer and Novartis. Rob joined Thermo Fisher (formerly Life Technologies) in 2012, through an acquisition of Navigenics – where he led development and account growth of health plans, large employers, and voluntary benefit providers. Rob was also a Territory Vice President at RelayHealth, with duties that included payer-facing sales of solutions that included e-prescribing and webVisits. And prior to RelayHealth, Rob held senior sales and sales management positions with UnitedHealthcare.

Louis Jacques, MD, SVP and Chief Clinical Officer, ADVI

Louis Jacques, MD is Chief Clinical Officer and a Senior Vice President at ADVI, a health care advisory services firm, where he is also a partner. He also serves on several institutional boards and advisory panels. Before joining ADVI in 2014, Dr. Jacques was the Director of the Coverage and Analysis Group (CAG) in the Centers for Medicare & Medicaid Services (CMS) from 2009 - 2014, where he managed Medicare fee for service coverage policy development on technologies as diverse as molecular diagnostic testing, implanted cardiac devices, advanced imaging, chemotherapeutics, wound care, and screening and preventive services. From 2004 – 2009 he was a division director within CAG, focusing on Part B drugs and diagnostic tests. Before joining CMS in 2003, he served as the Associate Dean for Curriculum at Georgetown University School of Medicine; where he also saw patients at the Lombardi Cancer Center in his practice of hospice and palliative medicine.

Eugean Jiwanmall, MPH, MBA, Senior Research Analyst, Technology Evaluation and Medical Policy, Independence Blue Cross

No biography available

Roger Longman, CEO, RealEndpoints

Mr. Longman is recognized as an expert in biopharmaceutical strategy and reimbursement and often speaks at key industry events organized by important trade organizations, investment banks, venture capital firms, and leading biopharma companies. His most recent focus has been on new value-based approaches to paying for drugs and diagnostics, harnessing tools and systems for objective, transparent analysis of drug value and economic impact. He is developing these initiatives in collaboration with major provider, payer, pharmaceutical and diagnostic companies, and patient organizations. Mr. Longman has been involved with the health-care industry for more than 30 years. At his first venture, Windhover Information, he and his team created a number of industry-standard analytical sources, including must-read strategy publications such as IN VIVO and Start-Up, the strategic transactions database and a major conference business for senior executives. The business was acquired by Elsevier where for two years Longman ran the company’s pharmaceutical business information group. Mr. Longman lectures regularly at several leading universities and co-directed the Wharton-Windhover pharmaceutical program at The Wharton School. Mr. Longman completed his BA at Cornell University and MBA at the University of North Carolina at Chapel Hill, then taught for three years at the European division of the University of Maryland.

Hisani Madison, PhD, MPH, Senior Scientific Reviewer, Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration

Hisani Madison is a senior scientific reviewer in the Office of In Vitro Diagnostics and Radiological Health (OIR) at the Center for Devices and Radiological Health (CDRH) in the Food and Drug Administration (FDA). Dr. Madison leads the review of submissions in the Molecular Pathology and Cytology Branch as part of the Division of Molecular Genetics and Pathology (DMGP). The Molecular Pathology and Cytology Branch is responsible for reviewing a wide range of devices including next generation sequencing technologies and hybridization-based molecular techniques to detect genetic alterations associated with cancer. Dr. Madison specializes in review of devices intended to aid in selection of therapy for patients with solid tumors. Prior to her current position, Dr. Madison was a postdoctoral fellow in the Hormonal and Reproductive Epidemiology Branch of the Division of Cancer Epidemiology and Genetics at the National Cancer Institute where she conducted molecular epidemiologic research focusing on breast cancer etiology and heterogeneity. Dr. Madison obtained her PhD in Pathology from Duke University, where her doctoral research focused on identifying and characterizing genetic and epigenetic markers for the early detection, prognosis and prediction of breast and ovarian cancer. She also has an M.P.H. from Johns Hopkins Bloomberg School of Public Health where she trained in epidemiology and biostatistics and received a Certificate in Health Disparities and Health Inequality.

Gary Martucci, Senior Vice President, Payer Relations & Reimbursement Strategy, Foundation Medicine

No biography available

Tyler Merkeley MS, MBA is the interim Director of the Division of Research, Innovation, and Ventures (DRIVe) responsible for Transforming Health Security at the Biomedical Advanced Research and Development Authority’s (BARDA) within U.S. Department of Health and Human Services (HHS).

Tyler joined BARDA in 2009 as a Health Scientist to accelerate the advanced research and development, procurement, stockpile and sustainment of medical countermeasures (MCM) against biological, chemical, radiological, and nuclear (CBRN) agents under Project BioShield.  Tyler’s expertise is in building and then leading novel public private partnerships in national security. During his tenure at BARDA he has led the smallpox antiviral procurement, co-founded HHS’s Combating Antibiotic Resistant Bacteria (CARB) Accelerator [CARB-X] initiative, managed BARDA’s 1^st agreement using Other Transaction Authority (OTA), served as the Acting Chief of Staff for BARDA and most recently supported the design  and launch of BARDA’s newest Division DRIVe.

Tyler Merkeley, BARDA’s CARB-X Program Manager, Health Scientist, Division of CBRN Countermeasures, BARDA

Tyler Merkeley MS, MBA is the interim Director of the Division of Research, Innovation, and Ventures (DRIVe) responsible for Transforming Health Security at the Biomedical Advanced Research and Development Authority’s (BARDA) within U.S. Department of Health and Human Services (HHS). Tyler joined BARDA in 2009 as a Health Scientist to accelerate the advanced research and development, procurement, stockpile and sustainment of medical countermeasures (MCM) against biological, chemical, radiological, and nuclear (CBRN) agents under Project BioShield. Tyler’s expertise is in building and then leading novel public private partnerships in national security. During his tenure at BARDA he has led the smallpox antiviral procurement, co-founded HHS’s Combating Antibiotic Resistant Bacteria (CARB) Accelerator [CARB-X] initiative, managed BARDA’s 1st agreement using Other Transaction Authority (OTA), served as the Acting Chief of Staff for BARDA and most recently supported the design and launch of BARDA’s newest Division DRIVe.

