• Examining the Impact of Real-World Evidence on Medical Product Development: A Workshop Series | Workshop 1: Incentives Date: September 19, 2017 - September 20, 2017 (8:30 AM Eastern)

    An ad hoc committee of the National Academies of Sciences, Engineering, and Medicine (NASEM) will plan and conduct a three-part workshop series to be held over the course of a two-year period. As part of FDA's continued focus on building a national governance system for evidence generation, the proposed focus of these workshops will be on the generation and utilization of real-world evidence to evaluate efficacy, effectiveness, tolerability, and safety for both review of new indications and postapproval studies.
  • Enabling Precision Medicine: The Role of Genetics in Clinical Drug Development – A Workshop Date: March 8, 2017 (8:00 AM Eastern)

    This one-day public workshop will examine and discuss successes, challenges, and best practices for effectively utilizing genetic information in the design and implementation of clinical trials to support the development of precision medicines, including exploring the potential advantages and disadvantages of such trials across a variety of disease areas. Topics covered could include strategies for including genetically focused populations in clinical trial design, logistical challenges in conducting genetics-based clinical trials, and mechanisms for engaging with and educating potential trial participants.
  • Real-World Evidence Generation and Evaluation of Therapeutics—A Workshop Date: October 19, 2016 (8:00 AM Eastern)

    The traditional process for evaluating new therapeutics does not produce the evidence that patients, clinicians, and payers need for real-world decisions.
  • Advancing the Discipline of Regulatory Science for Medical Product Development: An Update on Progress and a Forward-Looking Agenda: An IOM Workshop Date: October 20, 2015 - October 21, 2015 (8:00 AM Eastern)

    This workshop will provide a venue to review progress in building the foundations of regulatory science and to explore a forward-looking agenda for bolstering the field. Participants will examine the current state and scope of the discipline, highlight opportunities to address barriers to success, and explore ways to foster collaboration.
  • Financial Incentives to Support Unmet Medical Needs for Nervous System Disorders: A Workshop Date: January 20, 2015 - January 21, 2015 (8:30 AM Eastern)

    This workshop will explore opportunities to foster private sector innovation by supporting new investments directed toward the development of novel therapeutics to meet unmet needs for nervous system disorders.
  • Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products Date: May 12, 2014 (9:00 AM Eastern)

    This two-part public workshop series will address the opportunity to advance the development of more systematic and structured approaches to characterize and communicate (a) the sources of uncertainty in the assessment of benefits and risks; and (b) their implications for pharmaceutical regulatory decisions. Specifically, the workshop series will explore potential analytical and communication approaches and identify key considerations on their development, evaluation, and incorporation into the assessment of benefits and risks in pharmaceuticals.
  • Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products Date: February 12, 2014 - February 13, 2014 (9:00 AM Eastern)

    Discuss the challenges in applying more systematic approaches to characterizing and communicating uncertainty in the assessment of a drug’s benefits and risks.
  • International Regulatory Harmonization Amid Globalization of Biomedical Research & Medical Product Development Date: February 13, 2013 - February 14, 2013 (8:30 AM Eastern)

    This public workshop will address needs for international harmonization of regulatory standards to support the development, evaluation and surveillance of biomedical products. Specifically, the discussions at the workshop will help identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards.
  • The Global Crisis of Drug-Resistant Tuberculosis and the Leadership of the BRICS Countries: Challenges and Opportunities Date: January 16, 2013 - January 18, 2013 (7:00 AM Eastern)

    The increasing burden of drug-resistant tuberculosis introduces new challenges to traditional TB control and treatment programs and calls upon the global health community to collaborate and share scientific information in new and different ways. This 3-day workshop is sponsored by the Forum on Drug Discovery, Development, and Translation of the U.S. National Academy of Sciences, Institute of Medicine (IOM) and the Institute of Microbiology of the Chinese Academy of Sciences (CAS). Following an inaugural meeting in Washington, D.C. in 2008, this workshop in Beijing is the fourth in a series of international workshops convened by the U.S. IOM. The objective of the workshop series is to realistically assess the impact of and challenges resulting from drug-resistant TB globally and in the four countries with the most people affected (China, India, Russia, and South Africa).
  • IOM Workshop on Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant TB Date: July 31, 2012 - August 1, 2012 (8:00 AM Eastern)

    Two-day workshop on Developing and Strengthening the Global Supply Chain for Second-Line Drugs for Multidrug-Resistant TB.