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DIA/FDA Biostatistics Industry and Regulator Forum


  • William  Wang, PhD

    William Wang, PhD

    • Executive Director, Clinical Safety Statistics, BARDS
    • Merck Research Laboratories, United States

    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 is a deputy topics-leader in the ICH E17 working group on multi-regional clinical trials. Dr Bill Wang was recently elected as a Fellow of American Statistical Association (2018) and received the DIA Global Inspire Award in 2017 .

  • Mouna  Akacha, PhD

    Mouna Akacha, PhD

    • Statistical Methodologist
    • Novartis Pharma AG, Switzerland

    Mouna Akacha is a consultant in the Statistical Methods & Consulting Group of Novartis Pharma AG, based in Basel, Switzerland. In this role she provides internal advice for clinical projects across all development phases and therapeutic areas. Her role also includes training of internal statisticians and collaborations with external statistical centers and researchers. Mouna has a wide range of research interests including topics on missing data, estimands, longitudinal data and recurrent event data. Before joining Novartis, Mouna studied mathematics at the University of Oldenburg in Germany and holds a PhD in statistics from the University of Warwick in the UK.

  • Aloka  Chakravarty, PhD

    Aloka Chakravarty, PhD

    • Acting Director, Office of Biostatistics, Office of Translational Sciences, CDER
    • FDA, United States

    Dr. Chakravarty joined CDER in 1992. She served as an Adjunct Faculty in Depart. of Statistics, Foundation for Advanced Education in the Sciences, NIH. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development and has presented and published widely on it. Dr. Chakravarty received the FDA Award of Merit in 2008 and Dr. Frances O. Kelsey Drug Safety Excellence Award in 2012. She received her PhD in Statistics from Temple University, and M.Stat from Indian Statistical Institute. Dr. Chakravarty is a Fellow of ASA and an Associate Editor of Statistics in Biomedical Research.

  • Jonathan  Haddad, MPH

    Jonathan Haddad, MPH

    • Director, Biostatistics
    • GlaxoSmithKline, United States

    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.

  • Rima  Izem, PhD

    Rima Izem, PhD

    • Biostatistician, Division of Biostatistics and Study Methodology
    • Children’s Research Institute at Children’s National Medical Center , United States

    Dr. Rima Izem is a Senior Mathematical Statistician in the Division of Biometrics 7 at the Center for Drug Evaluations and Research at the Food and Drug Administration. The team of statisticians she leads has expertise in regulatory statistical reviews of post-market drug safety studies. The team also collaborates with other scientists at FDA or the Sentinel community in conducting drug safety studies, evaluating statistical methods, and developing new methods and tools. Dr. Izem has been at FDA for nearly 10 years and her experience in drug review spans pre-market and post-market development across a wide range of therapeutic areas including reproductive health, cardiovascular, analgesia and addiction, anti-infective and antiviral.

  • Min  Lin, MD, PhD

    Min Lin, MD, PhD

    • Mathematical Statistician, Division of Biostatistics, CBER
    • FDA, United States

    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.

  • Dionne  Price, PhD

    Dionne Price, PhD

    • Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER, FDA
    • FDA, United States

    Dionne Price is the Director of the Division of Biometrics IV, Office of Biostatistics in the Office of Translational Sciences, Center for Drug Evaluation and Research, FDA. During her FDA career, Dr. Price has played an active role in the development and application of methodology used in the regulation of a variety of therapeutic areas. Dr. Price received her MS in Biostatistics from the University of North Carolina at Chapel Hill and a PhD in Biostatistics from Emory University. Dr. Price is an active member of the American Statistical Association (ASA) and the Eastern North American Region of the International Biometrics Society. In 2018, she became a Fellow of the ASA.

  • Karen Lynn Price, PhD, MA

    Karen Lynn Price, PhD, MA

    • Senior Research Advisor, Statistical Innovation Center
    • Eli Lilly and Company, United States

    Karen received her Ph.D. in Statistics from Baylor University in 2001, and joined Eli Lilly and Company at that time. She is currently Senior Research Advisor 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 2012, 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. In 2016, Karen was elected a Fellow of the American Statistical Association.

