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. Lin joined the Division of Biostatistics at Center for Biologics Evaluation and Research (CBER), US FDA in 2011 as a Mathematical Statistician with special focus on Adaptive Designs. In her current role, Dr. Lin performs critical statistical reviews of regulatory pre-marketing submissions to the Office of Tissues and Advanced Therapies (OTAT) and provides statistical trainings to non-statisticians within CBER. She supervises the FDA interns in conducting biostatistical methodology researches in the area of adaptive designs that are related to CBER regulated biologics products and medical devices.

Dr. Jingyu (Julia) Luan is a Senior Director of Global Regulatory Affairs in AstraZeneca, leading global drug development and regulatory strategies as well as innovative regulatory initiatives, eg, RWE. Prior to AstraZeneca, she worked at FDA for 13 years and held positions with increasing responsibilities, including Statistical Reviewer, Team Leader, and Acting Deputy Division Director. She had extensive experience in multiple therapeutic areas for both new and generic drugs. In addition, she was a research faculty member at Johns Hopkins University and a statistical consultant at the University of Kentucky. Dr. Luan is President-elect of Chinese Biopharmaceutical Association and Board Member/Committee Co-chair of FDA Alumni Association.

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.

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.

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).

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.

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.

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. Yan Wang has over 10 years research experiences in the general area of pharmaceutical sciences, with special expertise in complex drug delivery systems, such as polymeric microspheres/implants. She is currently the Scientific Lead for long acting drug products in the Office of Research and Standards, Office of Generic Drugs. She is involved in developing scientific policy relating to generic drug development and review for a variety of complex formulations. Dr. Wang is also heavily involved in GDUFA funded research projects focusing on the development of proper scientific tools to facilitate setting proper standards for evaluation of complex drug products.

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.

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.

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.

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.

Elias Bareinboim is an assistant professor in the Departments of Computer Science and Statistics at Purdue University. His research focuses on causal and counterfactual inference and their applications in data-driven sciences. He received a Ph.D. in Computer Science from UCLA advised by Judea Pearl. Bareinboim's work was the first to propose a general solution to the problem of “data-fusion” and provides practical methods for combining datasets generated under different experimental conditions. His recognitions include NSF CAREER Award, IEEE AI’s 10 to Watch, the Dan David Prize Scholarship, and the 2014 AAAI Outstanding Paper Award

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.

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.

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.

Cyrus Hoseyni, Ph.D. is Global Head of Statistics and Decision Sciences at Janssen Research & Development, Pharmaceutical Companies of Johnson & Johnson, leading a diverse team of talented leaders supporting Discovery, Early Development & Translational Medicine, Late Development, Medical Affairs, Manufacturing, advanced Modeling & Simulation and Statistical Methodology. Prior to joining Janssen R&D in 2015, Cyrus held senior leadership positions in Quantitative Sciences at Novartis, where he was responsible for the development and leadership of multi-functional organizations, integrating statistical and quantitative drug development sciences to support model-informed drug development and decision-making.

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.

Senior Director at GSK with over 20 years of clinical trials experience including 14 global submissions, regulatory interactions and advisory committee meetings at Pharma. Applied innovative and creative thinking in Bayesian meta analyses, finding optimal combinations in cancer drug development, competing risks, consulted with external thought leaders. Has provided administrative and technical direction and leadership to statisticians for 15 years. Responsible for critical global submissions with experience in ODAC, Oral Explanation and other regulatory interactions, approval and launch worldwide for a novel agent in Multiple myeloma.

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.

Dr. Shenghui Tang is team leader for the Division of Oncology Products 1 (Breast, Gynecologic/Supportive care, Genitourinary) in the Division of Biometrics V of the Office of Biostatistics, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Prior to becoming team leader he was a primary reviewer for Investigational New Drugs and New Drug Applications reviewed in the Office of Hematology and Oncology Products. He received his PhD from the University of Iowa. Dr. Tang has been with the FDA since 2003 and has expertise in the design and analysis of oncology trials.

