MD: Harvard Medical School 1973; Internal Medicine--Mass General Hospital 1973-75; Medical Oncology and Clinical Pharmacology Fellowship--NCI, Bethesda, MD 1975-78; Chair, Medical Oncology, City of Hope Cancer Center 1981-2004; Director, NCI Division of Cancer Treatment and Diagnosis, 2004-Present

Sumimasa Nagai, M.D., Ph.D. is Deputy Director of the Translational Research Center at the University of Tokyo Hospital. He received his M.D. from Faculty of Medicine, the University of Tokyo in 2003 and his Ph.D. from Graduate School of Medicine, the University of Tokyo in 2010. Before he joined PMDA as Clinical Reviewer at Office of New Drug V (Oncology) in 2011, he spent most of his career as a physician at Department of Hematology and Oncology, the University of Tokyo Hospital.

Bray was the Director of Strategic Partnerships at Evidation Health. She develops collaborations to support the design and implementation of participant-centered studies and measures, and serves on the All of Us National Advisory Panel and the Digital Medicine Society Scientific Leadership Board. Previously, Bray served on the National Academies of Sciences, Engineering, and Medicine (NASEM) Health Science Policy Board, led engagement for the Duke Clinical Research Institute Project Baseline Study Coordinating Center, and served as co-chair on the Advisory Committee to the NIH Director that authored the Precision Medicine Initiative's Cohort Program. Bray holds a BS degree from the University of Georgia and MFS from National University.

Jeff Allen, Ph.D. serves as the President and CEO of Friends of Cancer Research (Friends). During the past 25 years, Friends has been instrumental in the creation and implementation of policies ensuring patients receive the best treatments in the fastest and safest way possible. As a thought leader on many issues related to Food and Drug Administration, regulatory strategy and healthcare policy, he is regularly published in prestigious medical journals and policy publications, and has contributed his expertise to the legislative process on multiple occasions. Dr. Allen received his Ph.D. in cell and molecular biology from Georgetown University, and holds a Bachelors of Science in Biology from Bowling Green State University.

Shayesteh Fürst-Ladani is the CEO and founder of SFL Group of Companies. Shayesteh has been involved in reviewing and assessing the impact of EU and US legislation, such as the Cell & Tissue Directive, the ATMP Regulation, the Orphan Medicinal Product Regulation, Drug & Device Combination Products and Personalized Medicine. Shayesteh is President of the “Rare Disease Action Forum” (RDAF) as well as the “Medtech & Pharma Platform” (MPP) Associations. Shayesteh is Special Coach at Innosuisse, Adjunct Instructor for Regulatory Affairs at the George Washington University as well as Lecturer at IFPMA/Kings College. Before founding SFL, Shayesteh hold senior positions in various biotech and major pharmaceutical companies.

Dr. Leptak joined FDA in 2007 as a Medical Officer in the GI division, focusing on immunomodulators for inflammatory bowel disease. He became OND's Biomarker and Companion Diagnostic Lead in 2010. Since 2017, he has served as Director of CDER's Biomarker Qualification Program. Chris joined Greenleaf in 2021, bringing 14 years of FDA regulatory experience to his role as Senior Vice President of Drug and Biological Products. He specializes in the regulatory use of novel clinical endpoints, including surrogates for both traditional and accelerated marketing approval.

Maria Orr is currently Head of Precision Medicine for Biopharmaceuticals in AstraZeneca. In this role she leads the delivery of precision medicines and their associated companion diagnostics for drugs across a diverse range of therapeutic areas including cardiovascular, renal, metabolism (CVRM), respiratory and immunology (R&I), microbial science and neuroscience. Maria has extensive experience in the field of precision medicine and companion diagnostic development. She has contributed to the successful launch of three personalised treatments in oncology and the delivery of over 30 companion diagnostic assays to the market to date.

John Piccone currently leads the Watson Health offerings for life sciences at IBM. In this role, he defines the analytics and cognitive solutions that Watson Health is offering to it’s pharmaceutical, biopharma, medical device and biotech clients. The current focus of his work is developing Real World Evidence solutions to identify unmet medical need, differentiate therapeutic alternatives and personalize therapies for individual patients.

Mike Benecky joined GSK in October 2011 as Senior Director, Global Regulatory Affairs in located in Research Triangle Park, North Carolina. Mike is a Subject Matter Expert in the Regulatory Aspects of Digital Medicine. Successful projects at GSK included launch of the MyAsthma mobile medical device app in the UK, execution of the PARADE Virtual Clinical Study in Rheumatoid Arthritis Patients and implementation of digital adherence technology within respiratory medicine clinical trials. In April 2020, Mike joined UCB as a Senior Director, Global Regulatory Affairs where he provides regulatory strategy for UCB Teams seeking to implement wearable sensor technology in clinical trials.

Scott McGoohan is Director of US Regulatory Policy and Intelligence at Vertex Pharmaceuticals. Before joining Vertex, Scott served as Director of Science and Regulatory Affairs at the Biotechnology Innovation Organization, where he led an array of regulatory policy activities related to the development and review of biopharmaceutical products. Prior to joining BIO, Scott managed regulatory, reimbursement and scientific policy for the American Clinical Laboratory Association.

Doug received his PhD from North Carolina State University in 2003 in Statistical Genetics. He worked at BMS for 5 years and moved to Novartis in 2009 where he is now a Senior Director and Global Head of the Biomarkers and Diagnostics Biometrics team in Oncology. He manages a team of bioinformaticians and biomarker and diagnostics statisticians who analyze biomarker data from clinical trials with the hope of developing companion diagnostics which may then facilitate patient selection strategies.