  • Frank W. Rockhold, PhD, MSc

    Frank W. Rockhold, PhD, MSc

    • Professor of Biostatistics
    • Duke Clinical Research Institute, Duke University Medical Center, United States

    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.

  • Nevine  Zariffa

    Nevine Zariffa

    • Vice President and Head Biometrics & Information Sciences
    • Astrazeneca Pharmaceuticals, United States

    After her training at McGill University and at the University of Waterloo, she began her career as a statistician supporting agricultural research before moving to Philadelphia to join SmithKline Beecham in 1991, which went on to become GlaxoSmithKline. She joined AstraZeneca in November 2011 and is currently VP and Head of Biometrics and Information Sciences in Global Medicine Development. She has supported early & late-stage clinical development and marketed products-primarily in the area of Cardiovascular and Metabolism - and has led global teams of experts across many disciplines. Névine has been a statistical Reviewer for The Lancet and is the (co-) author of 25+ publications in peer reviewed biostatistics and medical journals.

  • Kun  Jin, PhD

    Kun Jin, PhD

    • Statistical Team Leader, OB, OTS, CDER
    • FDA, United States

    Dr. Kun Jin is a Statistical Team Leader at the Center for Drug Evaluation and Research, U.S. Food and Drug Administration. His team supports the Division of Neurology Drug Products and conducts statistical reviews and research on regulatory submissions of neurological drug products. Dr. Jin received his B.S. in Applied Mathematics from Anhui University, China, M.S. in Statistics from Beijing University, China, and Ph.D. in Statistics from the University of California, Berkeley. Prior to joining the FDA, he was a faculty member at the University of Pittsburgh School of Medicine.

  • Scott  Komo, DrPH

    Scott Komo, DrPH

    • Mathematical Statistician, Office of Translational Sciences, CDER
    • FDA, United States

    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.

  • Pandurang M Kulkarni, PhD

    Pandurang M Kulkarni, PhD

    • Vice President, Global Biometrics & Advanced Analytics
    • Eli Lilly and Company, United States

    He obtained his PhD in Statistics at the LaTrobe University, Melbourne, Australia. He taught and did research in statistics at the University of South Alabama for10 years attained full professorship. He received grants from the Air Force for the development of techniques to evaluate and study the effects of environmental contaminants. He also received grants from NASA to study the effects of microgravity to see the effectiveness of exercise countermeasures in minimizing the effects of microgravity on astronauts. He joined Eli Lilly in 2000 and has held leadership positions within and outside of Statistics. He has published more than 50 articles in statistics and medical areas in peer reviewed journals.

  • Mark S. Levenson, PhD

    Mark S. Levenson, PhD

    • Director, Division of Biometrics VII, Office of Biostatistics, OT, CDER
    • FDA, United States

    Mark Levenson is the Director of the Division of Biometrics 7 in the Office of Biostatistics/Office of Translational Sciences/Center for Drug Evaluation and Research of FDA. At FDA, he has been the primary reviewer or secondary reviewer on many major pre-market and post-market drug safety problems. He has contributed to the methodology of the application of meta-analysis and propensity score analysis to the regulatory setting. He is active in CDER’s efforts in the Sentinel Initiative, reducing prescription opioid abuse, and real-world evidence.

  • Jingyu (Julia)  Luan, PhD

    Jingyu (Julia) Luan, PhD

    • Statistical Team Leader, OB, OTS, CDER
    • FDA, United States

    Jingyu (Julia) Luan joined the FDA CDER in 2006. She was a reviewer in Division of Biometrics I, and in 2014 she was selected as a Team Leader in Division of Biometrics VIII. Before the FDA, she was a research faculty at Johns Hopkins University. Prior to Hopkins, she was a statistical consultant at University of Kentucky Medical Center, where she received her Ph.D. degree in Statistics. She has received multiple FDA awards, received FDA RSR and ORISE grants, given presentations internally and externally, served in steering committees of international workshops and forums, and organized/chaired many sessions at international conferences.

