Speaker Biographies

Speaker Biographies by Track

Plenary

Cynthia Bens, Senior Vice President for Policy, Personalized Medicine Coalition
Cynthia A. Bens Senior Vice President, Public Policy at the Personalized Medicine Coalition (PMC) leads the Coalition’s policy development and government relations efforts and serves as the primary liaison with the U.S. Congress and federal regulators. In collaboration with the PMC’s Senior Vice President, Science Policy, Ms. Bens is responsible for implementing research, regulatory and reimbursement policy strategies that promote the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system. Before joining the PMC, she was the Vice President of Public Policy at the Alliance for Aging Research. Ms. Bens guided the Alliance’s federal policy work, represented the organization in multiple national coalitions, and directed all aspects of coalitions led by the Alliance. She spent more than a decade at the Alliance advancing policies to expedite the development of interventions for neurological diseases and physical frailty; to remove access barriers for cardiovascular disease treatments; and to enhance the quality of care for older adults living with multiple chronic conditions. Prior to joining the Alliance, Ms. Bens was a senior manager of government affairs with the Loeffler Group. As part of its federal government affairs practice, she represented client interests before the U.S. Congress and the administration. Her core areas of focus included appropriations, budget, health care, education, telecommunications and international trade. Through various other positions on Capitol Hill and in the private sector, she has acquired extensive experience researching and analyzing federal legislation and regulations. Ms. Bens holds a Bachelor of Arts degree from New York University with concentrations in political science and women’s studies.

Tara Burke, PhD, Senior Director, Public Policy and Advocacy, Association for Molecular Pathology
Tara Burke, PhD joined the Association for Molecular Pathology (AMP) in 2014 and currently serves as AMP’s Senior Director of Public Policy & Advocacy. She leads AMP’s advocacy program and is the main staff liaison to both the Professional Relations Committee and Economic Affairs Committee. AMP advocacy focuses on reimbursement and regulatory issues affecting molecular pathology, including regulation of laboratory developed testing procedures, as well as coding, coverage, and payment policy. Tara has over a decade of biomedical research experience specializing in biochemistry, molecular genetics, and epigenetics. She holds a BS in Molecular Biology from Vanderbilt University, a PhD in Biochemistry and Molecular Genetics from The University of Virginia and completed a postdoctoral fellowship at the National Institute of Child Health and Human Development (NICHD) at the NIH. In her current role at AMP, Tara enjoys being able to combine her genetics expertise with policy interests to serve AMP members and their mission.

Katherine Donigan, PhD, Acting Director of Personalized Medicine, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration
Dr. Katherine Donigan is on the Acting Deputy Director for Personalized Medicine and Molecular Genetics in FDA’s Office of In Vitro Diagnostics in the Center for Devices and Radiological Health. She earned her Ph.D. in genetics from Yale University in 2011, where her studies focused on tumor-associated mutations in human DNA repair genes. She completed postdoctoral work in the Laboratory of Genomic Integrity at the National Institute of Child Health and Human Development (NICHD), where she studied DNA damage tolerance and translesion DNA synthesis. In 2013, she was selected as the 12th Genetics and Public Policy Fellow, a fellowship program cosponsored by the American Society of Human Genetics (ASHG) and the National Human Genome Research Institute (NHGRI). During her fellowship, Katherine worked on policy issues related to genetics in both the Office of the NHGRI Director and at ASHG. She also served as a Congressional Health Fellow in the Office of Senator Elizabeth Warren. She joined the Office of In Vitro Diagnostics at FDA in 2014, with a focus on policy related to diagnostic regulation and personalized medicine.

Donald E. Horton, Jr., Senior Vice President, Global Government Relations & Public Policy, Laboratory Corporation of America Holdings
Donald E. Horton, Jr. is Senior Vice President of Global Government Relations & Public Policy at Laboratory Corporation of America Holdings (LabCorp), headquartered in Burlington, North Carolina. In his current role, Don is responsible for monitoring and responding to legislative and regulatory developments for the Company at both the Federal and State levels in the U.S., as well as internationally. An active participant in industry associations and coalitions such as the American Clinical Laboratory Association (ACLA), the Diagnostic Test Working Group (DTWG), and the Personalized Medicine Coalition (PMC), Don has advised and represented LabCorp for over 19 years on a wide range of policy and legal issues in his current position and previously as Assistant General Counsel and Senior Counsel. Prior to joining LabCorp in 2000, Don practiced law for over ten years, both as in-house corporate counsel and in private practice. He received his undergraduate and law degrees from the University of North Carolina at Chapel Hill.

Julie Khani, MPA, President, ACLA
Julie Khani became president of the American Clinical Laboratory Association (ACLA), the largest organization representing the public policy interests of laboratories, in 2017. Khani joined ACLA in July 2013 as senior vice president and was named executive vice president in 2016. Khani leads ACLA’s efforts to advance public policies that promote innovation and protect and enhance patient access to life-improving and life-saving diagnostics. ACLA members represent the diversity of the clinical laboratory industry and include national, regional, specialty, hospital, ESRD, anatomic pathology, skilled nursing facility and academic medical center laboratories. Ms. Khani is recognized as an effective leader, consensus builder, and advocate. Prior to joining ACLA, she served in senior roles at the National Association of Chain Drug Stores (NACDS). During her tenure at NACDS, she was instrumental in the inclusion of pharmacy access standards in Medicare Part D, establishing incentives for TRICARE beneficiaries to obtain immunizations at retail pharmacies, and played a leading role in the implementation of the Affordable Care Act provisions on Medicaid reimbursement for generic drugs. Previously, Khani served as legislative manager at Ford Motor Company, where she was responsible for health and labor issues and the company’s political action committee. Before joining Ford Motor Company, Ms. Khani was associate director, government relations at Planned Parenthood Pennsylvania Advocates, where she managed several successful statewide campaigns on health and welfare issues. She holds a Bachelor of Arts from New York University and a Master of Public Administration from George Washington University.

Laura Lasiter, PhD, Science Policy Analyst, Friends of Cancer Research
Laura Lasiter, PhD is a Science Policy Analyst at Friends of Cancer Research (Friends) where she spearheads coverage and reimbursement policy initiatives, focused on diagnostic tests, and leads Friends’ legislative efforts on the VALID Act. Laura also directs the Friends’ Real-World Evidence Pilot Project to advance the use of real-world evidence for regulatory and payment purposes. Prior to joining Friends, Laura was an American Association for the Advancement of Science (AAAS) Congressional Science Fellow. As a Fellow, she was responsible for Senator Al Franken’s health portfolio focusing, primarily, on the FDA Reauthorization Act of 2017 and prescription drug pricing legislation. Laura received her PhD in Biomedical Sciences from the University of Tennessee Health Science Center with a research focus in infectious diseases, which was conducted at St. Jude Children’s Research Hospital. She concurrently served as the Executive Director of the Mid-South Academic Alliance, which is the workforce development arm of Life Science Tennessee, a nonprofit that advocates for the life sciences industry.

Charles Mathews, Principal, ClearView Healthcare Partners
Mr. Mathews has worked on a variety of diagnostic reimbursement projects involving the analysis, development, and implementation of coding, coverage, and payment strategies for both emerging and established innovators. This includes involvement in the commercialization of over 100+ different test products in the cancer, diabetes, cardiovascular disease, and infectious disease spaces. These tests range from simple point of care technologies to esoteric molecular approaches involving drug diagnostic combinations. He has knowledge gained by working not only with IVD platform and kit developers but also sole-source laboratories that are pursuing value-based pricing. He also has specific knowledge and expertise in the development of global market access plans for companion diagnostics. Mr. Mathews’ prior experience includes several years of working on health policy issues as a legislative aide on Capitol Hill. He also worked for the government affairs office of a biotechnology company and has worked on a National Institutes of Health sponsored clinical trial focused on genetic testing for Alzheimer’s disease. Mr. Mathews completed his undergraduate work at Colgate University and received a Master’s Degree in Public Policy at Duke University.

Susan Van Meter, Executive Director, AdvaMedDx
Susan Van Meter joined AdvaMedDx as Executive Director in January 2018. AdvaMedDx represents leading diagnostics manufacturers, advocating for the power of innovative medical diagnostics tests and technologies that facilitate evidence-based medicine, enable early detection of disease, enhance patient health and health care, and advance public health in the United States and abroad. AdvaMedDx is a division of The Advanced Medical Technology Association (AdvaMed), the world’s largest medical technology association, with approximately 300-member companies that develop medical devices, diagnostic tools, and health information systems. Previously, Ms. Van Meter led the Washington Office of the Healthcare Association of New York State (HANYS), representing New York’s hospitals and health systems in federal legislative and regulatory matters. Additionally, Ms. Van Meter served as the association’s divisional head of Health Information Technology. Before joining HANYS, she held a position in the Office of Legislation of the Centers for Medicare and Medicaid Services. Ms. Van Meter has a Bachelor of Arts degree from Villanova University and a Master of Arts degree from Boston University.

Enabling Point-of-Care Diagnostics

Larry Atupem, MBA, Senior Business Development Specialist, Zeon
Larry Atupem is the Senior Business development specialist at Zeon Specialty materials with responsibility for development and marketing of Cyclic Olefin Polymer business in North America. He has over decade of experience in multiple industries spanning from pharmaceutical science, thermal packaging, and thermoplastics. He holds a Bachelor of Science degree in Chemical & Biological Engineering from Tufts University along with management business coursework from Boston University.

Bryan Bothwell, MBA, Director, Strategy, Business Development, Qorvo Biotechnologies, LLC
Bryan Bothwell is Qorvo Biotechnologies Director of Strategy and Business Development - with responsibility for new market, technology and customer development worldwide.  He received undergraduate degrees in Biology/ Biochemistry, and Masters degrees in Electrical Engineering and Business Administration.

Charles Chiu, MD, PhD, Professor, Departments of Laboratory Medicine and Medicine, Division of 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 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. Chiu currently heads a translational research laboratory focused on next-generation sequencing assay development for infectious disease diagnostics, discovery and 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. He is also actively developing RNA sequencing approaches to detect and identify diagnostic profiles of the body’s response to infection. His work is supported by funding from the National Institutes of Health (NIH), Abbott Laboratories, Department of Defense, NASA/Translational Research Institute, philanthropic grants (Charles and Helen Schwab and Steven and Alexandra Cohen Foundations), and the California Initiative to Advance Precision Medicine. Dr. Chiu has authored more than 80 peer-reviewed publications, holds over 15 patents and patent applications, and serves on the scientific advisory boards for Therabio, Inc., and Mammoth Biosciences, Inc.

Nick Davala, MBA, Business Development Manager, BBI Solutions

Nick Davala is a Business Development Manager at BBI Solutions specializing in lateral flow assay development & manufacture, and Novarum DX technology platforms. Nick has over 20 years of experience in immunohistochemistry applications, and received his MBA from Babson College's F.W. Olin Graduate School of Business.

Joseph R. Ecker, PhD, Professor and Salk International Council Chair in Genetics, Howard Hughes Medical Institute Investigator, The Salk Institute for Biological Studies
Joseph Ecker earned his PhD in Microbiology at the Pennsylvania State University College of Medicine and carried out postdoctoral studies at the Department of Biochemistry at Stanford University. He served on the Faculty at the University of Pennsylvania (1987-2000) before joining The Salk Institute for Biological Studies (2000) where he is a Professor in the Plant Biology Laboratory and Director of the Salk Institute Genomic Analysis Laboratory. He is holder of the Salk International Council Chair in Genetics. His research focuses on genomic and epigenomic regulation in plants and mammals and on the application of DNA sequencing technologies for genome-wide analysis of DNA methylation, transcription and gene function. Professor Ecker serves on the Editorial Board of Proceedings of the National Academy of Science. From 2005-2008, he served as President of the International Society for Plant Molecular Biology. He has been the recipient of multiple honors, including: the Kumho Science International Award in Plant Molecular Biology and Biotechnology (2001), the International Plant Growth Substances Association Distinguished Research Award (2004), the American Society for Plant Molecular Biology Martin Gibbs Medal (2005), and was chosen as the Scientific American 50: Research Leader of the Year in Agriculture in 2004. He was elected to the US National Academy of Sciences in 2006. In 2007 he received the John J. Carty Award for the Advancement of Science from the US National Academy of Sciences. In 2009, research from his laboratory on the sequencing of the first human DNA methylomes was ranked the #2 Scientific Discovery of the Year by Time Magazine. In 2011, he was awarded the George W. Beadle Award from the Genetics Society of America for outstanding contributions to the community of genetics researchers and was selected as an Investigator of the Howard Hughes Medical Institute. In 2015 he was elected as a member of the American Academy of Arts and Sciences.

Omai Garner, PhD, D(ABMM), Assistant Clinical Professor, Section Chief, Clinical Microbiology; Director, Point of Care Testing, UCLA Department of Pathology and Laboratory Medicine
Dr. Omai Garner is a Health Sciences Assistant Clinical Professor and Section Chief of Clinical Microbiology in the UCLA Health System. He received his PhD from UC San Diego in Biomedical Sciences. He was a Postdoctoral Clinical Microbiology CPEP Fellow in the Department of Pathology at UCLA, and a former McNair Scholar. Dr. Garner is Board Certified by the American Board of Medical Microbiology. Dr. Garner's research focuses on novel Point of Care Devices for infectious disease diagnosis in the developing world.

Daniel Irimia, MD, PhD, Associate Professor, Surgery, Massachusetts General Hospital (MGH)
Daniel Irimia is a bioengineer, a medical doctor by training, and a researcher in the areas of microfluidics, inflammation, and sepsis. He is an Associate Professor in the Surgery Department at Massachusetts General Hospital (MGH), Shriners Burns Hospital, and Harvard Medical School. He was recently awarded the "Pioneers of Miniaturization" prize from the Chemical and Biological Microsystems Society for his work on microfluidic tools for analyzing neutrophils and other leukocytes in health and disease.

Joshua LaBaer, MD, PhD, Executive Director, The Biodesign Institute, Arizona State University
Joshua LaBaer is one of the nation’s foremost investigators in the rapidly expanding field of personalized diagnostics. His efforts focus on the discovery and validation of biomarkers — unique molecular fingerprints of disease — which can provide early warning for those at risk of major illnesses, including cancer and diabetes. Formerly founder and director of the Harvard Institute of Proteomics, LaBaer was recruited to ASU’s Biodesign Institute as the first Piper Chair in Personalized Medicine in 2009. The Virginia G. Piper Center for Personalized Diagnostics (VGPCPD) has a highly multidisciplinary staff of molecular biologists, cell biologists, biochemists, software engineers, database specialists, bioinformaticists, biostatisticians, and automation engineers. VGPCPD applies open reading frame clones to the high throughput (HT) study of protein function. In addition, his group invented a novel protein microarray technology, Nucleic Acid Programmable Protein Array, which has been used widely for biomedical research, including the recent discovery of a panel of 28 autoantibody biomarkers that may aid the early diagnosis of breast cancer. LaBaer earned his medical degree and a doctorate in biochemistry and biophysics, from the University of California, San Francisco. He completed his medical residency at the Brigham and Women’s Hospital and a clinical fellowship in oncology at the Dana-Farber Cancer Institute, both in Boston. He has contributed more than 150 original research publications, reviews and chapters. LaBaer is an associate editor of the Journal of Proteome Research, a recent member of the National Cancer Institute’s Board of Scientific Advisors, Chair of the Early Detection Research Network Steering Committee and recent president of the U.S. Human Proteome Organization.

Marc Madou, PhD, Chancellor's Professor, Mechanical and Aerospace Engineering, University of California, Irvine
No bio available

Bill Marquardt, C(ASCP), MBA, CSSBB, Vice President, Lab Intelligence, McKesson Laboratory Solutions
Bill Marquardt is currently the Vice President of Laboratory Intelligence at McKesson Laboratory Solutions. Bill has over 20 years of experience in clinical laboratory informatics, automation, and process management. He is an author on the Auto10-A CLSI document entitled “Autoverification of Clinical Laboratory Test Results” and is currently the chairman for the CLSI committee on department specific autoverification algorithms (who’s documents are currently in review.) Bill’s previous publications include an article from CAP Today in 2015 titled ‘A step-by-step process to 95% autoverification’.   Bill’s previous role was that of Laboratory IT services director for the 4th largest laboratory in the US and has consulted and held positions in several IVD companies. Bill was a practicing paramedic for 25 years, holds a clinical chemistry degree from Penn State Geisinger Medical Center and an MBA, and is also a certified LEAN Six Sigma Black Belt. 

James H. Nichols, PhD, DABCC, FACB, Professor of Pathology, Microbiology and Immunology & Medical Director, Clinical Chemistry and Point-of-Care Testing, Vanderbilt University School of Medicine
James H. Nichols, PhD, DABCC, FAACC 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.

Timothy Pearcy, Managing Director, BIOLYPH LLC
https://www.linkedin.com/in/timothypearcy

Joel Saltz, MD, PhD, Chair and Professor Department of Biomedical Informatics, Vice President, Clinical Informatics Stony Brook Medicine, Cherith Endowed Chair, Stony Brook University
Joel Saltz is a boarded Clinical Pathologist trained at Johns Hopkins. He holds an MD-PhD in Computer Science from Duke University. He is the founding chair of Biomedical Informatics departments at Stony Brook, Emory and Ohio State and is the Director of the newly formed Institute for Engineering Driven Medicine at Stony Brook. Dr. Saltz is a fellow of the American College of Medical Informatics and the Cherith Chair of Biomedical Informatics.

Robert Schlaberg, MD, MPH, Assistant Professor of Pathology, University of Utah; Medical Director, ARUP Laboratories; Co-Founder and CMO, IDbyDNA, Inc.
Robert Schlaberg, MD, MPH is an Assistant Professor of Pathology at the University of Utah, a medical director at ARUP Laboratories, and Co-founder and CMO at IDbyDNA, Inc. He completed his Clinical Pathology residency and Master of Public Health training at Columbia University, and a Medical Microbiology fellowship at ARUP Laboratories. His research is focused on next-generation sequencing-based infectious disease diagnostics. He has co-developed technology for ultrafast, user-friendly, and diagnostic-grade metagenomics data analysis to accelerate development of precision diagnostics for infectious disease. He is board-certified in Clinical Pathology and Medical Microbiology by the American Board of Pathology and has served on the College of American Pathologists’ Microbiology Resource and Standards Committees.

Stuart Sealfon, MD, Glickenhaus Family Professor of Neurology, Icahn School of Medicine at Mount Sinai
Stuart Sealfon is a systems biologist-neurologist who uses computational and mathematical analysis of transcriptomic and epigenomic data to understand and predict response specificity. He has studied signaling specificity in the pituitary gonadotrope for three decades and his research has contributed to the development of elagolix, which was recently FDA-approved for treating endometriosis. He has led an NIH-supported center for immunological modeling for more than a decade, and he directs an assay site for the NIH Molecular Transducers of Physical Activity consortium that is developing a molecular map of the response to physical activity. He directs the Center for Advanced Research on Diagnostic Assays at the Icahn School of Medicine at Mount Sinai. 

Richard Spero, PhD, CEO, Redbud Labs, Inc.
Dr. Richard Spero is a microfluidics expert and is the CEO and co-founder of Redbud Labs, which he began after completing his PhD at UNC Chapel Hill in 2010. Since then, he has lead the company's success in raising millions and commercializing two families of microfluidic chip products. 

Bharath Takulapalli, PhD, Founder & CEO, INanoBio Inc
Bharath Takulapalli is the Founder & CEO of INanoBio, a company pioneering technologies at the confluence of nanotechnology, systems biology and machine learning. Bharath founded INanoBio with the ambitious goal of developing advanced nano-biotechnologies for resolving biological complexity, to deliver early stage diagnostics for disease preemption, reduce healthcare expenditures to a fraction of today's. He has invented multiple nano-sensor technologies for genomic, epigenomic and proteomic applications, resulting in over 30 global patents. Bharath got his bachelors from Indian Institute of Technology Madras India and PhD in nano-electronics from Arizona State University. 

Nam Tran, PhD, Associate Clinical Professor, Clinical Chemistry, Special Chemistry, Toxicology, POCT and SARC Sections, Department of Pathology and Laboratory Medicine, University of California, Davis
Dr. Tran is Associate Professor of Clinical Pathology and Director of Clinical Chemistry, Special Chemistry/Toxicology, and Point-of-Care Testing at UC Davis. He completed his PhD degree in Comparative Pathology in 2008 and conducted a postdoctoral training fellowship under the National Institute of Bioimaging and Bioengineering (NIBIB) sponsored UC Davis Point-of-Care (POC) Technologies Center focused on developing novel molecular pathogen detection technologies and defining the environmental robustness of commercially available POC devices for critical, emergency, disaster care settings.

Enabling Technologies for Circulating Biomarkers  

Irun Bhan, MD, Clinical Instructor, Transplant Hepatologist, Gastroenterology, Massachusetts General Hospital, Harvard Medical School

Dr. Irun Bhan is a transplant hepatologist and physician scientist at Massachusetts General Hospital and an instructor at Harvard Medical School. He earned a bachelor’s degree with honors in biophysics from Johns Hopkins University. He went on to graduate magna cum laude with an MD degree from the Harvard-MIT Health Sciences and Technology program at Harvard Medical School, where he studied the molecular regulation of the tumor suppressor protein p53 as a Howard Hughes Medical Institute fellow. He subsequently completed his residency training in internal medicine at Columbia University, where he served as Chief Resident. He further trained as a clinical and research fellow in gastroenterology and subsequently advanced/transplant hepatology at Massachusetts General Hospital. His current research interests include the prevention, early detection, and treatment of hepatocellular carcinoma in patients with chronic liver disease. His ongoing work includes the development of blood-based biomarkers including circulating epithelial cells in hepatocellular carcinoma.

Daniel T. Chiu, PhD, A. Bruce Montgomery Professor, Chemistry and Bioengineering, University of Washington, Seattle
Daniel T. Chiu is the A. Bruce Montgomery Professor of Chemistry, Endowed Professor of Analytical Chemistry, Washington Research Foundation Professor, and Professor of Bioengineering at the University of Washington, Seattle. He obtained a B.A. in Neurobiology and a B.S. in Chemistry from the University of California at Berkeley in 1993 and a Ph.D in Chemistry from Stanford University in 1998. He is currently a member of the Center for Nanotechnology and the Neurobiology and Behavior Program at the University of Washington, as well as a member of the Cancer Consortium at the Fred Hutchinson Cancer Research Center.

