Discuss PDUFA V Statistical Topics and Emerging New Issues - Apr 28 - May 1

Discuss PDUFA V Statistical Topics and Emerging New Issues Now in its seventh year, this unique forum continues the dialogue on issues including FDA guidance development and regulatory science initiatives including PDUFA V initiatives, as well as statistical opportunities and challenges associated with data standards and innovative approaches to the design, monitoring, analysis, and reporting of clinical trials and assessments of safety and effectiveness in the pre- and postmarket settings. Over the three days, in-depth discussions on key topics relevant to the evaluation of therapeutic products will take place, and include input from key thought leaders from regulatory agencies, industry, and academia. With the success of last year’s forum we will continue to offer additional avenues for interaction and scientific discourse via a scientific poster session during the networking reception and an interactive round-table luncheon event. Keynote Speakers: International Year of Statistics April 29 | 9:00-10:30AM ET Janet Woodcock, MD Director Left for Drug Evalulation and Research FDA Robert N. Rodriguez, PhD Senior Director Statistical Research and Development SAS Institute, Inc. PDUFA V Overview April 29 | 11:00AM-12:00PM This session will discuss the key PDUFA V commitments, current plans for their implementation, areas of interest for statisticians in particular, and perspectives on the potential impact on stakeholders. Speakers:      • Stephen J. Ruberg, PhD, Distinguished Research Fellow, Eli Lilly and Company      • Theresa M. Mullin, PhD, Associate Director, Office of Planning and Informatics, CDER, FDA      • Jay P. Siegel, MD, Chief Biotechnology Officer, Head Global Regulatory Affairs         Janssen Research & Development, LLC      • Stephen E. Wilson, DrPH, Director, Division of Biometrics III, CDER, FDA      • Robert T. O'Neill, PhD, Senior Statistical Advisor, Office of Translational Sciences, CDER, FDA (Premarketing) Benefit-Risk Assessment in Clinical Development and Regulatory Review April 30 | 1:30-3:00PM In this session, speakers will discuss various Benefit-risk assessment approaches that can be potentially used to meet the needs of global regulatory agencies and prescribers, as well as challenges that may arise in implementing them. Speakers:      • Qi Jiang, PhD, Executive Director, Amgen Inc.      • Jonathan D. Norton, PhD, Mathematical Statistician, Division of Biometrics V, OB, CDER, FDA      • Scott Evans, PhD, Senior Research Scientist, Harvard University School of Public Health      • Steven M. Snapinn, PhD, Vice President, Global Biostatistical Science, Amgen Inc.      • Frank W. Rockhold, PhD, Senior Vice President, Global Clinical Safety and Pharmacovigilance        GlaxoSmithKline      • Patrick Frey, Director, Office of Planning and Analysis, CDER, FDA Overview and Commentary of FDA Guidances: Multiplicity and/or Enriched Populations May 1 | 3:00-4:30PM Key contributors from FDA will present highlights of the FDA guidances, and speakers from industry and academia will provide key suggestions and comments on the draft guidances. Speakers:      • Walter Offen, PhD, Global Head of Statistical Innovation & Safety Statistics, Abbvie      • Mohamed A. Alosh, PhD, Team Leader, FDA      • Frank Bretz, PhD, Global Head of Statistical Methodology, Novartis Pharma AG, Switzerland      • Gary G. Koch, PhD, MS, Director, University of North Carolina at Chapel Hill      • Lisa M. LaVange, PhD, Director, Office of Biostatistics, Office of Translational Science        CDER, FDA      • Stephen J. Ruberg, PhD, Distinguished Research Fellow, Eli Lilly and Company      • Robert J. Temple, MD, Deputy Left Director for Clinical Science, CDER, FDA      • Kathleen S. Fritsch, PhD, Mathematical Statistician, OTS, CDER, FDA      • Sue-Jane Wang, PhD, MA, MS, Associate Director, Adaptive Design & Pharmacogenomics        Office of Biostatistics, OTS, FDA      Jumpstart Your Education at this Annual Forum by Adding a Tutorial:      • Statistical Methods for Safety Surveillance      • Missing Data in Clinical Trials          • Benefit-Risk Evaluation   Overview | Agenda | Register Online          Upcoming Webinars: March 27 | 10:00-11:30AM ET April 24 | 11:00AM-12:30PM ET April 25-26 | 10:00-11:30AM ET

