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.

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.

More than 20 years' experience in Biotech, CRO & Pharma. Built and managed biostatistics, statistical programming & data management groups. Clinical trial experience in Oncology, Inflammatory Diseases, Dermatology & HIV. Keen interest in functional alignment, statistics in decision-making & quantitative Benefit-Risk methodology.

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).

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.

Lei Nie has worked for FDA since 2007 and previously worked for Georgetown University where he served as the director of Graduate Study in the Department of Biostatistics, Bioinformatics, and Biomathematics. He graduated from the University of Illinois at Chicago with a Ph.D. in statistics in 2002. He is an elected ASA Fellow and has authored/authored a total of 99 peer reviewed publications.

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.

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 .

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.

Karen received her Ph.D. in Statistics from Baylor University in 2001, and joined Eli Lilly and Company at that time. She is currently Research Fellow at Eli Lilly and Company where she leads the Statistical Innovation Center, a team that focuses on innovative design and analysis of clinical trials. In 2011, Karen helped form and led the DIA Bayesian Scientific Working Group and currently serves as past-chair. This group includes members in Industry, Regulatory, and Academia. Her research interests include Bayesian design and analysis of clinical trials and master protocols. In 2016, Karen was elected a Fellow of the American Statistical Association.

Following his educational endeavors in statistics at the University of Minnesota-Morris and the University of Virginia, Mat joined FDA/CDER in September 2004. His first 6 years were spent reviewing dermatology and dental products before joining the Division of Biometrics 7 as Team Lead and later as Deputy Division Director. In these roles, Mat is involved in the quantitative assessment of safety covering a spectrum of statistical issues ranging from retrospective assessment of safety signals to prospective design of safety outcome trials.

Scott Komo is a Senior Statistical Reviewer in the Office of Biostatistics, Center for Drug Evaluation and Research, FDA. He is involved with the design, analysis, and interpretation of studies that use clinical outcome assessments. He has supported multiple medical areas since joining the FDA in 1999. He received a BA in Chemistry from the University of California, Davis and an MS and DrPH in Biostatistics from the University of California, Los Angeles.

Pallavi Mishra-Kalyani, Ph.D. is the Deputy Director of the Division of Biometrics V, Office of Biostatistics in the Center for Drug Evaluation and Research (CDER). Since joining the Food and Drug Administration (FDA) in 2015, Dr. Mishra-Kalyani has contributed to the efforts to address the statistical issues related to the potential use of Real World Data and Real World Evidence for regulatory purposes. Her research interests include statistical methods for observational data, causal inference, and non-randomized trial design. Dr. Mishra-Kalyani received her Ph.D. in Biostatistics from Emory University and her Master’s degree in Epidemiology from the T.H. Chan School of Public Health at Harvard University.

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.

Gregory Levin is the Associate Director for Statistical Science and Policy in the Office of Biostatistics in the FDA’s Center for Drug Evaluation and Research. He received a Ph.D. in biostatistics from the University of Washington in 2012. Greg has experience supporting drug review across a wide range of therapeutic areas and has represented CDER on several policy and guidance working groups, including efforts related to adaptive design, master protocols, benefit-risk, and the evaluation of effectiveness.

Dr. Collins, Director of the Office of Biostatistics at FDA/CDER, leads a staff of statisticians responsible for statistical review of regulatory submissions promoting innovative, science-based, quantitative decision-making throughout the drug development life cycle. Prior to FDA, she led global operations in statistics, data management and statistical programming in the pharmaceutical industry. She led global teams in pioneering electronic data capture in several large companies and established unified worldwide strategies for efficient and faster drug development. She received her BS in Mathematics from the American University of Beirut, her PhD in Statistics from Boston University and completed a MS in Computer Science from NYU.

Andrew Potter is a mathematical statistician in the Division of Biometrics I at the Center for Drug Evaluation and Research of the US Food and Drug Administration, supporting the review work in the Division of Psychiatry. He also leads digital health technology initiatives in the Office of Biostatistics at CDER. His research interests include the use of digital health technologies in clinical trials and the analysis of high-frequency outcome data. He is involved in FDA working groups on this topic.

