Scott Berry is President and a Senior Statistical Scientist at Berry Consultants, LLC. He earned his MS and PhD in statistics from Carnegie Mellon University and was an Assistant Professor at Texas A&M University before co-founding Berry Consultants in 2000. His primary interests are in Bayesian Analysis, Design of Innovative Trials, Platform Trials, Clinical Trial Simulation, and Hierarchical Modeling.

Abby Bronson is the Vice President of Patient Advocacy and External Innovation at Edgewise Therapeutics where she leads patient advocacy and external relationships within the Muscular Dystrophy community. Previously she was Senior Vice President of Research Strategy at PPMD, focusing on Duchenne Muscular Dystrophy. She has experience from a variety of areas, including NIH, Children's National Medical Center and MedImmune. She holds an MBA from the Wharton School of Business at the University of Pennsylvania and a BA from the University of Vermont.

Craig Lipset is an advisor, educator, advocate and innovator focused on novel solutions for clinical trials and medicine development. He is the founder of Clinical Innovation Partners, providing advisory and board leadership with pharma, tech and investors. Craig is Co-Chair for the Decentralized Trials & Research Alliance and Vice President of the Foundation for Sarcoidosis. He is Adjunct Assistant Professor in Health Informatics at Rutgers University, and serves on the Advisory Council for HL7 Project Vulcan and External Stakeholder Board for IMI Trials at Home. Craig was previously the Head of Clinical Innovation and Venture Partner at Pfizer, and on the founding management teams for two successful startup ventures.

Lisa LaVange, PhD, is Professor and Chair of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill and former director of the department’s Collaborative Studies Coordinating Center (CSCC). From 2011 to 2017, Dr. LaVange was director of the Office of Biostatistics in the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry. Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and was the 2018 ASA President.

Daniel Millar leads Strategic Business Transformation in Quantitative Sciences at Janssen R&D. He is an advocate for utilizing quantitative innovation to advance patient-centric R&D while simultaneously delivering transformational efficiencies. Daniel is a founding leader and champion for multi-stakeholder engagement in the recently launched Innovative Medicines Initiative (IMI) public-private partnership for Integrated Research Platforms. Daniel obtained a MBA from the University of Chicago Booth School of Business and a BA in Mathematics from the University of Pennsylvania. He lives in Manhattan and enjoys traveling. His current “country number” is 115.

Dr. Janet Woodcock began her long and distinguished FDA career in 1986. In 1994, Dr. Woodcock was named Director of the CDER. In that position, she has led many of the FDA’s groundbreaking drug initiatives. In 2020 Dr. Woodcock was asked to lend her expertise to “Operation Warp Speed” the initiative to develop therapeutics in response to the pandemic. Dr. Woodcock was named Acting Commissioner of Food and Drugs on January 20, 2021-February 17, 2022. Dr. Woodcock is now the FDA's Principal Deputy Commissioner. In this role she works closely with the Commissioner of Food and Drugs to develop and implement key public health initiatives and helps oversee the agency’s day-to-day functions.

Dr. Lewis is Professor and former Chair in the Department of Emergency Medicine at Harbor-UCLA Medical Center and the Senior Medical Scientist at Berry Consultants, with expertise in the design and oversight of adaptive and platform clinical trials. He is a member of the National Academy of Medicine, and a prior member of the Board of Directors for the Society for Clinical Trials, and the Blood Products Advisory Committee of the FDA/CBER. He has served as a member of the Medicare Evidence Development & Coverage Advisory Committee for CMS and chaired numerous data and safety monitoring boards (DSMB). He has authored or coauthored over 270 original research publications, reviews, editorials, and chapters.

Dr. Victoria Manax is the Chief Medical Officer of the Pancreatic Cancer Action Network. She provides strategic direction and operational oversight to the organization’s high-priority clinical and medical initiatives, with emphasis on the Precision Promise initiative and its Clinical Trial Consortium. She works closely with cancer research institutions and biopharmaceutical companies to build a productive and collaborative team that will accelerate progress to improve patient outcomes. Dr. Manax joined PanCAN after holding many leadership positions in the pharmaceutical industry. Her areas of interest include drug development, precision medicine strategy, and innovative clinical trial design.

