Dr. Fairouz Makhlouf is the deputy director for Division VIII in the Office of Biostatistics, Office of translational science, Center for Drug Evaluation and Research, FDA. Since joining FDA in 2006, Fairouz focuses in providing support for research and regulatory evaluation of generic drug product. Fairouz received her Ph.D in Mathematical Statistics from American University, Washington D.C. in 2005.

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.

Hye Soo Cho is a statistician in the Office of Biostatistics at CDER/FDA. She has regularly been involved in the review of IND/BLA/NDA applications. In addition to review work, she has been involved with the standardization of programs for data analysis, the development of a R Shiny application, and digital health technology and rare disease working groups. Hye Soo graduated from UC Berkeley with a bachelor’s degree in Statistics. After 3 years of working as a financial analyst, she realized her passion was in public health, and she returned to school to obtain her MS degree in Biostatistics from Northwestern University.

Mallorie has been with FDA CDER’s Office of Biostatistics since 2016. She is a statistical team leader supporting the Office of Oncologic Diseases. She received her PhD in Biostatistics from the University of Arizona and BS in Statistics from UCLA. In addition to her review work, Mallorie’s research interests include estimands, statistical analysis of patient-reported outcomes in cancer trials, and missing data.

Shanti Gomatam is a senior Mathematical Statistician in FDA/CDER. She currently works for the division that assesses quantitative safety. She has over 29 years of experience in academic and regulatory environments, of which almost 20 years have been with the FDA. Her experience at the FDA covers both CDER and CDRH, efficacy, safety, therapeutics and diagnostics. She received her Ph.D. from Florida State University. Her statistical interests span a range of topics, she has been focusing on the estimand framework recently.

Lisa is a member of the Statistical Methodology group at Novartis and is based in Basel. Prior to joining the pharmaceutical industry, Lisa was a Lecturer in Statistics at Lancaster University, and held a UK Medical Research Council Career Development Award in Biostatistics. Her research interests are in clinical trials, including group sequential tests, adaptive designs for treatment selection, and Bayesian approaches for early phase dose-escalation trials. More widely, she is interested in developing approaches for leveraging existing information in trials, extrapolation, and methods to evaluate the probability of success of a drug development program. Lisa holds a PhD in Statistics from the University of Bath.

Karen Higgins has worked at FDA/CDER for over 20 years and is currently a supervisory mathematical statistician supporting the Office of Immunology and Inflammation. She received her doctorate in biostatistics from Harvard University, School of Public Health.

Dr. Dalong Huang has been with FDA CDER’s Office of Biostatistics since 2015. He is statistical team leader supporting cardiac safety study reviews. Dr. Huang has been very active in regulatory science research with multiple publications and conference presentations related to statistical issues in cardiac safety studies. Prior to FDA, Dr. Huang has more than 8 years of pharmaceutical industry experience in diabetes, CNS, and cardiovascular therapeutic areas. He obtained his Phd in statistics from the George Washington University.

Renee Iacona is the Vice President of Oncology Biometrics at AstraZeneca where she is in her 23rd. year. Renee has led or been involved in various Cross Pharma Oncology statistical initiatives including issues related to Non-Proportional Hazards in Oncology drug development and sensitivity analysis methods related to Progression-Free Survival. Renee serves on Cytel Innovation Advisory Board, Vanderbilt University Graduate School Board and the University of Tennessee Foundation Board. She received her PhD and MPH from Vanderbilt University.

Venkat is Head of Biometrics and Data Sciences at BMS. Prior to BMS, Venkat was a partner at ZS, a mngt consulting firm, where he led R&D clinical services. Prior to ZS, Venkat held leadership roles at BMS, Novartis Onc. and GSK. Venkat joined BMS in 2012 leading the early dev. biometrics and in 2016, took responsibility for the specialty pipeline, leading early and late stage biometrics. Prior to BMS, Venkat led the biometrics at Novartis Onc, and was involved with several dev. programs including Tasigna and Affinitor. Venkat has a PhD in Statistics from Temple Univ. and an MBA from Wharton Business School. Venkat is a member of Statistical and Data Science community and has served on the board of Biopharm. Section of American Stat Assoc.