Ram C. Tiwari received his MS and PhD degrees from Florida State University in Mathematical Statistics; he is a Fellow of the American Statistical Association, and a past President of the International Indian Statistical Association. He has published 200+ research papers on a wide range of statistical topics.

Matt Downs joined Statistics Collaborative, Inc. (SCI) in 1996. Since 1999, he has served as the independent reporting statistician to DMCs for multinational Phase 2 and 3 trials in a variety of indications. Matt received his MPH in Epidemiology and Biostatistics from the University of California, Berkeley.

Dr. Scott Evans is a Professor and Founding Chair of the Department of Biostatistics Bioinformatics and the Director of The Biostatistics Center at George Washington University. He is the: Director of the SDMC for the Antibacterial Resistance Leadership Group (ARLG); PI of the Coordinating Center for the ENICTO Consortium; Co-Chair of the Benefit-Risk Balance for Medicinal Products Working Group of the Council for International Organizations of Medical Sciences (CIOMS); and Editor of a mini-Series on DSMBs for the NEJM Evidence. He is a recipient of the Mosteller Statistician Award, the Zackin Distinguished Collaborative Statistician Award, the ASA's Founders Award, and is a Fellow of the ASA, SCT, ISI, and the IDSA.

Dr. Christopher Granger is a Professor of Medicine in the Division of Cardiology at Duke University and Director of the Cardiac Care Unit for the Duke University Medical Center. He has served on FDA advisory committees on an ad hoc basis. He is on the Board of External Experts of the National Heart, Lung and Blood Institute (NHLBI). Dr. Granger’s primary research interest is in the conduct and methodology of large randomized clinical trials in heart disease; he has co-authored more than 500 peer-reviewed manuscripts. He currently serves on a number of clinical trial steering committees and data safety monitoring committees.

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.

Janet Wittes is President of Statistics Collaborative, a company that consults on design of clinical trials. She has participated in many Data Safety Monitoring Committees for government and for industry. Her research deals with statistical monitoring of 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.

Kelley M Kidwell, PhD, is an associate professor of Biostatistics at the University of Michigan School of Public Health. Her methodological focus is on the design and analysis of sequential, multiple assignment, randomized trials (SMARTs) and she is the PI of a PCORI funded methodology grant applying SMARTs to rare disease research. Collaboratively, she is interested in novel and standard trial design and analysis across a wide variety of settings, especially oncology and other chronic 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.

Mark van der Laan is the Jiann-Ping Hsu/Karl E. Peace Professor of Biostatistics and Statistics at the University of California, Berkeley. He has made contributions to survival analysis, semiparametric statistics, multiple testing, and causal inference. He also developed the targeted maximum likelihood methodology and general theory for super-learning. He is a founding editor of the Journal of Causal Inference and International Journal of Biostatistics.

Robert Lionberger, Ph.D. serves as Director of the Office of Research and Standards (ORS) in the Office of Generic Drugs (OGD). Dr. Lionberger leads OGD’s implementation of the GDUFA science and research commitments including internal research activities and external research grants and collaborations to ensure the therapeutic equivalence of generic drug products. ORS also provides pre-submission advice on complex generics through pre-ANDA meetings, product specific guidance and correspondence responses. He received his undergraduate degree from Stanford University in Chemical Engineering, and a PhD from Princeton University in Chemical Engineering.

Dr. Rothmann (Mark) is the Director of the Division of Biometrics II. He earned his Ph. D. in Statistics at the University of Iowa in 1990. He then spent the next nine years as a professor at various universities before coming to the FDA in 1999. At the FDA, when he was a reviewer and team leader he was involved in the review on Oncology, Hematology, and Metabolism and Endocrinology products. He has done research in several areas involving the design and analysis of clinical trials and co-authored the book Design and Analysis of Non-Inferiority Trials. He leads three Office of Biostatistics Working Groups and Committees in Bayesian Analysis, Drug Trials Snapshots and Pediatric Studies and has serves on many other groups.

