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DIA/FDA Biostatistics Industry and Regulator Forum

This event is now offered in a new entirely virtual format.


Speakers

  • Mouna  Akacha, PhD

    Mouna Akacha, PhD

    • Group Head of Statistical Methodology
    • Novartis Pharma AG, Switzerland

    Mouna Akacha is the Group Head of the Statistical Methodology group of Novartis Pharma AG, based in Basel, Switzerland. She and her team provide internal advice for clinical projects in all development phases and therapeutic areas. She is engaged in developing and implementing innovative statistical methods for clinical projects covering estimand discussions and approaches for missing data, longitudinal data, and recurrent event data. Before joining Novartis, Akacha studied mathematics at the University of Oldenburg in Germany. She holds a PhD in statistics from the University of Warwick in the United Kingdom.

  • Brenda  Crowe, PhD

    Brenda Crowe, PhD

    • Associate Vice President, Statistics
    • Eli Lilly and Company, United States

    Brenda Crowe is an Associate Vice President in Statistics at Eli Lilly and Company. She has more than 20 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.

  • Jonathan  Haddad, MPH

    Jonathan Haddad, MPH

    • HIV Disease Area Head, Clinical Statistics
    • 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

    • Associate Director Statistical Methodology
    • Novartis, Switzerland

    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).

  • Shiowjen  Lee, PhD

    Shiowjen Lee, PhD

    • Deputy Director, Division of Biostatistics, OBPV, CBER
    • FDA, United States

  • Cristiana  Mayer, DrSc, PhD

    Cristiana Mayer, DrSc, PhD

    • Head of Biostatistics
    • Johnson & Johnson Vision, United States

    Cristiana Mayer is the Head of Biostatistics at Johnson & Johnson Vision, a company dedicated to the eye care, eye health and eye products. She has 20+ years of experience in the pharmaceutical industry. After 18 years in drug development at Janssen R&D LLC working in different therapeutic areas and 5 years in Statistical Modeling & Methodology group, Cristiana is currently leading the biostatistics and data management groups across the Surgical and Vision Care businesses of JNJ Vision. Her current interests are in CID, Bayesian designs and patients’ engagement. Her recent publications are about simulation practices for innovative designs, ethics and innovation in the pandemic and patient engagement in rare diseases.

  • Lei  Nie, PhD

    Lei Nie, PhD

    • Associate Director, Division of Biometrics II, Office of Biostatistics, OTS, CDE
    • FDA, United States

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

  • Frank 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.

  • William  Wang, PhD

    William Wang, PhD

    • President
    • Merck & Co, Inc, 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 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 .

  • Aloka  Chakravarty, PhD

    Aloka Chakravarty, PhD

    • Senior Statistical Advisor, Office of the Commissioner
    • FDA, United States

    Dr. Aloka Chakravarty is currently the Sr. Statistical Advisor in the Office of the Commissioner, FDA for real-world data and evidence activities related to collaborations on COVID-19 and others. She is also working on select strategic data initiatives at FDA with the Chief Data Officer.Prior to that, she was the Deputy Director of the Office of Biostatistics in CDER, FDA. She is an internationally recognized thought leader in multi-regional clinical trials, safety evaluation, real world data and evidence, surrogate markers and biomarkers in drug development. Dr. Chakravarty served as an Adjunct Faculty in Department of Statistics, FAES, NIH and has been on Advisory Board of multiple academic institutions.

  • Karen Lynn Price, PhD

    Karen Lynn Price, PhD

    • Senior Research Fellow, Statistical Innovation Center/Design Hub
    • 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 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.

  • Mat  Soukup, PhD

    Mat Soukup, PhD

    • Deputy Director, Division of Biometrics VII, OB, 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.

  • Jeffrey S Barrett, PhD

    Jeffrey S Barrett, PhD

    • Head Quantitative Sciences
    • Bill & Melinda Gates Medical Research Institute , United States

  • Scott  Komo, DrPH

    Scott Komo, DrPH

    • Lead 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.

  • Pallavi  Mishra-Kalyani, PhD, MS

    Pallavi Mishra-Kalyani, PhD, MS

    • Lead Mathematical Statistician, CDER
    • FDA, United States

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

  • Dionne  Price, PhD

    Dionne Price, PhD

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

    Dr. Price is the Deputy Director of the Office of Biostatistics. In her role at FDA, she promotes collaborative efforts to advance the use of complex innovative trial designs. An invited speaker at conferences world-wide, she has served as Chair of ASA’s Biopharmaceutical Section and on the Regional Committee of the Eastern North American Region of IBS. She is a Fellow of the ASA and the President-Elect of the ASA. With an MS in Biostatistics from UNC, and PhD from Emory, her research interests focus on clinical trial designs. She has co-authored papers in Statistics in Medicine, Clinical Trials, and Statistics in Biopharmaceutical Research.

