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.

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.

Since graduating from the University of Wisconsin at Madison in 1988, Eric started his career with Sanofi-Aventis gaining experiences spanning from research in preclinical, bioavailability/bioequivalence, clinical pharmacology, phase 2/3, post-marketing/medical affairs and health technology assessment. In 2003, he joined Amgen leading the inflammation therapeutic area, and in 2011, Eric moved to the newly formed Biosimilar Division to lead the Biostatistics and Statistical Programming group.

Brenda Crowe is an Associate Vice President in Statistics at Eli Lilly and Company. She has more than 25 years of pharmaceutical industry experience. She obtained a PhD in Statistics from the University of Toronto. She has worked extensively with both clinical trials and observational studies. She has participated in or led several expert teams. As examples, she was a co-chair of the cross-industry Safety Planning, Evaluation and Reporting team, and served as the lead editor of the Council for International Organizations of Medical Sciences report on meta-analysis of safety data. She is a fellow of the American Statistical Association.

Dr. Aloka Chakravarty is currently the Sr. Statistical Advisor in the Office of the Commissioner, FDA for real-world data and evidence activities related to collaborations on COVID-19 and others. She is also working on select strategic data initiatives at FDA with the Chief Data Officer.Prior to that, she was the Deputy Director of the Office of Biostatistics in CDER, FDA. She is an internationally recognized thought leader in multi-regional clinical trials, safety evaluation, real world data and evidence, surrogate markers and biomarkers in drug development. Dr. Chakravarty served as an Adjunct Faculty in Department of Statistics, FAES, NIH and has been on Advisory Board of multiple academic institutions.

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.

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.

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.

Yi Tsong is the Director and supervisor of CDER OB Division VI. He supervises the review and researches in the areas of statistical methods in product quality assessment, analytical biosimialrity, new drug bioequivalence, in-vitro bioequivalence, Drug abuse potential and deterrent, Thorough QT studies, pharma-toxicology.

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.

Dr. Yang received a Ph.D. in statistics from The Ohio State University in 1997. She joined FDA in 1999 as a statistical reviewer of oncology drug products. Since 2005 she has been a team lead. Her team provides statistical support for Division of Psychiatry Products.

Dr. Chen is the Team Leader of the Division of Biometrics IX within CDER of FDA, supervising reviewers for the Division of Non-Malignant Hematology Products. She joined FDA in 2000 after receiving her Ph.D. from the University of Iowa. She has had years' experience in reviewing drug applications for many diseases in psychiatry, cardiovascular and renal systems, gastroenterology, liver and inborn errors and hematology. Her research interests focus on two-stage enrichment designs and small-size clinical trials.

Dr. Robert M. Califf was confirmed as the 25th Commissioner of Food and Drugs. He also served in 2016 as the 22nd Commissioner, and immediately prior to that as the FDA’s Deputy Commissioner for Medical Products and Tobacco. He has spent a good portion of his career affiliated with Duke University, where he served as a professor of medicine and vice chancellor for clinical and translational research, director of the Duke Translational Medicine Institute, and was the founding director of the Duke Clinical Research Institute. He has had a long and distinguished career as a physician, researcher, and leader in the fields of science and medicine.

Dr. D'Agostino holds a Ph.D. in Statistics from Harvard University, is a Fellow of the American Statistical Association He has served as the Director of the Biostatistics Core of the Comprehensive Cancer Center at WFSM since 2004. He has been the PI for several RO1 grants/subcontracts funded by the NIH. Served on numerous Data Safety and Monitoring boards for NIH and industry funded clinical trials. Published over 260 manuscripts and book chapters in areas of statistical methodology, cardiovascular disease, diabetes, and cancer. He has extensive experience in the design and analysis of clinical trials, observational studies and large scale epidemiologic studies.

Dr. McShane is Chief of the Biostatistics Branch in the Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI). She advises on development of tumor markers for use in cancer care. She holds a Ph.D. in Statistics from Cornell University and is a Fellow of the American Statistical Association. She co-led development of “Reporting guidelines for tumor marker prognostic studies (REMARK)” and “Criteria for the use of omics-based predictors in clinical trials.” She is an author of over 100 statistical and biomedical publications and a co-author of “Statistical Design and Analysis of DNA Microarray Investigations.

Holds a mathematics degree with emphasis on statistics from the University of Trier, Germany. Involved in international clinical drug development for more than 25 years in multiple therapeutic areas; 13 years at Novartis in Switzerland in various leading roles, in particular the Cardiovascular area. Currently, he leads a global group of statisticians providing strategic and scientific input to all Novartis cardiovascular clinical development programs and regulatory submissions and ensuring that state-of-the-art and novel statistical methodologies are implemented consistently in cardiovascular trials (including large outcome trials). Areas of interest and expertise: multiplicity, recurrent event data analysis, and sample size re-estimation.