PDUFA V Statistical Topics and Emerging New Issues

Call for Posters and Roundtable Luncheon Topics Deadlines Extended This year’s theme is PDUFA V Statistical Topics and Emerging New Issues. Now in its seventh year, this unique forum continues the dialogue on issues including FDA guidance development and regulatory science initiatives including PDUFA V initiatives, as well as statistical opportunities and challenges associated with data standards and innovative approaches to the design, monitoring, analysis, and reporting of clinical trials and assessments of safety and effectiveness in the pre- and post-market settings. Over the three days, in-depth discussions on key topics relevant to the evaluation of therapeutic products will take place, and include input from key thought leaders from regulatory agencies, industry, and academia. With the success of last year’s forum we will continue to offer additional avenues for interaction and scientific discourse via a scientific poster session during the networking reception and an interactive round-table luncheon event. Call for Posters Submission Deadline: February 28 Call for Roundtable Luncheon Topics Submission Deadline: February 28 Please Note: DIA User ID and Password is needed to submit an abstract. Did you land on the My DIA Page? If so, please select “My Abstract Submissions” on the left side to submit an abstract. Overview | Agenda | Register Online Keynote Speaker: Monday, April 29 Robert N. Rodriguez, PhD Past President, American Statistical Association Senior Director, Statistical Research and Development SAS Institute Session Topics: • PDUFA V Overview • Statisticians as Leaders • FDA Upcoming Guidance Update (Multiplicity and Enriched Populations) • Dichotomizing Continuous Measures for a Primary Efficacy Endpoint – Weighing the Benefits and Risks • Measures for Primary Efficacy Endpoint – Are we Substantially Compromising Statistical Power? • Pre-Competitive Collaboration • Meta Analysis for Safety Data • Companion Diagnostics • (Premarketing) Benefit-Risk Assessment in Clinical Development and Regulatory Review • (Premarketing) Benefit-Risk Assessments • Health Technology Assessment and Comparative Effectiveness Research: Their Impact on Access to Pharmaceutical Products and Their Role in Designing Product Development Strategies • Missing Data: When is it Important to Collect Data After Study Drug Discontinuation? • Missing Data: Case Study Presentation and Panel Discussion • Overview and Commentary of FDA Guidances: Multiplicity and/or Enriched Populations Tutorial Topics: • Statistical Methods for Safety Surveillance • Missing Data in Clinical Trials • Benefit-Risk Evaluation We look forward to seeing you in April! Regards, Constance Burnett Content Lead Constance.Burnett@diahome.org We think you might also like these... Introduction to Signal Detection and Data Mining Global Considerations for Regulatory Strategy Development DIA/FDA Industry PDUFA V Conference Unwrapping FDA’s 2012 UFA Package: What’s Inside the Statute, What’s Next?

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FDA: Navigating the changes with professional development

The Food and Drug Administration Safety and Innovation Act (FDASIA) is Law. Now What?  Join DIA, Food and Drug Administration (FDA), and The Food and Drug Law Institute (FDLI) as they convene the foremost experts in separate conferences to explain the nuances and forecast the implications of the User Fee Acts—PDUFA V, MDUFA III, GDUFA, and BsUFA. DIA/FDA Biosimilars Conference: Guidances, Science, and BsUFA September 12-13 | Washington, DC Co-sponsored by In 2009, the Biologics Price Competition and Innovation Act (BPCI Act) was enacted as part of the Affordable Care Act. This conference will deal with the scientific and regulatory issues related to the demonstration of biosimilarity, focusing both on the FDA’s current thinking on approaches to biosimilar development as well as perspectives of other regulators. Hotel Early-Bird Rates End August 27! In collaboration with Keynote Speaker: Janet Woodcock, MD Director, Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA) View Program Online | Register Today Unwrapping FDA's 2012 UFA Package: What's Inside the Statute, What's Next? September 20 | Washington, DC Co-sponsored by The content of the UFA packages will shape the timeliness of reviews of life-saving medicines and medical devices, the requirements of all phases of medical product development, and the industry’s ability to innovate and develop needed medical products. This one-day conference will provide a first look at the final packages enacted for PDUFA V, MDUFA III, GDUFA and BsUFA. FDA will discuss the goals and commitments for their Centers, the changes of emphasis, and the potential impact on future programs. Reactor panels will provide the exchange of views on what the UFA provisions will mean for innovation, how they will improve patient access to needed medical products over the next five years, and next steps in preparing for 2017. Keynote Speakers: Jeanne Ireland Assistant Commissioner for Legislation Food and Drug Administration (FDA) Jeffrey E. Shuren, MD, JD Director, Center for Devices and Radiological Health (CDRH) Food and Drug Administration (FDA) View Program Online | Register Today DIA/FDA Industry PDUFA V Conference October 18-19 | Arlington, VA Co-sponsored by With the recent authorization of PDUFA V, this two-day conference sets the stage for FDA, industry, patient, consumer, and healthcare professional group representatives, and technology vendors to discuss the key PDUFA V commitments, current plans for their implementation, and potential impact on all stakeholders. Keynote Speakers: Theresa M. Mullin, PhD Associate Director, Office of Planning and Informatics Center for Drug Evaluation and Research (CDER) Food and Drug Administration (FDA) David Wheadon, MD Senior Vice President, Scientific and Regulatory Affairs PhRMA   View Program Online | Register Today My DIA    |    Forward to a Friend    |