Lee Newcomer, MD, Consultant

Lee N. Newcomer, MD spends his time creating new approaches to make cancer care more effective and affordable. He utilizes expertise in medical oncology, health plan strategy and operations, health services research, finance and communications to find disruptive methods for improved care of cancer patients. The majority of his career was with UnitedHealth Group. He was their Chief Medical Officer with responsibilities for clinical services, Medicare and Medicaid from 1991 to 2001. He focused his later work on the development of performance measures and incentives for the improvement of clinical care. He returned in 2006 to lead an initiative combining clinical, financial and program management experts to focus on cancer care. This team was the first to complete an episode payment program for cancer treatment and it has built the only commercial database combining clinical and claims information for cancer patients.Prior to his work at UnitedHealth Group Dr. Newcomer practiced medical oncology for nine years in Minneapolis and Tulsa, Oklahoma. He served as the Medical Director for Cigna Healthcare, in Kansas City and he was a founding executive of Vivius, a consumer directed venture that allowed consumers to create their own personalized health plans. He is a former Chairman of Park Nicollet Health Services (HealthPartners), an integrated system of physicians and hospitals based in Minnesota with national recognition for its leadership in quality, safety and cost effectiveness. Dr. Newcomer holds a B.A. degree from Nebraska Wesleyan University, a MD degree from the University of Nebraska College of Medicine and a Masters of Health Administration from the University of Wisconsin at Madison. His clinical training included an internal medicine residency at the University of Nebraska Medical Center and a medical oncology fellowship at the Yale University School of Medicine.

Anand Pathak, MD, Medical Officer, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health, FDA

Anand Pathak, M.D., Ph.D., M.P.H. is a Medical Officer at the FDA’s CDRH, Office of In Vitro Diagnostics and Radiological Health, Division of Molecular Genetics and Pathology, Molecular Genetics Branch. He earned an A.B. with honors from Harvard University, followed by training in the MSTP (Medical Scientist Training Program, M.D./Ph.D.) at the University of Cincinnati. He received a Ph.D. in Molecular, Cellular and Biochemical Pharmacology; he trained significantly in wet lab aspects of molecular biology and biochemistry. Subsequently, he completed his residency training at the University of Michigan, where he also earned an M.P.H. in Epidemiology. After this, he trained as a fellow in the National Cancer Institute’s Division of Cancer Epidemiology and Genetics, Clinical Genetics Branch, where he focused on emerging technologies, including next-generation sequencing and bioinformatics approaches in oncology. Upon completion of his fellowship at the NCI, he joined the FDA, where he works with on a broad range of genetic applications in oncology and other genetic disorders. Dr. Pathak has a significant interest helping to harness new, cutting edge technologies and bioinformatics to advance Precision Medicine in the 21st century.

Daryl Pritchard, PhD, Senior Vice President, Science Policy, Personalized Medicine Coalition

Daryl Pritchard, PhD, is the Senior Vice President of Science Policy at the Personalized Medicine Coalition (PMC), where he leads PMC’s efforts to increase awareness and understanding of personalized medicine; identify and address barriers to the adoption of personalized medicine into the health care system; and develop and promote appropriate clinical, health care infrastructure, regulatory, and payment policies. Before coming to PMC, Dr. Pritchard served as the Director of Policy Research at the National Pharmaceutical Council (NPC). Prior to joining NPC, he served as the Director of Research Programs Advocacy and Personalized Medicine at the Biotechnology Industry Organization (BIO). Dr. Pritchard received his PhD and master’s degree in genetics from the George Washington University, and completed a post-doctoral research fellowship at the Children’s National Medical Center. He was awarded the first American Society of Human Genetics (ASHG)/National Human Genome Research Institute (NHGRI) Fellowship in Genetics and Public Policy, where he worked as a health legislative assistant in the House of Representatives.

Ammar Qadan, Vice President, Global Market Access, Illumina

Ammar Qadan is currently and since Nov 2016 the Vice President and Global Market Access Lead at Illumina. In his current job, Ammar is responsible for Health Economic Outcomes Research, Market Access/Pricing strategy, Field Market Access, Payer Policy and Advocacy. Through his career, Ammar has been distinguished as a passionate, patient-focused Biotech leader who worked on multiple disease areas and biotechnology- related strategic programs and major corporate initiatives across functions and geographies. Most recently, Ammar was the Vice President and Global Product Team Lead at Halozyme Therapeutics, a Biotech focused on Oncology development in San Diego. He was instrumental in revamping their lead biomarker-driven oncology program strategy, leading to new clinical development programs and major partnerships. Ammar & his team’s work on market access and health outcomes research and the continuous interaction with payers resulted in adding new endpoints in clinical development programs and the presentation of major outcomes data in major congresses where the data was used to update clinical guidelines around certain interventions in pancreatic cancer patients. Prior to joining Halozyme, Ammar spent nearly 20 years at Bristol Myers Squibb in roles of increasing complexity in areas like market access, marketing, country management and product development, where he worked & lived in 6 different countries across North America, Europe & the Middle East. Ammar is a Pharmacist by training.

Bruce Quinn, MD, PhD, Principal, Bruce Quinn Associates

Bruce Quinn, MD PhD, is a professional strategy consultant helping innovative companies achieve their goals under U.S. federal health policies. His consulting practice, with offices in Los Angeles and San Francisco, works with leading genomic, medical technology, and biopharma companies. Originally trained as a neuropathologist, earlier in his career he held tenure-track faculty positions at NYU Medical School and the Northwestern University School of Medicine. As a physician executive, he has held positions with Accenture’s healthcare strategies practice, the Medicare program, and with health policy groups in two law and lobbying firms. Recent publications have included articles on defining clinical utility for diagnostic tests and a review of the emerging digital genomics industry. In addition, his blog, www.DiscoveriesInHealthPolicy.com, covers innovative health care policy developments and receives over 100,000 hits per year.