Nikunj is passionate about developing new medicines and technologies that will improve how patients feel, function, and survive. As a PRO Director, he sets and leads PRO measurement strategies in oncology TA medical product development at AstraZeneca. Prior to AstraZeneca, Nikunj was a clinical outcome assessment (COA) reviewer at the US Food and Drug Administration where he advised pharmaceutical companies on COA measurement strategies and reviewed marketing applications (INDs, NDAs, BLAs) across TAs. While at FDA, Nikunj also led FDA scientific policy development initiatives related to patient outcomes.

Martin Posch is professor for medical statistics at the Medical University of Vienna. From 2011-2012 he worked as statistical expert at the European Medicines Agency (London, UK) in the Human Medicines Development and Evaluation sector, where he contributed to guideline development and the assessment of study designs. His main research interests are group sequential trials, adaptive designs and multiple testing, focusing on applications in clinical trials. Martin Posch serves as Associate Editor of Biometrics and Biometrical Journal and is Observer at the EMA Biostatistics Working Party. Furthermore, he is member of the EU Patient-centric clinical trial platform IMI EU-PEARL.

Estelle Russek-Cohen, Ph.D., is the director of the Division of Biostatistics in the Center for Biologics Evaluation and Research (CBER) in the Office of Biostatistics and Epidemiology. She serves as regulatory chair of the ICH E9 R1 working group on estimands. Her personal interests include personalized medicine and methods to support safety of medical products. She is a fellow of the American Statistical Association.

Alec Walker is a Principal at WHISCON, an Adjunct Professor at the Harvard TH Chan School of Public Health, and a senior scientific adviser to the Reagan Udall Foundation for the FDA. His research encompasses drug safety and the effective use of electronic health data for safety studies.

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 P. Abernethy, MD, PhD is the President of Product Development and Chief Medical Officer at Verily, where she leads teams in the development and delivery of solutions that bridge the gap between clinical research and care. Before joining Verily, Dr. Abernethy was Principal Deputy Commissioner and Acting Chief Information Officer of the US Food & Drug Administration. Prior roles include serving as CMO/CSO of Flatiron Health and multiple roles at Duke University, where she was Professor of Medicine. Dr. Abernethy went to the University of Pennsylvania and then Duke University Medical School, and received her PhD from Flinders University in Australia.

Dr. Amur is currently the Scientific Lead for the Biomarker Qualification Program housed in the Office of Translational Sciences (OTS) in CDER, FDA. She received her Ph.D. in biochemistry from Indian Institute of Science, India and completed post-doctoral fellowships at Temple University and at UCLA. She then gained experience in diagnostic and biotech sectors (Specialty Laboratories in Santa Monica, CA and Applied Biosystems in Foster City, CA, and Neotropix, Inc, PA.) before joining CDER, FDA as a senior genomics reviewer in the Office of Clinical Pharmacology (OCP). Her current research interest areas include pharmacogenomics, HLA-associated adverse events and biomarkers in autoimmune diseases and Alzheimer’s.

Dr. Claggett is an Associate Scientist in the Division of Cardiovascular Medicine at Brigham and Women's Hospital and Instructor in Medicine at Harvard Medical School. He received a PhD in Biostatistics from Harvard University in 2012. He has collaborated with researchers in a variety of disease areas, including HIV/AIDS, diabetes, and heart failure. His research expertise includes topics relevant to the analysis of clinical trials, including survival analysis, multiple patient-level outcomes, meta-analysis, and the identification of patient subpopulations who may or may not respond to a novel treatment. He has more than 50 peer-reviewed publication and has served as statistician for large, multinational, phase-3 clinical trials.

Cassie is a Statistics Reviewer in CMC Review Team at office of Biostatistics, FDA and holds a Masters in Chemistry and PhD in Statistics. She joined FDA in 2012. Her primary review work concentrates on the analytical similarity assessment and product quality control. She also has research experience in clinical trials design and measurement error. Dr. Dong has won several FDA awards and is the author of more than 20 scientific journal articles.

Dr. Laurie Muldowney serves as the Deputy Director of the Office of Scientific Investigations (OSI) in the Center for Drug Evaluation and Research (CDER) at the U.S. FDA. In this role, she manages the development and implementation of patient focused, risk-based inspection, compliance, and enforcement activities under the Agency Bioresearch Monitoring Program. Before joining OSI in 2019, Dr. Muldowney served in multiple positions across CDER, including clinical team leader with the Office of New Drugs and associate director for medical policy in the Office of Translational Science. Dr. Muldowney received a B.S. in chemistry from the College of William and Mary and earned her medical doctorate from Jefferson Medical College.

Andrew Stone has worked for AstraZeneca for over 23 years and currently leads the Statistical Innovation team. Prior to that Andrew occupied various leadership positions in oncology for 9 years – managing a team of 45 statisticians in the UK and US. At the end of May he will be venturing onto pastures new working as a Statistical Consultant.

Ron Wasserstein has been the executive director of the American Statistical Association (ASA) since 2007. In this role, Wasserstein provides executive leadership for the world’s largest professional association of statisticians and is responsible for ensuring the ASA fulfills its mission to promote the practice and profession of statistics. From 1984-2007, Wasserstein was a mathematics and statistics department faculty member and administrator at Washburn University in Topeka, Kan. During his last seven years at the school, he served as the university’s vice president for academic affairs. Wasserstein is a Fellow of the ASA and American Association for the Advancement of Science.

