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. Satrajit Roychoudhury is an Executive Director and a member of Statistical Research and Innovation group in Pfizer Inc. Prior to joining, he was a member of Statistical Methodology and Consulting group at Novartis. His primary expertise includes implementation of innovative statistical methodology in clinical trials. He has co-authored several publications/book chapters in this area and provided statistical training at major conferences. His areas of research include the use of survival analysis, model-informed drug development and Bayesian methods in clinical trials.

Dr. Yun Wang is the Deputy Division Director for Division of Biometrics II in the Office of Biostatistics at CDER/FDA since March 2021. Before taking her current role, Dr. Wang was a statistical team leader and reviewer supporting anti-diabetic and hematologic products development in OB/FDA from 2011 – 2021. Prior to joining FDA, Dr. Wang was a senior principal biostatistician at Novartis Oncology from 2008-2011, and an assistant professor in the University of Pittsburgh from 2005 – 2008.

Yunfan Deng is a senior mathematical statistician in the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration. Being a statistical reviewer in FDA for over 18 years supporting various therapeutic area, she has worked on numerous reviews with complicated statistical issues. She is currently serving as one of the leaders for the Office of Biostatistics Estimand Working Group, leading a group of statisticians and collaborating with clinicians in developing and optimizing the implementation of ICH E(9) R1 estimand framework into CDER’s review process.

Jessica possesses over twenty years of extensive experience in blood product evaluation from CBER, as well as safety, bioequivalence, and biosimilar evaluation from CDER. Presently, she serves as a supervisory mathematical statistician at the Division of Biometrics VIII, CDER/FDA, where her primary focus lies in assessing generic and biosimilar drug products. Her research interests span various areas, including the detection of influential observations, non-inferiority design, adaptive design, and meta-analytic methods in clinical trials. Jessica has been actively involved in organizing clinical trial training courses and workshops for the FDA community, demonstrating her commitment to advancing knowledge and expertise within the field.

Munish Mehra serves as Executive Director and Principal Biostatistician at Tigermed US and as Managing Director at Tigermed, India Pvt. Ltd. During a career spanning 33 years, he gained extensive experience in the design, analysis and reporting of phase I-IV clinical trials across multiple therapeutic areas. He has represented sponsors at FDA Type B pre-IND, end of phase II and pre-NDA as well as Type C meetings as an expert biostatistician. Dr. Mehra is currently Chair of the DIA Statistics and Data Sc. Community and has chaired sessions at several DIA Annual Meetings. He holds a PhD in biostatistics and a MS in computer science from the Univ. of KY, as well as a MS in mathematics from the Indian Institute of Technology.

Dr. Mukhopadhyay currently leads the breast cancer biostatistics group at AstraZeneca and is responsible for leading biometrical strategic, scientific and operational aspects of the entire breast cancer folio. Prior to joining AstraZeneca, he oversaw key oncology development programs at Daiichi-Sankyo and Novartis and oversaw the development and approval of key products such as Enherru, Kisqali and Afinitor. Prior to Novartis, Dr Mukhopadhyay was leading biostatics teams at Schering-Plough corporation, overseeing HCV therapeutic area. Dr. Mukhopadhyay obtained a Ph.D. degree in statistics from North Carolina State University.

Dr. Rodriguez is the Deputy Division Director of the Division of Biometrics IX at CDER/FDA. She earned her PhD from Cornell University and certificate in Strategic Decision and Risk Management from Stanford University. Prior to joining FDA in 2012, Dr. Rodriguez supported a variety of therapeutic areas in industry. Her work at FDA has covered issues in oncology, hematology, meta-analyses, evaluation of biomarker and PRO/COA endpoints, survival analyses, and adaptive designs, and she recently served as co-organizer of the FDA-AACR-ASA Workshop on Overall Survival. She co-leads the Benefit-Risk Assessment Planning (BRAP) Taskforce within the ASA Biopharm Safety Working Group and is part of several internal FDA scientific working groups.

Joshua Sampson is a senior science advisor in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration (FDA). Prior to joining the FDA, he was a Senior Investigator in the Division of Cancer Epidemiology and Genetics at the U.S. National Cancer Institute. His research interests include high dimensional mediation analysis, causal inference, and clinical trials.

