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.
How will you respond to the ever-changing landscape in drug development?
View this guide for hot topics, exclusive highlights, speaker spotlights, and key reasons why you need to attend the leading Statistics Forum of the year!
View eBookWhy Attend?
Learn new and evolving regulatory, legal, and quality issues at this year's forum!
View InfographicFeatured
Short Course or Primer
-
Apr 24, 2017
Course 2: Assessing Biosimilarity and Interchangeability - Issues and Recent Development
Learn more -
Apr 24, 2017
Course 1: New Graphical Methods for Clinical Trials
Learn more
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
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Dionne Price, PhD • Deputy Director, Office of Biostatistics, OTS, CDER
FDA, United States -
Jerald Schindler, DrPH • Vice President, Enterprise Biostatistics
Medtronic, United States -
Frank Bretz, PhD • Distinguished Quantitative Research Scientist
Novartis , Switzerland -
Aloka Chakravarty, PhD • Director, Data Analytics
Office of Data, Analytics, & Research, Office of the Commissioner, FDA, United States -
Rima Izem, PhD • Associate Director Statistical Methodology
Novartis, Switzerland -
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 • Statistical Science Director
Astrazeneca, United States -
Jeff Maca, PhD • Senior Director, Biostatistics; Advisory Services Analytics
Quintiles, United States -
Cristiana Mayer, DrSc, PhD • Head of Biostatistics
Johnson & Johnson Vision, United States -
William Wang, PhD • President
Merck & Co, Inc, United States -
Steve Wilson, PhD • Senior Staff Fellow, OB, OTS, CDER
FDA, United States -
Amy Xia, PhD • Vice President, Center for Design and Analysis
Amgen Inc., United States -
Lisa LaVange, PhD • Professor and Chair, Department of Biostatistics
University of North Carolina At Chapel Hill, United States -
Nevine Zariffa • Vice President and Head Biometrics & Information Sciences
Astrazeneca Pharmaceuticals, United States
Contact us
Registration Questions?
Exclusive Podcast!
DIA Forum Acts on Statistical Impact of 21st Century Cures
Complimentary On Demand Webinar
Multi-Regional Clinical Trials and ICH E17
Short Course 1*
New Graphical Methods for Clinical Trials
Short Course 2*
Assessing Biosimilarity and Interchangeability: Issues and Recent Developments
