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.

Michelle Detry, PhD, is the Director of Adaptive Trial Execution and a Senior Statistical Scientist for Berry Consultants. Dr. Detry’s expertise is in the implementation of adaptive clinical trials, including platform trials. As part of her role in implementing Berry Consultant’s trial designs she is a member of numerous statistical analysis committees that conduct the interim analyses. In addition, she has expertise in clinical trial design, reporting for Data Monitoring Committees, and also serves on Data Monitoring Committees.

Dr. Freda Cooner is currently a Senior Director in Eli Lilly and Company. Prior to that, she is a Statistics Director in Amgen, leading the prostate cancer statistics program and exploration of innovative designs for several oncology and non-oncology products, including master protocols and seamless trials. Before joining Amgen late 2018, she was an associate director in Sanofi leading several diabetes products and studies. Prior to Sanofi, Dr. Cooner worked in FDA for over 10 years, where she reviewed hundreds of products in multiple therapeutic areas and led several working groups. She obtained her Ph.D. in Biostatistics from School of Public Health, University of Minnesota.

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).

Terry Katz is Sr Dir of Biostatistics and DM Planning and Functional Excellence at Daiichi Sankyo. Previously he was Head of Global Data Management and Statistics at Merck Animal Health, Head of Biometrics at ImClone Systems, Senior Manager of Analysis & Reporting for PRA, and a Statistician at Schering-Plough. He holds Accreditation as a Professional Statistician, and Certifications as a Quality Engineer and in Six Sigma. He is Chair of DIA's GCP-QA Community, on the Core Committee for NJ CDISC User Group, and former Chair of Statistical Taskforce for the Animal Health Institute. Terry recently completed a 3 month Fellowship in Kenya to improve capacity to run oncology clinical trials.

Yi Liu is Vice President of Biometrics at Nektar Therapeutics leading Biostatistics and Statistical Programming functions. Prior to that, she lead the statistical methodological group at Takeda designing and implementing innovative designs in multiple pivotal trials. Her research interests include multiple comparisons, adaptive designs, and issues with efficacy estimands for time-to-event endpoints. She is in the leadership team of the DIA Innovative Designs Scientific Working Group.

May Mo is an Executive Director of Biostatistics and the Head of Design and Innovation (D&I) group within the Center of Design and Analysis (CfDA) at Amgen. In her role, she leads an internal statistical consulting team with Directors of Statistical Innovation and Modeling and Simulation statisticians to provide strategic consultation and analytic expertise to product teams and promote innovative clinical trial designs and enable simulation-guided development program planning. May has many years of drug and device development experience across disease areas including oncology, hematology oncology, inflammation, neurology and nephrology.

Dr. Veronica Bubb is the Vice President of Operations and Consulting Statistician at Advance Research Associates. In her role, she utilizes her academic expertise and her industry experience as a statistician to advise clients on the implementation of innovative trial designs, data collection, and reporting of clinical trial results. Dr. Bubb approaches clinical trials from a synergistic and interdisciplinary perspective to achieve operational excellence across all facets of trial design and execution through collaboration with sponsors, vendors, and regulatory agencies across the pharmaceutical, biotech, medical device, and medical diagnostic industries.

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.

Terri has over two decades of drug development experience, starting at Covance Laboratories. In 1998 she joined Eli Lilly and held positions in Clinical Development, Project Management, IT and Operational roles, including Sr. Director for Immunology Clinical Development, Sr Director & COO of Chorus, COO for Global Patient Safety and the Clinical Design Hub. In 2013, Terri joined Abbvie as the Global Head of Immunology Clinical Operations where she led the Humira clinical operations franchise expansion to products such as Skyrizi and Rinvoq. Terri rejoined Eli Lilly in 2018, and is currently the Associate Vice President/COO, Clinical Design and Development. She earned her BS from Purdue University and MBA from the University of Indianapolis.

Pritibha Singh, a leader at Novartis data42, brings 17 years of global experience spanning Switzerland, Germany, the United Kingdom, Australia, and New Zealand with extensive cross-sector experience (Tech space, Pharmaceutical, Biosimilar, Academia, FMCG, and Banking). Her expertise covers diverse therapeutic areas, including Cardiovascular, Diabetes, Neuroscience, Respiratory, Oncology, Immunology, and Hematology, with a comprehensive background in discovery, development, and late-phase. A blend of expertise in Drug Development (Psychology, Statistics, and Business). Currently pursuing a Doctorate (Dr. sc. ETH Zurich), specializing in sustainable strategies for decentralized clinical trials.

Peter Stein, MD, is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters. A nationally-recognized leader in pharmaceutical research and development, Dr. Stein joined CDER in 2016 as the OND Deputy Director. Before coming to FDA, he served as Vice President for late stage development, diabetes, and endocrinology at Merck Research Laboratories.