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. 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.

Lisa Wruck is Associate Professor of Biostatistics and Bioinformatics at Duke School of Medicine and founding Director of the Duke AI Health Data Science Fellowship Program. In her work at Duke Clinical Research Institute, Dr. Wruck leads statistical teams in multi-center studies with a focus on analysis of cognitive outcome data. She is currently PI of the Statistics Core for the NINDS-funded Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY (DISCOVERY) study and leads the Statistics Core for MarkVCID, an NINDS-funded consortium with the mission of identifying and validating biomarkers for the small vessel diseases of the brain that produce vascular contributions to cognitive impairment and dementia.

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. 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.

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.

Alexei C. Ionan is a Senior Mathematical Statistician in the Division of Biometrics IX of the Office of Biostatistics, supporting application review in the Office of Oncologic Diseases at the FDA. He has been evaluating, developing, and applying statistical methods in oncology since 2003. He leads multiple groups at the FDA. His research interests include Bayesian methods, estimands, decision theory, causal inference, predictive biomarkers, early detection of cancer, and optimal design.

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.

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. Selena Daniels serves as a Team Leader in the Division of Clinical Outcome Assessment at the Food and Drug Administration (FDA). She leads a team of expert analysts who provide consultation and advice on clinical outcome assessment (COA) endpoint development and validation, including considerations for clinical trial design, conduct, analysis, interpretation, and reporting for regulatory determinations of medical product benefit. Prior to joining the FDA in 2015, Dr. Daniels worked in the Health Economic and Outcomes Research (HEOR) group at Allergan, Inc for almost five years, where she developed and executed HEOR strategies, as well as developed and implemented innovative COA strategies and endpoints for clinical trials.

Marc Vandemeulebroecke joined Novartis in 2006. He has been supporting development programs in early and late phase development across various disease areas as statistician and pharmacometrician. Currently he is Global Group Head in Immunology. He received the Gustav-Adolf-Lienert award from the German Region of the International Biometric Society (IBS) for his PhD thesis, which focused on adaptive designs. He co-authored various scientific publications and one R package, and has been teaching on group sequential and adaptive designs as well as statistical graphics. Marc's current interests include machine learning and regulatory statistics.

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.

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.

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.

Clinical team leader in the Division of Pulmonology, Allergy, and Critical Care within the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research. Received M.D. at the University of Maryland and completed internal medicine residency and fellowship in Allergy and Clinical Immunology at The Johns Hopkins School of Medicine. Assistant Professor at The Johns Hopkins School of Medicine and a practicing allergist.

Daniel Rubin joined the Food and Drug Administration as a statistical reviewer in 2009. He has mainly focused on the design and analysis of clinical trials to evaluate the safety and efficacy of anti-infective drugs. He has worked on the development of multiple FDA guidance documents, including the Agency’s 2021 revised draft guidance on adjusting for covariates in randomized clinical trials.

Ben Saville is a Director & Senior Statistical Scientist for Berry Consultants, where he specializes in the design of innovative Bayesian adaptive clinical trials. He works primarily with medical device companies, pharmaceutical companies, and academic investigators to solve challenging problems via Bayesian designs, many of which are reviewed by the U.S. Food and Drug Administration (FDA). Dr. Saville has authored approximately 100 peer-reviewed publications in the statistical and medical literature, with expertise in Bayesian hierarchical models and Bayesian adaptive platform trial designs.

Jaejoon Song, MS, PhD is a Senior Statistical Reviewer at the Division of Biometrics VII, Office of Biostatistics, in the FDA’s Center for Drug Evaluation and Research. He provides statistical reviews for a wide range of drug safety studies during the pre- and post-marking stages. He received his PhD in Biostatistics at the University of Texas School of Public Health and postdoctoral training at the University of Texas, MD Anderson Cancer Center.