  • Gregory  Levin, PhD

    Gregory Levin, PhD

    • Deputy Director, DBIII, OB, OTS, CDER
    • FDA, United States

    Greg Levin is a supervisory mathematical statistician at the Center for Drug Evaluation and Research within FDA. He joined FDA after receiving a PhD in biostatistics from the University of Washington in 2012. At FDA, Greg has helped regulate products across a wide range of therapeutic areas. His research interests include missing data, adaptive design, labeling, and making real-world inferences from clinical trials.

  • Sylva  Collins, PhD

    Sylva Collins, PhD

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

    Dr. Collins is the Director of the Office of Biostatistics, OTS/CDER/FDA. Prior to joining the FDA in August 2019, she has spent more than 30 years leading large global biometrics organizations and has contributed to dozens of successful regulatory submissions in multiple jurisdictions. She pioneered the large-scale deployment of electronic data capture at multiple companies including Bayer and Novartis. She implemented standardization of biometrics systems and processes for large pharma organizations to allow near simultaneous regulatory submissions globally. Sylva received her B.S. in Mathematics from the American University of Beirut, M.A. and Ph.D. in Statistics from Boston University, and M.S. in Computer Science from NYU.

  • Andrew  Potter, PhD

    Andrew Potter, PhD

    • Mathematical Statistician, OB, OTS, CDER
    • FDA, United States

    Dr. Andrew Potter is a mathematical statistician in the Division of Biometrics I in CDER supporting the review work in the Division of Psychiatry. His research interests include the use of digital health technologies in clinical trials and the analysis of high frequency outcome data and in involved in working groups at FDA on this topic. He received his PhD in Biostatistics from the University of Pittsburgh and his BA in Physics from Cornell University.

  • Jeremy A Rassen, DrSc, MS

    Jeremy A Rassen, DrSc, MS

    • Co-Founder and President
    • Aetion, United States

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

  • Sara L. Eggers, PhD

    Sara L. Eggers, PhD

    • Director, Decision Support and Analysis Team, OSP, CDER
    • FDA, United States

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

  • Miguel  Hernan, DrPH, MD

    Miguel Hernan, DrPH, MD

    • Professor
    • Department of Epidemiology, Harvard T.H. Chan School of Public Health, United States

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

  • Paul Michael Imbriano, PhD, MSc

    Paul Michael Imbriano, PhD, MSc

    • Mathematical Statistician
    • FDA, United States

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

  • Matilde  Kam, PhD

    Matilde Kam, PhD

    • Associate Director Analytrics and Informatics, OB, OTS, CDER
    • FDA, United States

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

  • Mark  Levenson, PhD

    Mark Levenson, PhD

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

    Mark Levenson is currently the Director of the Division of Biometrics VII in the Office of Biostatistics/Office of Translational Sciences/Center for Drug Evaluation and Research of the US Food and Drug Administration (FDA). At FDA, he has been the primary reviewer or secondary reviewer on many major pre-market and post-market drug safety problems. He contributes to statistical policy and guidance development in the areas of drug safety, real-world data, and regulatory evidence. He is a member of the CDER Medical Policy Program Review Committee and the FDA Real-World Evidence Committee. Dr. Levenson received a Ph.D. in Statistics from the University of Chicago and a B.A. from Cornell University in Mathematics.

  • John  Scott, PhD, MA

    John Scott, PhD, MA

    • Director, Division of Biostatistics, OBPV, 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 a Fellow of the American Statistical Association.

  • Aracelis  Torres, PhD

    Aracelis Torres, PhD

    • Director, Quantitative Sciences
    • Flatiron Health, United States

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

  • Hao  Zhu, PhD

    Hao Zhu, PhD

    • Deputy Division Director
    • FDA, United States

  • Anubha  Gupta, PhD

    Anubha Gupta, PhD

    • Pharmacometrician/Clinical Pharmacologist
    • GSK, United Kingdom

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

  • Roger J. Lewis, MD, PhD

    Roger J. Lewis, MD, PhD

    • Professor and Chair, Department of Emergency Medicine
    • Harbor-UCLA Medical Center, United States

    Dr. Lewis is Professor and Chair in the Department of Emergency Medicine at Harbor-UCLA Medical Center and the Senior Medical Scientist at Berry Consultants, with expertise in the design and oversight of adaptive clinical trials. He is a member of the National Academy of Medicine, the Board of Directors for the Society for Clinical Trials, and the Blood Products Advisory Committee of the FDA/CBER. He has served as a member of the Medicare Evidence Development & Coverage Advisory Committee for CMS and chaired numerous data and safety monitoring boards (DSMB) for both federally-funded and industry-sponsored clinical trials. He has authored or coauthored over 240 original research publications, reviews, editorials, and chapters.

