Frank Bretz is a Distinguished Quantitative Research Scientist at Novartis. He has supported the methodological development in various areas of drug development, including dose finding, estimands, multiple testing, and adaptive designs. He was a member of the ICH E9(R1) Expert Working Group on 'Estimands and sensitivity analysis in clinical trials' and currently serves on the ICH E20 Expert Working Group on 'Adaptive clinical trials'.

Dr. Pandu Kulkarni is Chief Analytics Officer – R&D / Vice President – Statistics, Data & Analytics. His organization is comprised of statisticians, statistical analysts, data analysts, and others working in the full pharmaceutical research cycle, from discovery to commercialization. Pandu is on one of the Board of Directors for CDISC and Accumulus. He also is the chair of the Biopharmaceutical Statistical Leaders Consortium. He is a fellow of the American Statistical Association. Pandu joined Eli Lilly and Company in 2000, has held numerous leadership positions including technical and management positions within and outside of Statistics. He obtained his Ph.D. in Statistics at the LaTrobe University, Melbourne, Australia.

Jeff Maca is a Principal Scientific Advisor in Advisory Services Analytics at Quintiles, with over 19 years of experience in the pharmaceutical industry. Prior to Quintiles, he worked with Novartis Pharmaceuticals as a project statistician, prior to assuming the role of a statistical consultant within the statistical methodology group. He has been active in statistical methodology research and has numerous publications on pharmaceutical statistics, including adaptive designs, multiplicity, and interim decision making. Along with research and consulting work, Jeff also participates in the DIA Adaptive Designs SWG. Jeff received his PhD in Statistics from Texas A&M University.

Cristiana Mayer is the Head of Biostatistics at Johnson & Johnson Vision, a company dedicated to the eye care, eye health and eye products. She has 20+ years of experience in the pharmaceutical industry. After 18 years in drug development at Janssen R&D LLC working in different therapeutic areas and 5 years in Statistical Modeling & Methodology group, Cristiana is currently leading the biostatistics and data management groups across the Surgical and Vision Care businesses of JNJ Vision. Her current interests are in CID, Bayesian designs and patients’ engagement. Her recent publications are about simulation practices for innovative designs, ethics and innovation in the pandemic and patient engagement in rare diseases.

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.

Dr. William (Bill) Wang is an executive director, clinical safety statistics, Merck Research Laboratories. He has over 25 years of experience in the pharmaceutical industry, with ~18 years with Merck & Co Inc. He is co-chairing the ASA safety working group, and a deputy topics-leader in the ICH E17 working group on multi-regional clinical trials. Dr Bill Wang was elected as a Fellow of American Statistical Association (2018) and received the DIA Global Inspire Award in 2017 .

Amy Xia is Vice President, Center for Design and Analysis at Amgen. Amy has worked on designing, implementing, and analyzing Phase I-IV clinical trials as well as observational studies over the past two decades. Currently, she heads up the Center for Design and Analysis organization which includes Biostatistics, Design & Innovation and Data Sciences at Amgen, providing leadership and holistic vision for strategic drug development and driving innovative approaches across Amgen’s portfolios for evidence generation and decision-making. Amy received her PhD in Biostatistics from the University of Minnesota, and her medical degree from Peking University, China.

Thomas E. Gwise, Ph.D. is the Director of the Division of Biometrics IX. The Division, which is part of the Offices of Translational Science and Biostatistics in FDA’s Center for Drug Evaluation and Research, provides statistical expertise to the Office of New Drugs and the Oncology Center of Excellence in application review and research related to hematologic drug and therapeutic biologic approval. Biometrics IX has reviewed multiple proposals to use Real World Data in support of hematology product approval. Prior to joining CDER in 2011, Dr. Gwise led a team of statisticians in FDA’s Center for Devices and Radiological Health reviewing diagnostic devices.

Dr. Rima Izem joined Novartis in February 2021 where she supports statistical methodology development and use in all phases of therapeutic development. In her prior roles in academia and the US Food and Drug Administration, she designed or reviewed clinical studies across a wide range of therapeutic areas and data sources (clinical trials and observational data; efficacy and safety). She also developed new methods for causal inference and signal detection in claims databases and electronic healthcare data. Her current methodological interests include causal inference, hybrid designs (clinical trials data and real world data), and statistical methods in small samples (e.g., rare diseases or pediatrics).

Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification to trials of all sizes. Her division covers a wide variety of therapeutic areas. She works across FDA on patient focused drug development and rare disease initiatives, master protocols, and other programs. Prior to working at the FDA, she spent over a decade at the U.S. National Institutes of Health working on and overseeing clinical research and research support programs.

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.

Mark Levenson is currently the Director of the Division of Biometrics VII in the Office of Biostatistics/Office of Translational Sciences/Center for Drug Evaluation and Research of the US Food and Drug Administration (FDA). At FDA, he has been the primary reviewer or secondary reviewer on many major pre-market and post-market drug safety problems. He contributes to statistical policy and guidance development in the areas of drug safety, real-world data, and regulatory evidence. He is a member of the CDER Medical Policy Program Review Committee and the FDA Real-World Evidence Committee. Dr. Levenson received a Ph.D. in Statistics from the University of Chicago and a B.A. from Cornell University in Mathematics.

Rajeshwari Sridhara, Ph.D. is the Division Director of Division of Biometrics V, Office of Biostatistics which supports Office of Hematology Oncology Products in the Oncology Center of Excellence and Center for Drug Evaluation and Research. As a leader in the field, she routinely presents regulatory policies and scientific philosophy of the Office at national and international professional meetings including oncology drug advisory committee meetings. Dr. Sridhara has contributed in the understanding and addressing the statistical issues that are unique to the oncology disease area. She has worked on regulatory guidance documents and extensively published in refereed journals. She is an elected fellow of the American Statistical Association.

Dr. Wilson worked as a mathematical statistician at FDA for more than 35 years.  He retired from FDA’s Office of Biostatistics at the Center for Drug Evaluation and Research (CDER) in April of this year.  Steve received his doctorate in Biostatistics from the University of North Carolina, Chapel Hill, in 1984.  His professional experience has also included positions with the East West Center, the Indonesian Central Bureau of Statistics, the University of North Carolina, the Federated States of Micronesia and the World Bank.  His professional interests and activities are currently focused on issues related to the improvements in clinical trials science and practice, data standards, and the review of drug and biological therapies.

Mouna Akacha is the Group Head of the Statistical Methodology group of Novartis Pharma AG, based in Basel, Switzerland. She and her team provide internal advice for clinical projects in all development phases and therapeutic areas. She is engaged in developing and implementing innovative statistical methods for clinical projects covering estimand discussions and approaches for missing data, longitudinal data, and recurrent event data. Before joining Novartis, Akacha studied mathematics at the University of Oldenburg in Germany. She holds a PhD in statistics from the University of Warwick in the United Kingdom.

A Fellow of the ASA and a Distinguished Scientist focusing primarily on statistical support for late-stage oncology drug development at Merck Research Laboratories since 2003. Areas of research have included risk prediction for cardiovascular disease and adaptive design with a focus on group sequential design. A current interest is in non-proportional hazards models and multiplicity in group sequential trials due to their relevance for immuno-oncology development. Keaven has previously worked in many drug, biologic and vaccine development areas at Merck and at Centocor/J&J. He is the primary author and maintainer of the open source R package gsDesign and its associated web interface for designing group sequential trials.

Dr. Berlin received his doctorate in biostatistics from the Harvard School of Public Health in 1988. After 15 years on faculty at the University of Pennsylvania, Jesse left Penn to join Janssen R&D in Biostatistics. He now serves as Vice President of Epidemiology across all of Johnson & Johnson. He has over 260 peer-reviewed publications. He was elected as a fellow of the American Statistical Association in 2004. In 2013, Dr. Berlin received the Lagakos Distinguished Alumni Award from the Department of Biostatistics at the Harvard School of Public Health.

Jesse Bridgewater leads data science at Livongo, a digital health company that empowers people with chronic conditions to live better. Jesse is excited to help people live healthier by applying lessons learned leading teams at consumer internet companies including Twitter, Ebay, and Microsoft. His academic training is in Physics and Electrical Engineering and did his PhD at UCLA.