Kapil Sen serves as a Global Project Biostatistics Head at Novartis. In this role, he has been collaborating with cross-functional teams to build and execute the clinical development programs for CAR-T therapies. Recent interests include application of Estimand framework in guiding suitable designs for clinical trias. He received his Ph.D. from NC State University and has been working in the pharmaceutical industry since 2001.

Dr. Summar is well-known for his pioneering work in caring for children diagnosed with rare diseases. He joined Children’s National in 2010 from Vanderbilt University. At Children’s National he leads the Division of Genetics and Metabolism, currently the largest known clinical division seeing over 8000 patients a year with rare diseases. Dr. Summar’s laboratory works on both devices and treatments for patients with genetic diseases and adapting knowledge from rare diseases to mainstream medicine. His work has resulted in new drugs in FDA trials for patients with congenital heart disease. His laboratory is best known for its work in the rare diseases affecting nitrogen and ammonia metabolism.

Marc L. Berger, MD, is a retired, part-time consultant who serves on the advisory boards of several companies. Until July 2017, he was Vice President, Real World Data and Analytics at Pfizer, Inc. During his career in industry, he has been involved with all aspects of drug development and commercialization including the design and execution of Phase 2/3/4 clinical trials, real world data studies, and market access strategies. Marc has written or co-written more than 100 peer-reviewed articles, book chapters, and other publications on a range of topics including health services research, outcomes research, health economics, and health policy.

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.

Lucas Kempf, MD works as a regulatory consultant for CNS drugs and Rare Diseases. He has 8 years of experience in drug review, development, and regulatory experience at the U.S. Food and Drug Administration most recently in the role of Associate Director of Rare Diseases in CDER. He was responsible for all Divisions performing the scientific review and evaluation of rare disease therapeutic drugs and biologics subject to regulation by the CDER/OND. He has strong knowledge of review and development of small molecules and biologics targeting the central nervous system.

Sarfaraz Niazi, Ph.D., is Adjunct Professor of Biopharmaceutical Sciences, an author of 50+ books, 100+ research papers, and 100+ patents on new drugs, formulations, demonstrating analytical and biological equivalence of products have globally affected the regulatory guidance for generics and biosimilars. His petition to FDA to substitute bioequivalence testing with more robust in vitro and in silico methods was accepted by the FDA, in part. His petition on removing FDA guidance on establishing analytical and clinical similarity resulted in withdrawal of a pivotal guidance and the FDA has proposed a new Biosimilars Action Plan that includes recommendations made by Niazi.

Melanie Quintana is a Director of Consulting and Senior Statistical Scientist at Berry Consultants, LLC. She is an expert in utilizing Bayesian statistics to design innovative clinical trials and answer complex clinical questions across a wide range of therapeutic areas. At Berry Consultants, she collaborates with a wide range of clinical experts to find the best solution for answering complex clinical questions and mentors and oversees a group of consultants to do the same. Her work includes the design of over 100 innovative clinical trials in a wide range of therapeutic areas including adaptive designs, platform trials & statistical innovation in rare disease and unmet medical needs.

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. James Harnett is the Executive Director for HEOR for Oncology/Hematology at Regeneron. Prior to this, Dr. Harnett worked at Pfizer for over 20 years, most recently as the Lead in Global Medical Epidemiology for Oncology and Vaccines helping to establish external control arms and generate epidemiological data for COVID-19 vaccine and antiviral programs. Dr. Harnett supported establishing the RWDnA function at Pfizer in 2012, which facilitated Pfizer's first regulatory RWE submission and label expansion for Ibrance and a more recent publication on regulatory use of RWE in the autoimmune space. As a prior Team Lead in HEOR, he established the first long-term research payer partnership with Humana and advanced the first payer rPCT.

Dr. Robert Temple serves as CDER’s Deputy Center Director for Clinical Science and Senior Advisor in the Immediate Office of the Office of New Drugs (OND). Bob is a consultant to the OND director on matters related to clinical program objectives. Dr. Temple received his MD from the NYU School of Medicine in 1967. In 1972, he joined CDER as a Medical Officer in the Division of Metabolic and Endocrine Drug Products. He later moved into the position of Director of the Division of Cardio-Renal Drug Products.