  • Cristiana  Mayer, DrSc, PhD

    Cristiana Mayer, DrSc, PhD

    • Director, Statistics and Decision Sciences
    • Janssen R&D, United States

    Cristiana Mayer is Director at Statistics and Decision Sciences, at Janssen R&D, Johnson & Johnson, with 20+ years of experience in the pharmaceutical industry. Cristiana is also the Head of the Adaptive Clinical Trials Center of Excellence at Janssen, and Vice-Chair of the DIA Adaptive Design Working Group. After 15 years in Biostatistics where she held roles of increasing responsibility in different therapeutic areas including hematology, neuroscience, immunology, and metabolism, she worked 5 years in Statistical Modeling & Methodology group at Janssen. In 2018 Cristiana has taken a functional management role in the IDV Biostatistics group.

  • Mat  Soukup, PhD

    Mat Soukup, PhD

    • Deputy Div. Director, Div. of Biometrics VII, Office of Biostatistics, OTS CDER
    • FDA, United States

    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.

  • Amy  Xia, PhD

    Amy Xia, PhD

    • Vice President, Biostatistics, Design & Innovation
    • Amgen Inc., United States

    Amy Xia is Vice President, Biostatistics, Design & Innovation at Amgen. Amy has worked on designing, implementing, and analyzing Phase I-IV clinical trials as well as observational studies in the past 22+ years. Currently, she heads up the Biostatistics and Design & Innovation organizations in the Center for Design and Analysis at Amgen, providing leadership and holistic vision for strategic drug development and driving innovative program/study designs 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.

  • Haoda  Fu

    Haoda Fu

    • Senior Research Scientist
    • Eli Lilly and Company, United States

    Dr. Haoda Fu is a research advisor and a stats group leader for Machine Learning, Artificial Intelligence, and Digital Connected Care from Eli Lilly and Company. He is also an adjunct professor of biostatistics department, Indiana university school of medicine. Dr. Fu received his Ph.D. in statistics from University of Wisconsin - Madison in 2007 and joined Lilly after that. Since he joined Lilly, he is very active in statistics methodology research. He has more than 70 publications in the areas, such as Bayesian adaptive design, survival analysis, personalized medicine, indirect and mixed treatment comparison, joint modeling, Bayesian decision making, and drug safety evaluation for rare events.

  • Hana  Lee, PhD

    Hana Lee, PhD

    • Statistical reviewer
    • FDA, United States

    Hana Lee, PhD, is a Biostatistician for the Office of Biostatistics in the Center for Drug Evaluation and Research at FDA. Her primary research interests focus on developing statistical methods for problems relating to the analysis of survival data obtained from cost-effective design, causal inference based on observational data, and clinical research on prescription opioid and AIDS therapies. She is currently working on reviewing post-marketing requirement studies relating to prescription opioid products, as well as planning and monitoring programs for data and method enhancement in this area.

  • Joo-Yeon  Lee

    Joo-Yeon Lee

    • Mathematical Statistician
    • FDA, United States

    Joo-Yeon Lee is a senior mathematical statistician in Division of Biometrics VII at FDA/CDER. Since she joined FDA in 2007, she developed an expertise on pharmacometrics and design and analysis of post-market drug safety studies. She has reviewed sponsor led studies as well as collaborated with other investigators in FDA-led studies in Sentinel Distributed System and federal data partners. She has played a leading role in causal inference method working group in Division of Biometrics VII. Prior to joining FDA, she earned Ph.D in Biostatistics from Brown University.

  • Laine  Thomas

    Laine Thomas

    • Assistant Professor of Biostatistics and Bioinformatics
    • Duke University, Department of Biostatistics and Bioinformatics , United States

    Dr. Thomas’ primary interest is causal inference methods, particularly using large data sets such as registries, Medicare claims and electronic health records. She is a co-investigator on the NIH-supported Statistical Methods for Complex Data in Cardiovascular Disease and primary investigator on the AHRQ-supported Matching Methods for Comparative Effectiveness Studies of Longitudinal Treatments. She uses causal inference methods in collaborations in cardiovascular disease (CHAMP-HF, ORBIT-AF registries; ACTION-NCDR and CRUSADE registries linked to Medicare; ARISTOTLE and NAVIGATOR clinical trials) and uterine fibroids (COMPARE-UF). She teaches the causal inference course in the Biostatistics and Bioinformatics Masters and PhD programs.

