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DIA/FDA Statistics 2016 Forum

Now in its tenth year, the Forum fosters open discussion of timely topics of mutual theoretical and practical interest to biostatisticians and clinical trialists.


Speakers

  • Pandurang M Kulkarni, PhD

    Pandurang M Kulkarni, PhD

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

    Pandu Kulkarni 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 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.

  • Jeff  Maca, PhD

    Jeff Maca, PhD

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

    Jeff Maca is a Principal Scientific Advisor in Advisory Services Analytics at Quintiles, with over 19 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. Along with research and consulting work, Jeff also participates in the DIA Adaptive Designs SWG. Jeff received his PhD in Statistics from Texas A&M University.

  • Jerald S. Schindler, DrPH

    Jerald S. Schindler, DrPH

    • Vice President
    • Alkermes, Inc., 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.

  • Stephen E. Wilson

    Stephen E. Wilson

    • Senior Staff Fellow
    • FDA, 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.

  • 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.

  • Eric M. Chi, PhD

    Eric M. Chi, PhD

    • Executive Director
    • Amgen, United States

    Since graduating from the University of Wisconsin at Madison in 1988, Eric started his career with Sanofi-Aventis gaining experiences spanning from research in preclinical, bioavailability/bioequivalence, clinical pharmacology, phase 2/3, post-marketing/medical affairs and health technology assessment. In 2003, he joined Amgen leading the inflammation therapeutic area, and in 2011, Eric moved to the newly formed Biosimilar Division to lead the Biostatistics and Statistical Programming group.

  • Brenda  Crowe, PhD

    Brenda Crowe, PhD

    • Senior Research Advisor, Global Statistical Sciences
    • Eli Lilly and Company, United States

    Brenda Crowe is a Senior Research Advisor 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.

  • Aloka  Chakravarty, PhD

    Aloka Chakravarty, PhD

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

    Dr. Chakravarty joined CDER in 1992. 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 served as an Adjunct Faculty in Depart. of Statistics, Foundation for Advanced Education in the Sciences, NIH. 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.

  • Laura Lee  Johnson, PhD

    Laura Lee Johnson, PhD

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

    Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification to trials of all sizes. Her division covers a wide variety of therapeutic areas. She works across FDA on patient focused drug development and rare disease initiatives, master protocols, and other programs. Prior to working at the FDA, she spent over a decade at the U.S. National Institutes of Health working on and overseeing clinical research and research support programs.

  • Lisa  LaVange, PhD

    Lisa LaVange, PhD

    • Professor 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 was the 2018 ASA President.

  • 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.

  • Cristiana  Mayer, DrSc, PhD

    Cristiana Mayer, DrSc, PhD

    • Director, Statistics and Decision Sciences
    • Janssen Research & Development, LLC, 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. Her current interests are in CID and platform trials and Bayesian designs.

  • 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 in the Oncology Center of Excellence and 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. She is an elected fellow of the American Statistical Association.

  • Yi  Tsong, DrSc, PhD

    Yi Tsong, DrSc, PhD

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

    Yi Tsong is the Director and supervisor of CDER OB Division VI. He supervises the review and researches in the areas of statistical methods in product quality assessment, analytical biosimialrity, new drug bioequivalence, in-vitro bioequivalence, Drug abuse potential and deterrent, Thorough QT studies, pharma-toxicology.

  • Sue-Jane  Wang, PhD, MA, MS

    Sue-Jane Wang, PhD, MA, MS

    • Mathematician Statistician
    • FDA, United States

    Dr. Sue-Jane Wang is Office Associate Director and Biostatistics Lead/Coordinator of FDA/CDER Biomarker Qualification Program from Office of Biostatistics, CDER, FDA. She is an ASA Fellow. Her well-recognized professional expertise includes pharmacogenomics, adaptive design and biomarker associated clinical trial designs and analysis methods with more than 100 peer-reviewed publications in clinical trials, bioinformatics, and specific clinical journals related to genomic/genetic and common diseases. Dr. Wang has served as an Editor-in-Chief for Pharmaceutical Statistics. She has also served as a Guest Editor-in-Chief for, e.g., Biometrical Journal, Journal of Biopharmaceutical Statistics. Dr. Wang is an Associate Editor for a few journals.

  • Peiling  Yang, PhD

    Peiling Yang, PhD

    • Statistics Team Lead, Division Biometrics I, Office of Biostatistics, OTS, CDER
    • FDA, United States

    Dr. Yang received a Ph.D. in statistics from The Ohio State University in 1997. She joined FDA in 1999 as a statistical reviewer of oncology drug products. Since 2005 she has been a team lead. Her team provides statistical support for Division of Psychiatry Products.