James Travis is a lead mathematical statistician in the Division of Biometrics II in the Office of Biostatistics in CDER leading the team supporting the Division of Pediatric and Maternal Health. James joined the Agency in 2014 following completion of his PhD at the University of Maryland, Baltimore County. He is a representative on the Pediatric Review Committee for the Office of Biostatistics. He has interests in Bayesian methods, particularly the use of informative priors in pediatric clinical trials.

Dr. Mengdie Yuan is a senior statistical reviewer in the Office of Biostatistics at the Center for Drug Evaluation and Research at the Food and Drug Administration. Dr. Yuan joined FDA in 2014, and has many years of experience in regulatory science, including the design and evaluation of clinical trials for cancer drugs, generics and biosimilar products. She has contributed to FDA guidance development and won the 2019 FDA Outstanding Service Award. Dr. Yuan earned her Ph.D. degree in Statistical Science from George Mason University. Her research interest includes adaptive designs, survival analysis, semiparametric modeling, and equivalence testing.

Lili Garrard is a statistical reviewer on the Clinical Outcome Assessment (COA) Statistical Support Team at the Division of Biometrics III, Office of Biostatistics (OB), Office of Translational Sciences (OTS), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Garrard primarily supports the Division of Gastroenterology and Inborn Errors Products (DGIEP) by providing statistical consultations and reviews related to the use of COAs. Dr. Garrard joined the FDA in 2016 from the University of Kansas Medical Center where she received a PhD in Biostatistics.

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'.

Dr Olivier Collignon works as Associate Director at GSK in the United Kingdom where he contributes to the development of clinical trials for immune-inflammatory diseases. He holds a PhD in Applied Mathematics and is especially interested in basket, umbrella and platform trials, use of historical controls and clinical prediction models. He previously worked as a biostatistician in France and Luxembourg for 16 years. During his mission at the Luxembourg Institute of Health he was seconded at the European Medicines Agency in London for 4 years, where he gained regulatory experience and participated to the scientific evaluation of the design and results of clinical trials to obtain marketing authorization of new drugs in Europe.

Jacqueline Corrigan-Curay, JD, MD, serves as Principal Deputy Center Director in the Center for Drug Evaluation and Research, FDA. Dr. Corrigan-Curay provides executive leadership on strategic initiatives that advance CDER's mission to deliver safe, effective and high-quality medications including serving on executive governance committees and overseeing policy development on real world evidence, prescription drug promotion, clinical trial oversight and innovative trial design.

After many years as an industry statistician, Susan joined FDA in 2018 and is now a Senior Mathematical Statistician reviewer in CDER, assigned to pulmonary, allergy and critical care indications. Susan’s interests in estimands, safety and benefit-risk assessment, and graphics have a common thread and focus: addressing the question of scientific interest, to make clear and precise decisions aligned with the clinical goals of the program by using structured thinking and framing during drug development and reporting, for the benefit of public health.

Melvin S. Munsaka is a Senior Director and Head of the Safety Statistics at AbbVie in the Statistical Sciences and Analytics Department. He has a PhD in Mathematical Statistics from Queen’s University in Canada. He has been in the industry for more than 25 years. He co-leads the DIA Bayesian Scientific Working Group Safety Subteam and the ASA BIOP Section Safety Scientific Working Group Methodology Sub-team, and some initiatives of the PHUSE Safety Analytics and the Data Visualization and Open-Source Technology Working Groups. He is the Publicity Chair of MBSW and an Editorial Board Member of Contemporary Clinical Trials and a lecturer at the University of Chicago Graham School.

Matt Psioda is Head of Statistical Innovation for Oncology and Vaccines within GSK’s Statistics and Data Science Innovation Hub. In that role, he leads a small team of statistical consultants to support use of innovative study designs and advanced statistical methods in GSK studies. His group works on a variety of applied and methodological research problems. Examples include extrapolating information on treatment effectiveness from adult to adolescent/pediatric settings, design and analysis of clinical trials with hybrid or external control arms, and design and analysis of adaptive basket and/or platform trials. Prior to joining GSK, most recently Matt was on the faculty in the Department of Biostatistics at UNC.

