SC8: Generating Evidence and Creating a Winning Dossier for Regulatory and Reimbursement Needs

WEDNESDAY, AUGUST 21 | DINNER, 6:45–9:15 PM

Arlington

John Sninsky, PhD, Consultant, Translational Sciences

Melina Cimler, PhD, CEO & Founder, PandiaDx

Shivang Doshi, Director, Boston Healthcare Associates, Inc.

Mark Hiatt, MD, Vice President, Guardant Health

ABOUT THIS COURSE:

Managing the clinical narrative for your diagnostic test requires judicious selection of the intended use, applicable statistical analysis and careful evaluation of the evidentiary requirements of stakeholders. Using clinical-grade tests and evidentiary requirements to determine clinical and economic study designs is the cornerstone of effective product development.

WHAT YOU WILL LEARN:

• Intended use: the first objective
• Clinically relevant diagnostic statistics
• Analytical Validity, Clinical Validity, Clinical Utility
• Diagnostic clinical trials: design, execution, reporting and publishing (the supportive evidence continuum)
• Health economic implications
• Creating a dossier for coverage and regulatory approval (emphasis on strategies and tips)

6:45 pm Course Introduction and Discussion

7:15 Dinner Break

7:30 Course Discussion and Examples

9:00 Q&A

9:15 Close of Course

INSTRUCTOR BIOGRAPHY:

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.

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.

Shivang Doshi, Director, Boston Healthcare Associates, Inc.

Shivang Doshi has worked with a variety of pharmaceutical and diagnostics clients on issues related to market access, evidence development, and reimbursement strategies of novel diagnostic technologies. His specific areas of expertise include value-based molecular assays, companion diagnostics, and informatics tools that support the delivery of precision medicine.

Mr. Doshi’s prior experiences include cancer drug discovery at Novartis Institutes for Biomedical Research and global health policy at the Dana Farber Cancer Institute.

Mr. Doshi has a Master of Public Health from Harvard School of Public Health and a Master’s degree in Biotechnology from Johns Hopkins University.

Mark Hiatt, MD, Vice President, 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.