Joseph Rubino, PhD, Senior Reimbursement Specialist, Cepheid

Joseph is the Senior Reimbursement Strategist for Cepheid’s Government and Reimbursement division, responsible for the incorporation of Cepheid’s role within the ACO and Healthcare integrated markets. He focuses on integrating laboratory services within healthcare payers and Bundled Payments. Joseph served as the Director of Health and Human Services for the state of New Jersey. Appointed to the position by Governor Chris Christie, he was responsible for the oversight and integration of health policy. Joseph and his colleagues developed one of the first Medicaid ACOs in the United States known as the Trenton Health Team. He is a nationally known expert on health policy. Joseph previously served as the Senior Director of Health Economics and Reimbursement for BG Medicine and Prometheus Laboratories. He has a PhD in clinical psychology from Hahnemann University and an M.S. from the University of Pennsylvania. He has also served as an Adjunct Professor of Health Economics for Rider University’s School of Business.

Marc Samuels, CEO, Founder, ADVI

Marc founded ADVI in 2013, and its predecessor HillCo HEALTH in 2000, and oversees all of the firm’s global activities. ADVI is one of the most active consulting firms in the lifescience and healthcare services sectors, with a focus on policy, strategy and commercial development, and offices in San Francisco, Austin, Chicago and Washington, DC. Clients include Chicago Pacific Founders and Kleiner Perkins, and Warburg Pincus; the top 15 biotechnology companies; top 10 diagnostic companies and most of the top device companies all in global sales. Marc has had an interest in next-generation life sciences and digital health for some time. He studied neuroscience and conducted neuropsychology research at University of Michigan. He attended Yale School of Medicine’s MPH Program and the University of Texas School of Law. He was also instrumental in the formation of MED-C, an organization charged with bringing standardization to molecular diagnostic testing and serves as policy counsel to the National Comprehensive Cancer Network (NCCN). Marc has been named one of the most popular [lobbyists] for Medicare by the Boston Globe. His comments and analyses have appeared in In Vivo, Journal of Oncology Practice, Medical Economics, the Fort Worth Star-Telegram, the Dallas Morning News, and Texas Medicine. He is a contributor to the third edition of the Managed Care Answer Book and the second edition of the HMO and Capitation Answer Book, published by Panel Publishers, New York.

David Sans, PhD, MBA, F.A.A.R.M., Managing Director, Healthcare Capital Markets, THINK EQUITY (A Division of Fordham Financial Mgmt., Inc.)

Dr. Sans has more than 20 years of healthcare-centric experience in life science corporate development, investment banking and hospital management. Dr. Sans has held management and executive positions at Novartis, Pfizer, ImClone, and Summer Street Research Partners and holds a Master's degree in Life Science from Technische Universitat in Berlin, a Ph.D. in Life Sciences from ETH in Zurich in combination with Universitat Ramon Llull, an MBA in Business Law from Fordham University in New York and successfully completed Business Seminars at Wharton School of Business. Dr. Sans is a Series 7, 63 and 79 licensed Registered Representative.

Anthony Sireci, MD, MSc, Physician Manager, Personalized Genomic Medicine, Assistant Professor of Pathology Columbia UniversityMedical Director, Medical Affairs, Loxo Oncology 

Dr. Anthony N. Sireci presently working as an Assistant Professor of Clinical Pathology, Columbia University with research interest developing process improvement plans in the laboratory setting to help deliver higher quality and more efficient care to the patients. He was awarded PhD degree from University of Utah, Salk Lake City.

Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories

No biography available

Katherine B. Szarama PhD, Presidential Management Fellow, CMS

No biography available

Dan Todd, Principal, Todd Strategy

Dan Todd is the Principal of Todd Strategy, LLC, a consulting firm founded in 2014 and based in Washington, DC. He provides legislative and regulatory strategic guidance and advocacy for healthcare stakeholders impacted by federal healthcare programs. Prior to Todd Strategy, Mr. Todd was a Senior Healthcare Counsel for the Republican staff of the Senate Finance Committee, the Committee of jurisdiction for the Medicare and Medicaid programs. His areas of responsibility for the committee included the Medicare Part B and Part D programs, which includes physician, medical device, diagnostic and biopharmaceutical issues. Before joining the Finance Committee, Mr. Todd spent several years in the biotechnology industry, where he led policy development and government affairs strategy. He also represented his companies’ interests with major trade associations such as PhRMA and BIO before federal and state representatives, as well as with key stakeholders such as physician and patient advocacy organizations. Dan also served as a Special Assistant in the Office of the Administrator at the Centers for Medicare & Medicaid Services (CMS), the federal agency charged with the operation of the Medicare and Medicaid programs. While at CMS, Dan worked on Medicare Part B and Part D issues during the implementation of the Medicare Modernization Act from 2003 to 2005.

Christine Vietz, Senior Director, Regulatory Affairs, Foundation Medicine

Dr. Vietz (PhD, RAC) is Director of Quality Assurance at Foundation Medicine, Inc. She has over 14 years of experience in assay development and clinical diagnostics. Her expertise in assay development began with work as a scientist developing high-complexity tests for a CLIA certified laboratory and has progressed through operational management roles to her current position directing quality assurance and regulatory activities at Foundation Medicine. Dr. Vietz has a broad range of quality and regulatory experience including successfully leading several laboratories through CAP accreditation, obtaining NY approval of the Foundation Medicine tests (NGS-based comprehensive genomic profile for cancer), and most recently on Companion Diagnostic PMA and IDE submission work at Foundation Medicine.

John Warren, Senior Director, McDermottPlus Consulting

John Warren is a highly experienced Medicare veteran with wide ranging experience in traditional Medicare fee-for-service, Medicare program integrity, and Medicare contracting issues. With over 22 years of experience inside the Centers for Medicare and Medicaid Services (CMS), John brings a unique perspective to clients of all types and sizes. As the former CMS director of the Divisions responsible for payment policy and program integrity, John is uniquely qualified to speak on matters related to Medicare payment for clinical laboratory services, Part B prescription drugs, and the Medicare physician fee schedule.