  • Sudip  Parikh, PhD

    Sudip Parikh, PhD

    • Senior Vice President and Managing Director, DIA Americas
    • DIA, United States

    Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

  • Jacqueline A. Corrigan-Curay, JD, MD

    Jacqueline A. Corrigan-Curay, JD, MD

    • Director, Office of Medical Policy, CDER
    • FDA, United States

    Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). Dr. Corrigan-Curay leads the development, coordination, and implementation of medical policy programs and strategic initiatives, including policy development on real world evidence, drug labeling, prescription drug promotion, clinical trial oversight and innovative trial design. She works collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes.

  • Kevin J. Anstrom, PhD

    Kevin J. Anstrom, PhD

    • Associate Director of Biostatistics
    • Duke Clinical Research Institute, United States

    Kevin J. Anstrom, PhD, is an Associate Professor of Biostatistics and Bioinformatics at Duke University. He is the Associate Director of Biostatistics at the Duke Clinical Research Institute.

  • Lisa M. LaVange, PhD

    Lisa M. LaVange, PhD

    • Prof and Associate Chair, Department of Biostatistics
    • University of North Carolina at Chapel Hill , United States

    Lisa LaVange, PhD, is Professor and Associate Chair of the Department of Biostatistics in the Gillings School of Global Public Health at the University of North Carolina at Chapel Hill. She is also director of the department’s Collaborative Studies Coordinating Center (CSCC). From 2011 to 2017, Dr. LaVange was director of the Office of Biostatistics in the United States Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). Prior to her government and academic experience, she spent 16 years in non-profit research and 10 years in the pharmaceutical industry. Dr. LaVange is an elected fellow of the American Statistical Association (ASA) and is the 2018 ASA President.

  • Jamie A. Mullen, MD

    Jamie A. Mullen, MD

    • Global Clinical Leader
    • AstraZeneca, United States

    Dr. Mullen is the Global Clinical Leader for Neuroscience at AstraZeneca. He is responsible for medical leadership of lanabesestat and for emerging neuroscience products. He previously held positions in late-phase neuroscience clinical development and was the medical leader on numerous regulatory submissions. Dr. Mullen graduated from Tufts University and received his medical degree at the University of Pennsylvania, and was on the faculty at the University of Pittsburgh.

  • Jose C. Pinheiro, PhD

    Jose C. Pinheiro, PhD

    • Head of Statistical Modeling and Methodology, SDS
    • Janssen Research & Development, LLC, United States

    José Pinheiro has a Ph.D. in Statistics from the University of Wisconsin – Madison, having worked at Bell Labs and Novartis Pharmaceuticals, before his current position as Global Head of Statistical Modeling & Methodology in the Statistics and Decision Sciences department at Janssen Research & Development. He has been involved in methodological development in various areas of statistics and drug development, including dose-finding, adaptive designs, and mixed-effects models. He is a Fellow of the American Statistical Association, a past-editor of Statistics in Biopharmaceutical Research, and past-president of ENAR

  • Donald J Schuirmann, MS

    Donald J Schuirmann, MS

    • Associate Director
    • U.S. Food and Drug Administration, United States

    Mr. Schuirmann was born in Takoma Park, Maryland and raised in Washington, D.C. He received his B.S. in Zoology from the University of Maryland in 1971 and his M.S. in Biometry from Cornell University in 1975. Mr. Schuirmann began working at the Center (actually, we were “The Bureau of Drugs” in those days) in March 1977. His chief areas of responsibility in his years at FDA have been the design and analysis of bioavailability/bioequivalence studies. Today, he is a senior statistical expert in bioavailability/bioequivalence in Division of Biometrics VIII, Office of Biostatistics, OTS, Center for Drug Evaluation and Research, FDA.