  • Yeh-Fong  Chen, PhD

    Yeh-Fong Chen, PhD

    • Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER
    • FDA, United States

    Dr. Chen is the Team Leader of the Division of Biometrics IX within CDER of FDA, supervising reviewers for the Division of Non-Malignant Hematology Products. She joined FDA in 2000 after receiving her Ph.D. from the University of Iowa. She has had years' experience in reviewing drug applications for many diseases in psychiatry, cardiovascular and renal systems, gastroenterology, liver and inborn errors and hematology. Her research interests focus on two-stage enrichment designs and small-size clinical trials.

  • Robert M. Califf, MD

    Robert M. Califf, MD

    • Donald F. Fortin, M.D. Professor of Cardiology, in the School of Medicine
    • Duke University , United States

    Robert Califf, MD is the Donald F. Fortin, MD, Professor of Cardiology. He is also Professor of Medicine in the Division of Cardiology and remains a practicing cardiologist. Dr. Califf was the Commissioner of FDA in 2016-2017 and Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as Commissioner in February 2016. Prior to joining the FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature.

  • Ralph  D'Agostino, PhD

    Ralph D'Agostino, PhD

    • Professor
    • Wake Forest School of Medicine, United States

    Dr. D'Agostino holds a Ph.D. in Statistics from Harvard University, is a Fellow of the American Statistical Association He has served as the Director of the Biostatistics Core of the Comprehensive Cancer Center at WFSM since 2004. He has been the PI for several RO1 grants/subcontracts funded by the NIH. Served on numerous Data Safety and Monitoring boards for NIH and industry funded clinical trials. Published over 260 manuscripts and book chapters in areas of statistical methodology, cardiovascular disease, diabetes, and cancer. He has extensive experience in the design and analysis of clinical trials, observational studies and large scale epidemiologic studies.

  • Lisa M. McShane, PhD

    Lisa M. McShane, PhD

    • Professor of Pediatrics
    • National Cancer Institute Biometric Research Branch, United States

    Dr. McShane is Chief of the Biostatistics Branch in the Biometric Research Program, Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI). She advises on development of tumor markers for use in cancer care. She holds a Ph.D. in Statistics from Cornell University and is a Fellow of the American Statistical Association. She co-led development of “Reporting guidelines for tumor marker prognostic studies (REMARK)” and “Criteria for the use of omics-based predictors in clinical trials.” She is an author of over 100 statistical and biomedical publications and a co-author of “Statistical Design and Analysis of DNA Microarray Investigations.

  • Guenther  Mueller-Velten, MS

    Guenther Mueller-Velten, MS

    • Senior Global Group Head Biometrics & Statistical Sciences
    • Novartis Pharma AG, Switzerland

    Holds a mathematics degree with emphasis on statistics from the University of Trier, Germany. Involved in international clinical drug development for more than 25 years in multiple therapeutic areas; 13 years at Novartis in Switzerland in various leading roles, in particular the Cardiovascular area. Currently, he leads a global group of statisticians providing strategic and scientific input to all Novartis cardiovascular clinical development programs and regulatory submissions and ensuring that state-of-the-art and novel statistical methodologies are implemented consistently in cardiovascular trials (including large outcome trials). Areas of interest and expertise: multiplicity, recurrent event data analysis, and sample size re-estimation.

  • Nikunj B. Patel, PharmD

    Nikunj B. Patel, PharmD

    • Director, Patient Reported Outcomes (Oncology) - Global Medical Affairs
    • AstraZeneca, United States

    Nikunj is passionate about developing new medicines and technologies that will improve how patients feel, function, and survive. As a PRO Director, he sets and leads PRO measurement strategies in oncology TA medical product development at AstraZeneca. Prior to AstraZeneca, Nikunj was a clinical outcome assessment (COA) reviewer at the US Food and Drug Administration where he advised pharmaceutical companies on COA measurement strategies and reviewed marketing applications (INDs, NDAs, BLAs) across TAs. While at FDA, Nikunj also led FDA scientific policy development initiatives related to patient outcomes.