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.

Marc Buyse holds master’s degrees from Brussels University (Belgium), the Cranfield School of Management (UK) and a doctorate degree from the Harvard School of Public Health (USA). He had worked for 12 years at the EORTC in Brussels and for 2 years at the Dana Farber Cancer Institute in Boston. Founder of IDDI and CluePoints, he is also an Associate Professor of Biostatistics at the Limburgs Universitair Centrum, Diepenbeek, Belgium. (http://publicationslist.org/marc.buyse).

Dr. Shen has served as the Vice President of Data & Statistical Sciences at AbbVie Inc. since 2011. In this capacity, Frank leads 350 quantitative scientists worldwide to support global drug discovery and development. He also leads AbbVie’s World-Class Clinical Science Excellence initiative which includes building a new real-world evidence capability in drug development. Frank received his PhD degree in Statistics from Temple University and a MS degree in Chemical Engineering. He was named a Fellow of the American Statistical Association in 2003 and served as the Chair of the PhRMA Biostatistics and Data Management Steering committee from 2005 to 2006.

A team leader and a senior statistical reviewer at the Center of Drug Evaluation and Research, Food and Drug Administration (FDA). She obtained her Ph.D. in statistics from Statistics Program of Department of Mathematics at University of Maryland at College Park in 2015 and her Ph.D. in Chemical Engineering from Department of Chemical Engineering at Iowa State University in 1999. She received four FDA Outstanding Service Awards for significant efforts and contributions in statistics related to reviews and research in Chemistry and Manufacturing Control and biosimilar evaluation. She has published more than 35 papers in the statistical, medical, and engineering journals.

Yuan-Li is the Division Director of the Division of Biometrics IX, Office of Biostatistics, Office of Translational Science, CDER, FDA. The division is responsible for statistical reviews of regulatory submissions of hematology products including both benign and malignant products. She received a doctorate in Biostatistics from the University of North Carolina, Chapel Hill. She has over 25 years of combined experience in clinical trial setting across academia, pharmaceutical industry and FDA.

Carl-Fredrik Burman is associated professor at Chalmers Univ. and Senior Statistical Science Director at AstraZeneca. He is principal investigor for Decision Analysis within the EU funded IDEAL project on innovative methodology for clinical trials in small population groups, including rare diseases. At AZ, Dr. Burman works on methodological development and consultations, especially for trial design and multiple inference. He serves as associated editor of the Journal of Biopharmaceutical Statistics and as scientific committee member of the European Federation of Statisticians in the Pharmaceutical Industry.

Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology Products. Prior to joining the FDA he was Professor of Urology, Pathology, Radiology, and Molecular Biology & Biochemistry at Johns Hopkins University.

Richard has over 15 years of experience in drug development spanning from scientist role (immunotherapy bench research and monoclonal antibody technology transfer) and crossing over to statistician role (R&D, CMC, quality, manufacturing, and biosimilars). He currently directs the nonclinical statistical aspects of Hospira’s biosimilars pipeline development including setting statistical approaches to demonstrate analytical similarity and application of CMC statistical methodologies such as specification setting, stability analyses, and method validation. He holds a Ph.D. in Chemical Engineering from Georgia Institute of Technology with a minor in Statistics with further post-doctoral statistics courses from numerous academic institutions.

Norman Stockbridge, MD, PhD has been in FDA/CDER's Division of Cardiovascular and Renal Products since 1991 and has been its Director since 2004.

Shein-Chung Chow, Ph.D. is an Associate Director, Office of Biostatistics, CDER/FDA. Prior to joining FDA, Dr. Chow was a Professor of Biostatistics and Bioinformatics at Duke University School of Medicine, Durham, NC. He was also a special government employee (SGE) appointed by the FDA as an Advisory Committee member and consultant to the FDA. Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Editor-in-Chief of the Biostatistics Book Series at Chapman and Hall and CRC Press. Dr. Chow is Fellow of the American Statistical Association, who is the author or co-author of 300 methodology papers and 29 books.

Dr. James Hung is currently Director, Division of Biometrics I, CDER, US FDA. The division provides services for the medical divisions: Neurology, Psychiatry, Anesthesiology, Addiction Medicine, and Pain Medicine, Medical Imaging and Radiation Medicine.

Dr. Bruce Binkowitz is Vice President of Biometrics at Shionogi Inc. where he leads the Biostatistics, Data Management, and Statistical Programming departments. Bruce has more than 30 years experience in the Pharmaceutical Industry at Merck and Co. and then Shionogi, Inc. as a Statistician, working across many therapeutic areas and across all phases of drug development. He has presented at all the major Statistics conferences and has publications spanning more than 30 years, including his contributions as a thought leader on the topic of multiregional clinical trials. Dr. Binkowitz is a Fellow of the American Statistical Association(ASA), and was the 2020 Chair and is current Past-Chair of the Biopharmaceutical Section of the ASA.

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.