Panelists

Michael Mckeown

Biotech scientist, entrepreneur, and scientific advisor in the cancer therapeutics space specializing in targeted therapies and biomarker/mechanism guided development.

Dhvanit Shah

Dhvanit Shah is the Founder, President, and CEO of Garuda Therapeutics, which seeks to eliminate the dependency on donor or patient cells for blood stem cell transplants entirely. Prior to founding Garuda, Dhvanit previously served as Principal Faculty of Harvard Stem Cell Institute, Associate Member of the Broad Institute of MIT and Harvard, and Principal Investigator at Brigham and Women’s Hospital.

Craig Lipset

Craig is Co-Founder and Co-Chair of the Decentralized Trials & Research Alliance, a global non-profit organization dedicated to the adoption of more accessible clinical research participation. He is Adjunct Assistant Professor in Health Informatics at Rutgers University, and an Adjunct Instructor at the University of Rochester Center for Health + Technology.

Craig serves on the Board of Directors as Vice President for the Foundation for Sarcoidosis Research, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science. He is an external advisor to EveryCure, IMI Trials at Home, HL7 Project Vulcan and the Duke i-Cubed Innovation Center.

As Managing Partner of Clinical Innovation Partners, Craig is an advisor to technology and biopharmaceutical companies, leading universities, and the venture community seeking to develop and implement innovative solutions for clinical research. He serves on the Board of Directors for Circuit Clinical, EmPath Labs, and MedVector. For nearly a decade Craig was the Head of Clinical Innovation at Pfizer, leading digital initiatives, patient engagement and collaborations across all therapeutic areas around the globe.

Moderator

Lynn Huynh, Ph.D, MPH, MBA

Vice President at Analysis Group, Inc.

Dr. Huynh, Vice President at Analysis Group, Inc., received a DrPH in Epidemiology, an MPH in Epidemiology and Biostatistics from Johns Hopkins Bloomberg School of Public Health; an MBA with a concentration in Health Economics from Johns Hopkins Carey Business School; and a BA in Chemistry from Harvard University. Dr. Huynh specializes in epidemiologic methodologies and health economics and outcomes research and has extensive experience collecting real-world clinical data through medical charts using center-based and physician panel-based approaches. She has conducted comparative effectiveness and cost-effectiveness research on various diseases, including aplastic anemia, asthma, chronic lymphocytic leukemia, chronic myelogenous leukemia, colorectal cancer, dry eye disease, dysfunctional uterine bleeding, epilepsy, hemophilia, hepatitis B, HIV, inflammatory bowel disease, lung cancer, metachromatic leukodystrophy, myelofibrosis, multiple sclerosis, neuroendocrine tumors, non-Hodgkin’s lymphoma, primary open-angle glaucoma, renal cell carcinoma, sickle cell disease, and thromboembolism. Dr. Huynh has experience designing and developing case report forms, coordinating with clinical centers for data collection, developing discrete choice experiment surveys, designing quality of life and humanistic burden surveys, leading qualitative interviews, performing mixed methods research, performing systematic literature reviews, analyzing longitudinal cohort studies, and developing discrete event simulation models and economic evaluations. She has been involved in conducting several real-world evidence studies to examine the natural history of disease progression in order to contextualize the results of single-arm trials in support of regulatory new drug application (NDA) or supplemental NDA submissions.