Joan Buenconsejo is VP, Head of Cardiovascular, Neuroscience, and Early Development Biostatistics at Bristol Myers Squibb (BMS). Prior to BMS, she was a strategy lead at AstraZeneca and a statistics team leader at CDER, FDA. She is a long-time DIA member, has chaired the DIA Statistics and Data Science Community, has worked with the Advisory Council of North America, and served as program chair and steering committee member for the Annual FDA/DIA Statistics Forum, and track co-chair for the DIA Annual Meeting. Dr. Buenconsejo received a master’s degree in mathematical statistics from University of California, Irvine, and a MPH and PhD in biostatistics from Yale University.

Gregory Daniel, PhD, MPH, is the Global Head of Public Policy at Eli Lilly & Company in Washington, D.C. Greg is also on the board of directors for the Innovation in Value Initiative (IVI), adjunct associate professor at the UNC Eshelman School of Pharmacy, and Visiting Expert at the Duke-NUS Centre of Regulatory Excellence, Duke-National University of Singapore Medical School. Formerly, he was deputy center director at the Duke-Margolis Center for Health Policy as well as fellow and managing director in the Center for Health Policy at the Brookings Institution. Greg received his PhD in pharmaceutical economics, policy, and outcomes from the University of Arizona, and an MPH, MS, and BS in Pharmacy from The Ohio State University.

Dr. John Farley is presently Director of the Office of Infectious Diseases in the Office of New Drugs at CDER, FDA. His office is responsible for the review of new antiviral and antibacterial drugs. In addition to new drug review work, Dr. Farley’s work at FDA has included implementation of the breakpoints provisions of the Cures Act, providing scientific leadership for establishment of the antimicrobial resistance focused regulatory science research program, and serving as a workstream lead for the Integrated Review as part of the Office of New Drugs Modernization. Prior to joining the FDA, Dr. Farley was on the faculty of the University of Maryland School of Medicine and focused care and research on perinatal HIV.

Renee Iacona is the Vice President of Oncology Biometrics at AstraZeneca where she is in her 23rd. year. Renee has led or been involved in various Cross Pharma Oncology statistical initiatives including issues related to Non-Proportional Hazards in Oncology drug development and sensitivity analysis methods related to Progression-Free Survival. Renee serves on Cytel Innovation Advisory Board, Vanderbilt University Graduate School Board and the University of Tennessee Foundation Board. She received her PhD and MPH from Vanderbilt University.

Frank is a full-time Professor of Biostatistics and Bioinformatics at Duke University Medical Center and Managing Partner of HunterRockhold, Inc., which provides strategic consulting to Industry and Government. His career includes senior positions at Lilly, Merck, and GlaxoSmithKline, where he retired as Chief Safety Officer. He has held faculty appointments at six different universities, served as Chairman of CDISC, and is past president of the Society for Clinical Trials. Frank holds a BA in Statistics and an ScM and PhD in Biostatistics. Frank is a Fellow of the American Statistical Association, The Royal Statistical Society, and the Society for Clinical Trials and is widely published across a wide variety of research topics.

John Scott is Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research, where he has also served as a statistical reviewer for blood products and for cellular, tissue and gene therapies. He holds a Ph.D. in Biostatistics from the University of Pittsburgh, an M.A. in Mathematics from Washington University in St. Louis, and a B.A. in Liberal Arts from Sarah Lawrence College. He is a Fellow of the American Statistical Association and a past Editor of the journal Pharmaceutical Statistics.

Judy Staffa, Ph.D., R.Ph., is the Associate Director for Public Health Initiatives at FDA, Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE), where she is responsible for setting strategic direction for complex, multidisciplinary reviews related to opioid abuse – from a planning, scientific, and policy point of view.

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.

Kunthel By is a biostatistician at the Center for Drug Evaluation and Research at FDA for the past 5 years. He works primarily in the post-market side of the regulatory process, with emphasis on the design and analysis of observational studies that assess safety outcomes after drug exposures. Prior to joining FDA, he was a graduate student at UNC Chapel Hill and a technical writer at SAS, composing documentations for various SAS products.

Dr. DeLong interests are in the field of comparative effectiveness in the area of quality-of-care, with emphasis on risk adjustment methodology, assessment of risk prediction models, and provider profiling. With 20+ years of biostatistics, clinical research, and bioinformatics experience, her responsibilities have included administrative and data analytic functions, as well as statistical methods development. She currently leads the Biostatistics and Study Design Core of the NIH Health Care Systems Research Collaboratory.

Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is chairing the QSTEPS (QS Technical Excellence and Program Strategy) Advisory Committee. He has 30 years of experience in developing the statistical methodology of adaptive designs and with 20 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. Vlad has made significant contributions to the development of the methodology of adaptive designs and to their application in clinical trials and has more than 75 publications in peer reviewed journals and books.

Dr. Kenneth Kaitin is a Professor of Medicine and Senior Fellow at the Tufts Center for the Study of Drug Development. He previously served as the group’s Director for 23 years. He’s also Advisory Professor at Shanghai Medical College, Fudan University. Dr. Kaitin writes and speaks regularly on drug development issues, and has provided testimony before the U.S. Congress. A former President of the Drug Information Association, Dr. Kaitin is Editor-in-Chief of Expert Review of Clinical Pharmacology, and consultant to the U.S. Department of Defense on bioterror countermeasures. Dr. Kaitin received his PhD in pharmacology from the University of Rochester.

Dr. Mandrekar is a Professor of Biostatistics and Oncology as well the Group Statistician for the Alliance for Clinical Trials in Oncology and Section Head for Cancer Center Statistics at Mayo Clinic. Her primary areas are lung cancer and leukemia. She is the faculty statistician for the national adjuvant lung cancer trial, ALCHEMIST, which is part of the NCI precision medicine initiative. Her research interests include adaptive dose-finding trial designs for Phase I trials, designs for predictive biomarker validation, and general clinical trial methodology related to identification of alternative Phase II cancer clinical trial endpoints. Dr. Mandrekar has co-authored140+ original papers, several book chapters and editorials.

Dr. Mullin is Associate Center Director for Strategic Initiatives. She leads various efforts including Patient-Focused Drug Development and CDER’s International Program. She leads the FDA delegation to ICH and currently chairs the ICH Management Committee. She led FDA negotiations for 2017 reauthorization of the Prescription Drug User Fee Act and also led the 2002, 2007 and 2012 PDUFA reauthorization cycles providing $1B in annual funding.  She received the 2019 Reagan-Udall Foundation Leadership Award for Innovations in Regulatory Science, US Food and Drug Law Institute 2017 Distinguished Service and Leadership Award, 2011 Presidential Rank Award for Distinguished Service, for Meritorious Service in 2006. 

Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

Michael Proschan has been a Mathematical Statistician in the Biostatistics Research Branch at the National Institute of Allergy and Infectious Diseases since January of 2006. Prior to coming to NIAID, he spent 16 years at the National Heart, Lung, and Blood Institute. He co-authored the books: Statistical Monitoring of Clinical Trials: A Unified Approach, with Gordon Lan and Janet Wittes (Springer, 2006) and Essentials of Probability Theory for Statisticians (CRC Press, 2016). Dr. Proschan received his Ph.D. in Statistics from Florida State University in 1989, and became a Fellow of the American Statistical Association in 2005.

Mary Redman is an Associate Member in the Clinical Biostatistics Group within the Clinical Research Division at the Fred Hutchinson Cancer Research Center. In addition she is the lead statistician for the Lung Cancer Committee in SWOG and the lead statistician of the Lung-MAP trial.

In her role as Vice President, Connected Care and Site Head, Cambridge Innovation Center, Marie oversees the R&D efforts for Lilly’s connected product systems portfolio and leads a cross-disciplinary research team focused on creating the future generation of product solutions for Lilly’s therapeutic portfolio. Prior to joining Lilly, Marie held a number of roles, including Managing Director at Health Advances and Co-Founder of the T1D Exchange, leading the development efforts of complex hardware and software product solutions for people with chronic diseases. Marie earned her Bachelor of Arts in chemistry from the University of Vermont.

Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous benefit:risk assessment of Amgen's medicines. Brian also holds an Adjunct Professor of Epidemiology appointment at the University of California, Los Angeles. He received his DSc in Epidemiology from Boston University and a MA in Education and Psychology from Pepperdine University. He has authored/co-authored 80+ peer-reviewed publications in the areas of pharmacoepidemiology, cancer, kidney, cardiovascular and bone disease.