Rui (Sammi) Tang, PhD is currently the VP, Global Head of Biometric Oncology, leading Global biostatistics, statistical Programming and US Medical Writing Departments at Servier Pharmaceuticals US. Her research interests are primarily in adaptive clinical trial design and statistical issues in precision medicine. She authored more than 40 articles in peer-reviewed scientific journals on methodology, study design, data analysis and reporting and is a co-inventor of several patents. She is a co-founder of DahShu, a non-profit organization, founded to promote research and education of 5000 members. She is an active member in ASA and ICSA.

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.

Robert Beckman, M.D. is an oncology clinical researcher and biomathematician focused on improving the way cancer therapies are developed and utilized. He has co-invented novel clinical strategies for proof of concept studies, basket trials, and biomarker driven clinical development, as well as novel therapeutic strategies incorporating tumor evolution. In a previous 18 year industry career, he played leadership roles in forming 4 oncology clinical research groups. He has contributed approximately 300 published articles, book chapters, and presentations, emphasizing quantitative approaches to basic and applied oncology, including a recent book on master protocols. He currently leads the DahShu Innovative Design Scientific Working Group.

Douglas Drake, MS, MBA, is originally a life science researcher with a passion for digital enablement of better patient care. With over 30 years of experience working in various aspects of diagnostics, therapeutic research and drug discovery, Douglas has broad experience in transformative technologies, data sciences, global business development and applying these to improving patient engagement and the patient journey.

Venkat is Head of Biometrics and Data Sciences at BMS. Prior to BMS, Venkat was a partner at ZS, a mngt consulting firm, where he led R&D clinical services. Prior to ZS, Venkat held leadership roles at BMS, Novartis Onc. and GSK. Venkat joined BMS in 2012 leading the early dev. biometrics and in 2016, took responsibility for the specialty pipeline, leading early and late stage biometrics. Prior to BMS, Venkat led the biometrics at Novartis Onc, and was involved with several dev. programs including Tasigna and Affinitor. Venkat has a PhD in Statistics from Temple Univ. and an MBA from Wharton Business School. Venkat is a member of Statistical and Data Science community and has served on the board of Biopharm. Section of American Stat Assoc.

Michael Wolf is a cognitive/behavioral scientist and health services researcher with interests in cognitive aging, self-management of multiple chronic conditions, health literacy, addressing health disparities, and pragmatic trials testing health system interventions to promote patient engagement, functional independence, and quality of life among middle-age and older adults.

Dr. Ying Yuan is Bettyann Asche Murray Distinguished Professor and Deputy Chair in the Department of Biostatistics at University of Texas MD Anderson Cancer Center. Dr. Yuan is an internationally renowned researcher in Bayesian adaptive clinical trial design. He published over 200 papers on top statistical and medical journals, and is the leading author of two books published by Chapman & Hall: “Bayesian Designs for Phase I-II Clinical Trials” and “Model-Assisted Bayesian Designs for Dose Finding and Optimization”. Dr. Yuan was elected as an American Statistical Association (ASA) fellow. He also serves as the Chair of Data Safety Monitoring Board (DSMB) at MD Anderson Cancer Center.

Demissie Alemayehu is Vice President of Statistics at Pfizer. He has over 25 years of leadership experience in the pharmaceutical industry and academic institutions. He has been influential externally, with decades of research and teaching experience at major institutions. He has held important offices at key professional societies and has served on editorial boards of major journals. Demissie has published extensively in refereed journals and has co-authored or edited three monographs. He is a Fellow of the American Statistical Association and holds a Ph.D. degree in Statistics from the University of California at Berkeley.

Eid has more than 20 years of experience in real-world evidence, epidemiology and biostatistics. Her passion for better public health led her to work for USAID, CDC and other donors in global health development with a focus on reproductive health and family planning and infectious diseases. Her current focus is supporting regulatory, safety, late-phase and post-marketing activities across therapeutic areas using clinical and real-world data to glean real-world insight.

Amy is a Senior Director of Clinical Development responsible for the delivery of Lilly’s IL-23, mirikizumab, adult ulcerative colitis and pediatric inflammatory bowel disease clinical programs. Amy graduated from Ball State University with a degree in Nursing and worked as a Certified Clinical Research Coordinator in urology prior to joining Lilly in 2000. For the past 22 years, Amy has held multiple leadership positions in drug development, innovative drug development and organizational change initiatives, and is a six sigma black belt.

Dr. Hugh Levaux is VP of Growth Strategy at Flatiron, where he drives product and overall strategy, and supports commercial activities. Before Flatiron, Dr. Levaux was Founder and CEO at Protocol First, bringing 20+ years of experience in trial design and operations—notably, SVP at UBC; VP of Product Strategy at Medidata Solutions; CEO of Ninaza; and SVP at Quintiles (IQVIA). He has developed and commercialized multiple clinical research offerings including EDC, ePRO/eCOA, remote monitoring, and EHR-to-EDC technologies. Dr. Levaux holds a Ph.D. in Policy Analysis from RAND Graduate School, MA in international economics and relations from SAIS at Johns Hopkins, and MA in international politics from Université Libre de Bruxelles.