Jeremy A. Rassen, ScD is a pharmacoepidemiologist with 25 years of academic and industry experience. He is co-founder, president, and chief science officer at Aetion, a health care technology company that delivers real-world evidence for life sciences companies, payers, and regulatory agencies. Prior to founding Aetion, Dr. Rassen was Assistant Professor of Medicine at Harvard Medical School, where he focused on methods to improve the quality and validity of real-world data studies. He also worked in Silicon Valley in a variety of tech companies. Dr. Rassen received his bachelor’s degree in Computer Science from Harvard College and his master’s and doctorate degrees in Epidemiology from the Harvard T.H. Chan School of Public Health.

Sara Eggers leads the Decision Support and Analysis Team withing FDA’s Center for Drug Evaluation and Research. This team contributes to the development and implementation of initiatives regarding human drug benefit-risk assessment, patient-focused drug development, risk evaluation and mitigation strategies, regulatory decision support, and other efforts. Before joining FDA in 2011, Sara conducted research and consulting in the area of decision science, stakeholder engagement, and risk communication. She has a Ph.D. in Engineering and Public Policy, with an emphasis on decision science, from Carnegie Mellon University

Miguel Hernán conducts research to learn what works to improve human health. Together with his collaborators, he designs analyses of healthcare databases, epidemiologic studies, and randomized trials. Miguel teaches causal inference methods at the Harvard T.H. Chan School of Public Health, where he is the Kolokotrones Professor of Biostatistics and Epidemiology. His edX course “Causal Diagrams” and his book “Causal Inference: What If”, with James Robins, are freely available online and widely used for the training of researchers. Miguel is an elected Fellow of the American Association for the Advancement of Science and of the American Statistical Association, Editor Emeritus of Epidemiology, and past Associate Editor of Biometrics and JASA.

Dr. Imbriano works as a statistical reviewer supporting the therapeutic areas of GI and liver at the FDA. He joined the FDA after graduating in 2018 from the University of Michigan with a PhD in Biostatistics. His research work at the University of Michigan focused on missing data in observational studies.

Matilde Kam, PhD., serves as the Associate Director for Analytics and Informatics for the Office of Biostatistics (OB) CDER/FDA. As Associate Director, Matilde has strategic and oversight responsibility for matters pertaining to analytics and informatics including data standards, data integrity and quality, data science, scientific computing and statistical programming activities in OB. Prior to joining FDA, Matilde had significant experience in building and overseeing highly effective statistics and analytics groups in the pharmaceutical industry. She is a Fellow of the American Statistical Association and has served in various leadership roles for the ASA Biopharm Section. She received her PhD in Statistics from Penn State University.

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.

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.

Aracelis Torres is Director of Quantitative Sciences at Flatiron Health, where her work over the past four years has focused on translation of real-world oncology data to generate evidence. She is also an Adjunct Professor at Columbia University Graduate School of Arts and Sciences, where she teaches a course on large-scale data processing and analysis. She received a Ph.D. in Cancer Epidemiology from Johns Hopkins Bloomberg School of Public Health and a Master’s degree in Chronic Disease Epidemiology from Yale University’s School of Public Health. Her research has focused on disparities and study design considerations for observational data.

Anubha Gupta is a Director of Clinical Pharmacology Modelling and Simulation at GSK and is based in United Kingdom. She has 12 years of industry experience in applying model-based approaches to inform drug development. She obtained a PhD degree in clinical pharmacokinetics and drug therapy from Uppsala University, Sweden. She has keen interest in applying quantitative pharmacological principles in decision making at various stages of drug development from early to late phase of clinical development and promoting collaborations across different quantitative divisions.

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.

Peter Mesenbrink, PhD is an Executive Director of Biostatistics at Novartis Pharmaceuticals Corporation in East Hanover, New Jersey. Peter received his BS in Mathematics from UVM in 1989 and a PhD in Statistics from NCSU in 1995. He joined Novartis in 1995 and is currently Therapeutic Area Head of Biostatistics for Rheumatology. He is an active member and leader within IMI EU-PEARL. Peter has research interests in statistical methodology for estimands/handling of missing data, design of master protocols, and meta-analysis methods. He is currently on the Board of Directors for the Clinical Research Data Alliance to improve how we share data within the scientific community.

