Menu Back to Speakers

Speakers

  • Frank  Bretz, PhD

    Frank Bretz, PhD

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

    Joined Novartis in 2004, currently Global Head of the Statistical Methodology group. Areas of expertise include dose-finding, multiple comparisons and adaptive designs. Adjunct Professor at the Hannover Medical School, the Shanghai University of Finance and Economics, and the Medical University of Vienna.

  • 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 for 10 years and attained tenure and full professorship. He received several grants from the Air Force for 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. He has given presentations across the globe and published over 50 articles in statistics and medical areas in peer reviewed journals.

  • Jeff  Maca, PhD

    Jeff Maca, PhD

    • Senior Director, Biostatistics; Advisory Services Analytics
    • Quintiles, United States

    Jeff is a leading expert in adaptive designs, with over 18 years of experience in the pharmaceutical industry. Prior to Quintiles, he worked with Novartis Pharmaceuticals as a project statistician, prior to assuming the role of a statistical consultant within the statistical methodology group. He has been active in statistical methodology research and has numerous publications on pharmaceutical statistics, including adaptive designs, multiplicity, and interim decision making. Jeff received his PhD in Statistics from Texas A&M University, a Masters degree in Statistics, and Bachelors’ degree in Applied Mathematics from the same University. Along with research and consulting work, Jeff also participates in the DIA Adaptive Designs SWG

  • Cristiana  Mayer, PhD

    Cristiana Mayer, PhD

    • Scientific Dir, Statistical Modeling, Methodology, Statistics, Decision Science
    • Janssen Research and Development LLC, United States

    Cristiana joined the Statistical Modeling group in 2013, where she is the Immunology Therapeutic Area Head. Prior, Cristiana worked in the Clinical Biostatistics Department for 15 years at Janssen R&D and was the Global Statistical Leader for many compounds in Neuroscience. During her 18-year tenure at Johnson & Johnson she worked in many TA’s including hematology, neurology, psychiatry, and metabolism. Research interests include issues and solutions in the implementation of adaptive designs, statistical modeling of safety data and the assessment and analysis of suicidal ideation and behaviors.

  • Dionne  Price, PhD

    Dionne Price, PhD

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

    Dionne Price, PhD, is Director of the Division of Biometrics IV at the Center for Drug Evaluation and Research of the Food and Drug Administration. Dr. Price provides leadership to statisticians involved in the application and development of methodology applied to anti-infective, anti-viral, ophthalmology, over-the-counter, special pathogen, and transplant drug products. She is an active member of Eastern North American Region of IBS and the American Statistical Association.

  • Jerald S. Schindler, DrPH

    Jerald S. Schindler, DrPH

    • VP, Biostatistics, Merck Research Labs and Adjunct Professor,
    • Harvard Chan School of Public Health, United States

    Dr. Schindler is VP, Biostatistics & Research Decision Sci. & leads the Late Development Biostat. groups in Merck Research Labs. He is involved in optimizing the development process of new drugs & biologics including use of innovative adaptive CTs & efficient integrated clinical info systems.

  • William  Wang, PhD

    William Wang, PhD

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

    Bill has over 20 years of experience in the pharmaceutical industry, with expertise and research publications in statistical design, analysis, clinical data management and relevant technology enablement. During his 15-year tenure at Merck, he supported regulatory filings in multiple therapeutic areas and led the establishment of the BARDS Asia Pacific operation in China (2007-2014). Since 2010, he has served on the DIA China Regional Advisory Board and DIA’s Global Community Leadership Council. He was a recipient of the DIA global outstanding service award in 2012. Currently chairs anASA safety working group, and serves as a deputy topics leader for the ICH E17 working group on Multi-Regional Clinical Trial (MRCT).

  • Amy  Xia, PhD

    Amy Xia, PhD

    • Executive Director, Biostatistics
    • Amgen, Inc., United States

    Amy Xia is Executive Director, Biostatistics at Amgen. She has worked on designing, implementing, and analyzing Phase I-IV clinical trials as well as observational studies in the past 20 years. Her research interests include Bayesian and adaptive design, safety biostatistics, meta-analysis and innovative approaches for pediatrics/rare diseases drug development. Amy is an ASA Fellow. She is the Editor for the Biopharmaceutical Report in 2016-2017. She also is a member of the DIA Bayesian Scientific Working Group. Amy received her Ph.D. in Biostatistics from the University of Minnesota, and B.Med. (M.D. equivalent) from Peking University, China.