  • Martin  Posch, DrSc, PhD

    Martin Posch, DrSc, PhD

    • Professor
    • Medical University of Vienna, Austria

    From 2011-2012 Martin Posch worked as statistical expert at the European Medicines Agency (London, UK) in the Human Medicines Development and Evaluation sector, where he contributed to guideline development and the assessment of study designs. He has a PhD in Mathematics from the University of Vienna and was scientific assistant and associate professor at the Medical University of Vienna. His research interests are group sequential trials, adaptive designs and multiple testing, focusing on applications in clinical trials and Bioinformatics. Martin Posch serves as Associate Editor of Biometrics and Biometrical Journal.

  • Estelle  Russek-Cohen, PhD

    Estelle Russek-Cohen, PhD

    • Senior Advisor, Office of Biostat
    • FDA, United States

    Estelle Russek-Cohen, Ph.D., is the director of the Division of Biostatistics in the Center for Biologics Evaluation and Research (CBER) in the Office of Biostatistics and Epidemiology. She serves as regulatory chair of the ICH E9 R1 working group on estimands. Her personal interests include personalized medicine and methods to support safety of medical products. She is a fellow of the American Statistical Association.

  • Alec  Walker, DrPH, MD

    Alec Walker, DrPH, MD

    • Drug Safety Epidemiologist
    • World Health Information Science Consultants, United States

    Alec Walker is a Principal at WHISCON, an Adjunct Professor at the Harvard TH Chan School of Public Health, and a senior scientific adviser to the Reagan Udall Foundation for the FDA. His research encompasses drug safety and the effective use of electronic health data for safety studies.

  • 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 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 .

  • Amy  Abernethy, MD, PhD

    Amy Abernethy, MD, PhD

    • Principal Deputy Commisssioner
    • FDA, United States

    Amy P. Abernethy, MD PhD is the Chief Medical Officer and Chief Scientific Officer at Flatiron Health, a healthcare technology company focused on organizing the world's cancer data and making it actionable for providers, patients, researchers and life sciences. She is a hematologist/oncologist and palliative medicine physician, and internationally recognized cancer clinical researcher with over 400 publications.

  • Shashi  Amur, PhD

    Shashi Amur, PhD

    • Scientific Lead, Biomarker Qualification Program Office of Translational Science
    • FDA, United States

    Dr. Amur is currently the Scientific Lead for the Biomarker Qualification Program housed in the Office of Translational Sciences (OTS) in CDER, FDA. She received her Ph.D. in biochemistry from Indian Institute of Science, India and completed post-doctoral fellowships at Temple University and at UCLA. She then gained experience in diagnostic and biotech sectors (Specialty Laboratories in Santa Monica, CA and Applied Biosystems in Foster City, CA, and Neotropix, Inc, PA.) before joining CDER, FDA as a senior genomics reviewer in the Office of Clinical Pharmacology (OCP). Her current research interest areas include pharmacogenomics, HLA-associated adverse events and biomarkers in autoimmune diseases and Alzheimer’s.

  • Brian  Claggett, PhD, MA, MS

    Brian Claggett, PhD, MA, MS

    • Instructor
    • Harvard Medical School, United States

    Dr. Claggett is an Associate Scientist in the Division of Cardiovascular Medicine at Brigham and Women's Hospital and Instructor in Medicine at Harvard Medical School. He received a PhD in Biostatistics from Harvard University in 2012. He has collaborated with researchers in a variety of disease areas, including HIV/AIDS, diabetes, and heart failure. His research expertise includes topics relevant to the analysis of clinical trials, including survival analysis, multiple patient-level outcomes, meta-analysis, and the identification of patient subpopulations who may or may not respond to a novel treatment. He has more than 50 peer-reviewed publication and has served as statistician for large, multinational, phase-3 clinical trials.

  • Cassie  Dong, PhD

    Cassie Dong, PhD

    • Mathematical Statistician, Division of Biometrics VI, OTS, CDER
    • FDA, United States

    Cassie is a Statistics Reviewer in CMC Review Team at office of Biostatistics, FDA and holds a Masters in Chemistry and PhD in Statistics. She joined FDA in 2012. Her primary review work concentrates on the analytical similarity assessment and product quality control. She also has research experience in clinical trials design and measurement error. Dr. Dong has won several FDA awards and is the author of more than 20 scientific journal articles.

  • Laurie  Muldowney, MD

    Laurie Muldowney, MD

    • Lead Medical Officer, OND, CDER
    • FDA, United States

    Dr. Laurie Muldowney is a Clinical Team Leader within the FDA’s Division of Gastroenterology and Inborn Error Products. In this role, Dr. Muldowney focuses primarily on the review of products to treat inborn errors of metabolism. Dr. Muldowney previously served as a medical officer in the Office of Pharmaceutical Science, where she led Center-wide working groups charged with evaluating drug quality issues with potential impact on the safety and efficacy of drug products. Dr. Muldowney received a B.S. in chemistry from the College of William and Mary and earned her medical doctorate from Jefferson Medical College in Philadelphia, PA.