Dr. Ying Yuan is Bettyann Asche Murray Distinguished Professor and Deputy Chair in the Department of Biostatistics at University of Texas MD Anderson Cancer Center. Dr. Yuan is an internationally renowned researcher in Bayesian adaptive clinical trial design. He published over 200 papers on top statistical and medical journals, and is the leading author of two books published by Chapman & Hall: “Bayesian Designs for Phase I-II Clinical Trials” and “Model-Assisted Bayesian Designs for Dose Finding and Optimization”. Dr. Yuan was elected as an American Statistical Association (ASA) fellow. He also serves as the Chair of Data Safety Monitoring Board (DSMB) at MD Anderson Cancer Center.

Dr. Zhu received his Ph.D. in Statistics from the University of Virginia in 2010 and subsequently completed postdoctoral training in Dr. Hongyu Zhao's Lab at Yale University. In 2012, he joined UTHealth and was promoted to tenured Associate Professor. Currently, he is a Director in the Statistical Innovation Group at AbbVie Inc. In this role, he offers strategic, innovative thinking and develops novel statistical methodology for various Therapeutic Areas, including Immunology, Oncology, and Eyecare. His primary research focuses on adaptive clinical trial designs aimed at achieving efficient and ethical objectives. He is an Elected Member of the International Statistical Institute (ISI).

Donna Boyce is Senior Vice President of Global Regulatory Sciences and a member of the Pfizer Research and Development (PRD) Leadership Team. She joined Pfizer in May 2013 as the Vice President, Global Regulatory Affairs, Vaccine. In her current role, Donna is responsible for the global regulatory strategy, regulatory operations, U.S. advertising & promotion and global regulatory policy and intelligence for Pfizer’s Drug and Vaccines Portfolio.

Dr. Roberto Crackel has been with the FDA/OB/DBII since 2015, and is currently working with the Diabetes, Lipids, Obesity, and General Endocrinology team. He received his M.S. in Biostatistics from UCLA and completed his PhD in Applied Statistics from UC Riverside. His research interests include Missing Data, Bayesian Statistics, and Extrapolation in pediatric T2DM.

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.

I graduated from University of New Mexico and hold a PhD degree in statistics. I have been working as a clinical trial statistician for more than 6 years in pharmaceutical industry. My experiences are mainly in oncology, especially the trials for solid tumors from phase 1 to phase 3. Currently I am gratefully working at AstraZeneca as a statistical science associate director.

Dave is the Chief Science Officer at Unlearn, overseeing the Clinical Affairs, Regulatory, Clinical Applications and Clinical Methods function. He has expertise in prognostic models, clinical trials, observational studies, and diagnostic devices. Prior to joining Unlearn, Dave was Head of Biostatistics & Epidemiology for Verily Life Sciences. Other past roles include Lead Program Biostatistician at Genomic Health and Sr Dir of Medical Affairs Statistical Analysis at ICON Clinical Research. Dave received his bachelors and masters in Statistics from Carnegie Mellon. He has co-authored over 100 peer-reviewed papers in medical journals.

David Paulucci is Director of Data Science in the Department of Global Biometrics and Data Sciences at Bristol Myers Squibb. In his role, David is responsible for conducting exploratory analyses, and developing statistical learning models to support global drug development in oncology. Prior to working at BMS, he spent 3 years at Mount Sinai Hospital, carrying out analyses leading to more than 20 publications on surgical outcomes for localized kidney and prostate cancer. David received his MS in Biostatistics from the Icahn School of Medicine at Mount Sinai. His key areas of interest include supervised machine learning, and predictive modeling of heterogenous treatment effects.

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. 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.

Sarah Yim, M.D. has been the Director of the Office of Therapeutic Biologics and Biosimilars, in CDER's Office of New Drugs (OND), FDA since 2019. Prior to that, she spent 2 years as Director of the Division of Clinical Review in the Office of Generic Drugs, and 11 years in various roles in rheumatology drug review in OND. She received her undergraduate degree from Stanford University, her Doctor of Medicine degree from the Uniformed Services University of Health Sciences, and completed a postdoctoral fellowship in rheumatology at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), at the National Institutes of Health.