  • Peter  Mesenbrink, PhD

    Peter Mesenbrink, PhD

    • Executive Director of Biostatistics
    • Novartis Pharmaceuticals Corporation, United States

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

  • Tyler  Reynolds

    Tyler Reynolds

    • Digital Health Consultant
    • PA Consulting, United States

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

  • Telba  Irony, PhD, MS, MSc

    Telba Irony, PhD, MS, MSc

    • Senior Scientific Director, Quantitative Sciences
    • Janssen R&D, United States

    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.

  • Pandurang M Kulkarni, PhD

    Pandurang M Kulkarni, PhD

    • Chief Analytics Officer-R&D / Vice President of Statistics, Data & Analytics
    • Eli Lilly and Company, United States

    Dr. Pandu Kulkarni is Chief Analytics Officer – R&D / Vice President – Statistics, Data & Analytics. His organization is comprised of statisticians, statistical analysts, data analysts, and others working in the full pharmaceutical research cycle, from discovery to commercialization. Pandu is on one of the Board of Directors for CDISC and Accumulus. He also is the chair of the Biopharmaceutical Statistical Leaders Consortium. He is a fellow of the American Statistical Association. Pandu joined Eli Lilly and Company in 2000, has held numerous leadership positions including technical and management positions within and outside of Statistics. He obtained his Ph.D. in Statistics at the LaTrobe University, Melbourne, Australia.

  • Thomas  Louis, PhD

    Thomas Louis, PhD

    • Professor Emeritus, Department of Biostatistics
    • John Hopkins Bloomberg SPH, United States

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

  • Veronica  Miller, PhD

    Veronica Miller, PhD

    • Executive Director
    • Forum For Collaborative Research, United States

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

  • Lothar  Tremmel, PhD

    Lothar Tremmel, PhD

    • Vice President, Quantitative Clinical Sciences and Reporting
    • CSL Behring, United States

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

  • Frank  Bretz, PhD

    Frank Bretz, PhD

    • Distinguished Quantitative Research Scientist
    • Novartis Pharma AG, Switzerland

    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'.

  • Michael  Crutchlow, DrMed, MD

    Michael Crutchlow, DrMed, MD

    • Distinguished Scientist, Clinical Research
    • Merck & Co, Inc, United States

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

  • Lisa  Lupinacci, PhD, MS

    Lisa Lupinacci, PhD, MS

    • Senior Vice President, Biostatistics and Research Decision Sciences
    • Merck and Co., Inc., United States

    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.

  • Yong  Ma, PhD

    Yong Ma, PhD

    • Lead Mathematical Statistician, OB, OTS, CDER
    • FDA, United States

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

  • Andrew  Thomson, PhD, MA, MS

    Andrew Thomson, PhD, MA, MS

    • Statistician, Methodology Taskforce
    • European Medicines Agency, Netherlands

    Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics subgroup of ICH E11A on pediatric extrapolation. Before joining EMA, he headed the Epidemiology Unit in the Vigilance and Risk Management of Medicines Division of the MHRA, the UK regulator and was also previously a Statistical Assessor within the Licensing Division of the MHRA

  • Amy  Xia, PhD

    Amy Xia, PhD

    • Vice President, Center for Design and Analysis
    • Amgen Inc., United States

    Amy Xia is Vice President, Center for Design and Analysis at Amgen. Amy has worked on designing, implementing, and analyzing Phase I-IV clinical trials as well as observational studies over the past two decades. Currently, she heads up the Center for Design and Analysis organization which includes Biostatistics, Design & Innovation and Data Sciences at Amgen, providing leadership and holistic vision for strategic drug development and driving innovative approaches across Amgen’s portfolios for evidence generation and decision-making. Amy received her PhD in Biostatistics from the University of Minnesota, and her medical degree from Peking University, China.

  • Greg  Ball, PhD

    Greg Ball, PhD

    • Head of Safety Statistics, Global Vaccine Safety
    • Novavax, Inc., United States

    Greg served in the Navy and taught HS math and physics before earning his MS in statistics from Purdue and PhD in biostatistics from the University of Texas. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). He co-leads, with Mary Nilsson, the PhUSE Safety Analytics working group. Greg established, with Bill Wang, the ASA Biopharm Safety Monitoring working group and has been pioneering the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group, to advocate for aggregate safety assessments and cross-disciplinary scientific engagement.

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Biostatistics Industry Resource Kit