Medpace and Medidata imaging experts will discuss the role of Quantitative Imaging Biomarkers in clinical trials. The value of quantitative image analysis in early phase drug discovery is apparent in providing surrogate biomarkers for trials across therapeutic areas. Imaging is often part of eligibility assessment for patients as well as an endpoint for making go-no-go decisions about investigational products. Quantitative image analysis is needed to generate imaging biomarkers from patient images acquired at participating sites. Several examples of quantitative imaging biomarkers will be illustrated during the presentations including:

• Oncology Progression Criteria: RECIST and other measures
• Neuroscience trials based on volumetric brain mapping
• Non-Alcoholic Steato-Hepatitis (NASH) therapeutic trials using Proton Density Fat Fraction measured by MRI (MRI-PDFF) mapping of the liver

Each of these indications and imaging biomarkers present unique challenges to clinical trial management and execution. Experts discuss Medidata and Medpace seamless solution that facilitates image data management and quantitative analysis of patient imaging data for reporting of safety and efficacy endpoints to regulatory authorities.

Featured Speakers

Andrea Falkoff Director, Clinical Imaging Delivery Medidata, a Dassault Systèmes company

Andrea Falkoff is Director of Clinical Imaging Delivery, responsible for ensuring smooth implementation of our Rave Imaging platform. Andrea works directly with customers and internal stakeholders to ensure best practices are applied across imaging and event adjudication trial builds. Andrea joined Medidata from WorldCare Clinical, where she led the operations team, ensuring quality delivery of Imaging and Event Adjudication trials for pharmaceutical, biotech and medical device companies. She has more than 14 years of experience working for various imaging core labs and a proven track record for customer satisfaction and quality delivery. Andrea earned a BS in microbiology from Umass Amherst and a Master’s in Business Administration from Boston University.

Richard Scheyer, MD Vice President, Medical Department, Neurology, Pharmacology Medpace

Dr. Richard Scheyer is a board certified neurologist with over 30 years of professional medical experience which includes 20 years dedicated to clinical drug development. He is a pioneer in translational medicine and Phase I/II drug development, with special interest in early demonstration of clinical efficacy. Dr. Scheyer received his B.S. in Physics from Stanford University, his M.D. from The State University of New York, Upstate Medical University, and completed residency training in Neurology and fellowship training in Epilepsy and Clinical Pharmacology at Yale University before joining the Yale faculty, serving as Associate Professor of Neurology. Prior to joining Medpace, Dr. Scheyer held a number of leadership roles at biopharmaceutical firms where he was responsible for clinical, biomarker, and pharmacogenomic strategy and execution for more than 70 development candidates across therapeutic areas. Experience includes small molecule, macromolecular, and genetic therapies for common and rare neurologic disease.

Lyon Gleich, FACS Vice President, Medical Department, Hematology and Oncology Medpace

Dr. Lyon Gleich is board certified in otolaryngology and has provided medical leadership over Medpace’s oncology division for more than 12 years. He has extensive expertise in new drug development, biologic therapy development, gene therapy development, and multi-cytotoxic agent studies. Previously, Dr. Gleich was a Professor, Department of Otolaryngology at the University of Cincinnati; Associate Professor, Department of Otolaryngology – Head and Neck Surgery; and Director of Resident Research, Department of Otolaryngology. He is an active member of ASCO and ASH, as well as a key opinion leader with numerous publications in the field of hematology and oncology. He earned a Doctor of Medicine from State University of New York and completed his fellowship in Oncology at the University of Cincinnati.

Piotr Krzeski, MD, PhD, FFPM Senior Medical Director, Medical Department, Gastroenterology and Hepatology Medpace

Dr. Piotr Krzeski is an internist with a broad background in pharmaceutical research. He has over 19 years of experience in clinical drug development, with global expertise in the design and medical oversight of clinical trials in the area of gastroenterology and hepatology including NAFLD and NASH. Dr. Krzeski completed his internal medicine training at the Gastroenterology Department at the Warsaw Postgraduate Centre in Poland. He earned his PhD in Hepatology. Dr. Krzeski is recognized in the field for his contribution to the pioneering work on standardization of central imaging in drug development.