Monica Morell is a statistical reviewer on the Patient-Focused Statistical Support (PFSS) Team at the Division of Biometrics III, Office of Biostatistics (OB), OTS, CDER, FDA. Dr. Morell’s team provides statistical and psychometrics reviews on the development and use of clinical outcome assessments (COAs) across multiple therapeutic areas. Prior to joining FDA, Dr. Morell was a clinical research coordinator at the Sylvester Comprehensive Cancer Center’s Department of Radiation Oncology. Dr. Morell received a PhD in Measurement, Statistics, and Evaluation from the University of Maryland, and both an MSE degree in Research, Measurement, and Evaluation and a BA degree in Psychology from the University of Miami.

Dr. Bullock is currently a Senior Vice President in the Integrated Drug Development (Consulting) Division of Certara. She has over 20 years of drug development experience and is a recognized drug development scientist with scientific and regulatory expertise focused in the therapeutic areas of oncology/hematology. Julie has been working in the oncology dose finding space since 2013 and is a recognized Key Opinion Leader. She has provided risk-assessment and tactical dose justification support for over 80 early and late-stage oncology assets since the launch of Project Optimus in 2022. Prior to Certara, Julie was at FDA/CDER for 10 years and had roles as reviewer and team leader in Oncology/Hematology Clinical Pharmacology .

Dr. Yoonhee Kim is a team lead of the Diabetes statistical team in the Division of Biometrics II of the Office of Biostatistics, at the Center for Drug Evaluation and Research at US Food and Drug Administration. Dr. Kim has over 15 years of industry and government experiences for research and regulatory review works with applied statistical methods. Over the years at FDA, Dr. Kim made substantial contributions for regulatory reviews with her expertise of linear model, missing data analysis, and survival analysis. Her interests include Bayesian borrowing analysis, estimands, clinical outcome assessment and digital health technology analysis for evaluating the efficacy of pre-market anti-diabetic drugs.

Lily Mulugeta is th Associate Director for Policy and Research in the Division of Pediatrics and Maternal Health at the FDA. She engages in scientific and regulatory review and research related to pediatric drug development. Dr. Mulugeta serves as a representative for the Division on the FDA Pediatric Review Committee (PeRC). Prior to joining the Division in 2017, Lily was the Scientific Lead for Pediatrics in the Division of Pharmacometrics at the FDA. Prior to joining the FDA, Dr. Mulugeta practiced as a Critical Care Specialist at Children’s National Medical Center (CNMC) in Washington D.C. She also served as a faculty member in the Department of Pediatrics at the George Washington School of Medicine and in the Department of Pharma

Steve Ruberg has spent over 40 years in the pharmaceutical industry in many leadership and technical roles. He is a Fellow of the American Statistical Association and an elected Fellow of the International Statistics Institute. He retired from Lilly as a Distinguished Research Fellow and is an Adjunct Professor of Statistics at Purdue University. He has served on or led many industry and professional society committees, including being a Deputy Chair of the ICH-E9 Expert Working Group. He served on an Advisory Committee to the US Secretary of HHS for the use of electronic medical records. He has published widely on many topics of importance to drug development in both statistical and scientific journals.

Dr Fürst-Recktenwald is a Principal Medical Director in the Personalized Health Care (PHC) Safety Interface team within Roche. Her team works to better understand patient-centric drivers of response to optimize the benefit/risk balance. She is a board-certified pediatrician with specialty in pediatric diabetology. With over 20 years of experience in drug development, including strategic roles in both early and late clinical research and medical affairs. She has a broad experience in the management of international pediatric trials, served as EFPIA representative on the ICH E11 guideline update from 2013-2017 and serves as EFPIA representative on the ICH E11A pediatric extrapolation guideline, currently in Step 2B (consultation closed).

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.