  • Thomas E. Gwise, PhD

    Thomas E. Gwise, PhD

    • Deputy Division Director, Division of Biometrics V, CDER
    • FDA, United States

  • Rima  Izem, PhD

    Rima Izem, PhD

    • Lead Mathematical Statistician, Office of Translational Science, CDER
    • FDA, United States

    Rima Izem is a Statistical Team Leader at the Office of Biostatistics in CDER/FDA. She supervises a team of statisticians reviewing post-market studies assessing drug safety or direct to consumer drug advertising. She previously reviewed pre-market drug safety meta-analyses for diabetes and weight loss drugs, efficacy studies for ophthalmic drugs and anti-infective drugs, and consumer behavior studies submitted to the Division of Nonprescription Clinical Evaluation.

  • Laura Lee  Johnson, PhD

    Laura Lee Johnson, PhD

    • Associate Director, Office of Biostatistics, DB III, OTS, CDER
    • FDA, United States

    Dr. Laura Lee Johnson is the patient reported outcomes liaison for the Office of Biostatistics at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research. She serves on the FDA-NIH Interagency Clinical Outcome Assessments Working Group and co-directs the NIH Principles and Practice of Clinical Research course. Prior to working at the FDA she spent over a decade at the NIH working on and overseeing clinical research and research support programs. She has been involved with numerous projects developing, validating, and using clinical outcome assessments in both patient care and research.

  • Lisa M. LaVange, PhD

    Lisa M. LaVange, PhD

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

    Lisa LaVange, PhD, is Director of the Office of Biostatistics in the Center for Drug Evaluation and Research at FDA. She is a former faculty member in the Department of Biostatistics at the University of North Carolina at Chapel Hill. Prior to that, she spent 10 years in the pharmaceutical industry and 16 years in non-profit research. She is Fellow of the American Statistical Association and former President of the Eastern North American Region of the International Biometric Society.

  • Mark S. Levenson, PhD

    Mark S. Levenson, PhD

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

    Mark Levenson is the Deputy Director of the Division of Biometrics 7 in the Office of Biostatistics/Center for Drug Evaluation and Research of FDA. At FDA, he contributes to statistical policy in the area of drug safety. He has been active in the development of FDA guidances for drug safety. He leads the statistical support for CDER-sponsored drug safety studies. He is active in CDER’s efforts in the Sentinel Initiative including methods development and surveillance studies.

  • Sudip  Parikh, PhD

    Sudip Parikh, PhD

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

  • Rajeshwari  Sridhara, PhD

    Rajeshwari Sridhara, PhD

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

    Rajeshwari Sridhara, Ph.D. is the Division Director of Division of Biometrics V, Office of Biostatistics which supports Office of Hematology Oncology Products, and Division of Medical Imaging Products at the Center for Drug Evaluation and Research. As a leader in the field, she routinely presents regulatory policies and scientific philosophy of the Office at national and international professional meetings including oncology drug advisory committee meetings. Dr. Sridhara has contributed in the understanding and addressing the statistical issues that are unique to the oncology disease area. She has worked on regulatory guidance documents and extensively published in refereed journals.

  • Stephen E. Wilson, DrPH

    Stephen E. Wilson, DrPH

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

    Dr. Wilson received his doctorate in Biostatistics from the University of North Carolina, Chapel Hill, in 1984, and has worked for FDA’s Center for Drug Evaluation and Research for over 29 years. Steve is currently the Director of the Division of Biometrics III in the Office of Biostatistics. His professional experience also includes positions with the East West Center, the Indonesian Central Bureau of Statistics, the University of North Carolina, the Federated States of Micronesia and the World Bank. His professional interests and activities are currently focused on issues related to the improvements in clinical trials science and practice, data standards and the review of drug and biological therapies.

