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Biostatistics Industry and Regulator Forum


Speakers

  • 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 Deputy Director, Office of Biostatistics, OTS, 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, Clinical Statistics
    • GlaxoSmithKline, United States

    20 years experience building & leading Biometrics groups in biotech sector. Experience includes oncology, inflammatory diseases and dermatology.

  • Rima  Izem, PhD

    Rima Izem, PhD

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

    Rima Izem currently supervises a team of statisticians reviewing sponsor studies for post-market safety and consumer behavior studies for OTC drugs. Her team is actively involved in multiple FDA led safety studies using FDA's Sentinel System or Center for Medicare and Medicaid Services as well as social science studies assessing direct to consumer drug advertising. At FDA, she has worked in multiple therapeutic areas including cardiovascular, anti-infective, anti-viral, reproductive health, analgesia and addiction. Prior to joining the FDA in June 2008, she was an Assistant Professor at the Statistics Department at Harvard University for four years. She earned a PhD in Statistics from the University of North Carolina at Chapel Hill in 2004.

  • Dionne  Price, PhD

    Dionne Price, PhD

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

    Dionne Price is the Director of the Division of Biometrics IV, Office of Biostatistics, Office of Translational Sciences, Center for Drug Evaluation and Research, US Food and Drug Administration (FDA). In this role, Dr. Price provides leadership to statisticians involved in the development and application of methodology used in the regulation of anti-infective, anti-viral, ophthalmology, and transplant drug products. Dr. Price holds a 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 International Biometric Society and the American Statistical Association.

  • Karen Lynn Price, PhD, MA

    Karen Lynn Price, PhD, MA

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

    Karen received her PhD from Baylor University and is currently a Research Advisor at Lilly. She leads the Bayesian group at Lilly and chairs the DIA Bayesian Scientific Working group bringing together representatives from the academic, industry, and regulatory to improve use of Bayesian methods.

  • Frank W. Rockhold, PhD, MSc

    Frank W. Rockhold, PhD, MSc

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

  • 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.

  • Representative Invited

    Representative Invited

    • FDA, United States
  • 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.

  • Jingyu  Luan, PhD

    Jingyu Luan, PhD

    • Lead Mathematical Statistician
    • FDA, United States

  • Cristiana  Mayer, PhD

    Cristiana Mayer, PhD

    • Scientific Director, Statistical Modeling and Methodology, SDS
    • Janssen Research and Development LLC, United States

    Cristiana is Scientific Director at Janssen R&D, Johnson & Johnson. She joined the Statistical Modeling & Methodology group in 2013, after a 15-year tenure in the Biostatistics Department as Statistical Leader in many TA’s including hematology, neurology, psychiatry, immunology and metabolism. Cristiana is currently the Head of the Adaptive Clinical Trials Center of Excellence. Cristiana’s recent research interests include adaptive designs, Bayesian approaches to non-inferiority and one-arm trials, recurrent event models and analysis of suicidal ideation and behaviors. She has a Ph.D. in Statistics from the University of Trento, Italy. She currently co-leads the DIA adaptive design working group subteam on simulation report best practices.

  • Representative Invited

    Representative Invited

    • FDA, United States
  • William  Wang, PhD

    William Wang, PhD

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

    Bill has over 24 years of experience in the pharmaceutical industry. 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). He was a recipient of the DIA Global Inspire Award for Global Connector in 2017. Currently chairs an ASA 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. Her research interests include Bayesian and adaptive design, meta-analysis and innovative approaches in drug development. Amy is an ASA Fellow. She currently serves as Vice-Chair for the DIA Bayesian Scientific Working Group. Amy received her Ph.D. in Biostatistics from University of Minnesota, and an M.D. equivalent degree from Peking University, China.

  • Sudip  Parikh, PhD

    Sudip Parikh, PhD

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

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Submission Deadline: February 12