Anthony Dickherber, PhD, Program Director, Center for Strategic Scientific Initiatives, National Cancer Institute
Dr. Tony Dickherber is the Program Manager of Innovative Molecular Analysis Technologies at the National Cancer Institute. He was an AAAS Science & Technology Policy Fellow at the National Cancer Institute and a Postdoctoral Fellow at Georgia Tech. He earned his doctoral degree in Bioengineering (2008), Master’s in Electrical and Computer Engineering (2002) and Bachelor’s degree in Electrical Engineering (1999), all from Georgia Tech. He also completed the Graduate Certificate in Public Policy at Georgia Tech.

Amir Goldkorn, MD, Associate Professor of Medicine, Co-Leader, Translational & Clinical Science Program; Director, Circulating Tumor Cell Research Core, USC Norris Comprehensive Cancer Center & Keck School of Medicine; Chair, Prostate Cancer Organ Site Translational Medicine, SWOG
Dr. Goldkorn’s laboratory-based research program focuses on developing the therapeutic and biomarker potential of circulating tumor cells, cancer stem cells, and telomerase. Graduate students, postdocs and medical students in the laboratory conduct experiments ranging from basic molecular research to translational medicine assays for clinical trials. These research activities synergize with our clinical activities and provide unique opportunities to translate our laboratory and clinical advances into better care for our patients.
Dr. Goldkorn earned his medical degree from the UCLA School of Medicine. He then went on to complete his fellowship in hematology-oncology and post-doctoral research at University of California, San Francisco.

Sam Hanash, MD, PhD, Director, Red & Charline McCombs Institute; Evelyn & Sol Rubenstein Distinguished Chair, Cancer Prevention; Professor, Clinical Cancer Prevention-Research, Translational Molecular Pathology, University of Texas MD Anderson Cancer Center
No bio available

Michael J. Heller, PhD, Distinguished Scientist, Knight Cancer Institute at Oregon Health & Science University (OHSU), Center for Cancer Early Detection and Research (CEDAR); Professor Emeritus, Bioengineering and Nanoengineering, University of California San Diego
Michael J. Heller received his PhD in Biochemistry from Colorado State University in 1973. He was an NIH Postdoctoral Fellow at Northwestern University from 1973 to 1976. From 1976 to 1984 he was supervisor of the DNA Technology Group at Amoco Corporation (Standard Oil Indiana) During that time he carried out early bioengineering and recombinant DNA work on plants, algae and photosynthetic bacteria for energy and chemical production, and developed some of the first fluorescent resonant energy transfer (FRET) and chemiluminescent oligonucleotide probes for DNA hybridization analysis. He also oversaw Amoco’s sponsored energy and chemical research work at Cetus Corporation, which included the cloning of thermophilic enzymes. Dr. Heller was the Director of Molecular Biology at Molecular Biosystems, Inc., from 1984 to 1987.  He was a co-founder of Integrated DNA Technologies, and served as President and Chief Operating Officer from 1987 to 1989.  He was a co-found of Nanogen, and served as the Chief Technical Officer from 1993 to 2001. Nanogen carried out the successful development and commercialization of electronic DNA microarray technology for clinical diagnostic genotyping applications. Dr. Heller is a Professor (Recall/Emeritus) in the Departments of Nanoengineering and Bioengineering at the University California San Diego. He is also now a Distinguished Scientist at the Oregon Health & Science University (OHSU), Center for Cancer Early Detection and Research (CEDAR), in Portland, Oregon. He has also co-founded a company called Biological Dynamics which is developing new sample to answer cancer diagnostics technology, based on the novel dielectrophoretic (DEP) technology developed at his UCSD lab. Dr. Heller has extensive industrial experience in biotechnology, biomedical and molecular diagnostic devices and nanotechnology, with particular expertise in the areas of DNA probe diagnostics, electrokinetic lab-on-a-chip devices, DNA synthesis, FRET/fluorescent-based detection technologies and electric field assisted self-assembly of DNA nanostructures. Dr. Heller has over 100 publications and 56 issued US patents.

Hyungsoon Im, PhD, Assistant Professor of Radiology, Massachusetts General Hospital, Radiology, Massachusetts General Hospital
Hyungsoon Im is Assistant Professor at the Center for Systems Biology (CSB), Massachusetts General Hospital and Harvard Medical School. He received his Ph.D in Electrical Engineering from the University of Minnesota in 2011. Working with Drs. Ralph Weissleder and Hakho Lee, he has developed novel nanoplasmonic sensing technologies for exosome detection and characterization.

Shana O. Kelley, PhD, Professor, Leslie Dan Faculty of Pharmacy, Faculty of Medicine, Biochemistry, University of Toronto
Dr. Shana Kelley is a Distinguished Professor of Chemistry, Pharmaceutical Sciences, Biochemistry, and Biomedical Engineering at the University of Toronto. Dr. Kelley received her Ph.D. from the California Institute of Technology and was a NIH postdoctoral fellow at the Scripps Research Institute. The Kelley research group works in a variety of areas spanning biophysical/bioanalytical chemistry, chemical biology and nanotechnology, and have pioneered new methods for tracking molecular and cellular analytes with unprecedented sensitivity. Dr. Kelley’s work has been recognized with a variety of distinctions, including being named one of “Canada’s Top 40 under 40”, a NSERC E.W.R. Steacie Fellow, the 2011 Steacie Prize, and the 2016 NSERC Brockhouse Prize. She has also been recognized with the ACS Inorganic Nanoscience Award, Pittsburgh Conference Achievement Award, an Alfred P. Sloan Research Fellowship, a Camille Dreyfus Teacher-Scholar award, a NSF CAREER Award, a Dreyfus New Faculty Award, and was also named a “Top 100 Innovator” by MIT’s Technology Review. Shana is a founder of two molecular diagnostics companies, GeneOhm Sciences (acquired by Becton Dickinson in 2005) and Xagenic Inc. (acquired by General Atomics in 2017), and sits on the Board of Directors of the Ontario Genomics Institute and the Fight Against Cancer Trust. She is an Associate Editor for ACS Sensors, and an Editorial Advisory Board Member for the Journal of the American Chemical Society and ACS Chemical Biology.

G. Mike Makrigiorgos, PhD, Professor of Radiation Oncology, Dana Farber Cancer Institute and Harvard Medical School
Dr. Makrigiorgos is a Professor and Director of the Medical Physics & Biophysics division in Radiation Oncology at Dana Farber Cancer Institute and Brigham and Women’s Hospitals, Harvard Medical School.  He is as ABR-certified radiation oncology physicist and he also directs his DNA technology laboratory and a radiation pre-clinical facility.  His research interests include the development of novel DNA technologies for molecular diagnostics in Oncology and the detection of circulating cancer biomarkers.  Funded continuously by NIH over the last 25 years, he invented several new techniques for molecular diagnostics, including Balanced-PCR, COLD-PCR and NaME-PrO.  He is a Member of the Editorial Board of Clinical Chemistry and has published over 150 articles in journals including Nature Medicine, Nature Biotechnology, Nucleic Acid Research and Clinical Chemistry.  He received his undergraduate degree in Physics from the University of Athens, Greece, his PhD in Medical Physics from the University of Leeds, UK and his postdoctoral training in radiation biology from Harvard Medical School, Boston.

Stuart Martin, PhD, 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 Greenebaum Cancer Center at the University of Maryland School of Medicine. Dr. Martin is working to apply physical science and engineering approaches to the study of cancer metastasis. In 2010, Dr. Martin was one of only three investigators nationwide recognized with an Era of Hope Scholar Award from the Congressionally-directed Medical Research Program for his innovative research on breast cancer metastasis.

Ian Papautsky, PhD, Professor, Bioengineering; Co-Director, NSF Center for Advanced Design & Manufacturing of Integrated Microfluidics (CADMIM) Bioengineering, University of Illinois at Chicago
No bio available

Arturo Ramirez, Director, Oncology R&D, RareCyte, Inc.
Arturo Ramirez has been involved in R&D with RareCyte since 2010. He has performed or overseen every aspect of the development of this technology since its inception and is currently the Director of Oncology R&D. His expertise is in biomarker discovery for oncology and has a PhD in Molecular and Cellular Biology from the University of Washington.

Steven A. Soper, PhD, Chemistry, Mechanical Engineering, BioEngineering, KUMC Cancer Center University of Kansas, Lawrence; Director, NIH Biotechnology Resource Center of BioModular Multi-Scale Systems for Precision Medicine
Prof. Steven A. Soper received his PhD from the University of Kansas in 1989 followed by a Postdoctoral Fellowship at Los Alamos National Laboratory, where he worked on single-molecule detection for high speed sequencing of the human genome. In 1991, he joined the faculty at Louisiana State University (LSU) within the Department of Chemistry, where he filled the William H. Pryor Distinguished Chair of Chemistry. Prof. Soper also held joint appointments in Mechanical Engineering and Biological Sciences. While at LSU, he founded the Center of BioModular Multi-Scale Systems for Precision Medicine, which has as its primary charge to develop enabling and transformative tools for making health-related measurements from rare disease markers, such as liquid biopsy markers, with full process automation. 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). In 2011, Prof. Soper accepted a position within the Department of Biomedical Engineering and Department of Chemistry at the University of North Carolina, Chapel Hill. Prof. Soper is currently a Foundation Distinguished Professor in Chemistry and Mechanical Engineering at the University of Kansas, Lawrence. 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. He is also serving as a Science Advisor for a number of major worldwide companies. Prof. Soper is currently the Editor of the Americas for the Analyst and on the Editorial Board for Journal of Fluorescence and Journal of Micro- and Nanosystems. Prof. Soper is also serving as a permanent Member of the Nanotechnology study panel with the National Institutes of Health. As a result of his efforts, Prof. Soper has secured extramural funding totaling >$89M and has published over 315 manuscripts (h index = 62) 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. His list of awards, Includes Chemical Instrumentation by the American Chemical Society, the Benedetti-Pichler Award for Microchemistry, Fellow of the AAAS, Fellow of Applied Spectroscopy, Fellow of the Royal Society of Chemistry, R&D 100 Award, Distinguished Masters Award at LSU and Outstanding Scientist/Engineer in the state of Louisiana in 2001.

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 of 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.

Ryan M. Spengler, PhD, Postdoctoral Fellow, Muneesh Tewari Laboratory, Hematology/Oncology, University of Michigan
Dr. Spengler received his Ph.D. in Molecular and Cellular Biology from the University of Iowa in 2013. His doctoral research with Dr. Beverly Davidson led to contributions both in basic microRNA biology, and in making RNA interference (RNAi) safer for use as a gene therapy tool. Through this research, he also developed an interest and expertise in using computational tools and bioinformatics techniques to study RNA biology, in particular through applications of NGS technologies. Dr. Spengler currently works as a bioinformatics postdoctoral researcher in Dr. Muneesh Tewari’s lab at the University of Michigan, where he works on developing computational strategies to discover novel RNA biomarkers for human health and disease.

David Ting, PhD, Cancer Center, Massachusetts General Hospital, Harvard Medical School
Dr. Ting is Assistant Professor of Medicine at Harvard Medical School and a medical oncologist with a focus on gastrointestinal malignancies at the Massachusetts General Hospital (MGH) Cancer Center. After receiving undergraduate degrees in chemical engineering and biology from M.I.T., he completed his medical degree at Harvard Medical School. He completed internal medicine residency at the MGH and medical oncology fellowship in the combined Dana Farber Cancer Institute and MGH Cancer Center program. During his undergraduate and medical training, Dr. Ting trained with Robert Langer in the MIT Chemical Engineering Department working on nucleic acid delivery vehicles and George Daley at the Whitehead Institute on stem cell biology. He performed his post-doctoral training with Daniel Haber at the MGH Cancer Center, where he began work characterizing circulating tumor cells (CTCs) and primary tumors with RNA-sequencing.
The Ting laboratory utilizes RNA-sequencing and RNA in situ hybridization technologies to understand the complex transcriptional landscape of pancreatic cancer, one of the most lethal adult cancers in great need of advanced diagnostics and therapeutic strategies. The laboratory has used these technologies to identify non-coding sequences in RNA (ncRNA) that are differentially expressed in cancer versus normal tissues. This has provided novel insight into the pathogenesis of pancreatic cancer and offers a method to identify novel biomarkers and therapeutic targets. In parallel, Dr. Ting’s laboratory uses innovative microfluidic chip technology to capture pancreatic CTCs as a non-invasive cancer biomarker as well as a means to understand their role in the metastatic cascade. 

Yong Zeng, PhD, Associate Professor and Docking Faculty Scholar, Chemistry, KU Cancer Center, University of Kansas
Dr. Zeng currently is a Docking Scholar Associate Professor at the University of Kansas in the Department of Chemistry, the Bioengineering Graduate Program, and KU Cancer Center.  Working at the interface of chemistry and biology, a primary aim of his research is to develop new enabling tools for liquid biopsy-based cancer diagnosis and precision medicine.  Dr. Zeng is also interested in translational research to move technology innovations from laboratory benchtop into clinical practices to facilitate the advance of human health.  He received the J.R. & Inez Jay Award in 2014, and was named as prestigious Docking Family Faculty Scholar in 2017.  His research has been supported by a number of grants from National Institute of Health (NIH) and other funding agencies.

Emerging Technologies and Biomarkers for Cancer Immunotherapy

Forrest J. Holmes Blocker, PhD, Director, Scientific Affairs, NeoGenomics
Dr. Blocker joined NeoGenomics after consulting for the pharmaceutical and biotechnology industries, specializing in the mechanism of cancer therapeutics, and serving on the faculty of the University of Texas and the University of New Mexico. She attended graduate school at the University of California at San Francisco and did a postdoctoral fellowship at The Scripps Research Institute in La Jolla. 

Scott Ely, MD, MPH, Director, Pathology, Bristol-Myers Squibb

Scott Ely is a hematopathologist who designs and implements clinical biomarker assays for immuno-oncology and blood cancers.  He spent most of his career as an attending physician on faculty at Weill-Cornell/New York Presbyterian Hospital and is now Director, Pathology in Translational Medicine at Briostol-Myers Squibb.  He has patented multiplex chromogenic IHC assay platforms that enable clinically relevant data assessment such as colocalization of target molecules with lineage determining molecules.  Application of this technology has been used to prognosticate and predict response and pharmacodynamic effects in clinical trials for multiple myeloma, lymphoma, Kaposi’s sarcoma and solid organ tumors.  Recently, his team at Bristol-Myers Squibb has combined genetics, IHC and AI spatial cell-localization to develop a gene expression panel that quantitates CD8 T cells in tumor parenchyma vs. stroma.

Clifford Hoyt, Vice President, Translational and Scientific Affairs, Akoya Biosciences, Inc.
As VP of Translational and Scientific Affairs, Mr. Hoyt runs Akoya Biosciences’ Applications and Services Group, and leads strategy in the area of oncology, helping to identify translational opportunities and managing collaborations with academia and industry. Mr. Hoyt joined Akoya through the merger of Akoya and PerkinElmer’s Quantitative Pathology Solution’s (QPS) business unit, which spun out of PerkinElmer in the fall of 2018. The quantitative immunofluorescence platform developed by QPS, called Phenoptics, has its roots in Cambridge Research & Instrumentation (CRI), for which he was a cofounder. At CRI, Mr. Hoyt was principle investigator on NIH SBIR grants and helped lead development and commercialization of innovative technologies and products in the life sciences, telecommunications, and metrology. Mr. Hoyt received a BA in physics from Williams College in 1983 and Master’s in mechanical engineering from the Massachusetts Institute of Technology in 1987. He is a named inventor on over 20 patents.

Omar Laterza, PhD, DABCC, Executive Director, Molecular Biomarkers and Diagnostics, Merck & Co., Inc.
Dr. Laterza is the Executive Director of the Translational Molecular Biomarkers group at Merck & Co., Inc.  He has been at Merck for the last 15 years where he held positions of increasing responsibility in clinical biomarker development/validation and companion diagnostics. Dr. Laterza obtained his PhD in Biochemistry at Colorado State University and a post-doctoral fellowship in Clinical Chemistry at Washington University, School of Medicine, in St. Louis, Missouri.  Prior to working at Merck, he was an Instructor of Pathology at The Johns Hopkins School of Medicine and Director of the General Chemistry section of the Core Lab at The Johns Hopkins Hospital. He is the author of multiple publications, review articles and a co-inventor in patents and patents applications. He is a diplomat of the American Board of Clinical Chemistry (DABCC) and a Fellow of the American Academy of Clinical Biochemistry (FACB).

Tingyu Liu, PhD, Postdoctoral Scholar, Exploratory Immuno-Oncology, Novartis Institutes for BioMedical Research, Inc.
Tingyu joined NIBR Immuno-Oncology postdoc program in November 2016. Since then, she has been using primary patient tumor samples to investigate heterogeneity of tumor infiltrating T cells and identify defects of these T cells using multi-pronged approach, such as multi-color flow cytometry, bulk RNA-sequencing, IHC staining and in vitro T cell functional assays. Lately, she has been performing single-cell RNA sequencing on human tumors to gain deeper understanding of tumor infiltrating T cells and mechanisms that lead to T cell dysfunction. Before joining NIBR, Tingyu earned her PhD degree in Pharmacology from Duke University and did a short postdoc in Dr. Jeff Engelman’s lab at MGH cancer center.

Shannon Liudahl, PhD, Postdoctoral Researcher, Cell, Developmental & Cancer Biology, Oregon Health & Science University
Dr. Shannon Liudahl recently completed her PhD training in the laboratory of Dr. Lisa Coussens at Oregon Health & Science University. Her PhD research focused on immune dynamics and immunotherapy strategies in pancreatitis and pancreatic cancer. While in the Coussens lab, Dr. Liudahl contributed to the development of multiplexed immunohistochemistry approaches that she used to profile the immune microenvironment of human pancreatic cancer and evaluate relationships between tumor immune composition, mutational status, and patient outcome.

Elizabeth Maloney, Senior Research Associate, NGS & Molecular Biology, Gritstone Oncology

Elizabeth Maloney has served as the TCR (T cell receptor) sequencing guru in Gritstone Oncology’s NGS & Molecular Biology group since October 2018. She supports T cell sequencing for all clinical and R&D programs, expanding biomarker technologies both in vitro and in silico. Prior to Gritstone, from 2015 to 2018, Elizabeth served as a Graduate Scientist in AstraZeneca’s Oncology Translational Sciences group supporting the development of their clinical biomarker platform through TCR sequencing. Her prior scientific experience also includes research in Pfizer’s Oncology Bioconjugation group as well as Dr. David Kaplan’s silk biomedical engineering lab at Tufts University. She received a BS in biology from Tufts University and plans to pursue a PhD next fall.

Matthew Marton, PhD, Director, Companion Diagnostics and Genomics, Merck & Co., Inc.
Matt Marton is Director of Genomics and Companion Diagnostics in Merck’s Translational Medicine Department, where he applies predictive biomarkers to clinical research. His work has led to FDA-approval of an immunohistochemical PD-L1 companion diagnostic (CDx) in cervical cancer for pembrolizumab and to a CE-marked gene expression diagnostic.  His current interest focuses on CDx and regulatory strategies of novel genomic assays as molecular diagnostics, including those involved in homologous recombination repair pathway. Earlier in his career, his work contributed to the founding of Rosetta Inpharmatics LLC, where he contributed to the development of both the inkjet technology and the predictive gene expression signature that culminated in the Mammaprint test for breast cancer recurrence. Dr. Marton completed post-doctoral training at the NIH and holds a PhD from Princeton University. 

Joseph Melenhorst, PhD, Adjunct Associate Professor, Pathology & Laboratory Medicine, University of Pennsylvania
Dr. Melenhorst graduated with a bachelor’s degree in continuing education from Tilburg Fontys Teacher’s College, a master’s degree in Medical Biology from the Nijmegen Catholic University, the Netherlands, and a doctorate of philosophy from the Leiden University, the Netherlands. After a post-doctoral fellowship followed by a staff scientist appointment at the National Institutes of Health, he was recruited to the University of Pennsylvania in 2012 by Dr. Carl June, first as Deputy Director of the Clinical Cell and Vaccine Production Facility and later as the Director of Product Development & Correlative Sciences. In this role, he was at the cusp of the first ever CAR T cell therapy approved by FDA: Kymriah. Dr. Melenhorst contributed significantly to the evolution of the CAR manufacturing process and to in-depth mechanistic studies into the immunobiology of CAR T-cell therapies, work that was published in high impact journals such as Nature, Nature Medicine, Cancer Discovery, Science Translational Medicine, and the New England Journal of Medicine. Dr. Melenhorst’s research aims to understand and improve the efficacy, safety, and product consistency of adoptive cell immunotherapy through biomarker, mechanistic, and product development studies.

Amanda Paulovich, MD, PhD, Full Member & Aven Foundation Endowed Chair, Clinical Research Division, Fred Hutchinson Cancer Research Center; Professor, Division of Oncology, Department of Medicine at the University of Washington School of Medicine
Dr. Paulovich received her MD and PhD (in Genetics, working with Nobel Laureate Dr. Leland Hartwell) at the University of Washington. She completed a residency in Internal Medicine at Massachusetts General Hospital and a fellowship in Oncology at Dana-Farber/Partners Cancer Center in Boston. Her postdoctoral training was done at MIT-Whitehead Center for Genomics Research working with Dr. Eric Lander. As an oncologist, Dr. Amanda Paulovich was struck by the paucity of quantitative assays for measuring clinically relevant phenotypes in her patients, and the limitations that this put on her ability to practice “precision medicine.” Out of these experiences, she became passionate about developing technologies and strategies for translation of novel diagnostics and therapeutics to enable precision medicine. Over the past 14 years, Dr. Paulovich's research has focused on relieving a roadblock in biomedical research: a lack of validated and standardized tools for quantifying human proteins. The laboratory has been a major developer of multiple reaction monitoring mass spectrometry (MRM)-based proteomic assays. Dr. Paulovich's well established team is now pivoting from technology development to turning this technology into transformative tools that will fundamentally change biomedical research and lead to improvements in patient diagnosis and treatment by facilitating precision oncology. She was inducted to American Society for Clinical Investigation, received the 2014 Life Science Innovation Northwest Women to Watch in Life Science Award, received the 2015 Distinguished Achievement in Proteomic Sciences Award from the international Human Proteome Organization, and was awarded the Aven Foundation Endowed Chair in November 2018.