Donald Berry is a professor in the Department of Biostatistics of the University of Texas M.D. Anderson Cancer Center. He has held endowed faculty positions at Duke University and at M.D. Anderson. Dr. Berry has authored over 400 publications. He is listed by ScienceWatch.com as one of The World’s Most Influential Scientific Minds in Clinical Medicine in 2014. Through Berry Consultants he has designed innovative clinical trials in all therapeutic areas for industry and international consortia.

Amy Burd, Ph.D., is vice president of research strategy for The Leukemia & Lymphoma Society. Dr. Burd first began working with LLS in 2009 as senior director of LLS’s Therapy Acceleration Program. In her current role, Dr. Burd provides strategic planning and oversight for mission special initiatives. She also leads LLS’s Beat AML initiative, a significant multi-institution collaboration to change the paradigm of treatment and improve outcomes for patients with acute myeloid leukemia (AML).

Dr. Buxton is CEO of Global Coalition for Adaptive Research (GCAR), a nonprofit organization founded to expedite the discovery and development of treatments for patients with rare and deadly diseases, and home of several Phase II/III adaptive platform trials for drug registration. Dr. Buxton has been involved in clinical research and drug development for over 20 years. She has been instrumental in the establishment of numerous innovative clinical research programs, with extensive experience in building and running master protocols. Focused on efficient approaches to the design and execution of clinical trials, Dr. Buxton brings expertise in scientific and operational implementation, regulatory strategy, and partnership development.

Karen received her Ph.D. in Statistics from Baylor University in 2001, and joined Eli Lilly and Company at that time. She is currently Research Fellow at Eli Lilly and Company where she leads the Statistical Innovation Center, a team that focuses on innovative design and analysis of clinical trials. In 2011, Karen helped form and led the DIA Bayesian Scientific Working Group and currently serves as past-chair. This group includes members in Industry, Regulatory, and Academia. Her research interests include Bayesian design and analysis of clinical trials and master protocols. In 2016, Karen was elected a Fellow of the American Statistical Association.

Dr Gideon Blumenthal is a medical oncologist who is currently Deputy Center Director of the Oncology Center of Excellence at the U.S. FDA. He has extensive expertise in thoracic malignancies, previously serving as clinical team leader for thoracic malignancies and head and neck cancer and was an associate investigator in the thoracic oncology clinic at the National Cancer Institute. His interests include studying biomarkers and novel trial designs to expedite oncology drug development. In 2018, he was awarded the ASCO public service award.

Mark Fitzgerald is a biostatistician with Berry Consultants, where he is a lead developer of FACTS – a suite of clinical trials simulation software. He has been active in the development of disease progression modeling for use as an endpoint in clinical trials. He has been involved in modeling and simulation for the EPAD project for the last three and a half years.

Dr. Price is the Deputy Director of the Office of Biostatistics. In her role at FDA, she promotes collaborative efforts to advance the use of complex innovative trial designs. An invited speaker at conferences world-wide, she has served as Chair of ASA’s Biopharmaceutical Section and on the Regional Committee of the Eastern North American Region of IBS. She is a Fellow of the ASA and the President-Elect of the ASA. With an MS in Biostatistics from UNC, and PhD from Emory, her research interests focus on clinical trial designs. She has co-authored papers in Statistics in Medicine, Clinical Trials, and Statistics in Biopharmaceutical Research.

Karen Xia received her Ph.D. in statistics from Michigan State University in 2002. After working at Purdue pharma for three years, she joined Johnson & Johnson in 2005. Karen’s clinical trial experience spans from phase 0 through phase 4. She has covered a broad spectrum of indications, such as pain, lupus, T1D, T2D, asthma, COPD, RA, PsA, psoriasis, atopic dermatitis, and inflammatory Bowel Disease(IBD). Her current position is the immunology lead of translational medicine and early development statistics. Since 2016, Karen has led and supported the statistics activities of the Crohn’s Disease platform study of Janssen.