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Bethesda North Marriott Hotel and Conference Center

Apr 24, 2017 1:00 PM - Apr 26, 2017 4:30 PM

5701 Marinelli Road, , North Bethesda, MD 20852 , USA

DIA/FDA Statistics Forum

The DIA/FDA Statistics Forum fosters open discussion of timely topics of mutual theoretical and practical interest to biostatisticians and clinical trialists.


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


  • 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.


Want to learn more about DIA/FDA Statistics Forum? You've come to the right site!


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

Short Course or Primer

To keep you at the forefront.

Apr 24, 2017

Course 2:

Assessing Biosimilarity and Interchangeability - Issues and Recent Development

Apr 24, 2017

Course 1:

New Graphical Methods for Clinical Trials

Program Committee

  • Dionne  Price, PhD
    Dionne Price, PhD Deputy Director, Office of Biostatistics, OTS, CDER
    FDA, United States
  • Jerald  Schindler, DrPH
    Jerald Schindler, DrPH Chief Executive Officer
    Strategic Statistics, United States
  • Frank  Bretz, PhD
    Frank Bretz, PhD Distinguished Quantitative Research Scientist
    Novartis , Switzerland
  • Aloka  Chakravarty, PhD
    Aloka Chakravarty, PhD Director, Data Analytics
    Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States
  • Rima  Izem, PhD
    Rima Izem, PhD Associate Director Statistical Methodology
    Novartis, Switzerland
  • Pandurang M Kulkarni, PhD
    Pandurang M Kulkarni, PhD Chief Analytics Officer-R&D / Vice President of Statistics, Data & Analytics
    Eli Lilly and Company, United States
  • Min  Lin, MD, PhD
    Min Lin, MD, PhD Statistical Science Director
    Astrazeneca, United States
  • Jeff  Maca, PhD
    Jeff Maca, PhD Senior Director, Biostatistics; Advisory Services Analytics
    Quintiles, United States
  • Cristiana  Mayer, DrSc, PhD
    Cristiana Mayer, DrSc, PhD Head of Biostatistics
    Johnson & Johnson Vision, United States
  • William  Wang, PhD
    William Wang, PhD President
    Merck & Co, Inc, United States
  • Steve  Wilson, PhD
    Steve Wilson, PhD Senior Staff Fellow, OB, OTS, CDER
    FDA, United States
  • Amy  Xia, PhD
    Amy Xia, PhD Vice President, Center for Design and Analysis
    Amgen Inc., United States
  • Lisa  LaVange, PhD
    Lisa LaVange, PhD Professor Emerita
    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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