Andrea K. Pomerantz, PhD, Investigator III, Microscopy & Biophotonics, Analytical Sciences & Imaging, Novartis Institutes for BioMedical Research, Inc.
Andrea is a research investigator in the Microscopy and Biophotonics (MiBs) group in Analytical Sciences & Imaging at Novartis, where her lab integrates expertise in cell biology, biophysics, microfluidics and fluorescence microscopy to interrogate individual cells and develop assays to address key mechanistic questions in the development of new therapeutics, with an emphasis on preclinical immuno-oncology applications. Prior to joining Novartis, she earned her PhD in Biophysical Chemistry at Stanford, where she carried out single-molecule fluorescence studies of DNA structure and polymerase activity in the labs of Eric Kool and W.E. Moerner, followed by a postdoctoral fellowship RNAi therapeutics at NIBR in collaboration with Ian MacRae at Scripps.

Clifford Reid, MBA, PhD, CEO, Travera
Clifford Reid is the founding CEO of Travera. Previously, Dr. Reid was the founding Chairman, President and Chief Executive Officer of Complete Genomics (NASDAQ:GNOM), a leading developer of whole human genome DNA sequencing technologies and services. Prior to Complete Genomics he founded two enterprise software companies: Eloquent (NASDAQ:ELOQ), an internet video company, and Verity (NASDAQ:VRTY), an enterprise search engine company. Dr. Reid is on the Visiting Committee of the Biological Engineering Department at the Massachusetts Institute of Technology (MIT), a member of the MIT Corporation Development Committee, and an advisor to Warburg Pincus.  He earned a S.B. 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, Program Director, Office of Cancer Clinical Proteomics Research, Center for Strategic Scientific Initiatives, National Cancer Institute, National Institutes of Health
Dr. Robles is a Program Director in the Office of Cancer Clinical Proteomics Research (OCCPR) at the National Cancer Institute (NCI), National Institutes of Health (NIH), where she provides scientific expertise in Cancer Biology and Genomics to new and existing proteogenomics programs. Prior to joining OCCPR, Dr. Robles was an Associate Scientist at the NCI, where she focused on molecular epidemiology and the identification and functional characterization of lung cancer biomarkers. Dr. Robles has co-authored 3 book chapters and over 80 publications in peer-reviewed journals. She is member of the Editorial Boards of Carcinogenesis (ISSN 0143-3334) and Cancers (ISSN 2072-6694). Dr. Robles completed undergraduate training in Chemistry at University of Buenos Aires, Argentina, holds a PhD degree 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.

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.

Yvonne Saenger, MD, Department of Medicine, Division of Hematology/Oncology, Director, Melanoma Immunotherapy, Columbia University Irving Medical Center
https://www.linkedin.com/in/yvonne-saenger-0198905/

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

Coverage and Reimbursement for Advanced Diagnostics 

Jim Almas, MD, Vice President and National Medical Director for Clinical Effectiveness, LabCorp
Dr. Almas had years of service as a lab director of large non-profit hospitals.  He has worked as a consultant to BCBS-affiliates. Dr. Almas also worked as a Medical Officer at CMS in the Coverage and Analysis Group (CAG) and, before joining LabCorp in 2018, served as the Medical Director of the MolDX Program (at PalmettoGBA).

Suzanne Belinson, PhD, Vice President, Commercial Markets, Tempus, Inc.
Suzanne Belinson, PhD, MPH, is Vice President of Commercial Markets at Tempus Labs, Inc. Tempus is a technology company that has build the world’s largest library of clinical and molecular data and an operating system to make that data accessible and useful, starting with cancer. Her role focuses on commercial growth for Tempus through the development and execution of partnerships with organizations aiming to improve healthcare value and outcomes by leveraging molecular and clinical data. Before joining Tempus, Dr. Belinson served as an Executive Director, Clinical Markets, at the Blue Cross Blue Shield Association. In addition to leading the sales and market development for products and services developed within the Office of Clinical Affairs, Dr. Belinson led the day to day operations of Evidence Street. As part of the leadership team in the Office of Clinical Affairs she also spent time focused on the development of emerging programs and services that enhance value and brand leadership for the independent BCBS Plans. Dr. Belinson received her bachelor’s degree from Cleveland State University, and a PhD in Epidemiology from the University of North Carolina at Chapel Hill. She also holds a Master’s in Public Health from the University of Pittsburgh.

Gabriel A. Bien-Willner, MD, PhD, Medical Director, MoIDX, Palmetto GBA
Dr. Bien-Willner is the Medical Director of the MolDX program at Palmetto GBA, a Medicare Administrative Contractor (MAC). MolDX seeks to understand the molecular testing landscape to implement payer controls, coverage, and to set policy for affiliated MACs, which currently cover 28 states. He is a leader in the Precision Medicine space and practices as a Board-certified Anatomic Pathologist and Molecular Genetic Pathologist. Throughout his career, he has been active in research, development, and advancement of molecular diagnostic services, specifically next generation sequencing. He has worked closely with clinicians to develop clear clinical diagnostic and treatment pathways directing Precision Medicine programs for community cancer centers. Dr. Bien-Willner received his MD and PhD degrees from Baylor College of Medicine, with a PhD in Human Molecular Genetics. He completed his residency, fellowship, and attained a faculty appointment at Washington University in St. Louis prior to leadership roles in laboratory and biotech companies before joining Palmetto GBA.

Chandra N. Branham, JD, Vice President, Payment and Health Care Delivery Policy, The Advanced Medical Technology Association (AdvaMed)
Chandra Branham, JD, 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, value of medical technology 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 JD from the George Mason University School of Law.

Kristine Bordenave, MD, FACP, Corporate Medical Director, NMCARE, Healthcare Services, Humana https://www.linkedin.com/in/kristine-bordenave-md-facp-9b622212/

Tara Burke, PhD, Senior Director, Public Policy and Advocacy, Association for Molecular Pathology
Tara Burke, PhD joined the Association for Molecular Pathology (AMP) in 2014 and currently serves as AMP’s Senior Director of Public Policy & Advocacy.  She leads AMP’s advocacy program and is the main staff liaison to both the Professional Relations Committee and Economic Affairs Committee. AMP advocacy focuses on reimbursement and regulatory issues affecting molecular pathology, including regulation of laboratory developed testing procedures, as well as coding, coverage, and payment policy.  Tara has over a decade of biomedical research experience specializing in biochemistry, molecular genetics, and epigenetics. She holds a BS in Molecular Biology from Vanderbilt University, a PhD in Biochemistry and Molecular Genetics from The University of Virginia, and completed a postdoctoral fellowship at the National Institute of Child Health and Human Development (NICHD) at the NIH. In her current role at AMP, Tara enjoys being able to combine her genetics expertise with policy interests to serve AMP members and their mission.   

Mitchell Burken, MD, Associate Medical Director, Genetics, eviCore
Dr. Burken began his career in public policy in the early 1970’s with private sector experience in economics consulting, and after the completion of his medical training, his career continued on an administrative track with his laboratory management, quality improvement and epidemiology activities in the Department of Veterans Affairs.  During the last phase of his tenure with the VA, he was involved with research on technology evaluation, and this provided a segue to the next phase of his career with the Medicare program, where at the CMS Central Office, he worked for 5+ years in the Coverage & Analysis Group, developing National Coverage Determinations (NCDs), with an emphasis on emerging (imaging and laboratory) diagnostic devices.  His CMS experience provided a strong foundation for his subsequent LCD activities, along with managed care reviews, as a Medicare Medical Director with TrailBlazer Health Enterprises, BlueCross BlueShield of Tennessee, and Novitas Solutions, Inc.
Most recently with eviCore Healthcare, he has expanded his commercial payer experience to Laboratory Benefits Management.  He also has had biotechnology clients, including those in precision medicine.

Brian P. Carey, JD, Partner, Co-Chair, Administrative Law Department, Foley Hoag LLP
Brian Carey’s legal practice focuses on advising a wide range of clients on federal legislative and regulatory issues impacting the life sciences and health care sectors. He primarily advises biotechnology, medical device companies, health care providers, medical trade associations and private equity investors. Brian previously served as a co-chair of the firm's Administrative Law practice group.

His work with biopharma and medical technology companies includes advice on Medicare
coverage and payment, and food and drug approval issues for innovative technologies. He
regularly represents clients in matters before the Congress, Department of Health and
Human Services, and federal agencies.

In recent years, Brian has been counseling clients on the implementation of the Affordable
Care Act. In particular, he has advised clients on the implementation of new delivery system
and payment reforms.

Brian’s extensive background in health care policy matters includes serving as a legislative
aide to Senator Edward M. Kennedy on the Committee on Labor and Human Resources. In
that capacity he worked on health care, food and drug and biotechnology legislation. Prior to
Foley Hoag Brian was an associate at Sullivan & Cromwell in New York, and he was a judicial
law clerk for the Honorable Edward F. Harrington of the United States District Court of
Massachusetts. Brian splits his time between the firm's Washington, DC and Boston offices.

Anita Chawla, PhD, Managing Principal, Analysis Group
Dr. Chawla assists life sciences companies with product development and commercialization objectives, particularly with regard to evidence development, and coverage and reimbursement. Her work spans a range of therapeutic areas, including multiple indications in oncology. Dr. Chawla has led teams in conducting economic analyses of novel molecular diagnostics, as well as synthesizing medical and scientific information to support reimbursement decisions. 

Melina Cimler, PhD, CEO & Founder, PandiaDx

Dr. B. Melina Cimler is a senior quality, regulatory, and in vitro diagnostic device expert with over 29 years of experience in the life science and FDA-regulated global diagnostic industry, leading regulatory, quality systems, clinical affairs, research, and product development organizations with a focus on precision medicine.  She joined NDA Partners as an Expert Consultant in 2018.  She currently serves on the Board of Directors of Nanostics, Inc. and is a Scientific Board member of M3 Biotechnology. Prior to joining NDA Partners, Dr. Cimler served as SVP of Regulatory & Quality at Adaptive Biotechnologies where she worked with FDA and pharma partners to define the regulatory strategy for use of NGS-based immunosequencing in minimal residual disease. She was formerly Head of Global Quality and Vice President of Quality, Regulatory, Clinical, and Government Affairs at Illumina Inc., where she defined and executed on the regulatory strategy for the first next generation sequencing platform (MiSeqDx) to receive FDA marketing authorization. Dr. Cimler has also previously held executive leadership positions in quality, regulatory, clinical, and government affairs roles at Abbott Molecular, Beckman Coulter Inc., Gen-Probe Inc., and CR Bard, Inc., and was formerly head of Product Development at Epitope, Inc.  Dr. Cimler holds a Ph.D. in Pharmacology from the University of Washington.

Kaushal Desai, PhD, Director, Informatics & Outcomes Research, Merck & Co., Inc.

Kaushal is a Director at the Center for Observational and real-world evidence (CORE) at Merck, with responsibility for delivering outcomes research to support innovative reimbursement strategies in Oncology. With a career spanning more than 16 years in various data analytics and leadership roles in pharmaceutical R&D, Kaushal has helped organizations deliver robust value evidence for precision medicine programs. At AstraZeneca, Kaushal was a principal scientist and global RWE informatics lead in Clinical Development. Prior to joining Merck, Kaushal led a translational analytics group for cancer immunotherapy programs at Bristol-Myers Squibb. Kaushal has a PhD and Master’s degrees in Biomedical Engineering and Information systems from Drexel 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.

Mark Girardi, Vice President, Boston Healthcare Associates, Inc.
Mark Girardi has over 30 years of experience in life sciences, in vitro diagnostics, and medical devices commercialization and reimbursement. He has had roles in product management, sales and marketing, and most recently in strategy consulting.

Mark D. Hiatt, MD, MBA, MS, Vice President, Medical Affairs, Guardant Health
Mark D. Hiatt, MD, MBA, MS has extensive and varied experience in health care, including as vice president of medical affairs for a molecular diagnostics company, executive medical director for a multi-state health insurance plan, chief medical officer for a national medical benefits manager, and clinical department leader and board member for a large regional health system. He completed a fellowship in cardiovascular imaging at Stanford University, residency in radiology and MS in Health Evaluation Sciences at the University of Virginia, and MD and MBA with academic distinction at Wake Forest University. Dr. Hiatt serves on the boards of RadSite, the Utah chapter of the American Red Cross (for which he is Chair Elect), and the Utah Cancer Action Network; was appointed by the Governor of Utah to serve on that state’s Medical Education Council and Digital Health Service Commission (for which he is the immediate past Chair); and is a member of the Radiological Society of North America. He was honored by the Utah Business Magazine as a Healthcare Hero, and until recently was the voice of The Medical Moment on radio stations in two states for three years.

Laura T. Housman, MPH, MBA, Head, Access, Outcomes and Population Health, Exact Sciences; Founder, Access Solutions Consulting
Laura T. Housman, MPH, MBA is Head, Access, Outcomes and Population Health with Exact Sciences, an Adjunct Faculty member at the Massachusetts College of Pharmacy and Health Sciences, and Founder of Access Solutions Consulting (ASC), a healthcare advisory firm offering healthcare consulting with particular expertise and extensive network in companion and complementary Dx; precision medicine; patient communications; and pharmaceutical and biotech drug development and safety access initiatives.  Ms. Housman is a past Adjunct Faculty member at the Tufts University School of Medicine.
Ms. Housman received her Bachelor of Arts degree in Economics from the College of Arts and Sciences and a Minor in Business Administration from the School of Management from Boston University.  She received her Master of Public Health from the Boston University School of Public Health and her Master of Business Administration with honors from Boston University’s Questrom Graduate School of Management. 

Eugean Jiwanmall, MPH, MBA, Senior Research Analyst, Technology Evaluation & Medical Policy, Claim Payment Policy Department, Facilitated Health Networks, Independence Blue Cross
Eugean Jiwanmall's past professional experiences include basic science and clinical research. In his current role as a Senior Research Analyst for Medical Policy & Technology Evaluation at Independence Blue Cross’ Claim Payment Policy Department within Facilitated Health Networks, he has served as the subject-matter-expert, writer, reviewer, communicator, presenter, consultant, adviser/facilitator, and decision-maker for hundreds of medical policy topics and technology assessments within dozens of clinical disciplines and multiple business areas. Eugean has been invited and participated in numerous roles in a number of conferences, summits, etc.

Eugean is finishing graduate work in bioethics at the University of Pennsylvania School of Medicine. He holds a bachelor’s degree in biological sciences with honors from Drexel University (minor was in business administration), a master’s degree of public health in evaluative clinical sciences from Dartmouth Medical School, and an MBA in health care management and economics with honors from Drexel University.

Patti Karabel, Account Executive, TELCOR.
Patti Karabel has over 20 years’ experience working with a variety of companies including revenue cycle management, banking, collections and recovery. Patti’s current role of almost 10 years at TELCOR has provided her a unique insight through her consulting with hundreds of laboratories, all with the goal of re-engineering processes to improve their bottom-line despite the reimbursement pressures laboratories continue to face. Patti is a regional account manager with TELCOR Inc., under the Revenue Cycle Management Division; TELCOR’s solution empowers laboratories to improve back office processes by streamlining the revenue cycle management workflow, thus reducing labor-intensive processes and operating costs.

Kathryn Lang, MD, MRCP, FRCPath, Vice President, Outcomes and Evidence, LUNAR Program, Guardant Health
Dr. Kathryn Lang is a board certified hemato-oncologist, who completed clinical training in London, UK in 2016.  With a strong focus on outcomes research throughout her career and over 50 publications, Dr Lang moved to an industry role with Pfizer in 2016 where she led the global data science initiatives within Pfizer Oncology.  She moved to her current role with Guardant Health in 2018 where she is VP of Outcomes and Evidence in the LUNAR program focusing on early detection of cancer and applied HEOR.

Jennifer Leib, Founder, Innovation Policy Solutions, LLC
Jennifer Leib is the founder of Innovation Policy Solutions, a government relations firm specializing in genomics and precision medicine policy. Jennifer’s clients are innovators of disruptive technologies that are fundamentally changing the way research is done, the way medicine is practiced, and the way health care is delivered. She helps clients navigate the evolving regulatory and reimbursement landscape for targeted therapeutics, laboratory-based diagnostics, and mobile and digital health technologies. Jennifer also specializes in assisting young companies and associations with building a brand presence in Washington through relationship building with advocates and policymakers. Prior to launching Innovation Policy Solutions, Jennifer co-founded another consulting firm, HealthFutures, which was acquired by CRD Associates in 2009. Board certified in genetic counseling, she previously worked at the National Institutes of Health, the Senate Committee on Health, Education, Labor and Pensions, and in the biotechnology industry. Jennifer holds a master's degree in genetic counseling from The Johns Hopkins University and a bachelor's degree with honors and high distinction in sociology from the University of Michigan.

Robert Metcalf, MBA, CEO, Concert Genetics

An experienced software and information services executive, Rob has a passion for building world class companies that use technology to transform entire industries. As CEO of Concert Genetics, Rob is expanding the company’s offerings to advance precision medicine by providing the digital infrastructure for reliable and efficient management of genetic testing.

Prior to Concert Genetics, Rob led cognitive computing company Digital Reasoning as President and Chief Operating Officer, guiding the business through an expansion into financial services and healthcare markets. Prior to Digital Reasoning, Rob held executive positions in Mexico, Canada, and the United States with the information services leader LexisNexis. At LexisNexis, Rob oversaw numerous acquisitions as part of the acceleration of the company’s software strategy.

Rob earned his bachelor’s degree in history from Princeton University and his Master of Business Administration from Harvard Business School.

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.

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. The website for Dr. Quinn’s firm is www.brucequinn.com.

Danielle Scelfo, Senior Director, Health Policy and Reimbursement, Hologic, Inc.

Danielle Scelfo is Senior Director, Health Policy and Reimbursement for Hologic, Inc. and is based out of their diagnostic headquarters in San Diego, California. An experienced industry veteran, Ms. Scelfo has chaired the Reimbursement and Policy Workgroup for the Coalition for 21st Century Medicine, co-chaired the Diagnostics Workgroup for the California Healthcare Institute and is a member of the two leading US diagnostic trade associations, AdvaMed Dx and the American Clinical Lab Association. Ms. Scelfo has a comprehensive understanding of the US diagnostic industry, Medicare and Medicaid programs, and managed care delivery systems. Her extensive knowledge of government and commercial reimbursement policies and procedures lends valuable insights to the financial impact of reimbursement policy, legislation, and the regulatory rule-making process in healthcare. Ms. Scelfo has led efforts resulting in several successful coverage and payment policies for oncology therapeutics and advanced personalized diagnostic payment reform. Ms. Scelfo's current responsibilities, include representing Hologic in corporate reimbursement strategy, government affairs, coding, and payment of new technologies by payors.

Ester Stein, MBA, Director, Corporate Reimbursement, Government Affairs, Abbott Laboratories
https://www.linkedin.com/in/ester-stein-48ba935/

Katherine B. Szarama, PhD, Presidential Management Fellow, CMS
Dr. Katherine Szarama joined the Centers for Medicare and Medicaid Services (CMS) in January of 2016 where she serves as Social Science Research Analyst in the Coverage and Analysis Group of the Center for Clinical Standards and Quality (CCSQ). She was lead for the FDA-CMS Parallel Review of the National Coverage Determination for Next Generation Sequencing to support precision oncology and leads the National Coverage Analysis on Chimeric Antigen Receptor (CAR) T-cell therapy. In addition, Dr. Szarama writes regulations implementing the Medicare Appropriate Use Criteria Program for advanced diagnostic imaging services from section 218 of the Protecting Access to Medicare Act of 2014 (PAMA). Previously, she served the Center for Medicare and Medicaid Innovation (CMMI) to draft mandatory bundled payment models. Dr. Szarama is a recipient of the Hartwell Foundation Fellowship for Biomedical Research at St. Jude Children’s Research Hospital in Memphis, TN where she received post-doctoral training in cancer research. She received her baccalaureate in cellular and molecular neuroscience from The Johns Hopkins University in Baltimore, MD and earned her PhD from Karolinska Institutet in Stockholm, Sweden as part of a Graduate Partnership Program with the National Institutes of Health Intramural Research Program

Patrick Terry, CEO, Gray Group Ventures

Patrick is a +25yr veteran of the precision medicine industry. He has been involved in delivering hundreds of medical innovations into routine clinical care around the world. He has raised over $2 billion dollars in risk capital investing for companies in the international marketplace.  

John Warren, Senior Director, McDermott + 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.

Companion Diagnostics: Strategy & Partnerships

J.D. Alvarez, MD, PhD, Vice President, Oncology Diagnostics, Janssen Pharmaceutical Companies
J.D. Alvarez, MD, PhD is Vice President, Oncology Diagnostics, for the Janssen Pharmaceutical Companies of Johnson & Johnson.  In this position, he is responsible for developing and delivering diagnostic solutions that enable registration of compounds in the Oncology pipeline.

J.D. joined Janssen in 2009 as an Associate Director of Oncology Biomarkers and was responsible for establishing a molecular pathology laboratory to support the oncology biomarker investigations and strategies.  He has held positions of increasing responsibility within Biomarkers, Translational Research and Clinical Research.  He also represents Janssen on working groups within the Society for Immunotherapy of Cancer, the Association of Molecular Pathology and the Medical Device Innovation Consortium.

Prior to joining Janssen, J.D. served as a research associate at the University of Pennsylvania conducting independent National Institutes of Health grant-funded research on the function of circadian rhythms in disease physiology.  He also held positions in both discovery research and oncology translational medicine at Nippon Roche K.K. and at Wyeth Research.
J.D. received his medical degree and his doctorate in Molecular Cell Biology from the Washington University School of Medicine in St. Louis, Missouri.  He completed his residency and fellowship training through the University of Pennsylvania School of Medicine Department of Pathology and Laboratory Medicine.  He is board certified in Anatomic Pathology and Molecular Genetic Pathology.