  • John  Scott, PhD

    John Scott, PhD

    • Director, Division of Biostatistics, OBE, CBER
    • FDA, United States

    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 Deputy Director and as a statistical reviewer for blood products and for cellular, tissue and gene therapies. He has authored or co-authored numerous articles in areas including Bayesian and adaptive clinical trial design and analysis, drug and vaccine safety, data and text mining, and benefit-risk assessment. 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, and is Editor of the journal, Pharmaceutical Statistics.

  • Scott M Berry, PhD

    Scott M Berry, PhD

    • President and Senior Statistical Scientist
    • Berry Consultants LLC, United States

    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.

  • Hrishikesh  Chakraborty

    Hrishikesh Chakraborty

    • Associate Director
    • DCRI, Duke University, United States

    Hrishikesh Chakraborty has statistical expertise in single and multi-site pragmatic randomized and cluster randomized clinical studies, disease modeling, predictive modeling, big data methods, and risk analysis. His statistical research includes cluster randomized trial, probabilistic modeling, longitudinal and time-to-event methods, simulation studies, and other advance statistical methods. He has served in key data coordinating center roles as PI, co-PI, and co-I for large multicenter clinical and cluster randomized pragmatic trials. He has published widely on a variety of topics in statistical and scientific journals, led workshops in different topics, and presented his research as a keynote, invited, and contributing speaker.

  • Hong  Liu-Seifert, PhD

    Hong Liu-Seifert, PhD

    • Sr. Research Advisor
    • Eli Lilly, United States

    Dr. Hong Liu-Seifert, Ph.D., is a senior research advisor for the Alzheimer’s Disease Global Development Team at Eli Lilly and Company. She earned her doctorate degree in statistics from Tulane University in 2001 and upon graduation joined Lilly. She has worked on multiple major neuroscience compounds contributing to the regulatory and commercialization success of these assets. Currently she is the group leader of the statistical function supporting clinical research efforts for investigational treatments for Alzheimer’s disease, and has made significant contributions to the AD field.

  • Josephine  Park, MBA, MPH

    Josephine Park, MBA, MPH

    • Director, Patient Reported Outcomes
    • GlaxoSmithKline, United States

    Josephine Park has more than 18 years experience in patient-reported outcomes (PRO) and health economics and outcomes research in industry, and also in the hospital. Currently at GlaxoSmithKline, she is leading PRO efforts across a range of therapeutic areas and phases of product development. Prior to joining GSK, she was responsible for PRO strategies and implementation to support value propositions for Alcon/ Novartis ophthalmic medical device and surgical products and for ophthalmology products. With broad experience in PRO development and alignment across FDA and EMA, she has developed and supported PRO endpoints for medical products across a range of therapeutic areas.

  • Thomas J. Permutt, PhD

    Thomas J. Permutt, PhD

    • Associate Director for Statistical Science and Policy, OB, OTS, CDER
    • FDA, United States

    Tom Permutt is Associate Director for Statistical Science and Policy, Office of Biostatistics, Center for Drug Evaluation and Research at FDA. Tom’s contributions to causal inference in clinical trials date from 1989 when he proposed an instrumental-variable estimator of the effect among the treated. Tom was FDA liaison to the National Academy of Sciences panel on missing data and is FDA topic leader on the ICH E9 expert working group.

  • Sherri  Rose

    Sherri Rose

    • Associate Professor of Biostatistics
    • Harvard Medical School | Department of Health Care Policy, United States

    Sherri Rose is an Associate Professor of Health Care Policy (Biostatistics) at Harvard Medical School, where her work is centered on developing and integrating innovative statistical approaches to advance human health. Dr. Rose coauthored the first book on machine learning for causal inference and co-leads the Health Policy Data Science Lab, where she directs projects in computational health economics and clinical informatics. Her honors include an NIH Director’s New Innovator Award to develop robust estimators for generalizability. Dr. Rose received her Ph.D. in Biostatistics from UC Berkeley before completing an NSF Mathematical Sciences Postdoctoral Research Fellowship at Johns Hopkins University

  • Douglas E Faries, PhD

    Douglas E Faries, PhD

    • Research Fellow
    • Eli Lilly and Company, United States

    Doug Faries graduated from Oklahoma State University and joined Eli Lilly and Company in 1990. Doug’s experience at Lilly includes research on novel clinical trial designs, supporting development, registration, and commercialization of Neuroscience compounds, and research on statistical methodology for observational data. Currently, Doug is a Research Fellow in Global Statistical Science, leading real world data research and analytics across the Lilly portfolio. He has authored or co-authored over 100 peer-reviewed manuscripts.