Joe Marion is a Statistical Scientist for Berry Consultants where he designs Bayesian and adaptive clinical trials. His specialties include the use of external data in clinical trials, disease progression modeling of rare pediatric diseases, and the design and implementation of platform trials. He earned his Ph.D. in Statistics from Duke University in 2018, where his research focused on computational methods for Bayesian inference. Prior to graduate school, Joe served as an artillery officer in the US Army.

Keri Monda, PhD, is an Executive Director of Observational Research and Head of the Data & Analytics Center within the Center for Observational Research (CfOR) at Amgen. In her role, she leads a team of epidemiologists and data scientists responsible for generating real-world evidence in support of programs from research and early development through launch and end of patent expiry, and oversees a large, integrated real-world data and analytics ecosystem. Prior to her time at Amgen, Keri was a genetic epidemiologists on faculty in the Department of Epidemiology at the University of North Carolina, Chapel Hill.

Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas and is the lead scientific secretariat of the Methodology Working Party. He also is the lead of the Statistics subgroup of ICH E11A on paediatric extrapolation, sits on ICH E6 R3 Annex 2 group, and is the Regulatory Chair of both groups. Before joining EMA, he headed the Epidemiology Unit in the Vigilance and Risk Management of Medicines Division of the MHRA, the UK regulator and was also previously a Statistical Assessor within the Licensing Division of the MHRA.

Kert Viele is the Director of Research at Berry Consultants. He is a leader in clinical trial implementation of Bayesian hierarchical modeling, with expertise in platform and basket trials as well as clinical trials incorporating the use of historical information. He has authored or co-authored over 50 peer reviewed papers and developed over 100 custom Bayesian adaptive clinical trials for clients in industry, government, and academia, A former editor of the journal Bayesian Analysis, Dr. Viele is also an author of FACTS (Fixed and Adaptive Clinical Trial Simulator), clinical trial simulation software currently licensed to multiple industry, academic, and regulatory organizations.

With over 30 years experience as a technologist and clinical operations professional James has worked across Europe, North America and Asia specializing in central laboratories, cardiac safety, clinical supplies and logistics and since 2008 when he co-founded myClin clinical research his focus has been on providing solutions to the challenges with sharing and tracking the compliance and oversight of research documentation between sites, sponsors and cros.

Eric is a Senior Director in the Global Epidemiology group in the Real World division of IQVIA.

David Gold is a Director of Statistical Innovation in Amgen’s CfDA Design & Innovation group. David earned his doctorate in Statistics from Texas A&M University. Prior to Amgen, David served as a statistician at Bristol Myers Squibb, MedImmune, M.D. Anderson Cancer Center, and Roswell Park. David has devoted the majority of his more than 20 years of experience to clinical drug and co-diagnostic development. He leads the DIA Innovative Designs with Predictive Biomarkers Team.

Dieter A. Häring, PhD, Sr. Director Biostatistics Novartis. Dieter is the Biostatistics Group Head for Neuroinflammation in Neuroscience Novartis. Dieter joined Novartis in 2008 and has been working in roles of increasing responsibility in Neuroscience Novartis on various Multiple Sclerosis programs, including the Fingolimod (Gilenya), Siponimod (Mayzent) and Ofatumumab (Kesimpta) programs.

Dr. Elke Stahl, Clinical Trial Unit BfArM, Germany. Clinical Trials Senior Expert. CoChair of the Clinical Trial Facilitation Group (CTFG) till 2022. Involved in EMA’s EU CTIS groups as BfArM’s representative, National Contact Point for the CTR in Germany, representative in European Commissions CT working groups. Prior BfArM 10 years experiences as a pharmacokineticist at Bayer HealthCare AG, Germany, in early research up to candidate selection. PostDoc at Hoffmann-La Roche Inc and University of North Carolina (UNC). Ph.D. in pharmacology and licenced pharmacist.

Dr. Bo Huang is Executive Director, Head of Immuno-Oncology Statistics. He has 15 years of experience in the pharma industry. Over the years, he successfully led the submission of several oncology drugs at Pfizer. Bo is the author of more than 100 publications, including over 65 peer-reviewed papers. In addition, he has been serving as Associate Editor for several statistics journals, serving as chair and member on a number of professional committees and scientific programs of the ASA, DIA and ICSA.

Kelly is a postdoctoral researcher in biostatistics at Ghent University, Belgium. Her research focuses on more accurate and faster decision-making in randomized clinical trials by making optimal use of the available data. She also leads a working group of top statisticians initiated by the National Institute of  Statistical Sciences on how to analyse trials impacted by COVID-19.