Lourdes Barrera, PhD, Senior Director, Precision Medicine, Oncology Business Unit, Novartis

Doctor Lourdes Barrera is a biomedical researcher with an extensive knowledge in molecular and cell biology, immunology as well as expertise in diagnostics technologies. 

Lourdes was Principal Scientist and Head of Laboratory at the National Institute for Respiratory Diseases in Mexico City leading clinical and translation research in respiratory diseases and oncology.

She joined AstraZeneca in 2015, where she held positions as Global Medical Affairs Lead for Diagnostics in Immuno-oncology and Global Capability Director in Diagnostics.

Currently she is Precision Medicine, Senior Director at Novartis Oncology where she is working with the development and disease areas teams in the implementation of diagnostic strategies and customer access initiatives across oncology franchises and markets as well as identification, evaluation and commercialization of innovative technologies through partnership opportunities.

Lourdes holds Bachelor of Science in Pharmaceutical Chemistry and Biology, a PhD in Immunology and second PhD in Science Communication.

Jonathan Beer, MBA, DirectorDisruptive Technologies, Oncology – Precision Medicine, Novartis
Jonathan Beer has been a member of the Novartis Oncology, Precision Medicine COE, since 2011 and has supported multiple investigational new drug Phase III clinical trials which used diagnostics assays across technology and sample types, including Liquid Biopsies, to select patients for enrollment and has been a contributor on 7 Pre-Market Approval submissions to the US FDA for Companion Diagnostic Assays.  In addition to clinical support, Jonathan is the leader of the Disruptive Technologies Team, which identifies new and emerging technologies, performs feasibility testing of selected platforms or vendors, and makes recommendations on which assays will provide the highest impact exploratory biomarker data from precious clinical trial samples to Novartis drug development teams.

J. Carl Barrett, MD, Vice President, Oncology Translational Sciences, 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.

Kristine Bordenave, MD, FACP, Corporate Medical Director, NMCARE, Healthcare Services, Humana
https://www.linkedin.com/in/kristine-bordenave-md-facp-9b622212/

Flora Berisha, Director, Companion Diagnostics, Translational Sciences, Global Oncology R&D, Daiichi-Sankyo, Inc.
Flora Berisha is a companion diagnostic Director and lead of AML Franchise CDx development strategy, at Daiichi Sankyo Pharma. Flora received her BS in Biochemistry and master’s degree in Biology from City University of New York. Prior to Daiichi Sankyo, Flora was at Kyowa Hakko Kirin Pharma as a Senior Manager. At KHK she focused on strategic biomarker selection, development and translation into CDx assays. Prior to KHK, Flora was at Bristol-Myers Squibb where she progressed through the ranks gaining valuable experience in GLP and clinical Bioanalysis, biomarker and CDx assay development from design control through commercialization. In addition to Flora’s industry experience, she is currently an Adjunct Professor in the Department of Biology at CUNY (City University of New York) where she has been teaching anatomy-physiology for over a decade. 

Robert Dumanois, Manager, Reimbursement Strategy, Clinical Next-Generation Sequencing Division, 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.

Fritz Eibel, Senior VP, Marketing, 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 Ferrara, President, CEO, Boston Healthcare Associates, Inc.
Joseph Ferrara has over 20 years of experience in consulting, working with biopharmaceutical, medical device, diagnostics, & informatics clients. He leads the global team in reimbursement and pricing, health economics, market analysis, and business development strategy

Pamela Gallagher, PhD, Scientific Reviewer, FDA
Dr. Pamela Gallagher is a Scientific Reviewer at the Center for Devices and Radiological Health (CDRH), U.S. Food and Drug Administration (FDA). In her current role at FDA, she provides scientific expertise to make analytical and clinical assessments regarding data to support in vitro diagnostic device performance claims. Prior to joining FDA, she completed a postdoctoral fellowship at the National Cancer Institute in the Laboratory of Biochemistry and Molecular Biology. Dr. Gallagher received her PhD in Pharmacology at the University of Washington in 2013.

Carolyn Hiller, Program Director, Clinical Diagnostics initiative, Medical Device Innovation Consortium (MDIC)
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.

Stephen Hull, President, Founder, Hull Associates LLC
Stephen Hull is Principal and Founder of Hull Associates LLC, a specialized global reimbursement strategy firm focused on medical device, diagnostic, pharmaceutical and biotech technologies. Founded in 2007, Hull Associates has market access and reimbursement experts in all major product areas, and is dedicated to helping clients achieve market access and reimbursement success. With 40+ seasoned partners worldwide, Hull Associates LLC develops and executes strategies for reimbursement and product launches in the US and major global markets, including the Americas; Asia Pacific; Northern & Eastern Europe; The Middle East; and Western Europe. Stephen has an advanced degree in health policy from the Johns Hopkins Bloomberg School of Public Health, and a bachelor’s degree in international relations and French from Colgate University.

John Lubniewski, President, CEO, HTG Molecular Diagnostics
Mr. Lubniewski has served as President and Chief Executive Officer since April 2019. He previously served as our Chief Operating Officer. Mr. Lubniewski joined HTG from Ventana, a medical diagnostics company and member of the Roche Group and global headquarters of Roche Tissue Diagnostics, or RTD, where he served in senior leadership roles for nine years both before and after the acquisition of Ventana by Roche in March 2008. Prior to Ventana, Mr. Lubniewski worked for over ten years at Corning, Inc., a manufacturing company, in a variety of divisional, sector roles. Mr. Lubniewski earned a BS in Chemical Engineering from Clarkson University.

Hisani Madison, PhD, MPH, Associate Director, Diagnostics Expert, Oncology, AstraZeneca
Hisani Madison is an Associate Director, Diagnostics Expert in Oncology at AstraZeneca. As a part of the Oncology Companion Diagnostics Unit, Dr. Madison serves as the Diagnostic Lead for gastrointestinal cancers within the ImmunoOncology Franchise.  Prior to her current position, Dr. Madison was 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).  While at FDA, Dr. Madison led the review of submissions in the Molecular Pathology and Cytology Branch as part of the Division of Molecular Genetics and Pathology (DMGP) specializing in the review of devices intended to aid in selection of therapy for patients with solid tumors (companion and complementary diagnostics). Dr. Madison completed her postdoctoral training 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. She holds a PhD in Pathology from Duke University, an MPH from Johns Hopkins Bloomberg School of Public Health and a BS from Hampton University.

Timothy K. McDaniel, PhD, Senior Vice President, Emerging Opportunities, TGen
Timothy K. McDaniel, Ph.D., serves as Sr. Vice President of Emerging Opportunities. In this role, Dr. McDaniel works with TGen’s faculty and administrative leadership to expand the impact of the institute’s technology and know-how, through business development, external alliances, and clinical operations support.
Dr. McDaniel came to TGen from PMed Management, L.L.C., where he served as Executive Vice President and General Manager of Ashion Analytics, a clinical genomics laboratory. Prior to that, he worked at Illumina, Inc., where he served in a variety of roles in R&D, quality, product development, and clinical laboratory development. In these roles he was an early member of the team that grew Illumina from a privately held startup with no products to a $20 billion leader in genomics technology.
Dr. McDaniel has extensive experience in genomics, cancer biology, infectious disease, bioinformatics, technology development, clinical lab development, and commercialization of scientifically based products and services. He received a B.A. in Biological Sciences from UC Santa Barbara, a Ph.D. in Molecular and Cell Biology from the University of Maryland, Baltimore, and was a Damon Runyon Cancer Research Foundation Postdoctoral Fellow at Stanford Medical School.

Scott Patterson, PhD, Vice President, Biomarker Sciences, Gilead Sciences, Inc.
Dr. Patterson joined Gilead early in 2015 to lead biomarker discovery and development across all therapeutic areas (aside from direct acting antivirals), Inflammation, Oncology, Liver Fibrosis and host HBV/HIV Cure efforts; including responsibility for biomarkers which transition to in vitro diagnostics. From 1993-2000 and 2003-2015 he was at Amgen, Inc. initially leading their proteomics and apoptosis efforts and from 2003, as Executive Director, Medical Sciences, establishing and leading their biomarker and in vitro diagnostics programs across all therapeutic areas. From 2000-2003 he was Vice President, Proteomics at Celera Genomics Group where he established their protein-based therapeutic antibody target discovery program and Chief Scientific Officer at Farmal Biomedicines, LLC. He has served on multiple industry and professional groups associated with advancement of biomarkers and diagnostics. Dr. Patterson received his B.Sc and PhD in Physiology and Pharmacology at The University of Queensland, Australia where he also worked, ultimately as a Senior Research Officer in Dept Physiology and Pharmacology. He was a Staff Investigator at Cold Spring Harbor Laboratory, New York, received the Long island Biological Association, New Investigator award and was the 2002 Barnett Lecturer (Northeastern University). Dr. Patterson has authored over 110 publications, 25 book chapters and 9 patents.

Omar Perez, PhD, RAC, Head, Precision Medicine and Diagnostics, R&D, GSK
https://www.linkedin.com/in/omar-perez-10b9973

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.

John Sninsky, PhD, Consultant, Translational Sciences
John Sninsky, PhD is a translational medicine consultant with deep understanding of diagnostics and diagnostics paired with medicine intervention. John has served in senior management positions in small and large CLIA service companies and small and large in vitro diagnostic kit companies, including Cetus, Roche Molecular Systems, Celera, Quest and CareDx. His primary focus has been the application of genetic and genomic tools to identify diagnostic, prognostic and predictive biomarkers to address critical patient unmet needs. John is the author of numerous scientific papers, including pioneering applications of the polymerase chain reaction (PCR) to virology and cancer, inaugural genome-wide genetic association studies for common, complex disease and, most recently, clinical-grade NGS sequencing for solid organ transplantation.

Živana Težak, PhD, Associate Director for Science and Technology, Personalized Medicine Staff, Office of in vitro Diagnostic Device (IVD) Evaluation and Safety (OIR), CDRH/FDA  
Živana Težak, PhD, is an Associate Director for Science and Technology, Personalized Medicine Staff, in the Office of In Vitro Diagnostic Device (IVD) Evaluation and Safety (OIR), at the Center for Devices and Radiological Health, Food and Drug Administration (FDA). Prior to joining the FDA in 2004, as a scientific reviewer in microbiology, genomics and molecular biology, Dr. Težak worked in the biotechnology industry, holding research and development scientist positions in a bioinformatics and array developer company. Dr. Težak received a PhD in Biochemistry/Molecular Biology from Florida State University in 1997. From 1998 to 2001 she was a research fellow at the University of Pittsburgh Medical Center and Children’s National Medical Center, Research Center for Genetic Medicine, working on neuromuscular disorders, human genetics, gene therapy and high-throughput screening technologies. Her work resulted in a number of publications in peer-reviewed journals, book chapters and proceedings. In her current position, Dr. Težak has been leading efforts to develop flexible regulatory policies for novel technology-based IVDs, such as next-generation sequencing, in order to enable their smoother translation into the clinic.

Jorge Villacian, MD, Medical, Digital and Technical Solutions Leader, Respiratory ID, Janssen Pharmaceutica
Jorge Villacian is the Medical, Technical and Digital Solutions Leader for the Infectious Diseases and Vaccines Therapeutic area at Janssen R&D, developing diagnostic solutions spanning across companion diagnostics as well as novel diagnostic, digital tools and sensors to help the different development programs of the Therapeutic Area.

Previously, Jorge was Chief Medical Officer at Janssen Diagnostics, working across therapeutic areas in Janssen and building the clinical and medical capabilities for this unit. Before that, he worked for Tibotec-Virco developing solutions to manage HIV and other infectious diseases, as well as establishing the Medical Department at Virco, including diagnostic biostatistics and clinical virology groups, and the management of a diagnostic laboratory working in collaboration with multiple pharmaceutical companies for clinical development of compounds in hepatitis C and HIV. Prior to joining J&J, Jorge led international clinical development studies of a new protease inhibitor for treatment of HIV with Boehringer Ingelheim. He holds a MD degree and is an Internal Medicine and Infectious Disease Specialist with clinical experience internationally in the US, Mexico and Asia.

Barbara Zehnbauer, PhD, FACMG, FACB, Adjunct Professor of Pathology, Emory School of Medicine; Editor in Chief, Journal of Molecular Diagnostics
Barbara A. Zehnbauer, PhD, FACMG has more than 30 years’ experience leading laboratory quality and directing clinical diagnostic testing.  She received her education at Southern Illinois University and the University of Chicago.  Her professional appointments have included the John Hopkins University School of Medicine, Washington University School of Medicine, and the US Centers for Disease Control and Prevention.  She is currently an Adjunct Professor of Pathology at the Emory School of Medicine in Atlanta, Georgia. Barb has professional board certification in Clinical Molecular Genetics from the American Board of Medical Genetics.

Dr. Zehnbauer has led the development of professional practice guidelines and accreditation standards for laboratory testing with the College of American Pathologists (CAP) and the Clinical and Laboratory Standards Institute (CLSI). She is the Chair of the CLSI Molecular Methods Expert Panel and received the CLSI Excellence in Standards Development award in 2013.  She is an expert consultant and chairs the Steering Committee for a multi-stakeholder national project, the SPOT/Dx Quality Assurance Pilot to develop quality standards for precision molecular diagnostic testing in oncology therapeutics to advance precision medicine.  She is also a member of the Medical Device Innovation Consortium Cancer Genomic Somatic Reference Sample (MDIC SRS) project.

Dr. Zehnbauer is a past-president of the Association for Molecular Pathology, currently serving as an active member of the AMP Professional Relations Committee and the Publications and Communications Committee. She is the Editor‐in‐Chief of AMP’s official journal, The Journal of Molecular Diagnostics.  Dr. Zehnbauer received the Jeffrey A. Kant Leadership Award in 2015 for her exceptional leadership in AMP advancing the mission and vision of molecular diagnostics. 

Applications of Digital Pathology

Joe Corrigan, Head, Technology, Medical Technology, Cambridge Consultants
https://uk.linkedin.com/in/josephcorrigan

Timothy Craig Allen, MD, JD, FCAP, Professor and Chair, Department of Pathology, The University of Mississippi Medical Center
Timothy Craig Allen, MD, JD, obtained his medical degree from Baylor College of Medicine in 1984 and completed his residency in anatomic and clinical pathology, subsequently serving on the faculty of Baylor College of Medicine until 1995. He then attended the University of Chicago Law School and graduated with the degree of Doctor of Law with Honors in 1998, subsequently practicing health care law and litigation. Dr. Allen completed a 2-year fellowship in pulmonary pathology in the Texas Medical Center in 2004. Dr. Allen is the Chair of the Department of Pathology at University of Mississippi Medical Center in Jackson, Mississippi. Dr. Allen is a member of the Board of Directors and a member of the Academic Advisory Board of the Crime Prevention Research Center. Dr. Allen is certified by the American Board of Pathology in anatomic and clinical pathology, with added qualification in cytopathology. He is an associate editor of the Archives of Pathology and Laboratory Medicine. Dr. Allen is the Immediate Past-President of the Pulmonary Pathology Society and past President of the Texas Society of Pathologists. He is a Governor of the College of American Pathologists Board of Governors, and is chair, vice-chair, or member of several CAP Councils and Committees. He has authored and coauthored numerous articles and book chapters on pulmonary pathology and medicolegal issues and has coauthored and co-edited several books on pulmonary pathology. Dr. Allen is series coeditor of the Advances in Surgical Pathology series.

Michael J. Becich, MD, PhD, Associate Vice-Chancellor for Informatics in the Health Sciences; Chairman and Distinguished University Professor, Department of Biomedical Informatics (DBMI), University of Pittsburgh School of Medicine
Michael J. Becich, MD PhD, is a Distinguished University Professor of Biomedical Informatics and the founding chair of the Department of Biomedical Informatics at the University of Pittsburgh School of Medicine. He is jointly appointed as Professor of Pathology, Computing & Information, Clinical & Translational Sciences and Bioengineering. He currently serves as the Associate Vice-Chancellor for Informatics for the Health Sciences at Pitt. Dr. Becich is an MD PhD in Experimental Pathology from Northwestern University and trained in surgical pathology at Washington University. His research interests are in cancer biology and biomedical/pathology informatics. Currently, he focuses on developing data commons to integrate clinical, imaging and -omic data to biorepositories to enable AI/machine learning based discovery and translational science. He was a founder of two startups, Tissue Informatics and InterScope Technologies (formerly Trestle Corp.), which were merged into Clinical Data and Zeiss. He was Scientific Advisory Board member of Omnyx, a GE and UPMC joint venture which was recently acquired by Inspirata. He is currently co-founder of new startup company, SpIntellx, Inc. Finally, he is co-director of the Center for Commercial Applications (CCA) of Healthcare Data that is part of the Pittsburgh Health Data Alliance. Dr. Becich is an avid supporter of computational pathology applied to clinical and research issues in translational medicine. He is a member of 13 professional societies and has published more than 150 papers that contribute to the mission of biomedical and pathology informatics as applied to translational medicine. Dr. Becich help found the Pathology Informatics Summit in 1996, which has provided more than 350 educational awards to trainees in informatics. He also helped found the Association for Pathology Informatics (API) in 2000 and his department helps to support the Journal of Pathology Informatics, that was launched in 2010.

Chee Leong Cheng, MBBS, FRCPath, FRCPASingapore, Senior Consultant, Anatomical Pathology; Director, Computational and Digital Pathology, Singhealth Pathology ACP; Department of Anatomical Pathology, Singapore General Hospital
Dr. Cheng is currently a senior consultant pathologist in Singapore General Hospital, with special interest in haematolymphoid pathology and healthcare informatics. He is concurrently the director of Computational and Digital Pathology under the Singhealth Pathology Academic Clinical Programme and has been actively involved in the planning and implementation of the digital pathology system in Singapore General Hospital as well as leading the laboratory information system transformation initiative in the hospital and across Singhealth.

Joe Corrigan, Head of Technology, Medical Technology, Cambridge Consultants
Joe Corrigan is Head of Technology for Cambridge Consultant’s global medical technology division. He works with clients to leverage the latest advances in new technologies and bring them to market. Joe has founded two startups and has a background in minimally invasive medical devices, cardiovascular disease, statistics and machine learning. He has lead the development of multiple class 2b & 3 integrated medical products and helps structure businesses and processes to achieve success.

Filippo Fraggetta, MD, Head, Pathology Department, Cannizzaro Hospital
Filippo Fraggetta, MD is the head of Pathology at Cannizzaro Hospital (Catania) since 2011. Starting from being a surgical pathologist, he implemented the molecular as well as the digital pathology within the Pathology department in Catania. Actually, the Department of Pathology at Cannizzaro Hospital is one of the few fully digital labs worldwide. Member of the SIAPEC (Italian Society of Anatomic Pathology and Cytopathology), he is the founder and the responsible of DIGIPAT (Digital pathology section of SIAPEC) since 2018. Filippo Fraggetta is also in the editorial board of Jourmal of Pathology Informatics and is the author of more than 100 peer reviewed papers in the field of surgical, molecular and digital pathology. Filippo Fraggetta collaborates with national and international groups in the field of molecular and digital pathology.

Douglas Joseph Hartman, MD, Associate Professor of Pathology and Director of Pathology Informatics, University of Pittsburgh Medical Center
Dr. Douglas J. Hartman is the Director of the Division of Pathology Informatics at the University of Pittsburgh Medical Center (UPMC) and a gastrointestinal pathologist. He is board certified in anatomic and clinical pathology and clinical informatics. He has been implementing digital pathology for primary signout as well as for telepathology at UPMC. Dr. Hartman is also the director of the UPMC Image Analysis lab and has developed and implemented image analysis for clinical reporting. He has participated in implementing two different digital pathology solutions for routine anatomic pathology. Dr. Hartman’s research in informatics is varied but focuses on practical application of informatics. He has published on informatics topics and given national and international talks based on his informatics work.

Shyam Kalavar, MPH, CT(ASCP), Senior Scientific Reviewer, Molecular Pathology and Cytology Branch, Division of Molecular Genetics and Pathology, Center for Devices and Radiological Health, Office of In Vitro Diagnostics and Radiological Health, U.S. Food and Drug Administration
Shyam Kalavar is a scientific reviewer in FDA’s Office of In Vitro Diagnostic and Radiological Health. He joined the Office of In Vitro Diagnostics and Radiological Health in 2010. Mr. Kalavar provides scientific review of pre-submissions, 510(k)s and PMAs submitted to the Division of Molecular Genetics and Pathology. He specializes in the regulatory review of devices in the areas of cytology, immunohistochemistry and digital pathology and assessing their safety and effectiveness. His work is mostly focused on devices related to companion diagnostics in the field of oncology. Mr. Kalavar is an ASCP (American Society of Clinical Pathologists) board certified cytotechnologist. He received his master’s degree in Public Health from the George Washington University in Washington, DC. Mr. Kalavar has over twenty years of experience working in the clinical pathology laboratory setting and has extensive experience in diagnostic testing of patient samples and clinical laboratory operations. He also served as a College of American Pathologists laboratory accreditation inspector for several years.

Liron Pantanowitz, MD, Professor, Pathology & Biomedical Informatics, University of Pittsburgh Medical Center
Dr. Liron Pantanowitz is a Professor of Pathology and Biomedical Informatics at the University of Pittsburgh. He is the Vice Chair for Pathology Informatics and Director of Cytopathology at the University of Pittsburgh Medical Center. Dr. Pantanowitz is an Editor-in-Chief of the Journal of Pathology Informatics. He is also a member of the Association for Pathology Informatics council, College of American Pathologist's digital pathology committee, and Digital Pathology Association board of directors. He is well published and has written several textbooks in informatics, including digital pathology.