  • Henry "Skip" Francis, MD

    Henry "Skip" Francis, MD

    • Director for Data Mining and Informatics Evaluation and Research, OTS, CDER
    • FDA, United States

    Dr. Francis is the Director of the Data mining and Informatics Evaluation and Research Group in the Office of Translational Sciences, CDER, FDA.In that capacity he directs a trans-disciplinary group of senior sciences to test, create and operate data analysis program facilitating the efficient use of scientific methods to evaluate complex data information in order to make regulatory decisions for drug approval and drug safety.

  • Eric  Genevois-Marlin, MSc

    Eric Genevois-Marlin, MSc

    • Vice President, Biostatistics and Programming
    • Sanofi R&D, France

    Eric Genevois-Marlin holds a degree of statistician from Institute of Statistics from University of Paris (ISUP). Over the past 23 years, he worked as a Clinical Statistician at Rhone-Poulenc-Rorer which became Aventis, and joined Sanofi 10 years ago. He worked on multiple therapeutic domains, including anti-infective, oncology, cardiology/thrombosis, neurology from phase I to phase IV. He is now Vice-President of Biostatistics and Programming at Sanofi Research and Development.

  • Stella C. Grosser, PhD

    Stella C. Grosser, PhD

    • Division Director, Office of Biostatistics, OTS, CDER
    • FDA, United States

    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 newest division of biometrics 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.

  • Toshimitsu  Hamasaki, PhD, MS

    Toshimitsu Hamasaki, PhD, MS

    • Director of Data Science
    • National Cerebral and Cardiovascular Center, Japan

    Toshimitsu Hamasaki is the Director of Data Science at National Cerebral and Cardiovascular Center, Japan. His research interests include the design, monitoring, analyses, and reporting of clinical trials. He was the member of ICH-E5 Guideline Implementation Working Group as a representative of Japan Pharmaceutical Manufacturers Association to develop the Q & A document on the guideline. He is a steering committee member of CONSORT Adaptive Design Extension Project. He is the elected member of International Statistical Institute and the fellow of the American Statistical Association.

  • Brian  Hobbs, PhD

    Brian Hobbs, PhD

    • Associate Staff of Quantitative Health Sciences, The Section Head of C
    • The Taussig Cancer Institute at Cleveland Clinic , United States

    Brian Hobbs, PhD, is an Associate Staff of Quantitative Health Sciences as well as The Section Head of Cancer Biostatistics in The Taussig Cancer Institute at Cleveland Clinic. His methodological expertise comprises Bayesian inference, prediction, and trial design as well as cancer imaging and radiomics. Before joining Cleveland Clinic, Dr. Hobbs was a tenured Associate Professor in the Department of Biostatistics at The University of Texas MD Anderson Cancer Center in Houston, Texas. In 2010, he completed a doctoral degree in biostatistics at the University of Minnesota and then joined MD Anderson as a postdoctoral fellow.

  • Ram  Tiwari, PhD

    Ram Tiwari, PhD

    • Director, Division of Biostatistics, CDRH
    • FDA, United States

    Ram C. Tiwari, Ph.D. is the Director for Division of Biostatistics, CDRH, effective June 27, 2016. He joined FDA in April 2008 as Associate Director for Statistical Science and Policy in the Immediate Office, Office of Biostatistics, CDER. Prior to joining FDA, he served as Program Director at National Cancer Institute, NIH, and as Professor and Chair, Department of Mathematics, University of North Carolina at Charlotte. Dr. 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.