Microfluidics and Lab-on-a-Chips for POCT

Suman Bose, PhD, Postdoctoral Fellow, Koch Institute for Integrative Cancer Research, Massachusetts Institute of Technology

Suman obtained his PhD from Massachusetts Institute of Technology in 2014. In his graduate research, Suman employed microfabrication and numerical modeling to build microfluidic cell separation devices. During his PhD he received the Pappalardo Fellowship and awards from American Society for Mechanical Engineers. Suman went on to do his postdoctoral research with Prof. Robert Langer and Daniel G. Anderson at the Koch Institute at MIT, where he is developing treatments for type 1 diabetes and building platforms for investigating single cell biology. He received the JDRF Postdoctoral Fellowship, Mission Possible Award and was nominated Top 40 under 40 Healthcare Innovators by MedTech Boston in 2016.

Cesar M. Castro, MD, Director, Cancer Program, MGH Center for Systems Biology, Massachusetts General Hospital / Harvard Medical School

Dr. Castro is Director of the Cancer Program at the Massachusetts General Hospital (MGH) Center for Systems Biology, Assistant Professor of Medicine at Harvard Medical School, and Attending Physician at the MGH Cancer Center. As a Regent’s Scholar, Dr. Castro attended the University of California - Berkeley leading to receipt of both Bachelor’s and Master’s degrees. He attained his Medical Degree from the University of California - San Francisco (UCSF) where he also pursued Internal Medicine residency training. Dr. Castro completed a combined Adult Medical Oncology fellowship between the MGH and the Dana-Farber Cancer Institute in Boston. During this period, he also received a Master’s in Medical Sciences from Harvard Medical School while conducting post-doctoral research under Prof. Ralph Weissleder. Dr. Castro is a translational oncologist with experience developing and harnessing nanotechnology and molecular imaging platforms for cancer purposes. His work offers a “less is more” approach — to generate robust cancer analyses using scant amount of specimens. As such, his work with portable diagnostic platforms could also favorably impact resource-limited regions throughout the globe. Dr. Castro’s research has included funding from the V Foundation for Cancer Research, National Institutes of Health, Ovarian Cancer Research Fund, and the Department of Defense.

Manish Deshpande, PhD, Vice President, R&D, Point of Care BU, Siemens Healthcare

Manish Deshpande is the Head of R&D for the Point-of-Care Business at Siemens Healthineers. He has been in Siemens since 2011. Prior to Siemens, he worked in early-stage technology development at Covidien and for several medical-device startups focusing on microfluidics in the Boston area. He holds a PhD degree in mechanical engineering from the Pennsylvania State University.

Rachael Evans, CMO, Henry J. Austin Health Center, Family Medicine

Dr. Evans took on the position of Chief Medical Officer at Henry J. Austin Health Center in 2017 and since 2012 has provided direct care in the Women’s Health, General Medicine and Pediatric Departments at the health center. She has strong interests in women’s health and addiction medicine and spearheaded Henry J. Austin’s Medication-Assisted Treatment program, one of only a few in New Jersey that offer treatment for opioid dependencies in the setting of primary care. Dr. Evans obtained her undergraduate and medical degrees from New York University. She completed residency training in Family Medicine at the University of New Mexico Department of Family and Community Medicine and is board-certified in Family Medicine. Prior to joining Henry J. Austin in 2012, Dr. Evans was the Medical Director of a health center in New Mexico and also served as Chief of Staff at the critical-access hospital there. She is passionate about decreasing financial, linguistic and cultural barriers to healthcare.

Ionita Ghiran, MD, Associate Professor of Medicine, Beth Israel Deaconess Medical Center

Dr. Ghiran received his MD from the “Iuliu Hatieganu” Medical School University, Cluj Napoca in Romania, before completing his postdoctoral training at Beth Israel Deaconess Medical Center in Boston where he is currently an Assistant Professor in the Department of Medicine at the Beth Israel Deaconess Medical Center (BIDMC)/Harvard Medical School in Boston, MA. Dr. Ghiran’s focus in on understanding the regulation of extracellular vesicles originating from red cells, and the role of the red cell-derived miRNAs in normal and pathological conditions. Recently, Dr. Ghiran and his colleagues described the significant impact of the circadian rhythm in the number and protein composition of circulating blood extracellular vesicles, as well as in the origin and quantity of various extracellular miRNAs species.

Umer Hassan, PhD, Assistant Professor, Electrical and Computer Engineering, Rutgers University

Dr. Umer Hassan is an Assistant Professor at the Department of Electrical and Computer Engineering at Rutgers University. Previously, he worked as a Research Scientist in the Department of Bioengineering at University of Illinois Urbana-Champaign (UIUC) with a Research Affiliate appointment at Carle Foundation Hospital, Urbana. Dr. Hassan completed his Ph.D. in Electrical and Computer Engineering from UIUC in 2015. His research has been focused on developing point-of-care (PoC) translational biosensors for infectious disease diagnostic applications. He has received Brandt Early Career Investigator Award in Precision Medicine (2017), BMES Career Development Award (2017), Baxter Young Investigator Award (2016, & 2017), Emerging Engineer Award (2015), Cozad New Venture Competition Award (2014), NSF I-Corps Fellowship (2014) and Our Common Future Fellowship (2010). In 2014, Dr. Hassan cofounded a startup, Prenosis, Inc. that is working on commercializing his developed biosensors.

Diana R. Hernandez, PhD, Clinical Microbiology Research Director, Center for Infectious Diseases Diagnostics & Research, Geisinger

Clinical microbiology researcher with focus on new molecular technologies for the diagnoses of infectious diseases.

