Master Protocol Workshop
Scott M Berry, PhD, MS
- President and Senior Statistical Scientist
- Berry Consultants LLC, United States
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, MBA
- Senior Vice President of Research Strategy
- Parent Project Muscular Dystrophy , United States
Abby Bronson is the Senior Vice President of Research Strategy at Parent Project Muscular Dystrophy where she develops research strategies and tools that will accelerate drug development in the Duchenne space. She brings experience from a variety of areas, including industry, academic medical centers and NIH. Previously, she was responsible for Director of Operations at the Division of Clinical Innovation at the National Center for Accelerating Translational Science at NIH. Previous to that she was Manager of Special Projects at Children’s National Medical Center. 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, MPH
- Former Head of Clinical Innovation
- Pfizer, United States
Craig Lipset has led at the intersection of patient engagement, personal health data, and accelerating clinical research. He created and led Clinical Innovation at Pfizer, developing and scaling “first in industry” approaches to improving patient experience and innovative data capture. He served on the founding Operations Committee of TransCelerate. Craig serves on the Boards for the Foundation for Sarcoidosis Research, the MedStar Health Research Institute, and the People-Centered Research Foundation (with responsibility for the PCORnet national health data network). Craig also serves on the Editorial Board for Therapeutic Innovation and Regulatory Science. Views expressed are my own and do not represent the above organizations.
Lisa M. LaVange, PhD
- Professor and Associate Chair, Department of Biostatistics
- University of North Carolina at Chapel Hill , United States
Lisa LaVange, PhD, is Professor and Associate Chair of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill. She is also 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, MBA
- Senior Director, Strategic Business Transformation Quantitative Sciences
- Janssen Research & Development, United States
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 102.
Janet Woodcock, MD
- Director, Center for Drug Evaluation and Research (CDER)
- FDA, United States
Janet Woodcock is Director of the Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). In 2015, Dr. Woodcock also assumed the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ). Dr. Woodcock first joined CDER in 1994. For three years, from 2005 until 2008, she served FDA’s Commissioner, holding several positions, including as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer. Her responsibilities involved oversight of various aspects of scientific and medical regulatory operations.
Roger J. Lewis, MD, PhD
- Professor of Medicine, Department of Emergency Medicine
- Harbor UCLA Medical Center, United States
Dr. Lewis is Professor and Chair in Emergency Medicine at Harbor-UCLA Medical Center and the Senior Medical Scientist at Berry Consultants, with expertise in the design and oversight of adaptive clinical trials. He is a member of the National Academy of Medicine, the Board of Directors for the Society for Clinical Trials, and the Blood Products Advisory Committee of the FDA. 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) for both federally-funded and industry-sponsored clinical trials. He has authored or coauthored over 240 original research publications, reviews, editorials, and chapters.
Victoria Manax Rutson, MD
- Chief Medical Officer
- Pancreatic Cancer Action Network, United States
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 initiatives, with emphasis on the Precision Promise initiative and its Clinical Trial Consortium. She works closely with clinical cancer research institutions and biopharmaceutical companies to build a productive and collaborative team that will accelerate progress toward the goal to double pancreatic cancer survival by 2020. Dr. Manax joined the Pancreatic Cancer Action Network in 2016 from Celgene Corporation, most recently serving as their executive medical director and gastrointestinal therapeutic lead in Medical Affairs.
Donald A Berry, PhD
- Professor, Department of Biostatistics
- M.D. Anderson Cancer Center, United States
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, PhD
- Vice President, Research Strategy
- Leukemia & Lymphoma Society, United States
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).
Meredith Buxton, PhD, MPH
- Chief Operating Officer
- Global Coalition For Adaptive Research, United States
Meredith provides operational leadership for the Global Coalition for Adaptive Research (GCAR), a nonprofit research organization founded to expedite the discovery and development of cures for patients with rare and deadly diseases, and home of GBM AGILE, an international, seamless Phase II/III response adaptive randomization platform trial in glioblastoma. Before joining GCAR, Meredith was Director of Clinical Trial Strategy at Berry Consultants, providing strategic guidance for master protocols/platform trials. Previously, Meredith was an assistant professor at the University of California, San Francisco and served as Executive Director of the I-SPY TRIALs Consortium, innovative platform trials for locally advanced breast cancer.
Karen Lynn Price, PhD, MA
- Senior Research Advisor, Statistical Innovation Center
- Eli Lilly and Company, United States
Karen received her Ph.D. in Statistics from Baylor University in 2001, and joined Eli Lilly and Company at that time. She is currently Senior Research Advisor 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.
Gideon M. Blumenthal, MD
- Deputy Director Oncology Center of Excellence
- FDA, United States
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, PhD
- Statistical Scientist
- Berry Consultants LLC, United States
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.
Dionne Price, PhD
- Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER, FDA
- FDA, United States
Dr. Price is the Director of the Division of Biometrics IV providing leadership of analytical assessments in a regulatory setting. On the Senior Leadership Team and Statistical Policy Council, Dr. Price 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 an elected VP. 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.
Yichuan Xia, PhD
- Johnson&Johnson, United States
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.