  • Jesse Aaron Berlin, DrSc

    Jesse Aaron Berlin, DrSc

    • Vice President and Global Head of Epidemiology
    • Johnson & Johnson, United States

    Jesse Berlin is Vice President of Epidemiology at Johnson & Johnson, with responsibility for pharmaceuticals, devices and consumer products. He joined J&J over 11 years ago after spending 15 years at University of Pennsylvania, where he was a Professor of Biostatistics. He has authored or coauthored over 250 peer-reviewed publications in a wide variety of clinical and methodological areas, including papers on the study of meta-analytic methods as applied to both randomized trials and epidemiology. He received his doctorate in biostatistics from Harvard School of Public Health and in 2013 received the Lagakos Distinguished Alumni Award from its Department of Biostatistics.

  • Jesse  Bridgewater

    Jesse Bridgewater

    • Vice President, Data Science
    • Livongo, United States

  • Joan  Buenconsejo

    Joan Buenconsejo

    • Statistics Team Leader, Inflammation, Neuroscience & Respiratory TA, B&I Science
    • AstraZeneca Pharmaceuticals LP, United States

    Dr. Joan Buenconsejo is currently Statistics Team Lead supporting the Inflammation, Neuroscience and Respiratory Therapeutic Area at AstraZeneca. Prior to joining AZ, she was the statistics team leader supporting the Division of Pulmonary, Allergy, and Rheumatology Product at FDA. She has been involved in drug and biologics development for more than 10 years and in developing new statistical approaches to handle missing data. She is currently the chair of the DIA Statistics Community.

  • Tai-Tsang  Chen, PhD

    Tai-Tsang Chen, PhD

    • Associate Director
    • BMS, United States

  • Gregory  Daniel

    Gregory Daniel

    • Deputy Director, Duke-Margolis Center for Health Policy
    • Duke University, United States

    Dr. Gregory Daniel is a Clinical Professor in Duke's Fuqua School of Business and Deputy Director in the Duke-Robert J. Margolis Center for Health Policy. Dr. Daniel directs the DC-based office and leads its pharmaceutical and medical device policy portfolio aimed at developing strategies for improving development and access to innovative pharmaceutical and medical device technologies, postmarket evidence development, regulatory science, and payment reform.

  • John  Farley, MD

    John Farley, MD

    • Deputy Director, Office of Antimicrobial Products
    • FDA, United States

  • Frank W. Rockhold, PhD, MSc

    Frank W. Rockhold, PhD, MSc

    • Professor of Biostatistics
    • Duke University, United States

    Over a 40+ year career, Frank has had diverse leadership experience inside & outside GSK in clinical trials, data standards, benefit/risk, clinical research, epidemiology, cardiovascular development, & most recently pharmacovigilance. He has served on the board of directors for CDISC, & is a member of the PCORI Advisory Panel on Clinical Trials. He has +175 publications/presentations in major scientific journals. He is a Fellow of the ASA & the Society for Clinical Trials.

  • John  Scott, PhD

    John Scott, PhD

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

    John Scott is Deputy Director of the Division of Biostatistics in the FDA's Center for Biologics Evaluation and Research. Prior to joining the FDA in 2008, he worked in psychiatric clinical trials at the University of Pittsburgh Medical Center. 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 missing data. He holds a Ph.D. in Biostatistics from the University of Pittsburgh and an M.A. in Mathematics from Washington University in St. Louis, and is an associate editor of the journal, Pharmaceutical Statistics.

  • Judy Anne Staffa, PhD, RPh

    Judy Anne Staffa, PhD, RPh

    • Director, Division of Epidemiology II, OPE, OSE , CDER
    • FDA , United States

    Dr. Staffa is currently the Director, Division of Epidemiology II in FDA’s Office of Surveillance and Epidemiology (OSE). She directs the regulatory review work of epidemiologists in CDER, and also helps to direct staff in conducting epidemiologic research and surveillance using a variety of population-based data.