Hyungsoon Im, PhD, Assistant Professor, Center for Systems Biology, Massachusetts General Hospital

Dr. Im received his PhD in Electrical Engineering from the University of Minnesota, Twin-Cities. He trained as a NIH postdoctoral fellow in Biomedical Engineering and Systems Biology under Dr. Weissleder and Dr. Lee at MGH. He has expertise in nanofabrication, spectroscopy, microfluidics and imaging. His lab focuses on developing the next-generation diagnostic technology.

Sidhant Jena, MBA, Co-Founder & CEO, Jana Care

Sidhant worked at Medtronic in various R&D roles before founding Jana Care. He received his BS and MS in Electrical Engineering from Georgia Tech and received his MBA from Harvard Business School.

James Landers, PhD, Commonwealth Professor of Chemistry, Professor of Mechanical Engineering, Associate Professor of Pathology, University of Virginia

Dr. James Landers is currently Professor of Chemistry and Professor of Mechanical Engineering at the University of Virginia, as well as Associate Professor of Pathology at the University of Virginia Health System. He earned his Bachelor of Science degree in Biochemistry with a minor in Biomedicine and his PhD in Biochemistry from the University of Guelph in Ontario (Canada) in 1984 and 1988, respectively. After a year as a post-doctoral fellow at the Banting Institute at the University of Toronto School of Medicine, as a Canadian Medical Research Council (MRC) Fellow at the Mayo Clinic-Rochester, he studied cancer biology and diagnostics under Thomas Spelsberg, a renowned breast cancer biochemist. He launched and directed Mayo Clinic’s Clinical Capillary Electrophoresis Facility in the Department of Laboratory Medicine and Pathology, developing clinical assays based on capillary electrophoretic technology. Dr. Landers joined the Chemistry Department at the University of Pittsburgh in 1997, where he forayed into analytical microfluidic systems with the goal of developing the next generation molecular diagnostics platform. This research was bolstered by the move in 1999 to the University of Virginia where access to a dedicated class-100 cleanroom for microchip fabrication allowed for rapid prototyping of microdevices for separations, DNA purification, and DNA amplification. His group was among the first to generate a fully integrated lab-on-a-chip (PNAS 103:19272, 2006), successfully applied to detecting infectious agents in biofluids and cancer diagnostics, and more recently defined new approaches to fluidic control on microchips (NATURE Physics 5:231, 2009). He has authored more than 180 papers and 25 book chapters on topics as diverse as receptor biochemistry, capillary electrophoretic method development, microchip fabrication, forensic DNA analysis and integrated microfluidic systems for application to both the clinical and forensic arenas. In addition, he has recently completed the third in the succession of editions of CRC Press Handbook of Capillary Electrophoresis, with this one extrapolated to microchip electrophoresis and associated microtechniques.

Chang Lu, PhD, Fred W. Bull Professor, Chemical Engineering, Virginia Tech

Dr. Chang Lu is the Fred W. Bull professor of chemical engineering at Virginia Tech. Dr. Lu obtained his B.S. in Chemistry with honors from Peking University in 1998 and PhD in Chemical Engineering from University of Illinois at Urbana-Champaign in 2002. He then spent 2 years as a postdoctoral associate in Applied Physics of Cornell University. His research has been in the general area of developing microfluidic technologies for molecular/cellular manipulation and analysis, with recent focus on profiling epigenomes using tiny amounts of samples. These technologies have been useful for understanding disorders and processes such as cancer, stem cell differentiation, and brain development. His lab has published in leading journals such as Nature Methods, Nature Biomedical Engineering, Science Advances, and Nature Protocols. Dr. Lu received Wallace Coulter Foundation Early Career Award, NSF CAREER Award, and VT Dean’s award for research excellence among a number of honors.

John T. McDevitt, PhD, Chair, Department of Biomaterials, New York University College

John T. McDevitt serves as the Chair for the Department Biomaterials at New York University College of Dentistry, is a member of NYU’s Bioengineering Institute and participates as a faculty member in the NYU Department of Chemical and Biomolecular Engineering within the Tandon School of Engineering. McDevitt is a pioneer in the development of ‘programmable bio-nano-chip’ technologies. He has a strong track record of translating essential bioscience discoveries into real-world clinical practice. In this capacity, he serves as the Scientific Founder for three diagnostic companies. His most recent company, SensoDx, features a universal platform sensor technology with capacity to digitize biological signatures for a broad range of key health conditions. McDevitt and his team has raised over $45M in Federal and Foundation support. His recent research has been sponsored by major programs funded by the National Institute of Dental and Craniofacial Research (NIDCR) division of the National Institutes of Health (NIH), the Bill and Melinda Gates Foundation, Cancer Prevention Research Institute of Texas (CPRIT), the National Aeronautics and Space Administration (NASA), the Army and the United Kingdom’s Home Office Scientific Development Branch. McDevitt and his team have written more than 200 peer-reviewed scientific manuscripts and have contributed to more than 100 patents and patent applications. This work was recognized with the “2016 AACC Wallace H. Coulter Lectureship Award,” “Best of What's New Award” in the Medical Device Category for 2008 by Popular Science as well as for the “Best Scientific Advances Award” in 1998 by the Science Coalition. Dr. McDevitt’s individual honors include the Presidential Young Investigator Award, the 2010 California Polytechnic Distinguished Alumni Award and the Exxon Education Award. Over the past 7 years, Dr. McDevitt has served as the Principal Investigator for 6 major clinical trials and 2 clinical pilot studies, all involving the programmable bio-nano-chip. Through these clinical efforts, mini-sensor ensembles are being developed for major diseases in the areas of oral cancer, cardiac heart disease, trauma, drugs of abuse, ovarian cancer and prostate cancer.

