Megan Doyle is an attorney and policy professional with 15 years of experience in the regulation of drugs, medical devices, combination products, and in vitro diagnostics. She received her law degree from Georgetown University Law Center and her master’s degree in public health from Johns Hopkins University. After seven years in the medical device practice at Hogan Lovells, she joined Amgen as a Senior Counsel for Health Regulatory. For four years, she counseled Amgen on drug, device, combination product, digital health, and companion diagnostic matters. Currently, she is a Director in Amgen’s Global Regulatory and R&D Policy group, where she is the Global Policy Lead for Oncology and Medical Device-related matters.

Matthew Diamond, MD, PhD is the Chief Medical Officer for Digital Health at FDA's Center for Devices and Radiological Health (CDRH), where he is the senior clinical expert and focal point of contact for digital health medical devices and related clinical issues. In his role at FDA, Dr. Diamond oversees digital health policy development and implementation for emerging technologies including artificial intelligence and medical device software. Since March 2020, Dr. Diamond has been a leader on CDRH’s COVID-19 response team.

Anindita (Annie) Saha is the Associate Director for Strategic Initiatives for the Digital Health Center of Excellence (DHCoE) at the Food and Drug Administration (FDA). She is leading strategic initiatives in moving care into the home, Artificial Intelligence, and international collaborations for the DHCoE to advance health equity. This includes the use of patient-generated data and managing bias in DHTs and improve transparency. Additionally, Annie helped incubate and continues to support to advance the science and adoption of patient input as evidence, including patient preference information (PPI), clinical outcome assessments (COAs). Previously, Annie was the Director of the Partnerships team in CDRH.

Jeffrey Siegel is the Director of the Office of Drug Evaluation Sciences (ODES) in the Office of New Drugs (OND), CDER, FDA. ODES oversees Clinical Outcome Assessments, Biomarker Qualification, Research and Bioinformatics in OND. Dr Siegel has over 20 years of experience in research, regulatory, and clinical drug development. Jeff received his B.A. from Columbia University and M.D. from Yale University. Following his training in internal medicine and basic science research, he served at FDA from 1996-2010 as a medical officer and then Medical Team Leader. In 2010, he left FDA for industry and worked at Genentech/Roche and subsequently at Gilead Sciences before rejoining FDA in February, 2021.

Beth Kunkoski currently works in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP). She oversees several projects involving digital health technologies and electronic records and storage in clinical investigations. She worked for 15 years in the Center for Devices and Radiological Health (CDRH) in guidance document development and as a branch chief overseeing the review of orthopedic devices. She earned a Master’s Degree in Biomedical Engineering and a Bachelor’s Degree in Chemical Engineering from the University of Michigan.

Imein Bousnina, Pharm.D, is a Program Director of U.S. Regulatory Policy at Genentech, a member of the Roche Group. Imein trained as a pharmacist and holds an MSc in International Regulatory Affairs. Over her 8 years at Roche-Genentech, she has specialized in FDA's regulation of New Alternative Methods, digital health (including Software as a Medical Device and Digital Health Technologies used in drug development), rare disease drug development, and companion diagnostics. She actively engages in several external groups including BIO, PhRMA, EveryLife Foundation for Rare Diseases, NORD, DiMe, and PMC among others, and serves in leadership roles on some of their taskforces.

As Director of EU Regulatory Policy at Biogen, Simon is responsible for developing and leading Biogen’s European regulatory policy agenda and associated activities. Simon started at Biogen in 2003 in the clinical group before moving into Regulatory Sciences and undertaking increasingly senior roles across regulatory product development and lifecycle management. He has been working in regulatory policy since early 2016. Prior to joining Biogen, Simon worked in medical communications in different therapeutic areas. He is a biologist by training with an MSc in medical parasitology.