With 18 years in the pharmaceutical industry, Pritibha focuses on solving complex global business challenges by integrating analytics, development strategy, and stakeholder alignment to deliver outcomes. Pritibha’s Statistics and Program Management leadership in cross-functional teams has driven insights, operational efficiency, and sustainable growth. Leveraging her unique blend of psychology, statistics, and business expertise, she translates intricate data-driven insights into impactful strategies. Her sustainability doctoral research on decentralized clinical trials at ETH Zurich reflects her commitment to innovation and human-centric solutions.

Li Wang, PhD, is currently Senior Director and Head of Statistical Innovation group in AbbVie. Li is leading Design Advisory which provides strategic and quantitative consulting as requested to all Development teams in all Therapeutic Areas to facilitate innovative thinking and complex innovative design evaluation. Li also co-leads Development Advanced Analytics capability in AbbVie to drive Machine Learning and Advanced Analytics research and application in Development. He led Immunology and Solid Tumor statistical design and strategy discussions and multiple ML, RWE and Bayesian innovation projects from 2017 to 2019. From 2006 to 2017, he contributed to and subsequently led several submissions for Eliquis, Onglyza and Rinvoq.

Dr. Yang is a supervisory mathematical statistician at the Division of Biometrics I, Office of Biostatistics, CDER/FDA since August 2022. She has also been the statistical team leader at the same Division supporting the psychiatric drugs development since 2005. Prior to taking the team leader's role, Dr. Yang was s a statistical reviewer supporting the oncologic drugs development.

Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association for the Advancement of Science. She was also on the leadership teams of two health research organizations, serving as project director on multiple government contracts. Her areas of expertise include musculoskeletal, metabolic, immunity and inflammation disorders, as well as patient engagement. She received her PhD in Biochemistry and Cell Biology from Johns Hopkins.

Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant regulatory and health policy changes, seamlessly integrating relevant content into the development and advancement of DIA conferences and courses. Her responsibilities extend to overseeing content development and strategy within the Americas region.

Elyse Katz, PhD, supports the US Department of Defense's efforts to increase the medical readiness of active-duty service members through the development and deployment of psychological health and traumatic brain injury diagnostics and therapeutics. To facilitate this work, she leverages her background in biomarker and clinical development in Neuroscience, as well as experience working collaboratively with colleagues from other government agencies, academic institutions, and industry partners.

Sabrina Paganoni, MD, PhD is a physician investigator at the Healey Center for ALS at Mass General, Co-Director of the Neurological Research Institute at the Massachusetts General Hospital and Assistant Professor at Harvard Medical School. Dr Paganoni’s research focuses on clinical trials and therapy development for ALS. She has served as the Principal Investigator of many ALS clinical trials and has been using novel neuroimaging techniques, bio-fluid biomarkers and digital technology as measures of target engagement in these trials. Currently, she is the co-Principal Investigator of the HEALEY ALS Platform Trial. Her research has been funded by the NIH, several ALS Foundations and non-profits, and industry.

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.

ShaAvhrée Buckman-Garner, MD, PhD, FAAP is the Director of the Office of Translational Sciences, Center for Drug Evaluation and Research (CDER), at the FDA. Prior to serving as Director of OTS, Dr. Buckman-Garner served as Deputy Director for OTS and as medical team leader in the Division of Pediatric Drug Development, Office of Counter Terrorism and Pediatric Drug Development, CDER. Dr. Buckman-Garner received her MD and PhD degrees with an emphasis on molecular cell biology from Washington University School of Medicine. She completed Pediatric specialty training at Baylor College of Medicine.

Dr. Lackey has a Doctorate from UCLA in Environmental Science and Engineering and a Master of Health Science from the Johns Hopkins School of Public Health. Since 2018 she has been the program lead for decision support at FDA CDER, providing decision analysis and benefit-risk assessment for policy and regulatory decision-making teams across the Center. She serves on the ASA Benefit-Risk Assessment Planning Taskforce and ASA Bayesian Scientific Workgroup Benefit-Risk Team.