Joseph Rubino, PhD, Senior Reimbursement Specialist, Cepheid

Joseph is the Senior Reimbursement Strategist for Cepheid’s Government and Reimbursement division, responsible for the incorporation of Cepheid’s role within the ACO and Healthcare integrated markets. He focuses on integrating laboratory services within healthcare payers and Bundled Payments. Joseph served as the Director of Health and Human Services for the state of New Jersey. Appointed to the position by Governor Chris Christie, he was responsible for the oversight and integration of health policy. Joseph and his colleagues developed one of the first Medicaid ACOs in the United States known as the Trenton Health Team. He is a nationally known expert on health policy. Joseph previously served as the Senior Director of Health Economics and Reimbursement for BG Medicine and Prometheus Laboratories. He has a PhD in clinical psychology from Hahnemann University and an M.S. from the University of Pennsylvania. He has also served as an Adjunct Professor of Health Economics for Rider University’s School of Business.

Marie L. Salva, MSc., IT Engineer, Doctoral student, Science & Technology Precision Diagnostics, IBM Research Zurich

Ms Salva is currently working in the Precision Diagnostics group at IBM Research - Zurich as part of her European doctoral project. Her research focuses on developing capillary-driven microfluidic chips for point-of-care diagnostics (POCDs) and on understanding the underlying physics of such a technology. Previously, she was a visiting scholar at the Molecular and Microscale Bioengineering Laboratory of Columbia University in New York. In 2017, she worked on neurophysiology and biomechanics at Human Waves (Brussels) and received a French Innovation award for this work. Ms Salva studied advanced Mathematics and Physics in France before attended one of the leading French engineering school, Télécom Physique Strasbourg, where she received in 2017 her engineering diploma with a specialization in Healthcare IT. In parallel, she also received a dual Master of Sciences with highest honors in micro- and nano-electronics from the University of Strasbourg in 2017.

Joshua T. Smith, PhD, Research Staff Member, Translational Systems Biology and Nanobiotechnology, IBM T.J. Watson Research Center

Joshua Smith received his PhD in Electrical Engineering from Purdue University in 2011 on a National Science Foundation Graduate Research Fellowship Award and joined the IBM T. J. Watson Research Center as a Research Staff Member. With a background in low-dimensional nanoelectronics and semiconductor processing, Dr. Smith developed a growing interest in biomedical engineering and bionanotechnology, and in 2013 he helped establish the Translational Systems Biology and Nanobiotechnology group at IBM Research. Within the group, he oversees R & D efforts and works to establish paths toward manufacturing for microfluidic devices aimed at separation and detection of single molecules for advanced biomedical diagnostics and preparative technologies. He is a sought-after speaker on the subject of lab-on-a-chip applications for healthcare and his work has been highlighted by Forbes, CNN Money, IEEE Spectrum, and Pharma Technology Focus. Dr. Smith holds an adjunct Assistant Professor position at Columbia University in the Department of Electrical Engineering and is an IBM Master Inventor.

Ester Stein, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories

No biography available

John Warren, Senior Director, McDermottPlus Consulting

John Warren is a highly experienced Medicare veteran with wide ranging experience in traditional Medicare fee-for-service, Medicare program integrity, and Medicare contracting issues. With over 22 years of experience inside the Centers for Medicare and Medicaid Services (CMS), John brings a unique perspective to clients of all types and sizes. As the former CMS director of the Divisions responsible for payment policy and program integrity, John is uniquely qualified to speak on matters related to Medicare payment for clinical laboratory services, Part B prescription drugs, and the Medicare physician fee schedule

Paul Yager, PhD, Professor, Department of Bioengineering, University of Washington

Paul Yager, a native of Manhattan, received his A.B. in Biochemistry from Princeton in 1975, and a PhD in Chemistry from the University of Oregon in 1980, specializing in vibrational spectroscopy of biomolecules. After an NRC Fellowship at the Naval Research Laboratory (1980-1982), he joined the NRL staff as a Research Chemist. He moved to the Center (now Department) of Bioengineering at the University of Washington as Associate Professor in 1987, advancing to Professor in 1995; he served as Chair of the department from 2007 to 2013. Initially working on both self-organizing lipid microstructure and optically-based biomedical sensors, since 1992 his lab has focused primarily on development of microfluidics for the analysis of biological fluids for use in low-cost point-of-care biomedical diagnostics for the developed and developing worlds. From 2005-2010 a team led by Yager was supported by the Bill & Melinda Gates Foundation to develop a low-cost rugged point-of-care system for pathogen identification. Since 2008, most lab activity (with several close partners) has focused on developing two-dimensional porous networks for ultra-low-cost instrument-free pathogen identification for human diagnosis. Readout is often coupled with cell phones for quantitative analysis and data transmission; this has been under support of NIH, NSF, DARPA and DTRA. He has authored >150 publications in refereed journals, and 40 issued patents.

Sample Prep, Assay Development, and Validation

Orly Ardon, MSc, MBA, PhD, R&D Program Manager, ARUP Laboratories/University of Utah

Orly Ardon, PhD MBA, has over thirty years of academic and life science industry experience that includes laboratory research in microbiology, genetics, biochemistry, immunology and genomics. Orly’s business experience includes US and global research, marketing and sales across several segments. Orly has BS, MS, and PhD degrees in Microbiology from the Hebrew University of Jerusalem, and postdoctoral training in cell biology and virology at the University of Utah. She later joined the R&D Institute at ARUP Laboratories, a national reference lab in Salt Lake City, Utah, where she developed new commercial diagnostic tests in addition to managing a medical genetics lab at the University of Utah. After graduating from the Executive MBA program at the University of Utah, Orly joined the Business Development group at ARUP where she worked as an R&D market research manager. Her responsibilities included key functional areas in diagnostics market research as well as forming new initiatives and internal and external collaborations. Her roles expanded to overseeing the International Business initiative at ARUP. In this role she led a cross-functional program team that includes scientists, medical directors, and marketing and sales professionals. Orly is currently leading the development of digital imaging tools at ARUP's Research and Development Institute.

