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Overview

DIA and FDA Advancing Regulatory Science Initiatives and Statistical Approaches for Building Evidence for the Approval of New Therapies

April 24: Short Courses* 
April 24-26: Forum


Highlights

  • Two engaging Keynote Addresses from Janet Woodcock, MD, Director, CDER, FDA, and Kenneth I Kaitin, PhD, Professor of Medicine; Director, Tufts Center for the Study of Drug Development, Tufts University School of Medicine
  • In-depth discussions on the two new FDA Guidances and the PDUFA VI reauthorization
  • Summary of key forum take aways
  • Two interactive half day Short Courses for even more knowledge-sharing
  • Poster Presentations from researchers across the statistics field
  • Luncheon Round Table Discussions on cutting-edge topics with key thought leaders
  • 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


Now in its eleventh year, the DIA/FDA Statistics Forum fosters open discussion of timely topics of mutual theoretical and practical interest to statisticians and clinical trialists who develop new drugs and biologics. DIA is committed to this important dialog. To ensure critical participation by regulatory staff, academics and industry, DIA invests in this forum to provide pricing that is well below comparable DIA activities yet maintains the quality, experience, and neutrality expected of a DIA-led meeting. 

DIA and FDA have focused this Forum 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.

This program is developed in collaboration with the Statistics Community.

Approved by the Regulatory Affairs Professionals Society for 12 RAC credits.



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:

  • Assess the impact of 21st Century Cures and PDUFA VI on statistical practice
  • Introduce statistical solutions to assess the efficacy, safety, and abuse liability of opioids
  • Discuss recent statistical and clinical trial developments in oncology
  • Describe opportunities for statistical innovation in antimicrobial drug development
  • Outline trends in modeling and decision support in drug development
  • Identify non-traditional data sources and discuss their role in drug development
  • Discuss the synthesis of real-world evidence and randomized controlled clinical trials
  • Propose recommendations for improving inter-stakeholder communication about complex, multi-dimensional issues in developing new therapeutics
  • Summarize the latest trends and updates from regulatory agencies

Program Committee

  • Dionne  Price, PhD
    Dionne Price, PhD Director, Division of Biometrics IV, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Jerald S. Schindler, DrPH
    Jerald S. Schindler, DrPH VP, Data Science & Statistics, Alnylam and Adjunct Professor,
    Harvard Chan School of Public Health, United States
  • Frank  Bretz, PhD
    Frank Bretz, PhD Global Head of Statistical Methodology and Consulting Group
    Novartis Pharma AG, Switzerland
  • Aloka  Chakravarty, PhD
    Aloka Chakravarty, PhD Acting Deputy Director, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Rima  Izem, PhD
    Rima Izem, PhD Lead Mathematical Statistician, Office of Translational Science, CDER
    FDA, United States
  • Pandurang M Kulkarni, PhD
    Pandurang M Kulkarni, PhD Vice President, Global Biometrics & Advanced Analytics
    Eli Lilly and Company, United States
  • Min A. Lin, PhD
    Min A. Lin, PhD Mathematical Statisitician
    FDA, United States
  • Jeff  Maca, PhD
    Jeff Maca, PhD Senior Director, Biostatistics; Advisory Services Analytics
    Quintiles, United States
  • Cristiana  Mayer, PhD
    Cristiana Mayer, PhD Scientific Director, Statistical Modeling and Methodology, SDS
    Janssen Research and Development LLC, United States
  • William  Wang, PhD
    William Wang, PhD Executive Director, Clinical Safety Statistics, BARDS
    Merck Research Laboratories, United States
  • Stephen E. Wilson, DrPH, MPH
    Stephen E. Wilson, DrPH, MPH Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Amy  Xia, PhD
    Amy Xia, PhD Executive Director, Biostatistics
    Amgen, Inc., United States
  • Lisa M. LaVange, PhD
    Lisa M. LaVange, PhD Director, Office of Biostatistics, Office of Translational Sciences, CDER
    FDA, United States
  • Nevine  Zariffa
    Nevine Zariffa Vice President and Head Biometrics & Information Sciences
    Astrazeneca Pharmaceuticals, United States
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