  • Andrew  Stone, MSc

    Andrew Stone, MSc

    • Head of Statistical Innovation
    • AstraZeneca, United Kingdom

    Andrew Stone has worked for AstraZeneca for over 23 years and currently leads the Statistical Innovation team. Prior to that Andrew occupied various leadership positions in oncology for 9 years – managing a team of 45 statisticians in the UK and US. At the end of May he will be venturing onto pastures new working as a Statistical Consultant.

  • Ronald  Wasserstein

    Ronald Wasserstein

    • Executive Director
    • American Statistical Association, United States

    Ron Wasserstein has been the executive director of the American Statistical Association (ASA) since 2007. In this role, Wasserstein provides executive leadership for the world’s largest professional association of statisticians and is responsible for ensuring the ASA fulfills its mission to promote the practice and profession of statistics. From 1984-2007, Wasserstein was a mathematics and statistics department faculty member and administrator at Washburn University in Topeka, Kan. During his last seven years at the school, he served as the university’s vice president for academic affairs. Wasserstein is a Fellow of the ASA and American Association for the Advancement of Science.

  • Robert A. Beckman, MD

    Robert A. Beckman, MD

    • Professor of Oncology, Biostatistics, Bioinformatics, and Biomathematics
    • Georgetown University Medical Center, United States

    Robert Beckman, M.D. is an oncology clinical researcher and biomathematician focused on improving the way cancer therapies are developed and utilized. He has co-invented novel clinical strategies for proof of concept studies and for biomarker driven clinical development, as well as novel therapeutic strategies incorporating tumor evolution. In an 18 year industry career, he has played leadership roles in forming 4 oncology clinical research groups. He has contributed approximately 300 published articles, book chapters, and presentations, emphasizing quantitative approaches to basic and applied oncology, including a recent book co-edited with Zoran Antonijevic. He currently leads the DIA Adaptive Design Scientific Working Group.

  • Marc E. Buyse, DrSc

    Marc E. Buyse, DrSc

    • Chief Scientific Officer
    • International Drug Development Institute (IDDI), United States

    Marc Buyse holds master’s degrees from Brussels University (Belgium), the Cranfield School of Management (UK) and a doctorate degree from the Harvard School of Public Health (USA). He had worked for 12 years at the EORTC in Brussels and for 2 years at the Dana Farber Cancer Institute in Boston. Founder of IDDI and CluePoints, he is also an Associate Professor of Biostatistics at the Limburgs Universitair Centrum, Diepenbeek, Belgium. (http://publicationslist.org/marc.buyse).

  • Frank  Shen, PhD

    Frank Shen, PhD

    • Retired Vice President, Data and Statistical Sciences, GPRD
    • Abbvie, Inc., United States

    Dr. Shen has served as the Vice President of Data & Statistical Sciences at AbbVie Inc. since 2011. In this capacity, Frank leads 350 quantitative scientists worldwide to support global drug discovery and development. He also leads AbbVie’s World-Class Clinical Science Excellence initiative which includes building a new real-world evidence capability in drug development. Frank received his PhD degree in Statistics from Temple University and a MS degree in Chemical Engineering. He was named a Fellow of the American Statistical Association in 2003 and served as the Chair of the PhRMA Biostatistics and Data Management Steering committee from 2005 to 2006.

  • Meiyu  Shen, PhD

    Meiyu Shen, PhD

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

    A team leader and a senior statistical reviewer at the Center of Drug Evaluation and Research, Food and Drug Administration (FDA). She obtained her Ph.D. in statistics from Statistics Program of Department of Mathematics at University of Maryland at College Park in 2015 and her Ph.D. in Chemical Engineering from Department of Chemical Engineering at Iowa State University in 1999. She received four FDA Outstanding Service Awards for significant efforts and contributions in statistics related to reviews and research in Chemistry and Manufacturing Control and biosimilar evaluation. She has published more than 35 papers in the statistical, medical, and engineering journals.