  • Janet  Woodcock, MD

    Janet Woodcock, MD

    • Director, Center for Drug Evaluation and Research
    • FDA, United States

    In 2015, Dr. Woodcock also operated in the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ). Dr. Woodcock joined CDER in 1994. From 2005 - 2008, she served in FDA’s Commissioner’s office, holding several positions, as Deputy Commissioner, Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer. Her responsibilities encompassed oversight of various scientific and medical regulatory operations. Before CDER, Dr. Woodcock served as Director, Office of Therapeutics Research and Review, and Acting Deputy Director in FDA’s Center for Biologics Evaluation and Research. Dr. Woodcock received her MD from Northwestern Medical School. She joined FDA in 1986.

  • Kunthel  By

    Kunthel By

    • Biostatistician
    • FDA, United States

  • Elizabeth  Delong, PhD

    Elizabeth Delong, PhD

    • Chair, Biostatistics and Bioinformatics
    • Duke University, United States

  • Vladimir  Dragalin, PhD

    Vladimir Dragalin, PhD

    • VP, Head of QS Consulting, Quantitative Science
    • Janssen R&D, at Johnson & Johnson, United States

    Vlad Dragalin is a Vice President, Scientific Fellow in Quantitative Sciences at Janssen Pharmaceutical Companies of Johnson & Johnson. Vlad is the Head of QS Consulting and is leading the Adaptive Clinical Trial Center of Excellence. He is a well-known adaptive design expert with 25 years of experience in developing the statistical methodology of adaptive designs and with over 15 years of experience in pharmaceutical industry, including positions of increasing responsibilities at GlaxoSmithKline, Wyeth, Pfizer, Quintiles, and Aptiv Solutions. He has more than 75 publications in peer reviewed journals and books.

  • Kenneth I. Kaitin, PhD

    Kenneth I. Kaitin, PhD

    • Professor of Medicine; Director Tufts Center for the Study of Drug Development
    • Tufts University School of Medicine, United States

    Kenneth Kaitin is Professor and Director of the Tufts Center for the Study of Drug Development at Tufts University School of Medicine. He’s also Advisory Professor at Shanghai Medical College, Fudan University. Dr. Kaitin writes and speaks regularly on drug development issues, and has provided testimony before the U.S. Congress. A former President of the Drug Information Association, Dr. Kaitin is Editor-in-Chief of Expert Review of Clinical Pharmacology, and consultant to the U.S. Department of Defense on bioterror countermeasures. Dr. Kaitin received his PhD in pharmacology from the University of Rochester.

  • Sumithra J. Mandrekar, PhD

    Sumithra J. Mandrekar, PhD

    • Biostatistician
    • Mayo Clinic, United States

    Dr. Mandrekar is Associate Professor of Biostatistics at Mayo Clinic, Rochester MN. Her collaborative research includes clinical trials and research grants in the area of lung cancer. Her research interests include adaptive designs for Phase I trials, and designs for predictive biomarker validation.

  • Peter A. Milligan, PhD

    Peter A. Milligan, PhD

    • Head of Pharmacometrics
    • Pfizer Global Research & Development, United Kingdom

  • Theresa M. Mullin, PhD

    Theresa M. Mullin, PhD

    • Director, Office of Strategic Programs, CDER
    • FDA, United States

    Dr. Mullin leads center strategic planning and directs the CDER international program, business informatics, economic and decision analysis and program evaluation. This includes FDA development of a drug benefit-risk assessment framework, the patient focused drug-development initiative, and recently establishing the first formal pharmaceutical quality surveillance capability in CDER. Dr. Mullin also heads the FDA delegation to the International Conference on Harmonization. She served as the FDA lead negotiator for the 2012 reauthorization of the Prescription Drug User Fee Act (PDUFA). Dr. Mullin received her BA in Economics from Boston College and PhD in Public Policy Analysis from Carnegie-Mellon University.

  • Michael A. Proschan, PhD

    Michael A. Proschan, PhD

    • Biostatistics Research
    • National Institute of Allergy & Infectious Disease, United States

  • Mary  Redman, PhD

    Mary Redman, PhD

    • Lead Biostatistician, SWOG Lung Committee/LungMap
    • Fred Hutchinson Cancer Research Center, United States

    Mary Redman is an Associate Member at the Fred Hutchinson Cancer Research Center in the Clinical Statistics Dept as part of the Clinical Research Div. She joined the center in 2005. She has been the lead statistician for the Lung Cancer Committee in SWOG since 2005 and is the lead statistician for the Lung-MAP clinical trial. Her area of expertise is in clinical trial design incorporating and testing potentially predictive biomarkers.