  • Issam  Zineh, PharmD, MPH

    Issam Zineh, PharmD, MPH

    • Director, Office of Clinical Pharmacology, OTS, CDER
    • FDA, United States

    Dr. Zineh is Director of the Office of Clinical Pharmacology (OCP) at the U.S. FDA. He has held various leadership positions at FDA including Associate Director for Genomics in OCP (2008-2012), Co-Director of the CDER Biomarker Qualification Program (2009-2015), voting member of the CDER Medical Policy Council (2016-present), and others. Dr. Zineh also leads CDER’s Model-informed Drug Development (MIDD) program. Dr. Zineh leads a staff of 246 regulatory, research, policy, communications, program/project management, and administrative staff in FDA’s efforts to enhance drug development, optimize pharmacotherapy, and promote innovation through clinical pharmacology and experimental medicine principles.

  • Stuart  Bailey

    Stuart Bailey

    • Vice President - Early Development and Discovery Biostatistics
    • Novartis Institutes For Biomedical Research, Inc., United States

    Stuart leads an Analytics team supporting Oncology and Discovery Research and has spent 15 years developing adaptive dose finding methods to support early development and early decision-making. More than 150 studies across 60+ compounds have been designed using these approaches including novel designs for multi-drug combinations, pediatrics studies and pan-Asian escalation studies. Stuart holds a Doctorate from Sussex University, U.K. and his more recent research areas focus on evolutionary dynamics of tumors and the application of machine learning algorithms to multisource data (e.g., clinical, imaging, RWE) in support of better disease models to contextualize drug activity.

  • Jessica  Franklin, PhD

    Jessica Franklin, PhD

    • Biostatistician, Div of Pharmacoepidemiology & Pharmacoeconomics;Asst Professor
    • Brigham and Women's Hospital and Harvard Medical School, United States

    Jessica Franklin, PhD, is an Assistant Professor of Medicine at Harvard Medical School and biostatistician in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Her research focuses on developing and applying statistical methods for the study of medicines from large healthcare databases, including health insurance claims and electronic health records. Her methodological interests are in causal inference and hierarchical modeling. Dr. Franklin received her Bachelor’s degree in mathematics at the University of Georgia and her doctorate in biostatistics at the Johns Hopkins Bloomberg School of Public Health.

  • Robert  Lenz, MD, PhD

    Robert Lenz, MD, PhD

    • Vice President, Head of Center for Design and Innovation
    • Amgen, United States

    Rob received his MD, PhD with honors from the University of Maryland, with a research focus in Neuropharmacology. He then completed his residency in Neurology at UCLA. After completing his chief resident year, he joined Abbott within clinical development. Rob joined Amgen in 2012 as the Global Development Lead for the Neuroscience programs and then became the Therapeutic Area Head and Vice President of Neuroscience Development. He is currently the head of a quantitative science organization comprising global biostatistics, study design and data sciences called CfDA. He has authored or co-authored more than 25 peer-reviewed scientific publications.

  • Devan V. Mehrotra, PhD

    Devan V. Mehrotra, PhD

    • Senior Director, Biostatistics Department
    • Merck Research Laboratories, United States

    Dr. Devan Mehrotra is Associate Vice President, Clinical Biostatistics, at Merck Research Laboratories. He has made significant contributions towards the research, development and licensure of numerous medical drugs and vaccines. He is an Adjunct Associate Professor of Biostatistics at the University of Pennsylvania, an Associate Editor for The American Statistician and Pharmaceutical Statistics, and a Fellow of the American Statistical Association. He has served as a subject matter expert for the Bill and Melinda Gates Foundation, the US National Academy of Sciences, and the International Council on Harmonization (ICH). His current focus is on statistical approaches for enabling personalized medicine.

  • John  Peters, MD

    John Peters, MD

    • Deputy Director, Office of Generic Drugs, CDER
    • FDA, United States

    John R. Peters, MD graduated from the George Washington University School of Medicine. He is a Family Physician certified in Forensic Medicine with a Certification in Public Health from Georgetown University. He practiced Family and Emergency medicine in MN, later joining the US Army FP residency teaching staff at DeWitt Army Hospital Ft Belvoir and Uniformed Services University of Health Science. In 1992 he moved to the FP residency program of Georgetown University. He has been Director of Managed Care and Associate Director of an MCO. In 2006 he joined the FDA 2009 where he is currently the Deputy Director of the Office of Generic Drugs.