Anil Parwani, MD, PhD, MBA, Professor of Pathology and Biomedical Informatics, Vice Chair of Anatomic Pathology, Director of Pathology Informatics; Director, Digital Pathology Shared Resources, Wexner Medical Center - Department of Pathology, The Ohio State University
Dr. Anil Parwani is a Professor of Pathology at The Ohio State University. He serves as the Vice Chair and Director of Anatomical Pathology. Dr. Parwani is also the Director of Pathology Informatics and Director of the Digital Pathology Shared Resource at The James Cancer Hospital. His research is focused on diagnostic and prognostic markers in bladder and prostate cancer, and molecular classification of renal cell carcinoma. Dr. Parwani has expertise in the area of Anatomical Pathology Informatics including designing quality assurance tools, bio banking informatics, clinical and research data integration, applications of whole slide imaging, digital imaging, telepathology, image analysis and lab automation. Dr. Parwani has authored over 300 peer-reviewed articles in major scientific journals and several books and book chapters. Dr. Parwani is the Editor-in-Chief of Diagnostic Pathology and one of the Editors of the Journal of Pathology Informatics.

Juan Antonio Retamero, MD, Staff Pathologist, Department of Anatomical Pathology, Hospital Campus de la Salud
Dr. Juan Antonio Retamero is a practicing pathologist at Granada University Hospitals, Spain, a fully digital laboratory for primary histopathology diagnosis since summer 2016. He played an important role in the transition to digital pathology and 100% digitization of their biopsy caseload. Outside of the hospital, he enjoys playing the double bass in a popular music ensemble and has played in an amateur symphonic orchestra. Other interests range from literature to seasonal sports, enjoying skiing as well as being a certified open water scuba diver.

Michael Riben, MD, Director, Informatics, MD Anderson Cancer Center
Dr. Riben is an associate professor in the Department of Pathology at M.D. Anderson Cancer Center and the Director of Anatomic Pathology Informatics. Following his graduation from The University of Pennsylvania, he trained in pathology at Albany Medical Center, Albany NY, with advanced pathology fellowships at Cedar Sinai Hospital (Surgical Pathology), Los Angeles, CA, and M.D. Anderson Cancer Center (Cytopathology). He also completed a 2-year research fellowship in medical informatics, sponsored by the National Library of Medicine at Oregon Health & Sciences University, Portland, OR. His informatics interests include medical vocabulary/ontology development, the semantic web, digital pathology and pathology informatics. His clinical practice is exclusively cytopathology.

Mohamed E. Salama, MD, Professor, Pathology and Laboratory Medicine, Mayo Clinic School of Medicine and Medical Director, Mayo Clinic Reference Laboratories
Dr. Salama is a Professor of Pathology and Laboratory Medicine at Mayo Clinic School of Medicine and the Medical Director to Mayo Clinic Reference Laboratories. Dr. Salama’s clinical interests span all aspects of hematopathology, including morphology, flow cytometry, molecular, and other specialized studies of bone marrow and lymph nodes pathology. His research work has focused on characterization and correlation of genetic/molecular aberrations and protein expression as well as morphometry using novel digital imaging tools. Dr. Salama has special interest in developing innovative technologies and bringing these applications into the clinical laboratory. Dr. Salama has authored more than 100 peer reviewed publications, books and book chapters, most recently as a co-editor to the 7th edition of Hoffman’s Hematology; basic principles and practice and currently serves as the Chair of the Hematopathology Committee on MPN-RC.

Hamid Tizhoosh, PhD, Professor, Computer Science; Director, Kimia Lab, Faculty Affiliate, Vector Institute, University of Waterloo, Canada
Dr. Hamid R. Tizhoosh is a Professor in the Faculty of Engineering at University of Waterloo since 2001 where he leads the KIMIA Lab (Laboratory for Knowledge Inference in Medical Image Analysis). Before he joined the University of Waterloo, he was a research associate at the Knowledge and Intelligence Systems Laboratory at the University of Toronto where he worked on dynamic bandwidth allocation using AI methods such as reinforcement learning. Since 1993, His research activities encompass artificial intelligence, computer vision and medical imaging. He has developed algorithms for medical image filtering, segmentation and search. He is the author of two books, 14 book chapters, and more than 140 journal and conference papers. He has also filed 5 patents in collaboration with WatCo (Waterloo Commercialization Office). Dr. Tizhoosh has extensive industrial experience and has worked with numerous companies. Presently, he is the AI Advisor of Huron Digital Pathology, St. Jacobs, ON, Canada. As well, he is a Faculty Affiliate to the Vector Institute, Toronto, Canada.

Bin Yang, MD, PhD, Professor of Pathology, Co-Director of ePathology (International); Director of International Business and Collaboration, Tomsich Pathology & Laboratory Medicine Institute, Cleveland Clinic Lerner College of Medicine
Dr. Yang received his MD at Zhengzhou University School of Medicine in China, his PhD training in Molecular Biology at the Case Western Reserve University. He did his Pathology Residency training at the Cleveland Clinic, his Surgical Pathology Fellowship training at the Washington University in St. Louis, and his cytopathology fellowship and molecular pathology training at the Johns Hopkins Medical Institutions. He has been a Staff Pathologist at the Cleveland Clinic since 2003. Currently, Dr. Yang is a Professor of Pathology, Co-Director of ePathology responsible for International Telepathology, Director of the Women’s Health Pathology Fellowship, and Director of International Business and Collaboration. Dr. Yang is clinically specialized in gynecologic pathology and cytopathology. Dr. Yang is also an expertise in molecular pathology with focus on translation of advanced molecular techniques into disease detection and prognostic monitoring. Dr. Yang has been leading the efforts in international telepathology services at the Cleveland Clinic.

Expanding Dx Portfolio for Veterinary Applications

Chand Khanna, DVM, PhD, DACVIM (Onc), DACVP (Hon), CSO, Ethos Veterinary Health, President, Ethos Discovery
Dr. Chand Khanna is a graduate of the Western College of Veterinary Medicine. He then received specialty training in the fields of veterinary internal medicine and oncology first at the Ontario Veterinary College, University of Guelph and then the University of Minnesota. Dr. Khanna is a Diplomate of the American College of Veterinary Internal Medicine (Oncology). Following this clinical specialization Dr. Khanna received a PhD in Pathobiology from the University of Minnesota and then completed a post-doctoral fellowship with Dr. Lee Helman in the Pediatric Oncology Branch of the National Cancer Institute in Bethesda Maryland. He was recently awarded honorary membership as a Diplomate of the American College Veterinary Pathology. Dr. Khanna continued his work at the National Cancer Institute as the Head of Pediatric Oncology Branch’s Tumor and Metastasis Biology Section, and Director of the Center for Cancer Research, Comparative Oncology Program. In 2011, Dr. Khanna was granted full tenure and promoted to the position of Senior Investigator at the National Cancer Institute. His research interests and responsibilities focused on the problem of cancer metastasis and the development of new options to treat patients with metastasis. In 2013, Dr. Khanna transitioned his work at National Cancer Institute to that of a Strategy and Research Consultant with the Center of Cancer Research. He has over 100 publications in the area of cancer biology and therapy. Dr. Khanna has maintained a strong connection to the field of veterinary oncology and animal health. He continues to be an active clinician within his referral oncology practices, The Oncology Service, based in the greater Washington, D.C. area. He is also the founder of Animal Clinical Investigation a contract research company, involved in complex medical problems seen in pets. Dr. Khanna is the immediate past-president of the American College of Veterinary Internal Medicine in Oncology, the chair of the Children’s Oncology Group Bone Biology Subcommittee, and the Director of the SARC (Sarcoma Alliance for Research through Collaboration) Developmental Therapeutics Committee. Dr. Khanna is a founding member of the Canine Comparative Oncology and Genomics Consortium. Dr. Khanna is a two-time recipient of the NCI Distinguished Mentor Award and was the 2010 recipient of the NCI award for outstanding Research. As Chief Science Officer, Dr. Khanna’s primary roles will be to help embed the importance of science in our organization and develop scientific opportunities that can be commercialized, e.g. collaborating and developing relationships with investigators for the purpose of creating advanced diagnostics and platforms that can deliver personalized treatments for patients based on that pet’s specific genetics or other advanced testing results.

Chris Myatt, Founder & CEO, MBio Diagnostics, Inc.
Dr. Myatt is the founder and CEO of MBio Diagnostics, Inc. He is an entrepreneur with a proven track record for building technology companies, securing patents and licensing technology, raising funding, establishing commercial operations, and leading through growth. Prior to MBio Diagnostics, Chris successfully founded and led Precision Photonics Corporation, a successful laser and optical technology supplier that is now a division of IDEX. Trained as a physicist and measurement scientist, Chris invented and developed multiple technologies that formed the basis of his companies. He earned a B.S. in Physics and a B.A. in Mathematics at Southern Methodist University. Chris also earned a Ph.D. in Atomic Physics at the University of Colorado. He studied Bose-Einstein Condensation under Carl Wieman (Nobel Prize, 2001), helping to create the first BEC condensate in the Wieman lab. He also studied quantum information under David Wineland (Nobel Prize, 2012) as a National Research Council Postdoctoral Fellow at the National Institute of Standards and Technology (NIST) in Boulder.

Stephane Shu Kin So, PhD, MBA, CLP, Associate Director, Research Alliances, External Innovation, Zoetis
https://www.linkedin.com/in/stephane-shu-kin-so-6ba99b6/

Point-of-Care Product Strategies 

Joseph Campos, PhD, D(ABMM), F(AAM), Director, Microbiology Laboratory, Infectious Disease Molecular Diagnostics Laboratory, Laboratory Informatics, Children’s National Medical Center
Joseph M. Campos, Ph.D., D(ABMM), FAAM, is the Director of the Microbiology Laboratory, the Infectious Diseases Molecular Diagnostics Laboratory and the Section of Laboratory Informatics at Children's National Health System.

Dr. Campos has published more than 130 peer-reviewed journal articles and book chapters during his career. He has delivered more than 550 invited lectures globally on microbiology, virology, infectious disease diagnostics, laboratory informatics and quality improvement.

Robert H. Christenson, PhD, Professor, Pathology; Professor Medical and Research Technology, University of Maryland School of Medicine
No biography available

Mark Girardi, Vice President, Boston Healthcare Associates
Mark Girardi has over 30 years of experience in life sciences, in vitro diagnostics, and medical devices commercialization and reimbursement. He has had roles in product management, sales and marketing, and most recently in strategy consulting.

Lucy Hattingh, MBA, Principal, Lucy Hattingh Consulting
Lucy has been consulting to IVD test manufacturers since 2015 supporting more than 20 companies and building a deep understanding of all segments of the molecular diagnostics market.  She also works for various organisations in the global public health sector where the emphasis is on building access to diagnostics in low and middle income countries.  She has 30 years of experience commercializing products in the Life Science Research and Diagnostics industries, with a focus on molecular diagnostics.  She has managed sales and marketing teams in 3 countries - South Africa, Canada and the US and has led marketing teams with global responsibility for more than 10 years.  She has successfully commercialized IVD tests in diverse market environments - emerging economies and developed markets, markets with both public and private healthcare systems, and innovative new markets as well as competitive, mature markets.  She worked for Roche Diagnostics for many years in various roles, and subsequently led diagnostics programs for GenProbe Inc. (now Hologic) and Singulex.  She holds a Bachelor of Science Honours degree in Medical Biochemistry from the University of Cape Town Medical School, and an MBA from IMD in Switzerland

Mark Hughes, MBA, Vice President, Enterprise Analysis Corporation
Mark Hughes began his career in clinical research at the Harvard School of Public Health and progressed into immunoassay research and development for Dade Behring’s former Clinical Assay division.  He has held management positions in market research and business planning at the Ares-Serono Group and Gene-Trak Systems.

Mark has more than 30 years of experience in the clinical diagnostics industry and has been with EAC since 1997.  He has broad experience in characterization of in vitro diagnostic (IVD) and non-IVD market and product segments.  He also has done extensive work in technology assessments, market analysis, business strategies and due diligence.

Mark has worked on a wide range of assignments for major diagnostic, pharmaceutical and start-up biotechnology companies, as well as investment banks and venture capital firms.  He is often quoted in many industry publications for his insights into the IVD industry.

Mark received his BS from the University of Massachusetts at Amherst and his MBA from Duke University.

Marc R. Jones, Chief Operating Officer & CFO, Binx Health

Marc is COO/CFO of binx health.  Prior to binx, Marc was the COO & CFO of Good Start Genetics, a leading molecular genetics information company transforming the standard of care in fertility medicine, where he drove the successful turnaround of the company and its ultimate acquisition by Invitae (NASDAQ: NVTA) in Aug ‘17. Prior to Good Start Marc was CFO of T2 Biosystems, where he led the company's preparation for and completion of an IPO and raised nearly $100M; he built the finance team and implemented the necessary infrastructure and processes required of a public company, and he helped drive the commercialization of the company's first FDA approved product. Previously, Marc was CFO of Crashlytics, where he oversaw the company's nine-digit acquisition by Twitter (was the largest acquisition of any company by Twitter at that time). Marc was CFO of Ivenix (and Interim-Executive Chairman from Jan '13-Feb '14) where he led all finance, admin and operations functions, including raising capital. Before that, Marc served as CFO of CHiL Semiconductor, where he oversaw growth from pre-revenue to a $20M run-rate, raised $30M in venture financing, and the ultimate acquisition of the company in March 2011. Prior to CHiL, Marc held multiple positions at Picis, where he helped grow the company from < $20M to > $100M in annual revenue. In addition to his responsibilities for corporate finance, Marc oversaw various business operations initiatives, including a large field operations team responsible for more than $20M in annual revenue.

Jeanne Mumford, MT(ASCP), Pathology Manager I, Point of Care Testing, Johns Hopkins Medicine; President, KEYPOCC
Jeanne Mumford is currently the Pathology Manager over Point of Care Testing for Johns Hopkins Medicine, including 2 academic hospitals, 3 community hospitals and around 60+ ambulatory physician offices.  She obtained a BS in Medical Technology in 2000.  Over the last 19 years, she has worked in various roles in laboratory medicine, including transfusion medicine, immunology, special chemistry and laboratory management.  Jeanne offers years of experience in regulatory oversight, quality assurance projects and laboratory inspection preparedness and planning.  She was part of the team responsible for building the laboratory piece and implementing a universal EMR for Johns Hopkins Medicine.  Her team of point of care coordinators work closely with providers across the enterprise to support patients’ needs by engaging, educating and evaluating our clinical testing personnel.  

Victoria Pratt, PhD, FACMG, Director, Pharmacogenomics and Molecular Genetics Laboratories, Medical and Molecular Genetics, Indiana University School of Medicine; President, Association of Molecular Pathology

Dr. Pratt is a Medical and Clinical Molecular Geneticist board-certified by the American College of Medical Genetics.  She is the Director of the Pharmacogenomics Laboratory and Molecular Genetics Laboratory at Indiana University School of Medicine.  Prior to joining Indiana University, she was Chief Director, Molecular Genetics, for Quest Diagnostics Nichols Institute.

Dr. Pratt is the President of Association of Molecular Pathology.  Dr. Pratt is also the Past Chair of the Genetics, Clinical Practice and the Program committees and is currently a member of the Economic Affairs, Professional Relations committees for AMP.  She is a former advisor of EurogenTest for genetic test validation. Dr. Pratt serves on the American Medical Association’s (AMA) Molecular Pathology Current Procedural Terminology (CPT) Advisory committee. 

In addition to her work, Dr. Pratt served on the Centers for Medicare and Medicaid Services Clinical Diagnostic Laboratory Tests Advisory Panel. Dr. Pratt continues to serve on the Centers for Disease Control and Prevention (CDC) GeT-RM program for reference materials for Molecular Genetics.  She is currently serving on the National Academy of Medicine’s (formerly Institute of Medicine) Roundtable on Genomics and Precision Health.  She also served on the U.S. Secretary of Health and Human Services Advisory Committee on Genetics, Health and Society for the Oversight of Genetic Testing and the Advisory Committee on Hereditary Disorders in Newborns and Children.  She also participated in the preparation of the Morbidity and Mortality Weekly Report for Best Practices in Molecular Genetic Testing for the CDC and the National Academy of Medicine’s Committee on Policy Issues in the Clinical Development and Use of Biomarkers for Molecularly Targeted Therapies. 

Dr. Pratt has authored over 50 peer-reviewed manuscripts and book chapters.  She is also an Associate Editor for the Journal of Molecular Diagnostics. 

Dr. Pratt graduated with a Ph.D. in Medical and Molecular Genetics from Indiana University School of Medicine, Indianapolis, IN in 1994.  Her fellowship training was in Ph.D. Medical and Clinical Molecular Genetics at Henry Ford Hospital, Detroit MI. 

Ryan Schmidt, Vice President, Sales & Marketing, Click Diagnostics
Mr. Schmidt has been Vice President of Sales & Marketing at Click Diagnostics since July 2017. He is responsible for developing and implementing Click’s marketing and sales strategy, including establishment of sales distribution channels. He has been commercializing diagnostics through different sales and marketing roles for over 20 years. Prior to joining Click Diagnostics, Mr. Schmidt was Vice President of Marketing for the Infectious Disease business unit at Alere Inc. where he supported the development and commercialization of the world’s first CLIA-waived point-of-care molecular diagnostic product. Prior to Alere, he worked at Johnson & Johnson as well as Thermo Fisher Scientific in various marketing and commercial roles. Mr. Schmidt received his Bachelor's Degree from Gustavus Adolphus College in Minnesota and his Masters of Business Administration from Marquette University in Milwaukee, WI.  

Gregory J. Tsongalis, PhD, HCLD, CC, Professor, Pathology, Director, Laboratory for Clinical Genomics and Advanced Technology (CGAT), Pathology and Laboratory Medicine, Dartmouth Hitchcock Health System, The Audrey and Theodor Geisel School of Medicine at Dartmouth
Greg Tsongalis is the Director of the Laboratory for Clinical Genomics and Advanced Technology (CGAT) at the Dartmouth-Hitchcock Medical Center and Norris Cotton Cancer Center (NCCC) in Lebanon, NH and a Professor of Pathology and Laboratory Medicine at the Audrey and Theodor Geisel School of Medicine at Dartmouth in Hanover, NH. He is a member of the NCCC Molecular Therapeutics Program and the gastrointestinal and breast cancer clinical oncology groups. In 2016 he became a member of Dartmouth College’s Program in Experimental and Molecular Medicine (PEMM), and he has served on the advisory board of the Health Care Genetics Professional Science Master’s Degree Program at the University of Connecticut (Storrs, CT). His area of expertise is in the development and implementation of clinical molecular diagnostic technologies. His research interests are in the pathogenesis of human cancers, personalized medicine and disruptive technologies. He has authored/edited twelve textbooks in the field of molecular pathology, published more than 200 peer reviewed manuscripts, and has been an invited speaker at both national and international meetings. He has served on numerous committees of the AACC, ASIP, FASEB and AMP where he is a past President. He is active in the Alliance for Clinical Trials in Oncology, the Association for Molecular Pathology, the American Association for Clinical Chemistry, the American Association of Bioanalysts, and the American Society for Investigative Pathology. He serves on the editorial boards of 8 journals including Clinical Chemistry, Experimental and Molecular Pathology, and the Journal of Molecular Diagnostics. He also serves on numerous corporate scientific advisory boards.

Nathaniel Whitney, President, Whitney Research
Mr. Whitney was involved in the early global move toward POCT with Corning Medical (now part of Siemens) beginning in 1966. He has seen many parallels with the clinical development of POCT in China where he did technology transfer in the mid 80’s of blood gas instruments, and has been specializing in China IVD market research since 1994. Mr. Whitney undertook a project for the Gates Foundation in 2007 called Diagnostic Cost Analysis for the Developing World where he and his staff traveled through the countryside in China visiting healthcare facilities at all levels down to the village clinics. He has been a participant in government’s Healthcare Reform within China and continues to focus on the market development and the economic opportunities for POCT in China. 

Lawrence J. Worden, Founder, Principal, IVD Logix
Larry consults with clients on the design and implementation of studies, coordinates with the MDxI analytical staff to develop key findings and recommendations, and helps clients integrate these findings into their organizational goals and objectives. He has more than 30 years of experience in the field of medical/scientific market research, including; thirteen years of consulting with CaseBauer, an international business development and research firm specialized in the field of medical devices and diagnostic testing. The firm conducted pioneering work in the development of diagnostic assays and worked with the major IVD manufacturers in the design and development of automated analytical platforms for the clinical diagnostic and research markets; eleven years in medical, biotech, and pharmaceutical marketing research with the Health Industry Manufacturers Association (now AdvaMed), Luning Prak Associates, and IMS Health/Dun & Bradstreet; five years' operating experience with Becton Dickinson Corporate (legislative affairs) and Becton Dickinson Diagnostic Systems (marketing research). Larry has developed syndicated data services for the clinical diagnostic, diagnostic imaging, and medical/surgical markets that have become industry standards. He has authored numerous regulatory compliance manuals for the diagnostic and medical device industries and served as the biomedical industry liaison to the College of American Pathologists’ Workload Recording Committee. He is currently on the Board of Directors of the Diagnostic Marketing Association (DxMA) as the organization’s President-elect.

Point-of-Care in the Pharmacy    

Jamie Bennett, PharmD, Clinical Services Leader, Fruth Pharmacy
No biography available

Marialice S. Bennett, RPh, Professor Emeritus, The Ohio State University, College of Pharmacy
No biography available

Benjamin M. Bluml, RPh, Senior Vice President, Research and Innovation, American Pharmacists Association Foundation
Benjamin Bluml is the Senior Vice President for Research and Innovation at the APhA Foundation.
Along with his 20-plus years as the principal architect for the patient care models at the APhA
Foundation and 12 years of pharmacy practice experience, Bluml is the author of numerous innovative
health care software applications and professional journal publications related to his work on
collaborative practice, health information technology, inter-disciplinary patient care, and quality
improvement. He works with pharmacists, physicians, payers, research organizations, and technology
companies across the United States to design and implement innovative collaborative practice
programs and health care service delivery systems.
Bluml received his BSPharm from the University of Missouri Kansas City School of Pharmacy. His
professional passion is improving people's lives by optimizing the way health care is delivered. He
focuses system change efforts on empowering patients, increasing collaboration, enhancing patient
safety, improving outcomes, and reducing total costs for care. Bluml believes that the best way to
improve health care is to put patients first, properly align incentives, optimize medication use, increase
communication, and to effectively and securely exchange health information.