Tyler is a life sciences management consultant at PA Consulting with a focus on digital health. His expertise spans the areas of strategic thinking, operating model design, process improvement, financial analysis, and project management. He’s consulted to organizations of varying size and complexity, ranging from Fortune 15 companies to boutique biopharmaceutical labs. Most recently, Tyler led a non-profit initiative managing a team of 40 digital health professionals from 15 pharmaceutical companies towards a goal of further enabling and accelerating the global use of digital health technologies in clinical research.

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. 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.

Former FDA Expert Statistical Consultant. Research applications include clinical trials, genomics, surveys, malaria prevention; environmental, health and public policy. Methods research emphases include Bayesian modeling, the analysis of observational studies, research synthesis and surveys. Honors and awards include President and also Honorary Life Member of the International Biometric Society; elected member of the International Statistical Institute; Fellow of the American Statistical Association, of the American Association for the Advancement of Science, of the Institute of Mathematical Statistics; an honorary degree from Hasselt University, Belgium.

Dr. Veronica Miller, ED of the Forum for Collaborative Research, and Professor at UCB SHP is a leading expert in regulatory science, engaging stakeholders from both sides of the Atlantic to advance the development of therapeutics and diagnostics for unmet medical need. The Forum collaborative model covers HIV, HCV, HBV, transplantation associated viral infections, NASH, PSC, and Rare Diseases. She teaches graduate courses in regulatory science and drug development. Previously, she directed the interdisciplinary HIV Research Group at the JW Goethe University in Frankfurt, Germany. Dr. Miller obtained a PhD in Immunology from the University of Manitoba, Canada. Dr. Miller has over 100 peer-reviewed publications.

Dr. Tremmel worked in the pharmaceutical industry for over 25 years, where he built and led highly effective groups of statisticians, programmers, and data managers. He is currently the VP of Quantitative Clinical Sciences and Reporting at CSL Behring. Recent appointments include Statistical Head for Astra Zeneca’s Diabetes Portfolio, and VP of Statistics and Programing at Incyte. Dr. Tremmel provided technical leadership for >10 successful new drug applications and label extensions in the areas of CNS/Pain, Oncology, digestive / metabolic disease, and orphan diseases. Dr. Tremmel holds a Ph.D. from the university of Giessen, Germany, and he an active contributor to the DIA Safety Statistics Working group.

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'.

Mike Crutchlow is an endocrinologist who has been in clinical research at Merck & Co. for the past 13 years. For the past 5 years, he has been in the late-stage clinical research group where he has served as the clinical and overall development team leader for multiple product development teams, including current oversight of a NASH development program.

Lisa Lupinacci holds a B.S. in Mathematcis from Villanova Univeristy and M.S. and Ph.D. degrees in Statistics from Virginia Tech. She is currently the Senior Vice President of Biostatistics and Research Decision Sciences at Merck. In this role, she has oversight for end to end statistical, epidemiology and health economics support for all of Merck's product development. During her 25 year career, Lisa has worked on multiple products in the vaccine, oncology and infectious disease areas. She has spent 21 years as a statistician and 4 years as a drug development team leader for several large infectious disease programs, an opportunity which gave her a much broader knowledge of drug development and much deeper insights into leadership.

Dr. Yong Ma joined the FDA as a mathematical statistician in 2015 and she became a Team Lead in 2020. She obtained her doctorate degree in Biostatistics from the George Washington University. Before Joining the FDA, she worked as an assistant research professor at George Washington University and her work was mostly on diabetes prevention studies which lead to numerous publications. After joining the FDA, she has been focusing on methodology tailored for post-marketing safety study such as causal inference and meta-analysis. In addition to her regulatory review work, she is also actively engaged in contemporary methodology research such as machine learning and natural language processing.

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.

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.

Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). Greg co-leads, with Mary Nilsson and Scott Proestel, the PHUSE Safety Analytics working group; he established (with Bill Wang) the ASA Biopharm Safety Monitoring working group; and he pioneered the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group.