  • Ram  Tiwari, PhD

    Ram Tiwari, PhD

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

    Ram C. Tiwari, Ph.D. is the Associate Director in the Office of Biostatistics, CDER. His prior positions include Program Director in National Cancer Institute, and Department Chair in University of North Carolina at Charlotte. He received his MS and PhD degrees from Florida State University. He is a Fellow of the American Statistical Association. His current research interests include developing frequentist and Bayesian methods in pre-and-post market drug evaluation.

  • Brian D. Bradbury, MA

    Brian D. Bradbury, MA

    • Executive Director and Head, Data and Analytic Center, CfOR
    • Amgen, Inc., United States

    Brian D. Bradbury, DSc, is an Executive Director and Head of the Data & Analytic Center (DAC) within the Center for Observational Research (CfOR) at Amgen, Inc. As the Head of the DAC, he leads a team of epidemiologists, biostatisticians, and programmers who provide strategic and tactical support across the drug development lifecycle. Brian received his DSc in Epidemiology from Boston University in 2004 and a MA in Education & Psychology from Pepperdine University in 1998. He has authored or co-authored over 65 peer-reviewed publications in the areas of pharmacoepidemiology, cancer and kidney disease epidemiology and methods for controlling confounding-by-indication in drug safety studies.

  • Margaret  Gamalo, PhD

    Margaret Gamalo, PhD

    • Statistical Scientist
    • Eli Lilly and Company, United States

  • Frank E Harrell, PhD

    Frank E Harrell, PhD

    • Professor and Chairman
    • School of Medicine, Vanderbilt University , United States

  • Kun  He, PhD

    Kun He, PhD

    • Mathematical Statistician
    • FDA, United States

  • Scott  Novak, PhD

    Scott Novak, PhD

    • Director of Prescription Drug Research
    • Battelle Memorial Institute , United States

  • Kert  Viele, PhD

    Kert Viele, PhD

    • Director and Senior Statistical Scientist
    • Berry Consultants, United States

    Kert Viele is a Director and Senior Statistical Scientist with Berry Consultants, LLC. His expertise involves Bayesian methods related to adaptive clinical trials. Dr. Viele has written more than 30 papers and is a former editor of the journal Bayesian Analysis. Dr. Viele is also an author of FACTS (Fixed and Adaptive Clinical Trial Simulator), a Bayesian adaptive design software product currently licensed to several of the top 20 Pharmaceutical companies in the United States.

  • Zhenzhen  Xu

    Zhenzhen Xu

    • Visiting Scientist
    • FDA, United States

  • Telba  Irony, PhD

    Telba Irony, PhD

    • Deputy Director, Office of Biostatistics and Epidemiology, CBER
    • FDA, United States

    Dr Irony joined FDA to implement Bayesian methods in Medical Device Trials. She was instrumental in preparing guidances on the Use of Bayesian Statistics in Medical Device Trials and Factors to Consider when Making Benefit: Risk Determinations. She leads the Decision Analysis initiative at CDRH.

  • Lian  Ma, PhD

    Lian Ma, PhD

    • Pharmacometrics Reviewer, CDER
    • FDA, United States

  • David Barrett Martin, MD, MPH

    David Barrett Martin, MD, MPH

    • Liaison to the Reagan-Udall Foundation IMEDS Program, OMP, CDER
    • FDA, United States

  • Eric  Gibson, PhD

    Eric Gibson, PhD

    • VP, Global Head Biostatistical Sciences and Pharmacometrics
    • Novartis Pharmaceuticals Corporation, United States

    Eric Gibson is currently the Head of Biostatistics and Pharmacometrics for Novartis Global Drug Development. Eric has his Ph.D. in Statistics from Kansas State University and has worked for 20 years leading teams of quantitative scientists to influence design and decision making within clinical drug development.