Hamilton Borden, PharmD, Pharmacy Consultant, MTM Coordinator, Blount Discount Pharmacy; Blount Discount Pharmacy Residency Program Director
No biography available

Kenneth Burton, MBA, Senior Manager, Strategic Growth and Operations, Minute Clinic, CVS Health
No biography available

Donald Klepser, PhD, MBA, Associate Professor and Vice Chair, Pharmacy Practice, University of Nebraska Medical Center
Donald Klepser is Associate Professor and Vice Chair of Pharmacy Practice and Science at the University of Nebraska Medical Center, College of Pharmacy. He has a Ph.D. in Pharmaceutical Socioeconomics from the University of Iowa, an MBA from the University of Minnesota’s Carlson School of Management, and a Bachelor’s degree in Communications from the University of Michigan. He has studied the use of POC testing in community pharmacies for the past 12 years and is currently the primary investigator on grants to develop community pharmacy practice models for managing diseases such as HIV, HCV, influenza, and group A Streptococcus. He is also the primary investigator on grants to better understand how state and local health departments perceive the role of pharmacists conducting POC tests. As President of POC Consultants, Inc., Dr. Klepser has served as a consultant to both retail pharmacy chains and diagnostic testing companies.

Michael Klepser, PharmD, FCCP, Professor, Pharmacy Practice, Ferris State University College of Pharmacy
Michael Klepser, PharmD, received his Doctor of Pharmacy from the University of Michigan College of Pharmacy in 1992. He 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. Dr. Klepser’s research interests include use of CLIA-waived 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.

Mary Miller, PharmD, Manager, Clinical and Pharmacy Services, Rite Aid Corporation
Mary Miller is the Manager of Clinical and Pharmacy Services at Rite Aid Pharmacy.  With over 10 years of experience in community pharmacy, Miller is responsible for the strategic planning and implementation of clinical programs that increase the scope of pharmacy practice, including contraceptive prescribing and point of care testing.  At Rite Aid, she oversees the operations and execution of Medication Therapy Management programs which have successfully increased in addressing gaps in care year over year.  Miller holds a Doctorate of Pharmacy degree from Duquesne University.  She is married to Jeffrey, also a pharmacist, and they have three children, Will, Grace and Abigail.    

Alexander Sbordone, JD, OTR/L, Senior Advisor, Operations, MinuteClinic, CVS Health
Alexander Sbordone, JD, OTR/L is a Senior Advisor of Ambulatory Operations for CVS Health/MinuteClinic.  In this position, his responsibilities include the strategic and day to day operations of over 1100 clinics throughout the country.  Additionally, he oversees the organization of laboratory services at MinuteClinic comprising of all point of care testing performed within the clinics, relationships with all current and potential laboratory services vendors, and reference laboratory management.   Mr. Sbordone received his JD from Suffolk University with a concentration in Heath and Biomedical Law, and a Bachelor’s degree in Occupational Therapy from Quinnipiac University.

Keith Yon, PharmD, Pharmacist, Rx Clinic Pharmacy
Keith is a pharmacist at Rx Clinic Pharmacy in Charlotte, NC. He is a second-generation Tar Heel pharmacist who completed a PGY1 Community-based Pharmacy Residency with the UNC Eshelman School of Pharmacy. Keith uses his hybrid role between the independent community pharmacy and primary care settings to develop and implement his passion for pharmacist-led clinical services that advance community pharmacy practice. Already in his young career, Keith has played a significant part in the integration of Rx Clinic Pharmacy’s clinical services into collaborative care, including pharmacogenetics and specialty pharmacy management of HCV and HIV.

Emerging Technologies at the Point of Care

Matt Bates, Head of R&D, Abbott Point-of-Care
https://www.linkedin.com/in/matthew-bates-65017b2/

Dionysios Christodouleas, PhD, Assistant Professor, Department of Chemistry, University of Massachusetts Lowell
Dionysios Christodouleas, Ph.D. joined the Department of Chemistry at the University of Massachusetts Lowell in 2016. Before that, he was a postdoctoral research associate in Harvard University working with Prof. George Whitesides. Christodouleas holds a Ph.D. in Chemistry, a M.Sc. in Chemical Analysis & Quality Control, and a B.S. in Chemistry, all from the University of Athens, the leading university in Greece. He also holds a M.Sc. degree in Techno-economical Systems (MBA). He has earned several highly prestigious awards and scholarships (e.g., Alexander S. Onassis Scholarship etc.) and he was selected by an international committee to participate in the 63rd Lindau Nobel Laureate Meeting (06/30/2013 - 07/05/2013, Lindau, Germany). Thus far, he has published more than 25 papers and 7 patents.

David Deetz, Founder, CTO, Ativa Med
David Deetz is a founder and CTO of Ativa Medical. Previously he founded two other medical device companies, one of which completed a successful IPO on NASDAQ and was identified by Deloitte as one of the fastest growing medical device companies in the nation. The other was acquired by Danaher/Radiometer and has become an important part of their POC product line. He also founded an artificial intelligence company which was the first AI application to get broad adoption by financial services companies. He has authored 11 U.S. patents and raised approximately $140 million in private and public capital for his companies.

Manish Deshpande, PhD, Vice President, R&D, Point of Care BU, Siemens Healthcare
Experienced in: Medical device development, Executive Management, Innovation and IP Development, Digitalization/Data aggregation, Microsystems (MEMS and Microfluidics), Cross-functional product development, Business Development, Consulting, Innovation and IP development
Specialties: Management, Technology innovation, technology/IP evaluation and development, Product development
https://www.linkedin.com/in/deshpandemanish/

Mehdi Javanmard, PhD, Assistant Professor of Electrical and Computer Engineering School of Engineering Rutgers, The State University of New Jersey

Mehdi Javanmard joined Electrical and Computer Engineering Department at Rutgers University in Fall 2014 as Assistant Professor. Before that he was Senior Research Engineer at the Stanford Genome Technology Center (SGTC) in the School of Medicine at Stanford University. He received his BS (2002) from Georgia Institute of Technology and the MS in Electrical Engineering at Stanford University (2004). In 2008, he received his PhD in Electrical Engineering at Stanford University. At SGTC, he worked as a postdoctoral scholar from 2008-2009, and then as a staff engineering research associate from 2009 till 2014. In 2019 he was receipient of the National Science Foundation CAREER Award. In 2017 he was recipient of the Translational Medicine and Therapeutics Award by the American Society for Clinical Pharmacology & Therapeutics for his group's work in point of care diagnostic tools for assessing patient response to cancer therapies. He has received various awards as Principal Investigator from the National Science Foundation, DARPA, and the PhRMA foundation to support his research. His interests lie in developing portable and wearable technologies for continuous health monitoring and understanding the effects of environment on health.

Wilbur A. Lam, MD, PhD, Associate Professor, Wallace H. Coulter Department of Biomedical Engineering and Department of Pediatrics, Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta, Georgia Institute of Technology and Emory University School of Medicine
Wilbur A. Lam, MD, PhD is an Associate Professor in the Wallace H. Coulter Department of Biomedical Engineering at the Georgia Institute of Technology and Emory University and in the Department of Pediatrics at Emory University School of Medicine. Dr. Lam obtained his BA in from Rice University, MD from Baylor College of Medicine, and his PhD in bioengineering from UC Berkeley and UCSF, where he also completed his clinical training in pediatrics and pediatric hematology/oncology. As a physician-scientist-engineer, Dr. Lam’s research interests involve developing micro/nanosystems to investigate the cellular biophysics of hematologic processes at the micro to nanoscales. Dr. Lam and his laboratory are also dedicated to clinically translating those technologies to function as novel diagnostic assays, drug discovery platforms, and drug delivery systems for his pediatric patients with blood diseases or cancer. Overall, the Lam laboratory has adopted a “basement-to-bench-to-bedside” approach in which the invention, development, translation, and clinical assessment of novel diagnostic and therapeutic microtechnologies takes place under one scientific “roof” with the ultimate goal of improving the lives of patients with hematologic disorders and cancer. Dr. Lam currently holds eight patents and he has co-founded and serves as chief medical officer for two medical device startups, one of which recently received FDA 510K clearance for a point-of-care anemia test. Among other honors, Dr. Lam was elected into the American Society of Clinical Investigation, named an Emerging Investigator by Lab on a Chip, and is recipient of an NSF CAREER award. He currently serves on the scientific committees of the American Society of Hematology and the International Society on Thrombosis and Haemostasis and is the Principal Investigator of the Atlanta Center for Microsystems Engineered Point-of-Care Technologies as part of the NIH’s Point-of-Care Technologies Research Network.

Changchun Liu, PhD, Associate Professor, Biomedical Engineering Department, University of Connecticut, UConn Health
Changchun Liu is a research associate professor in the Department of Mechanical Engineering and Applied Mechanics at the University of Pennsylvania. He received his B.S. and M.S. in Chemistry at the Yunnan University, China in 1999 and 2002, respectively, and Ph.D. in Electronic Engineering at the Institute of Electronics, Chinese Academy of Sciences (IECAS), China in 2005. He has a highly interdisciplinary background and training spanning Engineering (i.e., electronic, mechanical), Chemistry and Biomedicine. Dr. Liu's research interests include the development of microfluidic chips, BioMEMS (Biomedical MicroElectroMechanical Systems) devices, biosensors, wearable devices and their biomedical applications with a focus on point-of-care (POC) diagnostics. He is a recipient of the NIH Career Development Award (K25) in 2012-2017, the Penn One Health Award in 2015, and the W.W. Smith Charitable Trust Research Award in 2016.

Nina Menezes, Head, Marketing Innovation, Abbott Point-of-Care
https://www.linkedin.com/in/nina-menezes-ph-d-8aa58b1/

Shawn Mulvaney, PhD, Section Head - Surface Nanoscience and Sensor Technology Section, Chemistry, US Naval Research Laboratory
Dr. Shawn P. Mulvaney is the Section Head of the Surface Nanoscience and Sensor Technology Section in the Chemistry Division at the US Naval Research Laboratory. Dr. Mulvaney's group works at the interface of the biotic and abiotic worlds assuring that the various elements of the sensor system are compatible and functional. Dr. Mulvaney has been working on biosensors and diagnostic technologies for 20+ years. Dr. Mulvaney received his Ph.D. in Chemsitry from The Pennsylvania State University and his B.S. in Chemistry from the College of William and Mary. He also is an editorial board member for the journal Sensors and Biosensors Research.

Jonathan O’Halloran, CSO, QuantuMDx Group Ltd
Jonathan is the inventor of QuantuMDx’s proprietary sample preparation, amplification and detection technologies. Following studying for his PhD in genomics, he began his career working in pathology laboratories in the UK. He was consistently frustrated by the speed at which the laboratory was able to turn tests around, whether that be through the need to batch samples, transportation of samples, or simply the long analysis time. During his time in the pathology lab he defined the specifications for a POC MDx device and then set to build and alter the technologies to facilitate his dream in his garage at home. This early work was the foundation for which QuantuMDx’s technology is built upon. Jonathan spent two years in Cape Town, working to develop QuantuMDx’s technology in the market that will benefit the most from it. He spent many hours a week talking with frontline health workers, who routinely perform POC Dx, to understand the field. This valuable experience and knowledge has been channelled into QuantuMDx’s device, which will make it one of the most complete POC devices when it is launched. Jonathan was recognised for his achievements in 2015 when he was awarded European CTO of the Year.

Prasad V. A Pamidi, PhD, Director, Sensor Development, R&D, Instrumentation Laboratory, A Werfen Company
https://www.linkedin.com/in/prasad-pamidi-9805806/

Karl Poterack, MD, Medical Director, Applied Clinical Informatics, Mayo Clinic
Dr. Poterack is board certified in Anesthesiology and Clinical Informatics. He practices anesthesiology at Mayo Clinic Hospital in Phoenix, and is the Medical Director for Applied Clinical Informatics for the Mayo Enterprise. He also serves as Vice Chair of Mayo’s Clinical Systems Oversight Committee. He is active in AMIA’s Maintenance of Certification Subcommittee, the American Society of Anesthesiologists’ Electronic Media and Information Technology Committee, and the HIMSS Physician Committee.  Dr. Poterack also teaches medical students, residents and fellows in the operating room at Mayo Hospital, and has developed informatics rotations for medical students in the Mayo Clinical School of Medicine. His current research interests are primarily directed towards the use of wearable devices, EHR usability, and Patient Safety/Human Factors Engineering.

Matt Quinn, MBA, Senior Advisor, Health Technology, HRSA
Matt Quinn serves as Senior Advisor, Health Technology at the Health Resources & Services Administration (HRSA) in the U.S. Department of Health and Human Services (HHS). He was previously the East Coast Managing Director for Intel’s Healthcare and Life Sciences business and Director of Healthcare Initiatives for the Federal Communications Commission (FCC). Prior, he led efforts at NIST and AHRQ to improve the usability and accessibility of health IT and to realize the value of health IT in emerging models of care delivery. In addition, Matt served as program management lead for the National Resource Center for Health IT, as lead staff for the National Committee on Vital and Health Statistics (NCVHS), and as Co-Chair of the Assistive Technology Subcommittee of the Interagency Committee for Disability Research (ICDR). Before joining government, Mr. Quinn was the Healthcare Industry Program Manager for Teradata, responsible for healthcare strategy and partnerships. Prior, he led marketing for Quantros, a patient safety and clinical outcomes improvement software company, managed GE Healthcare's "Six Sigma for Healthcare" consulting services and data analytic products, helped build an early Personal Health Record (PHR) company, and served as an Army Engineer Officer. Matt earned an engineering degree from the United States Military Academy at West Point and an MBA from Colorado State University.

Jim Sackrison, Consultant
Experienced Senior Development Manager with a demonstrated history of working in the medical device industry with over 50 new successful IVD products. Skilled in Strategy, Development and Creative Innovation, Verification and Validation (V&V), Good Laboratory Practice (GLP), Medical Devices, Validation, and GMP. Strong research professional that translates research and technology into new products.

Ping Wang, PhD, DABCC, Chief, Clinical Chemistry, Director, Core Laboratory Hospital of University of Pennsylvania
Ping Wang, PhD, D(ABCC), FACB is currently Chief of Clinical Chemistry and Director of Core Laboratory at Hospital of University of Pennsylvania (HUP), and Associate Professor of Pathology and Laboratory Medicine at University of Pennsylvania.  In her position, Dr. Wang oversees the clinical operation of a 10-million tests/year core lab and 3-million tests/year point-of-care testing. Leveraging her clinical expertise, Dr. Wang conducts research aiming to improve precision-based disease diagnosis and prognosis by developing next-generation central laboratory methods and point of care devices with novel sensors, materials and microfluidics.  She is Principle Investigator on many NIH and industry funded projects developing these novel methods, and has held patents and published extensively on these topics. Dr. Wang has been elected as President of American Board of Clinical Chemistry serving the term 2017-2018 and President-elect of the Personalized Medicine Division of AACC for term 2017-2018.

Nianqiang (Nick) Wu, PhD, George B. Berry Chair Professor, Department of Mechanical & Aerospace Engineering, West Virginia University
Dr. Nianqiang (Nick) Wu is currently George B. Berry Chair Professor in the Materials Science Program at West Virginia University (WVU), USA. He is a Fellow of the Electrochemical Society (FECS) and a Fellow of Royal Society of Chemistry (FRSC). He was identified in the 2018 Highly Cited Researchers list by Clarivate Analytics (Thomson Reuters). He has received the Benedum Distinguished Scholar Award and the Alice Hamilton Award for Excellence in Occupational Safety & Health. He was the recipient of the WVU Statler College Outstanding Researcher Award. He served as Board of Directors in the Electrochemical Society (ECS) and Chair of ECS Sensor Division in the past. Dr. Wu conducts research on biosensors, lab-on-chips, point-of-care diagnosis and photodynamic therapy (precision medicine). His research was funded by NSF, NIH, DOD, DOE and other funding agencies. He has authored or co-authored 180 journal articles, 3 book chapters and 1 book entitled “Biosensors Based on Nanomaterials and Nanodevices”. His papers were cited more than 2,700 times in a single year in 2018, achieving a total citation of >17,400 throughout his career with an H-index of 63.

Molecular Diagnostics for Infectious Disease

Esther Babady, PhD, Director, Clinical Microbiology Operations, Memorial Sloan Kettering Cancer Center
Esther Babady, PhD, D (ABMM) is the Director of Clinical Operations for the Microbiology Laboratory at Memorial Sloan Kettering Cancer Center. She received her PhD Biochemistry and Molecular Biology and completed a post-doctoral fellowship in Clinical Microbiology both at the Mayo Clinic in Rochester, MN. Her research interests include rapid, molecular diagnosis of infectious diseases in immunocompromised hosts. She has published several peer-reviewed manuscripts, book chapters and reviews on molecular diagnostics tests.

Susan Butler-Wu, PhD, D(ABMM), Associate Professor of Clinical Pathology, Keck School of Medicine, University of Southern California, Director of Clinical Microbiology, LAC+USC Medical Center (AMP Economics Affairs Committee Member; AMP Member)
Dr. Butler-Wu received her Doctorate of Philosophy in Molecular Microbiology from Tufts University in 2005. Following her completion of a postdoctoral fellowship in bacterial pathogenesis at NYU, she subsequently completed a post-doctoral fellowship in Medical and Public Health Microbiology at the University of Washington, Seattle. Dr. Butler-Wu continued her career at the University of Washington where she was Associate Director of the Clinical Microbiology Laboratory and an Assistant Professor in the Department of Laboratory Medicine. She recently joined the faculty at the University of Southern California as an Associate Professor in Clinical Pathology and is also Director of Clinical Microbiology at LAC+USC Medical Center. Her research interests include the development and application of diagnostic methods for the rapid detection of infection and antimicrobial resistance, as well as improved diagnostic methods for the detection of prosthetic joint infections caused by Propionibacterium species. Dr. Butler-Wu is a Diplomate of the American Board of Medical Microbiology.

Samuel K. Caughron, MD, FCAP, Director, MAWD Molecular Lab, MAWD Pathology Group (AMP Economic Affairs Committee Chair and Representative to the AMP 2018 Board of Directors; AMP Member)
Dr. Caughron is Board Certified in Anatomic and Clinical Pathology and Molecular Pathology.

Dr. Caughron received his medical degree and did his Anatomic and Clinical Pathology residency at Creighton University Medical Center in Omaha, Nebraska. He then completed his Molecular Genetic Pathology fellowship at Vanderbilt University. He joined MAWD Pathology Group after establishing and directing a molecular genetic pathology laboratory in Billings, Montana.

Dr. Caughron is the Laboratory Medical Director for Shawnee Mission Medical Center.

Dr. Caughron, who is a Kansas City native, joined MAWD Pathology Group in September 2009.

Charles Chiu, MD, PhD, Professor, Departments of Laboratory Medicine and Medicine, Division of 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 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. Chiu currently heads a translational research laboratory focused on next-generation sequencing assay development for infectious disease diagnostics, discovery and 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. He is also actively developing RNA sequencing approaches to detect and identify diagnostic profiles of the body’s response to infection. His work is supported by funding from the National Institutes of Health (NIH), Abbott Laboratories, Department of Defense, NASA/Translational Research Institute, philanthropic grants (Charles and Helen Schwab and Steven and Alexandra Cohen Foundations), and the California Initiative to Advance Precision Medicine. Dr. Chiu has authored more than 80 peer-reviewed publications, holds over 15 patents and patent applications, and serves on the scientific advisory boards for Therabio, Inc., and Mammoth Biosciences, Inc.

Jennifer Dien Bard, PhD, D(ABMM), Director, Microbiology and Virology, Children’s Hospital Los Angeles; Associate Professor, Pathology and Laboratory Medicine, Keck School of Medicine, University of Southern California
Dr. Jennifer Dien Bard is the director of the clinical microbiology and virology laboratories at Children’s Hospital Los Angeles (CHLA) and Associate Professor of Pathology with Clinical Scholar designation at the University of Southern California Keck School of Medicine. Dr. Dien Bard’s research interests include studying the application of rapid diagnostics in the clinical setting to determine clinical utility. She has authored more than 50 scientific peered-reviewed publications and is a frequent speaker on the topics of rapid diagnostics such as syndromic testing. Dr. Dien Bard serves as a member of the professional development committee for ASM and economic affairs committee for AMP and is on the Editorial board of the Journal of Clinical Microbiology.

Christopher Doern, PhD, D(ABMM), Associate Director, Microbiology, Virginia Commonwealth University Medical Center, Medical College of Virginia Campus
Director of Clinical Microbiology at VCU Health System and the Medical College of Virginia in Richmond, VA. I am an Associate Professor of Pathology and Pediatrics.
Conducted undergraduate and graduate studies at Wake Forest University in Winston-Salem, NC. Completed a fellowship in Medical and Public Health Microbiology at Washington University in St. Louis in 2010 and am board certified by the American Board of Medical Microbiology (ABMM).

James Courtney Fackler, MD, Director, Pediatric Critical Care Medicine, Associate Professor of Anesthesiology and Critical Medicine, Johns Hopkins Medicine
Dr. Fackler’s clinical work is pediatric critical care and anesthesiology at Hopkins.  Before taking his current role at Hopkins in 1996, he was on the faculty of the Harvard Medical School where he co-founded the Children’s Hospital Informatics Program.  He worked for the Cerner Corporation from 2002 to 2006 and was responsible for the development and deployment of their critical care solution suite.  His academic interests are the harnessing of the data generated by, and about, critically ill children for use in identifying and reducing the clinician driven variability in the care of complex conditions (such as sepsis). He founded a startup, Rubicon Health, an early-stage startup and believes every child (or patient more broadly) deserves their health care (e.g. critical care) delivered with precision.   We create and maintain clinical team support software, so the teams consistently deliver high value care.  Our first solution provides Clinical Team Support Solution for sepsis* care assisting the bedside team from early detection through management. Rubicon, merges clinical expertise and AI in all processes to anticipate, treat and manage sepsis.  As a platform built by clinicians for clinicians, we understand the needs of sepsis care.  