Ryma Benayed, Technical Director, Clinical Next Generation Sequencing Laboratory, Assistant Attending, Pathology, Memorial Sloan Kettering Cancer Center

Ryma received her PhD in Cell Biology and Neuroscience from the University of Medicine and Dentistry of New Jersey. Her thesis work focused on understanding the genetic predisposition of Autism Spectrum Disorders. In 2007 she joined Hoffmann-La Roche Pharmaceuticals as a Principal Scientist where she focused on applying high-throughput whole genome SNP genotyping technologies toward the identification of genetic biomarkers in complex disorders. She then became the head of the genetics laboratory in the Genetics & Genomics group and advocated for the application of advanced genomic-based assays in support of the oncology biomarkers program, which led to the successful implementation of Next Generation Sequencing (NGS) technologies in the Genetics laboratory. In 2012 she joined the Oncology Clinical Biomarkers group at Astellas Pharma as a Senior Research Scientist where she managed Exome sequencing and RNASeq projects to study drug response mechanisms in colorectal and ovarian cancer patients. She is now an Assistant Attending at the Diagnostic Molecular Pathology Service in Memorial Sloan Kettering Cancer Center. Her role primarily focuses on the assessment, validation and clinical implementation of DNA and RNA-based NGS technologies for genetic alterations profiling in blood cancer and solid tumors.

Karen Bijwaard, MS, RAC, MB(ASCP), Scientific Master Reviewer, Molecular Pathology and Cytology Branch, Division of Molecular Genetics and Pathology, Office of In Vitro Diagnostics and Radiological Health, U.S. Food and Drug Administration

Karen Bijwaard, MS, RAC, MB(ASCP), joined the FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR) in April 2005 as a Scientific Reviewer in the Division of Immunology and Hematology Device evaluation (DIHD) and then in the Division of Molecular Genetics and Pathology (DMGP) when it was created in April 2014. In her current position, she reviews submissions for molecular pathology, genetics, instrumentation, software, and companion diagnostic In Vitro Devices (IVDs) and diagnostic software/instrumentation. She is the DMGP product specialist for cell-free/circulating-tumor DNA assays and medical device instrumentation and software. She is a consultant for other divisions in OIR and the Centers for Biologics and Drugs. She is a member in a number of genetics/genomics committees and working groups in FDA. Ms Bijwaard is certified by ASCP as Technologist in Molecular Biology and received her Regulatory Affairs Certification from the Regulatory Affairs Professional Society in 2009. She has been an active member of the Assoc. for Molecular Pathology since 1996. In addition, she is active in CLSI and has served as a Subcommittee member and Advisor on several new and revised guidelines. Ms. Bijwaard received her undergraduate degrees in Animal Science and Biology from VA Tech in Blacksburg, VA and her Master’s Degree in Pathology from Georgetown University in Washington, DC. Prior to joining OIR, she has extensive laboratory experiences in the area of molecular diagnostics. Previously she has worked as a medical technologist in the Molecular Diagnostics Laboratory (MDL) in the Dept. of Pathology at Georgetown University. In 1996, she joined the MDL at the Armed Forces Institute of Pathology as a medical technologist where she continued to perform and created new molecular assays until 2003, after which she worked in the Laboratory of Immunology at NIH/NIAID.

Carolyn Compton, MD, PhD, Professor, Life Sciences, Arizona State University

Carolyn Compton, MD, PhD is an academic pathologist who is Professor of Life Sciences at Arizona State University and the Chief Medical Officer of the Complex Adaptive Systems Institute and the National Biomarker Development Alliance. She is a former Professor of Pathology at Harvard Medical School and the former Strathcona Professor of Pathology at McGill Medical School. More recently she served as Director of the Office of Biorepositories and Biospecimen Research at the National Cancer Institute. Currently she is the chair of the Preanalytics for Precision Medicine Project Team at the College of American Pathologists, the chair of the Precision Medicine Core of the American Joint Committee on Cancer, and a member of the Beau Biden Cancer Moonshot BloodPAC team.

Sandra Gaston, Director, Molecular Biomarkers Research Laboratory, Pathology and Laboratory Medicine, Tufts Medical Center

As a translational cancer research scientist and as the Director of the Molecular Biomarker Research Laboratory in the Department of Pathology and Laboratory Medicine at Tufts Medical Center, I am committed to the development of practical, innovative technologies to support the use of human biospecimens in cancer research. My laboratory has developed tissue print technologies to support molecular biomarker analyses from fresh tumor specimens and we have fully implemented this approach in multicenter studies of RNA and DNA biomarkers in prostate biopsy tissues. This work has been supported by the NCI Innovative Molecular Analysis Technologies (IMAT) Program, the NCI Early Detection Research Network (EDRN) and by the DOD Prostate Cancer Research Program.

Carolyn Hiller, MBA, Program Director, Clinical Dx

Carolyn Hiller joined MDIC as Program Manager to launch their Clinical Diagnostics initiative. She brings diverse experiences in the healthcare sector; in addition to nearly a decade working in the medical device industry, she brings over a decade of executive leadership experience in the non-profit sector including national organizations representing patients, researchers, physicians, and clinical facilities. Drawing on over 20 years of experience, she uses logic and intuition to achieve success at leading teams, often comprised of members from competing organizations. She has developed programs from conception through phase-out. Her organizational development experience includes facilitating relationships between organizations, increasing volunteer engagement, creating collaborative partnerships, establishing strategies for resource allocation, providing organization-wide strategic direction, and managing risk. She has a particularly strong track record for successfully identifying and launching new programs in emerging markets. She has worked with physicians to develop and launch profitable educational product lines. She facilitated a summit of 12 national sleep-related organizations for coalition building, and followed up with successfully advocating for a patient-led lobbying coalition that led to establishing the National Center for Sleep Disorders Research within the federal National Institutes of Health NHLBI. She also guided the American Academy of Sleep Medicine’s successful application and acceptance into American Medical Association’s House of Delegates, the principal policy-making body of the AMA. She holds an MBA from the University of St. Thomas, as well as a BA in Marketing from Metropolitan State University, and an AAS in Animal Health Technology from the University of Minnesota.