  • Yuan-Li  Shen, DrPH

    Yuan-Li Shen, DrPH

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

    Yuan-Li is the acting Associate Director in Division of Biometrics V, Office of Biostatistics, Office of Translational Science, CDER, FDA. The teams that she is associated with support all statistical aspects of regulatory submissions in Gastrointestinal, Lung/Head and Neck, Neuro-oncology/Rare cancers/Solid Tumor, Pediatric Malignancies, Melanoma/Sarcoma products. She received a doctorate in Biostatistics from the University of North Carolina, Chapel Hill. She has over 25 years of combined experience in clinical trial setting across academia, pharmaceutical industry and FDA.

  • Carl-Fredrik  Burman, PhD

    Carl-Fredrik Burman, PhD

    • Assoc. Prof. in Biostatistics, Chalmers Univ of Tech; Senior Principal Scientist
    • AstraZeneca R&D, Sweden

    Carl-Fredrik Burman is associated professor at Chalmers Univ. and Senior Statistical Science Director at AstraZeneca. He is principal investigor for Decision Analysis within the EU funded IDEAL project on innovative methodology for clinical trials in small population groups, including rare diseases. At AZ, Dr. Burman works on methodological development and consultations, especially for trial design and multiple inference. He serves as associated editor of the Journal of Biopharmaceutical Statistics and as scientific committee member of the European Federation of Statisticians in the Pharmaceutical Industry.

  • Jonathan P. Jarow, MD, PhD

    Jonathan P. Jarow, MD, PhD

    • Chief Medical Officer, ODE, CDRH
    • FDA, United States

    Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology Products. Prior to joining the FDA he was Professor of Urology, Pathology, Radiology, and Molecular Biology & Biochemistry at Johns Hopkins University.

  • Richard O. Montes, PhD

    Richard O. Montes, PhD

    • Associate Director, Statistics (Biosimilars Pharmaceutical Sciences)
    • Hospira, A Pfizer Company, United States

    Richard has over 15 years of experience in drug development spanning from scientist role (immunotherapy bench research and monoclonal antibody technology transfer) and crossing over to statistician role (R&D, CMC, quality, manufacturing, and biosimilars). He currently directs the nonclinical statistical aspects of Hospira’s biosimilars pipeline development including setting statistical approaches to demonstrate analytical similarity and application of CMC statistical methodologies such as specification setting, stability analyses, and method validation. He holds a Ph.D. in Chemical Engineering from Georgia Institute of Technology with a minor in Statistics with further post-doctoral statistics courses from numerous academic institutions.

  • Norman  Stockbridge, MD, PhD

    Norman Stockbridge, MD, PhD

    • Director, Division of Cardiovascular and Renal Products, OND, CDER
    • FDA, United States

    Norman Stockbridge, MD, PhD has been in FDA/CDER's Division of Cardiovascular and Renal Products since 1991 and has been its Director since 2004.

  • Shein-Chung  Chow, PhD

    Shein-Chung Chow, PhD

    • Associate Director, OB, OTS, CDER
    • FDA, United States

    Shein-Chung Chow, Ph.D. is an Associate Director, Office of Biostatistics, CDER/FDA. Prior to joining FDA, Dr. Chow was a Professor of Biostatistics and Bioinformatics at Duke University School of Medicine, Durham, NC. He was also a special government employee (SGE) appointed by the FDA as an Advisory Committee member and consultant to the FDA. Dr. Chow is Editor-in-Chief of the Journal of Biopharmaceutical Statistics and Editor-in-Chief of the Biostatistics Book Series at Chapman and Hall and CRC Press. Dr. Chow is Fellow of the American Statistical Association, who is the author or co-author of 300 methodology papers and 29 books.

  • H. M. James  Hung, PhD

    H. M. James Hung, PhD

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

    Dr. James Hung is currently Director, Division of Biometrics I, CDER, US FDA. The division provides services for the medical divisions: Neurology, Psychiatry, Anesthesiology, Addiction Medicine, and Pain Medicine, Medical Imaging and Radiation Medicine.

  • Bruce  Binkowitz, PhD, MSc

    Bruce Binkowitz, PhD, MSc

    • Vice President, Biometrics
    • Shionogi, Inc., United States

    Dr. Binkowitz is Vice President of Biometrics at Shionogi, Inc. after spending 32 years at Merck and Co. Dr. Binkowitz has 30 years of drug development experience and is a fellow of the ASA. Bruce is involved in the statistical community including serving on the DIA Stat Community Core team, 3 committees for the ASA Biopharm Section; and serving a 3 year term on the ENAR regional board of regional advisors as well as being co-chair of the SCT/QSPI MultiRegional Clinical Trial Expert Group.

  • John  Scott, PhD, MA

    John Scott, PhD, MA

    • 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.

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