Steffen Unkel obtained an MSc in Statistics at the London School of Economics & Political Science. He holds a PhD in Statistics from the Open University in Milton Keynes (United Kingdom). At present he is a member of the Department of Medical Statistics at the University Medical Center Göttingen in Germany. His research interests include the analysis of time-to-event data, multivariate methods and computational statistics.

Pujita Vaidya serves as a Global Regulatory and R&D Policy Director at Amgen, working to develop, advocate for, and implement Amgen positions on regulatory policies (e.g., Patient Centricity, Pediatrics, and Innovative Trials). Her work includes partnering with cross-functional colleagues across Amgen to advance strategic regulatory policy plans, as well as engaging with regulatory authorities, industry, professional associations, and other stakeholders. Prior to Amgen, Pujita had over a 7-year tenure at FDA where she served as the CDER's expert to advise FDA leadership, lead initiatives, and provide strategic, regulatory, programmatic, and policy assistance to facilitate the incorporation of patient input into regulatory decision making.

Kyle has diverse experience in academia, consulting & industry. He is currently a Director of Model Based Drug Development at Jansen R&D for 9 years. Prior to that, he was at M.D. Anderson Cancer Institute where he had been for +10 years. He has also designed and implemented software for novel Bayesian designs.

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. Stella Grosser has over 25 years of experience in statistical consulting, biostatistics, and biomedical research. Since 2015, she has been division director of the division of biometrics VIII in FDA/CDER, which conducts statistical reviews of abbreviated new drug applications as well as carrying out related research as part of CDER's generic drug program. She has worked as a reviewer and team leader across multiple therapeutic areas in CDER. Prior to joining FDA, she was an adjunct assistant professor of biostatistics at UCLA.

Mr. Martin Ho was the Associate Director of Quantitative Patient Inputs & Real-World Patient Evidence at Office of Biostatistics & Epidemiology, CBER, FDA. Prior, he was the Director of Quantitative Innovation at Center for Devices, turning new data sources into regulatory-grade evidence for decision making, e.g., developing good review practices and review capacity for patient preference information and clinical outcome assessments. He was building Real-World Performance component of Digital Health Program. Mr. Ho was President of FDA Statistical Association (2016). He was elected as Chair (2020) of American Statistical Association (ASA) Medical Device & Diagnostic Section and co-leads the ASA Real-World Evidence Scientific Working Group.

David Martin leads Global RWE for Moderna. Previously he completed 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 Real World Evidence group in the Office of Medical Policy to drive the agency's scientific, guidance, and submission review responses to the RWE provisions of the 21st Century Cures Act. He initiated key RWE pathfinding efforts with external stakeholders including RCT Duplicate and the open-source FDA MyStudies mobile application. He holds an MD and MPH from Johns Hopkins and is board certified in occupational & environmental medicine as well as clinical informatics.

Dr. Peter Stein, M.D., is the Director of CDER’s Office of New Drugs (OND). OND is responsible for the regulatory oversight of investigational studies during drug development and decisions regarding marketing approval for new (innovator or non-generic) drugs, including decisions related to changes to already marketed products. OND provides guidance to regulated industry on a wide variety of clinical, scientific, and regulatory matters.

Elizabeth (Nicki) Bush is Associate Vice President and Head of Patient-Focused Endpoints and Measurement at Eli Lilly and Company, responsible for the design and implementation of patient-centered measurement strategies to support drug development efforts across Lilly’s portfolio. In this capacity, she and her team advise on the selection, modification and development of clinical outcome assessments (COAs) for use in clinical trials and other research studies, and utilize mixed methods approaches to evaluate the measurement properties of COAs as well as aid in interpretation of the resultant data. Nicki has held patient-centered measurement research and leadership positions in both consultancy and industry.