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Overview

Short Courses: April 23
Forum: April 23-25
The DIA/FDA Biostatistics Industry and Regulator Forum is a collaboration by DIA and FDA. We have focused this event on statistical thinking to inform policy, regulation, development, and review of medical products in the context of the current scientific and regulatory environments including pharmaceuticals, biologics and biosimilars, combination products and devices, and generics. Each session will be co-chaired by an FDA/Industry team working side-by-side with today’s experts to present a 360 degree perspective of statistical design, analysis, and methodological approaches to building evidence for pharmaceutical, biologic and biosimilar, combination product and device development, and approval.

Now in its twelfth year, the forum fosters open discussion of timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs, biologics, and combination products. This unique forum advances the dialogue between industry, regulatory agencies, and academia.


Highlights

  • Co-Sponsored with the FDA
  • In-depth discussions on new and revised guidances
  • Town Hall: An open discussion lead by an expert panel of leaders from industry and regulatory agencies
  • Each session is co-chaired by an Industry-FDA team
  • Two interactive half day Short Courses for even more in-depth knowledge-sharing
  • Poster Presentations from researchers across the statistics field
  • Luncheon Round Table Discussions on cutting-edge topics with key thought leaders
  • DIA Statistics Open Community Meeting

Preconference Short Courses

  • Artificial Intelligence, Machine Learning, and Precision Medicine
    This short course will provide an overview of statistical machine learning and artificial intelligence techniques with applications to precision medicine, in particular to deriving optimal individualized treatment strategies for precision medicine.
  • Causal Inference: Weighting Methods and Case Studies
    This course will start with a general overview on causal inference methods using weighting and a case-study using IPW method, then we will introduce recently developed methodology of overlap weights, which places emphasis on clinical equipoise and has statistical advantages over IPW.

On-Demand Complimentary Webinar

Structured Exploration of Clinical Trial Data
Gain an overview of a structured approach for safely applying these more advanced methods, discuss their application in practice, and explore how they can be used to guide scientific research.

Register Today.

Who should attend?

Professionals involved in:

  • Biostatistics
  • Pharmaceutical Development
  • Clinical Pharmacology
  • Health Economy
  • Epidemiology
  • Regulatory
  • Academia
  • Government

Learning objectives

At the conclusion of this forum, participants should be able to:

  • Describe the history and key statistical issues of bioequivalence studies
  • Identify the main features of biosimilar drug development and the concept of “switchability” between the innovator biologic and its biosimilar
  • Explain the role of the 21st Century Cures Act in enabling the inclusion of patient experience endpoints in drug development
  • Assess the process for identifying and developing measures of patient experience
  • Examine the role of COA office in regulatory acceptance of patient experience endpoints
  • Evaluate how these data are evaluated in the FDA review process
  • Define what loss in outcome ascertainment sensitivity we are willing to live with in a RWE study, state if that answer is different for a PCT vs an Obs study
  • Describe when one should consider a combination of RCT/PCT/Observational studies
  • Formulate scenarios to be considered when using Obs Studies, considering RCT/PCT’s are not ethical to perform

Program Committee

  • Cristiana  Mayer, PhD
    Cristiana Mayer, PhD Scientific Director, Statistical Modeling and Methodology, SDS
    Janssen Research and Development LLC, United States
  • Dionne  Price, PhD
    Dionne Price, PhD Acting Deputy Director, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Mouna  Akacha, PhD
    Mouna Akacha, PhD Statistical Methodologist
    Novartis Pharma AG, Switzerland
  • Aloka  Chakravarty, PhD
    Aloka Chakravarty, PhD Acting Director, Office of Biostatistics, Office of Translational Sciences, CDER
    FDA, United States
  • Jonathan  Haddad, MPH
    Jonathan Haddad, MPH Director, Clinical Statistics
    GlaxoSmithKline, United States
  • Rima  Izem, PhD
    Rima Izem, PhD Lead Mathematical Statistician,Div.of BiometricsVII,Office of Biostatistics,OTS
    FDA, United States
  • Pandurang M Kulkarni, PhD
    Pandurang M Kulkarni, PhD Vice President, Global Biometrics & Advanced Analytics
    Eli Lilly and Company, United States
  • Min  Lin, MD, PhD
    Min Lin, MD, PhD Mathematical Statistician, Division of Biostatistics, CBER
    FDA, United States
  • Jingyu (Julia)  Luan, PhD
    Jingyu (Julia) Luan, PhD Deputy Division Director (Acting), OB, OTS, CDER
    FDA, United States
  • Karen Lynn Price, PhD, MA
    Karen Lynn Price, PhD, MA Senior Research Advisor
    Eli Lilly and Company, United States
  • Frank W. Rockhold, PhD, MSc
    Frank W. Rockhold, PhD, MSc Professor of Biostatistics
    Duke Clinical Research Institute, Duke University Medical Center, United States
  • William  Wang, PhD
    William Wang, PhD Executive Director, Clinical Safety Statistics, BARDS
    Merck Research Laboratories, United States
  • Amy  Xia, PhD
    Amy Xia, PhD Executive Director, Biostatistics
    Amgen Inc., United States
  • Lisa M. LaVange, PhD
    Lisa M. LaVange, PhD Prof and Associate Chair, Department of Biostatistics
    University of North Carolina at Chapel Hill , United States
  • Nevine  Zariffa
    Nevine Zariffa Vice President and Head Biometrics & Information Sciences
    Astrazeneca Pharmaceuticals, United States
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