Kimberly Hanson, MD, MHS, Director, Transplant Infectious Diseases and Immunocompromised Host Service, Director, Medical Microbiology Fellowship Program, Section Head, Clinical Microbiology, University of Utah, ARUP Laboratories
Dr. Kimberly Hanson is the Head of Immuncompromised Host Infectious Diseases Services at the University Hospital and Huntsman Cancer Center as well as Director of Clinical Microbiology within ARUP Laboratories. She is an Associate Professor of Medicine and Pathology, splitting her time between patient care, laboratory administration, research and teaching. Dr. Hanson was recruited to the University of Utah in 2008 from Duke University, where she obtained specialty training in Adult Infectious Diseases, Medical Microbiology and Health Sciences Research. She maintains an active research program that is focused on the development and validation of novel, cost-effective diagnostic tests for Infectious Diseases. Dr. Hanson has authored over 60 scientific papers, book chapters and review articles with a focus on transplant-related infectious diseases and clinical diagnostics.

James E. Kirby, MD, D(ABMM), Director, Clinical Microbiology Laboratory, Beth Israel Deaconess Medical Center; Program Director, Medical Microbiology Fellowships, Beth Israel Deaconess Medical Center; Associate Professor of Pathology, Harvard Medical School
James Kirby is the Medical Director of Clinical Microbiology at Beth Israel Deaconess Medical Center and an Associate Professor of Pathology at Harvard Medical School. He is Board Certified in Clinical Pathology and is a Diplomat of the American Board of Medical Microbiology. He received degrees from Yale College and the University of Pennsylvania School of Medicine, and performed residency training at the Massachusetts General Hospital and research training at the National Institutes of Health and the Tufts Sackler School of Medicine. He is a National Institutes of Health-funded scientist whose research efforts include development of novel antimicrobial susceptibility testing platforms; antibiotic development; and understanding how bacterial pathogens cause disease, and. From 2009-2012, he was the President of the Northeast Branch of the American Society of Microbiology. He has served on the Editorial Boards of the  Journal of Clinical Microbiology, and Applied and Environmental Microbiology
More information about Dr. Kirby may be found at www.kirbylab.org.

Nathan Ledeboer, PhD, Professor and Vice Chair, Pathology and Medical Director, Medical College of Wisconsin
Nathan A. Ledeboer, Ph.D., D(ABMM), F(AAM)  received his  Ph.D. 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 joined the faculty of the Department of Pathology at the Medical College of Wisconsin in Milwaukee, WI.  He is currently a Professor and Vice Chair of Pathology and Medical Director of Microbiology, Molecular Diagnostics, reference services, and laboratory client services at Froedtert Hospital and Wisconsin Diagnostic Laboratories in Milwaukee, WI.  His research endeavors, particularly in the area developing diagnostic tools for infectious diseases, have led to numerous publications in peer-reviewed journals and more than 100 funded research projects.  Dr. Ledeboer is also a senior editor for the Journal of Clinical Microbiology.

Shawn Levy, PhD, CSO, Discovery Life Sciences

Shawn Levy, PhD, is a faculty investigator and the founding director of the Genomic Services Laboratory (GSL) at the HudsonAlpha Institute for Biotechnology. He serves as CSO of the new HudsonAlpha Discovery division. Dr. Levy focuses on the development and application of genomic and bioinformatic technologies and methods to support scientific investigation. His team uses high performance genotyping and sequencing technologies to support translational and clinical-based projects at the GSL

Amy J. Mathers MD, D(ABMM), Medical Director, Antimicrobial Stewardship & Associate Director, Clinical Microbiology, Infectious Diseases & International Health University of Virginia School of Medicine
Dr. Amy Mathers MD, ABMM is an Associate Professor of Medicine and Pathology at the University of Virginia.  She is Clinical Director of the Adult Antimicrobial Stewardship Program and is Associate Director of Clinical Microbiology for the University of Virginia Medical Center.
Focusing on the urgent clinical problem of increasing carbapenem resistance in Enterobacteriaceae she has been evaluating detection methods in clinical microbiology and molecular transmission of carbapenemase genes for the last ten years. Molecular characterization has included analysis of mobile resistance mechanisms with evaluation of plasmid evolution and mobility across species with next generation sequencing paired with more traditional techniques.  With current support for the Centers for Disease Control and Prevention she has been recently investigating the role that the hospital environment can play in evolution and dissemination of carbapenemase genes. 
With additional interest in antimicrobial susceptibility testing and its relation to antimicrobial use and stewardship, she dose clinical research on the impact of rapid diagnostics.  She is a current voting member of the Clinical Laboratory and Standards Institute (CLSI) Antimicrobial Susceptibility Testing Committee. She is the IDSA liaison for the CLSI.

Larissa May, MD, MSPH, MSHS, Director, Emergency Department, Outpatient Antibiotic Stewardship, University of California Davis
Larissa May, MD, MSPH, MSHS - Dr. Larissa May is Professor of Emergency Medicine and Director of Emergency Department and Outpatient 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 M.D. (2002), her MSPH in Public Health Microbiology and Emerging Infectious Diseases (2008), and her MSHS in Clinical and Translational Research (2013) from The George Washington University.  She completed her residency training at the George Washington University in 2006, where she served as a chief resident. Dr. May’s research interests center on the application of rapid molecular diagnostic assays, behavioral economics and clinical guidelines to improve antibiotic stewardship and other patient safety and quality improvement efforts in the ED and urgent care setting. Dr. May has served as an investigator on multiple federally-funded and industry-funded trials evaluating antimicrobial stewardship strategies in the ED and has published over 60 peer-reviewed articles in her field.  She has also served on numerous committees and task forces focused on antibiotic stewardship, emergency preparedness, and infectious diseases surveillance for the Centers for Disease Control and Prevention, the National Institutes of Health, and professional organizations including the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America.

Sally McFall, PhD, Director of Research of the Center for Innovation in Global Health Technologies, Biomedical Engineering, Northwestern University

Sally McFall, Ph.D., Director of Research of the Center for Innovation in Global Health Technologies at Northwestern University, Deputy Director of Administrative Core, Director of Technology Development/Refinement Core in Point-of-Care Technologies for HIV/AIDS at Northwestern University. Dr. McFall's background is molecular and clinical microbiology, with extensive experience in technology development.

Kfir Oved, PhD, CTO, MeMed

An accomplished entrepreneur with dual background in Medicine and Immunology. Co-founded MeMed in 2009; serves as CTO & Chairman. Kfir led development of the entire MeMed technology suite and its clinical validation while leading interdisciplinary multicultural teams. Selected as one of the top 25 voices in Precision medicine for 2019.

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.

Hooman H. Rashidi, MD, FASCP, Professor and Vice Chair, GME, Director of Residency Program; Director, Flow Cytometry & Immunology, Department of Pathology and Laboratory Medicine, University of California, Davis School of Medicine
Dr. Rashidi is Professor of Clinical Pathology and Director of Immunology and Flow Cytometry at UC Davis. He completed his medical school training at University of Texas, and pathology residency at Yale-New Haven Hospital. He is an expert in bioinformatics and artificial intelligence/machine learning. Dr. Rashidi has published several books, including the renowned “Hematology Atlas”, and also texts in in bioinformatics.  He also developed novel software applications (HemeQuiz1) and the online Hematology Outlines to support hematopathology education.

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 Ph.D. 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.

Nam Tran, PhD, Associate Clinical Professor, Clinical Chemistry, Special Chemistry, Toxicology, Point-of-Care Testing, SARC Sections, Pathology and Laboratory Medicine, University of California, Davis
Dr. Tran is Associate Professor of Clinical Pathology and Director of Clinical Chemistry, Special Chemistry/Toxicology, and Point-of-Care Testing at UC Davis. He completed his PhD degree in Comparative Pathology in 2008 and conducted a postdoctoral training fellowship under the National Institute of Bioimaging and Bioengineering (NIBIB) sponsored UC Davis Point-of-Care Technologies Center focused on developing novel molecular technologies for bedside infectious disease testing. These studies translated to a large multicenter trial evaluating the clinical impact of rapid molecular testing in sepsis in severely burned patients.

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.

Clinical Application of Circulating Biomarkers

Nishant Agrawal, MD, Professor of Surgery, Director of Head and Neck Surgery Oncology, University of Chicago
I received my Bachelor of Science degree in Biology in 1997 from Rutgers University. I went on to obtain my MD degree from the Johns Hopkins University School of Medicine in 2001. During medical school, I performed neuroscience research with Dr. Solomon Snyder focusing on neurodegenerative diseases and neuronal death. I completed by residency in Otolaryngology-Head & Neck Surgery at Johns Hopkins. My training involved two years in the lab of Drs. Bert Vogelstein and Ken Kinzler where I studied cancer genetics. I then completed a one-year clinical fellowship in head and neck surgical oncology at Memorial Sloan Kettering Cancer Center. I joined the faculty at Johns Hopkins as an Assistant Professor in Otolaryngology-Head and Neck Surgery in 2009 and was recruited to the University of Chicago in 2015. Currently, I am a Professor of Surgery, Chief of Otolaryngology-Head and Neck Surgery, and Director of Head and Surgical Oncology at the University of Chicago. 

Leonora Balaj, PhD, Instructor of Neurosurgery, Massachusetts General Hospital
https://www.linkedin.com/in/leonora-balaj-phd-3153736b

Chetan Bettegowda, MD, PhD, Jennison and Novak’s Families Chair, Departments of Neurosurgery and Oncology, Johns Hopkins University School of Medicine
Dr. Chetan Bettegowda is a surgeon-scientist whose research is focused on understanding the genetic underpinnings of central nervous system (CNS) cancers. He and his group have discovered several of the key driver genes involved in the pathogenesis of a myriad of brain cancers, many of which are now used routinely to define the molecular classification of primary brain tumors. Dr. Bettegowda has also been focused on translating these genetic discoveries for translational benefit by applying them for the earlier detection of cancers. He and his group have published several of the seminal papers in liquid biopsies including a landmark study demonstrating the wide applicability of circulating tumor DNA for the detection and monitoring of cancers throughout the body. He has also published extensively on non-plasma-based diagnostics for cancer detection. In addition to an active research enterprise, Dr. Bettegowda is a practicing neurosurgeon whose clinical efforts are focused on caring for individuals with primary and metastatic brain tumors. Dr. Bettegowda has been recognized by numerous organizations for his outstanding work. He inaugural recipient of the Jennison and Novak Families Endowed Chair in Neurosurgery at the Johns Hopkins University School of Medicine. His work is funded by the Burroughs Wellcome Career Award for Medical Scientists, Doris Duke Clinician Scientist Award, Department of Defense and National Cancer Institute.

Scott V. Bratman, MD, PhD, Radiation Oncologist, Radiation Medicine Program; Scientist, Princess Margaret Cancer Centre, University Health Network; Assistant Professor, Depts of Radiation Oncology and Medical Biophysics, University of Toronto
Dr. Scott Bratman is an Assistant Professor of Radiation Oncology and Medical Biophysics at the University of Toronto and serves as Clinician-Scientist and Staff Radiation Oncologist at The Princess Margaret Cancer Centre. Dr. Bratman was trained at Princeton University, Columbia University Medical Center, and Stanford Cancer Institute. Starting with his postdoctoral studies at Stanford, Dr. Bratman has developed cutting edge liquid biopsy technologies for detection and monitoring of cancer in the bloodstream. This work is revolutionizing cancer care by allowing cancer to be detected with a simple blood test. As a clinician-scientist, Dr. Bratman is at the front lines of translating liquid biopsies into improved health outcomes for patients. His research program has expanded to include lung cancer, cervix cancer, head and neck cancer, leukemia, among others. His work has been recognized through publication in high impact scientific journals such as Nature, Nature Medicine, Nature Biotechnology, and JAMA Oncology. The Bratman Lab strives to be a source of innovation and novel technologies for next-generation blood-based biomarkers.

Jamie E. Chaft, MD, Medical Oncologist, Memorial Sloan Kettering Cancer Center
Jamie E. Chaft is a thoracic medical oncologist at Memorial Sloan Kettering Cancer Center. She focuses on clinical and translational research in early stage lung cancer. She has led multiple studies of preoperative therapy for resectable non-small cell lung cancer and serves as the national study chair for the NCTN sponsored adjuvant nivolumab study. At MSKCC, Dr. Chaft co-leads the institution’s program on minimal residual disease. In this program, innovative trials are being launched to personalize care based on circulating biomarkers.

Brian Dougherty, PhD, MBA, Executive Director, Translational Science, Oncology IMED, AstraZeneca
Brian is the Executive Director of Translational Genomics Oncology at AstraZeneca Pharmaceuticals in Boston, MA, leading AstraZeneca’s cancer genomics efforts. He oversees a team of lab scientists and computational biologists applying leading-edge genomic and advanced algorithmic technologies to deliver on Precision Medicine - matching the right patient with the right drug. This includes biomarker development, patient selection and monitoring strategies, identifying new tumor drug resistance mechanisms, researching genetics-based translational hypotheses, and delivering novel cancer targets. When he was previously at Bristol-Myers Squibb, Pfizer, TIGR and Amgen, Brian led sequencing, genotyping, gene expression, high-content imaging, and functional genomics lab efforts, applying technologies to enable the discovery and development of medicines for diseases such as cancer, infectious diseases, chronic pain, and Alzheimer’s Disease. Brian holds a BA from the University of Delaware, a PhD from Wake Forest University Medical Center, an MBA from the University of New Haven, and completed a postdoctoral research fellowship in the laboratory of Nobel laureate Hamilton O. Smith at The Johns Hopkins University School of Medicine.

James G. Herman, MD, Hematology/Oncology, Professor of Medicine, UPMC Endowed Chair for Lung Cancer Research; Co-Director, Lung Cancer Program, University of Pittsburgh
My lab studies epigenetic changes in cancer, with a focus on lung cancer. Tumor suppressor gene inactivation can occur through genetic mechanisms (deletions, mutations) or through epigenetic silencing, usually associated with promoter region methylation. We first described these changes for well-established tumor suppressor genes (VHL, p16/CDKN2A, BRCA1, APC, MLH1, etc) and have found epigenetic silencing is a common occurrence for many other genes in cancer.  These changes are now considered critical for the development and progression of cancer. We have developed sensitive methods for detection of DNA methylation (Methylation Specific PCR and new modifications of this method) to allow detection of changes in DNA methylation in small, archived tumor biopsies and in body fluids. This has led to molecular detection of cancer changes as a method for early detection in lung cancer (sputum and blood), colon cancer (stool) and other tumor types (pancreas: blood, ovarian: peritoneal fluid, bladder: urine). The presence of epigenetic changes has also been used to determine sensitivity to chemotherapies, and we developed a test for detection of methylation of the DNA repair gene MGMT is now used to assess sensitivity to the alkylating agents, including temozolomide. I have been a member of TCGA (The Cancer Genome Atlas) involved in characterizing genome wide epigenetic changes in cancer. Dr. Herman received his Bachelors’ degree with a major in Chemistry from Hope College in 1984, and his MD from The Johns Hopkins University School of Medicine in 1989. He completed his internship and residency in Internal Medicine at Duke University and a Medical Oncology fellowship at Johns Hopkins before joining the faculty in 1996. He was promoted to Professor in 2009 and has recently moved to the University of Pittsburgh to lead the lung cancer program at the University of Pittsburgh Medical Center. His laboratory mentees include 3 medical, 6 PhD thesis students, and 23 post-doctoral fellows. He is board certified in medical oncology and is clinically involved in the management of patients with lung and esophageal cancer.

Yelena Y. Janjigian, MD, Medical Oncologist, Chief, Gastrointestinal Oncology Service, Memorial Sloan Kettering Cancer Center
Yelena Y. Janjigian MD is Chief of Gastrointestinal (GI) Oncology Service in the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK). Dr. Janjigian is an international expert in the management of cancers of esophagus and stomach, and is leading several seminal studies that will impact the standard of care for these diseases. She produced high impact publications describing the genomic basis for esophagogastric cancer pathogenesis and secured federal grants to fund future studies. Her research is focused on developing new treatments, with a special emphasis on defining the therapeutically relevant molecular characteristics of tumors in the GI tract, with 80 peer-reviewed publications to date.

Filip Janku, MD, PhD, Associate Professor, Department of Investigational Cancer Therapeutics, The University of Texas MD Anderson Cancer Center
Dr. Filip Janku, MD, PhD is an Associate Professor in the Department of Investigational Cancer Therapeutics (Phase I Program) and Center Medical Director for the Clinical and Translational Research Center at MD Anderson Cancer Center. Dr. Janku obtained his MD and PhD at the Charles University Prague. He joined the Department of Investigational Cancer Therapeutics in the 2011 after completion of the fellowship at MD Anderson. Dr. Janku is a principal investigator for numerous Phase I, most of which involve novel agents and routes of administration, many of those being novel first-in-class studies. Dr. Janku received multiple awards for his research efforts, including Sabin Family Fellow Award, Khalifa Scholar Award, Sidney Kimmel Scholar Award, several ASCO Merit Awards as well as an American Association for Cancer Research Scholar-in-Training Award. Dr. Janku has published over 200 articles in peer-reviewed journals. Dr. Janku's academic research interests includes liquid biopsies. In addition, he focuses on proof-of-concept clinical trials that possess a pivotal correlative component especially those involving novel intratumor therapeutic approaches activating pathways of innate immunity, and the PI3K/AKT/mTORm MAPK and IDH pathways.

Jennifer C. Jones, MD, PhD, Investigator, Laboratory of Pathology; Head, Translational Nanobiology Section, Center for Cancer Research, NCI, NIH
Dr. Jones received her MD and PhD from Stanford University. She is a board-certified radiation oncologist specialized training in radiosurgery, with graduate and postdoctoral training in both cancer biology and general immunology.

Romain Parillaud, PhD, Application Specialist, Stilla Technologies
Romain received his PhD in Neuro-Immunology at Paris VI University, using gene expression analysis on micro-dissected glia cells to determine the role of inflammatory cues in Parkinson Disease mice model. After leading the support of genomics portfolio for Bio-Rad in EMEA, Romain joined our forces as Application Specialist at Stilla Technologies.  

Abhijit Patel, MD, PhD, Associate Professor, Yale University School of Medicine
Abhi Patel’s research group at Yale University is working to develop and clinically validate novel cancer diagnostics-based on analysis of tumor-derived DNA fragments in blood. His lab has developed technologies that permit ultrasensitive detection of cancer-specific DNA signatures in blood, with the ultimate goal of enabling early cancer detection and prediction of treatment efficacy. He is an Associate Professor in the Department of Therapeutic Radiology at the Yale 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.

Thomas R. Pisanic II, PhD, Research Scientist, Johns Hopkins Institute for NanoBioTechnology, Johns Hopkins University
Thomas R. Pisanic II is a faculty research scientist at Johns Hopkins Institute for NanoBioTechnology. His career has focused on the design, development and translation of diagnostic strategies for a broad range of clinical applications. Prior to joining Johns Hopkins, he worked in industry as Head of Assay Development, leading development of nanotechnology-driven diagnostic assays for numerous in vitro diagnostic projects ranging from detection of circulating tumor cells and pathogenic bacteria to inflammatory molecules and nucleic acid targets. Since joining Johns Hopkins in 2013, he has worked in direct coordination with Professor Tza-Huei (Jeff) Wang on the development of epigenetic molecular diagnostic strategies for multiple cancer types using non-invasive sample types including blood, stool, sputum and Pap specimens. His future research goals are aimed at the development and implementation of innovative molecular techniques with advanced biostatistical and bioinformatic analyses to achieve inexpensive, clinically practical epigenetic assessment strategies for the study of carcinogenesis and the early detection of disease.

David F. Ransohoff, MD, Professor, Medicine and Epidemiology, University of North Carolina, Chapel Hill
David F. Ransohoff MD is a clinical epidemiologist (Clinical Scholars Program, Yale) and internist/gastroenterologist (Dartmouth/University of Chicago) with longstanding interest in improving the methods used to evaluate diagnostic tests for screening. An early paper helped establish the field of methods to evaluate diagnostic tests (NEJM, 1978). After studying conventional tests for cancer and other diseases, using tools of clinical epidemiology and health services research, he extended his work to include molecular tests, after being asked to chair the scientific advisory board of EXACT Sciences (stool-based DNA markers for colon cancer; NEJM, 2004, 2014) and after a sabbatical with NCI. He has also studied blood-based markers (DNA, proteomics) for screening for colon and ovarian cancer. He has described the methodologic challenges of work at the translational interface of clinical epidemiology and lab-based molecular methods (Science, Nat. Rev. Cancer, JNCI) and has worked with FDA and Institute of Medicine/NAM committees on molecular marker research. 

Michael R. Speicher, MD, Professor and Chairman, Institute of Human Genetics, Diagnostic and Research Center for Molecular BioMedicine, Medical University of Graz
Michael R. Speicher, MD is Professor of Human Genetics and Head of the Institute of Human Genetics at the Medical University of Graz in Austria. Dr. Speicher studied computer science at the University of Dortmund (Germany) and graduated with an MD degree from the University of Essen (Germany). He conducted his clinical and scientific training in Human Genetics at the University of Heidelberg (Germany), at Yale University, and at the University of Munich (Germany). For many years Dr. Speicher studied chromosome structure and morphology using various molecular cytogenetic approaches and mechanisms of chromosomal instability. His more recent research is focused on hereditary tumor syndromes, the contribution of germline and somatic genomic variants to cancer, and liquid biopsies. Current research projects are directed towards methods for the non-invasive monitoring of cancer evolution by analyses of circulating tumor cells and circulating tumor DNA.

Companion Diagnostics and Clinical Biomarkers in Immuno-Oncology

J.D. Alvarez, MD, PhD, Vice President, Oncology Diagnostics, Janssen Pharmaceutical Companies
J.D. Alvarez, MD, PhD is Vice President, Oncology Diagnostics, for the Janssen Pharmaceutical Companies of Johnson & Johnson.  In this position, he is responsible for developing and delivering diagnostic solutions that enable registration of compounds in the Oncology pipeline.

J.D. joined Janssen in 2009 as an Associate Director of Oncology Biomarkers and was responsible for establishing a molecular pathology laboratory to support the oncology biomarker investigations and strategies.  He has held positions of increasing responsibility within Biomarkers, Translational Research and Clinical Research.  He also represents Janssen on working groups within the Society for Immunotherapy of Cancer, the Association of Molecular Pathology and the Medical Device Innovation Consortium.

