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.

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.

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 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. 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.