  • Timothy E Rolfe

    Timothy E Rolfe

    • Director, Risk Based Monitoring
    • GSK, United Kingdom

    Tim Rolfe has over 20 years of experience working as a statistician at in the pharmaceutical industry. He is currently Director of Risk Based Monitoring at GlaxoSmithKline R&D. He has been part of GSKs RBM team since 2013, providing statistical leadership in the development and implementation of GSK’s RBM strategy within clinical trials. Before joining GSK, Tim studied Applied Statistics at Sheffield Hallam University and holds a MSc in Medical Statistics from the University of Leicester in the UK.

  • Xiang  GUO, PhD

    Xiang GUO, PhD

    • Executive Director, Head of Biometrics China
    • BeiGene (Beijing) Co., Ltd., China

    Tony Guo, PhD, is Executive Director, Head of Biometrics China, for the Chinese biotech company BeiGene. Before joining BeiGene, Dr. Guo served as Senior Director, Head of AP Statistics Group, for Merck Research Laboratories. He also worked for Sanofi China as Manager of the Statistics Group and Lead Statistician. Dr. Guo holds adjunct teaching positions in Beijing Normal University, and is Chair of DIA China Statistics Community, a member of the China Clinical Trial Statistics Working Group, and Secretary General of the Beijing Biometrics Association. Dr. Guo earned his PhD in Statistics from North Carolina State University. His research focuses on statistical inference, benefit-risk assessment, missing data analysis, and adaptive design.

  • Jennifer  Schumi, PhD, MS

    Jennifer Schumi, PhD, MS

    • Statistical Science Director
    • AstraZeneca Pharmaceuticals LP, United States

    Jennifer Schumi is a Director of Statistical Standards in AstraZeneca’s Biometrics and Information Sciences, Advanced Analytics Centre. She develops and maintains cross-therapeutic area standards and guidance documents on statistical methodology. Prior to joining AZ, she spent ten years at Statistics Collaborative, Inc., providing guidance on statistical issues to pharmaceutical and biotechnology clients. She has a special interest in using data visualization tools to simplify monitoring, both internally for risk-based quality monitoring and externally to support independent data monitoring committees. She holds an MS in Statistics (Iowa State University) and a PhD in Biostatistics (Harvard University).

  • Stephen E. Wilson

    Stephen E. Wilson

    • Statistical Consultant, United States

    Statistical reviewer/manager at FDA/CDER for more than 30 years; Captain in the USPHS; Retired as Dir. of Div. of Biometrics III/Office of Biostatistics on June 1, 2017; Received a doctorate in Biostatistics from UNC Chapel Hill in 1984; Also worked for the East West Center, the Indonesian Statistics Bureau, UNC, the Fed. States of Micronesia and the World Bank; and his professional interests include regulatory thinking/decision-making, clinical trials science, and data standards.

  • Jean M. Mulinde, MD

    Jean M. Mulinde, MD

    • Medical Officer, Senior Policy Advisor, Office of Scientific Investigations, OC,
    • FDA, United States

    Dr. Mulinde is currently the Senior Policy Advisor, Division of Clinical Compliance Evaluation in the Office of Scientific Investigations, CDER, FDA. Prior to joining the Office of Scientific Investigations, she was a Clinical Team Leader in the Division of Anti-Infective Products in OND. She received her M.D. and completed a residency in Internal Medicine at the University Of South Alabama School Of Medicine, and then completed a fellowship in Infectious Diseases at the University Of Maryland School Of Medicine.

  • Larry  Gould, PhD

    Larry Gould, PhD

    • Sr. Director, Scientific Staff
    • Merck Research Laboratories, United States

    Fellow of the American Statistical Association since 1988. Areas of research interest include use of Bayesian methods to improve effectiveness of the drug development process, adaptive trial design (including group sequential methods), evaluation of safety data from clinical trials, application of data mining and Bayesian methods to pharmacovigilance, use of data mining to identify relationships that can be used to design future trials, meta-analysis, modeling and simulation techniques to reduce cost and unnecessary patient exposure in drug development, and application of decision science methods to drug development strategy.