Prior to joining Janssen, J.D. served as a research associate at the University of Pennsylvania conducting independent National Institutes of Health grant-funded research on the function of circadian rhythms in disease physiology.  He also held positions in both discovery research and oncology translational medicine at Nippon Roche K.K. and at Wyeth Research.
J.D. received his medical degree and his doctorate in Molecular Cell Biology from the Washington University School of Medicine in St. Louis, Missouri.  He completed his residency and fellowship training through the University of Pennsylvania School of Medicine Department of Pathology and Laboratory Medicine.  He is board certified in Anatomic Pathology and Molecular Genetic Pathology.

Suzanne Belinson, PhD, Vice President, Commercial Markets, Tempus, Inc.
Suzanne Belinson, PhD, MPH, is Vice President of Commercial Markets at Tempus Labs, Inc. Tempus is a technology company that has build the world’s largest library of clinical and molecular data and an operating system to make that data accessible and useful, starting with cancer. Her role focuses on commercial growth for Tempus through the development and execution of partnerships with organizations aiming to improve healthcare value and outcomes by leveraging molecular and clinical data. Before joining Tempus, Dr. Belinson served as an Executive Director, Clinical Markets, at the Blue Cross Blue Shield Association. In addition to leading the sales and market development for products and services developed within the Office of Clinical Affairs, Dr. Belinson led the day to day operations of Evidence Street. As part of the leadership team in the Office of Clinical Affairs she also spent time focused on the development of emerging programs and services that enhance value and brand leadership for the independent BCBS Plans. Dr. Belinson received her bachelor’s degree from Cleveland State University, and a PhD in Epidemiology from the University of North Carolina at Chapel Hill. She also holds a Master’s in Public Health from the University of Pittsburgh.

Nicholas Dracopoli, PhD, Senior Vice President, Translational Science at Personal Genome 
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 BSc 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.

Kenneth Emancipator, MD, DABP, Executive Medical Director, Companion Diagnostics, Translational Medicine, Merck & Co., Inc.
Dr. Emancipator led the combined Merck/Agilent team which developed the first FDA-approved companion diagnostic in cancer immunotherapy, the 22C3 PD-L1 immunohistochemistry test, enabling Keytruda to become the first immunotherapy approved as first-line treatment for non-small cell lung cancer. PD-L1 is now an approved companion diagnostic in four tumor types, with positive trials announced for another two. Dr. Emancipator 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. More recently, he received the 2017 Philip Levine Award for Outstanding Research from the American Society for Clinical Pathology.

Dr. Emancipator received his AB degree from Harvard University and his MD from St. Louis University. He held appointments at US National Institutes of Health, US Food and Drug Administration, Cornell University, Beth Israel Medical Center, Bayer Healthcare, Siemens Healthcare, and Abbott Molecular before joining Merck.

George Green, PhD, Head, Pharmacodiagnostics, Bristol-Myers Squibb
https://www.linkedin.com/in/ggreeniv

Saul Kivimäe, PhD, Head, Pharmacology, Nektar Therapeutics
PhD in genetics and biochemistry from Rockefeller University. Postdoctoral studies at UCSF in mouse genetics, disease modeling and developmental biology. At Nektar Therapeutics since2016. In vivo pharmacology function lead at Nektar Theraputics in immuno-oncology.
https://www.linkedin.com/in/saul-kivim%C3%A4e-7053ab38/

Jeffrey Miller, PhD, Founder, CSO, CEO, & Chairman, Invivoscribe

Dr. Miller is a scientist, inventor, and serial entrepreneur who founded Invivoscribe in 1995 on the premise that healthcare providers, pharmaceutical companies and, most importantly patients, benefit from better standardization and more consistent performance of molecular diagnostic tests.

Iulian Pruteanu-Malinici, PhD, Investigator, Immuno-Oncology, Novartis
I use Bayesian statistics and frequentist statistical learning techniques to analyze large scale pharma-genomics assays in order to discover genomic correlates of sensitivity and resistance to cancer drugs.
https://www.linkedin.com/in/iulian-pruteanu-malinici-1198542/

Simon Lacey, PhD, Director, Translational and Correlative Studies Laboratory, Center for Cellular Immunotherapies, University of Pennsylvania
Simon Lacey is the Director of the Translational and Correlative Studies Laboratory (TCSL) at the Center for Cellular Immunotherapies, Perelman School of Medicine, University of Pennsylvania. His laboratory supports multiple Phase I/II clinical trials of cellular therapies for cancer, infectious disease and autoimmune disease at UPenn and the Children’s Hospital of Philadelphia. He has broad expertise in cellular, molecular and biochemical assays as applied to T cell immunity to viruses and cancer. His PhD was from the University of London, UK, and his postdoctoral training was at Duke University and the Beckman Research Institute of the City of Hope.

Kathryn Lang, MD, MRCP, FRCPath, Vice President, Outcomes and Evidence, LUNAR Program, Guardant Health
Dr. Kathryn Lang is a board certified hemato-oncologist, who completed clinical training in London, UK in 2016.  With a strong focus on outcomes research throughout her career and over 50 publications, Dr. Lang moved to an industry role with Pfizer in 2016 where she led the global data science initiatives within Pfizer Oncology.  She moved to her current role with Guardant Health in 2018 where she is VP of Outcomes and Evidence in the LUNAR program focusing on early detection of cancer and applied HEOR.

Margaret McCusker, MD, Senior Medical Director, Flatiron Health
Margaret McCusker is a board-certified preventive medicine physician who serves as a senior medical director at Flatiron Health. Margaret leverages her training and experience to explore how real-world evidence can be used to complement traditional evidence generation strategies both within the life sciences industry and in public health.
Prior to joining Flatiron Health, Margaret worked for Roche, within both the pharmaceutical and diagnostics divisions. Before Roche, she was a medical officer with the California Department of Public Health, where she focused on cancer prevention and control programs, including the California Cancer Registry.
Margaret received her undergraduate degree in biology from Boston University and MD from the University of Maryland School of Medicine. She completed a preventive medicine residency at the University of Maryland, where she also earned an MS in epidemiology and preventive medicine. After residency, Margaret served as an Epidemic Intelligence Service officer with the Centers for Disease Control and Prevention, and was stationed at the Texas Department of Health.

Mika Newton, BSc, CEO, xCures
Mika Newton has over twenty years of leadership experience in the life sciences. He is the CEO and Board Member at xCures. Most recently he was the Chief Commercial Officer of Doctor Evidence, LLC. Prior to Doctor Evidence he was the General Manager of Clinical Development Services at diaDexus, SVP of Client and Market Development at Evidera, VP of Sales and Marketing at Archimedes, and held sales management and sales operations roles at Quintiles, Invitrogen and Tripos.
Mr. Newton earned a BSc in biotechnology from Worcester Polytechnic Institute and studied corporate finance at the London School of Economics and Political Science.

Anand Pathak, MD, PhD, MPH, Medical Officer, FDA
Anand Pathak, MD, PhD, MPH 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, MD/PhD) at the University of Cincinnati.  He received a PhD 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 MPH 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.

Rajiv Raja, PhD, Director, Translational Medicine and Pharmacogenomics, MedImmune
Dr. Rajiv Raja has over twenty years of experience in molecular biology and molecular diagnostics and is currently the Director of Translational Medicine and Pharmacogenomics at MedImmune/AstraZeneca. At MedImmune, Dr. Raja’s team develops and implements new genomic technologies and biomarker assays to support clinical development programs in oncology, CVMD, auto-immunity and respiratory disorders. Prior to MedImmune, Dr. Raja was a group leader in Oncology Biomarker Development at Genentech, where he developed biomarker assays and companion diagnostic tests to support clinical development programs in oncology. 
Dr. Raja received his PhD in Molecular Genetics from Oklahoma State University and did his post-doctoral training at University of Illinois at Urbana-Champaign. Prior to joining Genentech, he has worked at UCSF, the Lawrence Livermore National Laboratory, Arcturus Biosciences and Molecular Devices.

Mitch Raponi, PhD, Vice President, Biomarker Development and Translational Research, BeiGene
Mitch Raponi, PhD, is Vice President of Biomarker Development & Translational Research at BeiGene. He is responsible for designing and executing companion diagnostic strategies to support the development and commercialization of the company’s immune-oncology and targeted cancer therapeutic pipeline. Mitch was previously VP of Molecular Diagnostics at Clovis Oncology where his work led to the development and approval of the first NGS-based companion diagnostics for the PARP inhibitor, rucaparib. Prior to this, Mitch spent 15 years at Johnson & Johnson building biomarker and companion diagnostic programs within the diagnostics and pharmaceutical franchises. He received his PhD in Molecular Genetics and Biochemistry from the University of New South Wales, Australia, and has published in the fields of gene therapy, cancer genomics, and personalized medicine.

Jamie Shaw, BSc, Principle Scientist, Exploratory Medicine – Clinical Biomarkers, EMD Serono, Inc.
Jamie is a Principle Scientist in Experimental Medicine – Clinical Biomarkers at EMD Serono. She has over 13 years of experience in drug development research, establishing precision medicine strategies for numerous agents in oncology and immunology, spanning from early discovery through late development. Her work has focused on studies of cellular pharmacology, pharmacodynamic biomarkers, mechanism of action and identification of predictive biomarkers for small molecule targeted therapies.

Vanessa Tumilasci, PhD, Commercial Director, Trans-Hit Biomarkers
Dr. Vanessa Tumilasci holds an MSc. degree in Biotechnology from Sao Paulo University (Brazil) and a PhD in Microbiology & Immunology from McGill University (Montreal, Canada).  Vanessa joined THB in 2016 to manage biospecimen procurement and is instrumental in the formation of new partnerships with pharmaceutical companies and biorepositories and plays an active role in corporate development initiatives.

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. 

Nancy Zhang, MD, Associate Director, Pharmacodiagnostics, Bristol-Myers Squibb
https://www.linkedin.com/in/nancy-zhang-4b7a8740/

Commercialization of Diagnostic Tests

Savita Bagga, PhD, MBA, MD, Segment Marketing Manager, In Vitro Diagnostics, MilliporeSigma
Savita is the IVD Segment Marketing Manager at MilliporeSigma.  She did her postdoctoral training at Harvard Medical School in Boston and studied therapeutic targeting of mast cells in inflammatory diseases.  She has a Ph.D. in Molecular Biology University of Maryland and an MBA from Delhi, India.

Aldo Carrascoso, PhD, CEO, InterVenn
Aldo is the Co-Founder and CEO of InterVenn Biosciences. InterVenn combines next generation glycomics (carbohydrates), instrumentation (LC/MS) and deep machine learning to augment cancer diagnosis, biomarker and target discovery for the development of more efficacious molecular diagnostics. Venn was founded by a team of serial entrepreneurs with repeated and proven track record of success (value creation of half a billion dollars) and execution in the fields of Machine Learning, Analytical Chemistry through Liquid Chromatography / Mass Spectrometry and in Oncological Glycoproteomics.
Prior to Venn, Aldo was the Founder and COO / CTO of San Francisco based Veem (formerly Align Commerce), a next generation replacement for outdated wire and telegraphic transfer systems. Align uses the blockchain and its proprietary multi-rail systems to change the way global cross border payments are done - making the process simpler, faster and more transparent to over 60 countries. Some of the company’s investors include Kleiner, Perkins, Caufield, Byers (the same venture capital responsible for Google, Twitter, Amazon, Uber, Waze, Slack and SnapChat among others), Google Ventures, Softbank Ventures, National Australian Bank, Silicon Valley Bank Ventures, Recruit Strategic Partners, and NYCA Investment Partnership LP (led by Hans Morris, former President of Visa and Max Levchin, founding CTO of PayPal).
Prior to founding Veem, Aldo was the Founder and CTO of Jukin Technologies / Jukin Media – one of the world's largest User Generated Content (UGC) payments and licensing platforms with over 60 billion global views, 50 million platform shares and over 10 million active contributors and subscribers in 221 markets. Jukin is currently being used by some of the world’s largest television networks and production companies including ABC, BBC, CBS, Comedy Central, CNN, Discovery, ESPN, FOX, HBO, MTV, NBC, TruTV, Vh1, and hundreds of other websites, and platforms throughout the world. Jukin’s main properties include FailArmy, JukinVideo, People Are Awesome, the Pet Collective, World’s Funniest on FOX and That’s Funny! on UK's Channel 5. Samsung Investments, Bertelsmann Digital Media Investments Inc., Launchpad LA, and Maker Studios are some of Jukin’s lead investors.
Aldo is a serial entrepreneur, angel investor and technology disruptor. Prior to Jukin, he founded a number of ventures in global B2B matchmaking, international trading / finance and business process outsourcing. Aldo has an MBA in Entrepreneurship from Babson and degree in Psychology from Ateneo De Manila University.

Lucas Dennis, PhD, Director Clinical Product Development, Foundation Medicine Inc.
No biography available

Cary Gunn, PhD, Founder, CEO, Genalyte
Prior to leading Genalyte, Cary served as co-founder and chief technical officer of Luxtera, a developer of innovative optical solutions; his military career includes almost 10 years in the United States Air Force, where he was responsible for launching GPS satellites. Holding 81 (and counting) issued U.S. patents, Cary has been recognized in publications including the MIT Technology Review, which named him a Top Young Innovator in 2003. Five years later, Cary’s achievements in silicon photonics were awarded with the Optical Society of America Adolph Lomb Medal and the Berthold-Leibinger Foundation Innovation Prize. He received his bachelor’s degree in applied physics and organic chemistry from the United States Air Force Academy and his PhD in electrical engineering from the California Institute of Technology (Caltech). At Genalyte, Cary is proud to pioneer technology that has “a positive impact on life and human health.”

Mark Jacobstein, Chief User Engagement Officer, Guardant Health
Mark is the Chief User Engagement Officer at Guardant Health, and has held numerous senior executive roles in mobile software and consumer Internet companies since 1994, when he founded the world’s first online fantasy sports company, Small World Sports, as well as the first web agency in New York City. Mark was co-founder and President of Digital Chocolate, and an EVP at loopt. Most recently, Mark was CEO of mobile VoIP pioneer iSkoot before its acquisition by Qualcomm, where Mark served as Vice President of Qualcomm iSkoot Technologies. He holds a BA from Harvard University with a concentration in Computer Science.

Roger D. Klein, MD, JD, Faculty Fellow, Center for Law Science and Innovation, Sandra Day O’ Connor Law School, Arizona State University; Expert, FDA & Health Working Group Federalist Society Regulatory Transparency Project
Provide medical, scientific, and business consulting, legal services, and litigation support services in the areas of regulation, intellectual property CPT coding and reimbursement, compliance, civil and criminal fraud, toxic torts, industry analysis, and due diligence on a national basis for the genomics, biotechnology, health care, clinical laboratory, and investment industries.

Board Certified in Clinical Pathology and Molecular Genetic Pathology. Licensed to practice medicine in Ohio, Florida, and Wisconsin. Licensed to practice law in the District of Columbia and Ohio. Admitted to United States Supreme Court Bar.

Specialties: Molecular Pathology, Molecular Oncology, Molecular Hematopathology, Molecular Diagnostics, Molecular and Clinical Genetics, Coagulation, Laboratory Medicine, Evidence-Based Medicine, Personalized Medicine, Internal Medicine, Diagnostic Laboratory Regulation, In Vitro Diagnostics Regulation, Intellectual Property Law, Health Law, Biotechnology and Life Sciences Law, Medical Devices Law

Nancy Knettell, Founder, Principle, SoftwareCyber510K, LLC

Nancy Knettell, Principle, SoftwareCyber510K, LLC has over 30 years in Regulatory, Compliance, Software Development experience consulting to major IVD and Med. Device companies such as Genomic Health, BioRAD, Johnson and Johnson, and ThermoFisher Scientific.

SoftwareCyber510k helps IVD Companies rapidly install IVDR and FDA Compliant Software Quality Mgt. Systems, assist companies to Design, Develop and Test Software to those standards, plus prepares FDA 510K/PMA filing to allow commercializing of their SAMD software.

Eric Konnick, MD, MS, Assistant Professor; Associate Director, Genetics and Solid Tumors Laboratory, University of Washington
I have over 20 years of experience designing, implementing, and evaluating clinical laboratory tests using molecular biology techniques. I am currently an Acting Assistant Professor and Associate Director of the Genetics and Solid-Tumor Laboratory in the Department of Laboratory Medicine at the University of Washington. I completed my residency in Anatomic and Clinical Pathology and a Molecular Genetic Pathology Fellowship at the University of Washington. I am board certified in Molecular, Anatomic, and Clinical Pathology. I have extensive experience in interpreting next-generation sequence data for germline and somatic mutations using target-capture methods, and designed and validated the amplicon-based next-generation sequencing method currently used in the hematopathology division of Laboratory Medicine at the University of Washington.

My research involves new methods of using laboratory techniques to improve diagnostic medicine and the intersection of germline and somatic mutation detection and analysis. I am also interested in regulation of laboratory medicine and how public policy impacts the the quality of and patient access to laboratory medicine.

Joshua Krieger, PhD, Assistant Professor, Entrepreneurial Management Unit, Harvard Business School
Josh Krieger is an assistant professor of business administration in the Entrepreneurial Management Unit. Josh’s research focuses on R&D strategy and the economics of innovation. His work examines project selection decisions, R&D competition, and how firms can benefit by learning from their competitors’ failures. His current work explores how firms and research organizations adjust their R&D efforts in response to new information and resources.
Josh has a BA in economics and government from Cornell University.  He received his PhD at the MIT Sloan School of Management, where he was a recipient of the Kauffman Dissertation Fellowship in Entrepreneurship Research, and a National Bureau of Economic Research Predoctoral Fellow in the International Network on the Value of Medical Research. Prior to his doctoral studies, he worked in economic and litigation consulting at Cornerstone Research in Boston.

Alexander Sbordone, JD, OTR/L, Senior Advisor, Operations, MinuteClinic, CVS Health
Responsible for the management of operational initiatives to promote business opportunities, drive volume, revenue and improve the patient and the provider experience at 1100+ retail health clinics across 34 states. Oversee high visibility projects impacting both MinuteClinic and CVS enterprise initiatives. Lead multiple committees to evaluate all potential new vendors, partnerships and equipment to be used in the clinics. Act as the primary liaison between MinuteClinic and multiple internal CVS stakeholders, as well as external business contacts, potential partners and regulatory agencies.

Sean Scott, VP, Business Development, QIAGEN 
Sean Scott, VP, Business Development of QIAGEN Bioinformatics will lead this session exploring how the initial identification of relevant candidate biomarkers in large data sets can be used to stratify patients into different groups, and how real-world data (RWD) can be applied to develop reliable clinical trial assays using QIAGEN Genomic Insights, leveraging the recently acquired N-of-One’s robust knowledgebase to inform and optimize QIAGEN’s already exceptional technical design, regulatory expertise, and manufacturing excellence.

Heike Sichtig, PhD, Principal Investigator and Team Lead, Microbiology Devices, Center for Devices (CDRH), FDA
Dr. Heike Sichtig is a principal investigator (PI) and subject matter expert (SME) in FDA’s Office of In-Vitro Diagnostics and Radiological Health in the Division of Microbiology Devices. She directs, as sole PI, the highly collaborative effort on developing FDA-ARGOS: FDA dAtabase for Regulatory Grade micrObial Sequences. For her exceptional leadership on this project, Dr. Sichtig was awarded the Commissioners’ Special Citation award in 2016. Dr. Sichtig joined the Division of Microbiology Devices in 2012 and is primarily focused on enabling next generation sequencing (NGS) based technologies for clinical diagnostics. Dr. Sichtig leads a multidisciplinary team developing and implementing concepts for validation and evaluation of NGS-based infectious disease diagnostic devices. She obtained a B.S. / M.S. in Computer Science/Statistics from Kean University in 2002 and 2003, respectively, and a Ph.D. in Biomedical Engineering from Binghamton University in 2009. Subsequently, Dr. Sichtig completed postdoctoral training at the University of Florida/Genetics Institute in Gainesville FL in pathogen signatures, transcriptional regulation and epigenetics.

Charlie Silver, Co-Founder, CEO, Mission Bio
Charlie Silver is CEO and co-founder of Mission Bio where he leads a team dedicated to solving complex biological problems with precision engineering, innovative biochemistry, and supported bioinformatics. Charlie has dedicated his career to commercializing next-generation hardware technology and scientific instrumentation at emerging ventures in healthcare and semiconductor. Prior to Mission Bio, he led engineering at Novelx (acquired by Agilent) and then served in R&D and marketing at Agilent. Charlie received a joint MBA from UC Berkeley and Columbia University, an MS in physics from UW Madison, and a BA in physics from Columbia University.

Brad Spring, Vice President, Regulatory Affairs & Diagnostic Systems, BD Diagnostics
Experienced Vice President Regulatory Affairs and Program Manager with demonstrated success in the in vitro diagnostic industry. Skilled in leading cross functional teams to develop global regulatory strategies, lower development costs, reduce time to market and create competitive advantage.

Tim Stenzel, MD, PhD, Director, Office of in vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health, U.S. Food and Drug Administration
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 MD and PhD, 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.

Larry K. Wray, PhD, Wray IVD Consulting
R&D Executive - in vitro diagnostics (IVD). Broad and deep understanding of the diagnostics sector and emerging technology. Experience with both early stage and established companies. Accomplished at both strategic and tactical elements in commercializing technology. Global multicultural management experience.

My passion is identifying and commercializing disruptive technologies to improve healthcare, including greater efficiencies and effectiveness through precision medicine. I have a successful track record of developing innovative strategies and building and leading effective global organizations which execute on bringing products to market with reduced cycle time, while meeting high standards for quality, compliance, and manufacturing, providing a competitive edge. This has resulted in over 100 product launches in both developed and emerging markets.

Products and services launched include immunoassays, molecular diagnostics, and mass spectrometry, with applications to a wide range of medical conditions.

Specific areas of expertise include: building and leading R&D organizations, new technology assessment and due diligence, opportunity assessment and strategy development, IVD and life science product development, design control, quality systems, manufacturing process development and supply chain, project and program management, external partnerships, internal and clinical studies supporting regulatory submissions and reimbursement.