Jennifer C. Jones, MD, PhD, Molecular Immunogenetics & Vaccine Research Section, Vaccine Branch, CCR, NCI

Dr. Jones (McIntire) positionally cloned the TIM gene family and demonstrated the genetic association between TIMs and immune response profiles (McIntire et al., Nature Immunology 2001, and Nature 2003). As a radiation oncologist, her current research is focused on developing immune-based therapies that synergize with radiation to produce optimal anti-tumor immune responses. Tumor cells, immune cells, and irradiated tissues release large quantities of biologically active (and distinct) nanoscale extracellular vesicles (e.g., exosomes and microparticles). Dr. Jones is developing improved methods to characterize, sort, and perform functional studies of nanoparticles, and has established a flow cytometry core facility, with instrumentation for preparation, analysis, counting, and cytometric study of extracellular vesicles.

Alex Lovejoy, PhD, Principal Scientist I, Roche Sequencing

Alex Lovejoy earned his PhD in Biochemistry from Stanford University where he focused on developing new NGS-based technologies in Pat Brown’s lab. As a postdoctoral scholar in the Oncology Department at Stanford, he worked on the CAPP-Seq technology for ctDNA NGS, a technology which was acquired by Roche. For the past 3 years, he has been working in the Oncology Assay Development team at Roche Sequencing Solutions, improving upon the technology and designing and developing the next generation of oncology assays.

Raja Luthra, PhD, Professor, Hematopathology, The University of Texas MD Anderson Cancer Center

No biography available

Trevor Pugh, PhD, FACMG, Scientist, Princess Margaret Cancer Centre, University Health Network, Assistant Professor, Department of Medical Biophysics, University of Toronto

Dr. Trevor Pugh, PhD, FACMG is a cancer genomics researcher and board-certified molecular geneticist interested in understanding clonal shifts in cancer and non-cancerous cell populations in response to treatment. He is appointed as Scientist at the Princess Margaret Cancer Centre and Assistant Professor in the University of Toronto Department of Medical Biophysics. He is Scientific Director of the Princess Margaret Genomics Centre and Co-Director of the Translational Genomics Laboratory, a joint initiative with the Ontario Institute for Cancer Research to enable clinically-oriented genomics projects. He also spends a portion of his time as a clinical molecular geneticist within the University Health Network Laboratory Medicine Program. Dr. Pugh serves on advisory committees for Cancer Care Ontario, Canadian Clinical Trials Group, HPC4Health, and the BC Cancer Agency Personal OncoGenomics Program. He has participated in multiple large-scale genomics and data-sharing programs including AACR GENIE, The Cancer Genome Atlas, and NCI TARGET.Since founding his lab in 2013, Dr. Pugh has collaborated and published with >20 clinical and research teams to report molecular mechanisms underlying a diversity of cancers and other diseases. Most recently, his group pioneered cell-free DNA sequencing as an alternative to painful bone marrow aspirates for plasma cell myeloma, and discovered somatic recovery of BRCA1/2 function as a resistance mechanism in ovarian cancer following >5-year response on olaparib. Previously, as a postdoctoral fellow at the Dana-Farber Cancer Institute and Broad Institute of Harvard and MIT, Dr. Pugh led landmark cancer genome studies describing three pediatric solid tumours: medulloblastoma, neuroblastoma, and pleuropulmonary blastoma. During this time, he also completed a clinical laboratory fellowship in the Harvard Medical School Genetics Training Program. Originally from Vancouver, Dr. Pugh received his PhD in Medical Genetics and BSc in Chemistry and Biochemistry with a Minor in Commerce from the University of British Columbia.

Julie Ramage, National Account Director, Diagnostics, Pfizer Oncology

23 years in the lab industry in various sales leadership roles and a focus in pathology at labs such as Nichols Institute, Quest Diagnostics, US Labs, NeoGenomics, and PhenoPath. Board member and Past President of the California Clinical Lab Association. A pivot into pharma in Pfizer Oncology occurred 4 years ago when a unique position was created for providing subject matter expertise in diagnostics and testing. The position includes a focus on working with the commercial labs, community pathologists, reimbursement in diagnostics and policy expertise in the lab and diagnostic community that impacts test to treat. I’ve been actively involved in data acquisition from the commercial labs and analyzing the content along with developing and working with data work streams throughout the oncology portfolio.

Nasrin Sarafan-Vasseur, PhD, Research Engineer, Genetics, Rouen University Hospital, Inserm

Nasrin Sarafan-Vasseur is a research engineer and molecular biologist at university of Rouen (France). Her work with the French National Institute of Health started in 1996. She has extensive experience in functional genomics by studying the impact of oncogenic alterations found in neoplasm diseases on human cells. Since 2013 she has specialized in Molecular biomarkers detection in human plasma and is involved in noninvasive Molecular diagnostics. She is the scientific leader of oncology research team (IRON group) in Rouen University Hospital and Normandy Centre for Genomic and Personalized Medicine.

Dana W. Y. Tsui, Assistant Attending, Pathology, Memorial Sloan Kettering Cancer Center

Molecular geneticist Dana Tsui studies circulating tumor DNA and other nucleic acids in plasma and body fluids for noninvasive molecular diagnostics.

Benjamin H. Wunsch, PhD, Materials Science & Engineering, Surface Chemist, Staff, Nanobiotechnology, IBM Research, IBM

Benjamin received his B.S.E. at Arizona State University in Materials Science and Engineering, and his PhD from the Massachusetts Institute of Technology in Materials Science, where he focused on the synthesis and chemistry of multi-ligand metal core nanoparticles. He has worked in the fields of carbon nanotube surface chemistry, organic photovoltaic thin films, aerogel gel synthesis, and nanocrystal self-assembly. He joined IBM in 2014 as part of the Nanobiotechnology Group, working on surface chemistry for biological compatibility. His scientific interests are in self-assembly and materials chemistry.

Charles Young, PhD, Principal Professional Staff, Assistant Program Manager, Applied Biology Group, Asymmetric Operations Sector, The Johns Hopkins University Applied Physics Laboratory

No biography available