Professor and Chairman, Dept. of Biostatistics, Vanderbilt University School of Medicine and Expert Statistical Adviser, Office of Biostatistics, FDA CDER

Kun He is a mathematical statistician in the Division of Biometrics V, Office of Biostatistics, CDER, FDA. He received a Ph.D in statistics from Cornell University, and previously served on the faculties of the University of Minnesota and the University of Kansas. Since joining FDA in 1999, he has provided statistical support for the clinical division of neurology, psychiatry, and hematology and oncology. Currently, he is supporting the Division of Oncology Products 2, Office of Hematology and Oncology Products.

Min Min received her PhD in Statistics from University of Maryland, College Park in December 2007. She joined the FDA in June 2008 and worked as a statistical reviewer with Pharmacology and Toxicology team for the six and half years. Currently, she is a stat reviewer for Division of Gastroenterology and Inborn Errors Products (DGIEP) team. Her research areas include rare disease, meta-analysis, longitudinal and categorical data analysis.

Scott Novak, PhD is the Managing Director of the Prescription Opioid Treatment and Research Unit at Battelle Memorial Institute. He is active in studies investigating the epidemiology of new synthetic/designer drugs of abuse in the United States and internationally as well as the use and abuse of marijuana and prescription opioids. Dr. Novak's expertise is in novel statistical and methodological approaches to the analysis of epidemiological and clinical data, including extensions of the generalized linear mixed model (e.g., HLM) to classification, measurement, and diagnosis of disease. He is the principal investigator on several NIH grants and commercial projects, and has authored more than 100 papers and presentations.

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.

Zhenzhen Xu attended Harvard University, graduating in 2004 with a M.A., and went on to earn a Ph.D. from Michigan Biostatistics in 2010. She currently works at FDA as a mathematical statistician in the center for Biologics evaluation and research. Dr. Xu’s research develops novel methods for the design and analysis of clinical trials, particularly cancer immunotherapy trials and cluster randomized trials.

Telba is Senior Scientific Director in Quantitative Sciences at Janssen R&D. She comes from FDA where she pioneered the use of Bayesian statistics and wrote several guidance documents. She received the FDA Excellence in Analytical Science Achievement Award for spearheading innovative regulatory science studies culminating in the release of novel guidance documents, supporting complex policy decision making and changing the submission review paradigm. Recently at the Center for Biologics, her portfolio expanded to include the Science of Patient Input, Complex Innovative Designs, and trials for rare diseases. She received a PhD from Berkeley, is fellow of the American Statistical Association and member of International Statistical Institute.

Dr. David Martin works across therapeutic areas as the Head of the Patient Centered Clinical Outcomes Center of Excellence at Novartis. Previously, he led Global RWE at Moderna, with accountability for provision of enterprise real world data and analytics as well as oversight for deliverables oriented toward regulators, payers, providers, and patients. He retired as a Captain after completing 20 years of active duty service split between the United States Air Force and Public Health Service. At the FDA he led the Division of Epidemiology in the Center for Biologics. Subsequently, he established the RWE group to drive the agency's scientific, guidance, and submission review responses to the RWE provisions of the 21st Century Cures Act.

Eric Gibson is currently the Global Head of Analytics for Novartis Global Drug Development. Eric has his Ph.D. in Statistics from Kansas State University and has worked for 22 years leading teams of quantitative scientists to influence design and decision making within clinical drug development.

Dr. Sue-Jane Wang is Office Associate Director and Biostatistics Lead/Coordinator of FDA/CDER Biomarker Qualification Program from Office of Biostatistics, CDER, FDA. She is an ASA Fellow. Her well-recognized professional expertise includes pharmacogenomics, adaptive design and biomarker associated clinical trial designs and analysis methods with more than 100 peer-reviewed publications in clinical trials, bioinformatics, and specific clinical journals related to genomic/genetic and common diseases. Dr. Wang has served as an Editor-in-Chief for Pharmaceutical Statistics. She has also served as a Guest Editor-in-Chief for, e.g., Biometrical Journal, Journal of Biopharmaceutical Statistics. Dr. Wang is an Associate Editor for a few journals.

Changming (Sherman) Xia is a mathematical statistician at the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He contributes to statistical regulatory activities in the area of drug safety. Prior to joining the FDA, he was a senior research statistician at AbbVie. He holds a PhD in Statistics from University of Rochester.