Meetings

  • Virtual Clinical Trials: Challenges and Opportunities - A Workshop Date: November 28, 2018 - November 29, 2018 (8:30 AM Eastern)

  • Examining the Impact of Real-World Evidence on Medical Product Development: Application Date: July 17, 2018 - July 18, 2018 (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. These workshops would include presentations and perspectives from thought and knowledge leaders representing a range of disciplines, including but not limited to federal regulatory and funding agencies, clinical and academic medicine and research, medical professional organizations, the regulated biopharmaceutical industry, patients and patient-focused and disease-advocacy organizations, payers, consumer organizations, health systems, and other interested stakeholders that represent the myriad views of those involved in drug, biologic, and device discovery, development, translation, and regulation. The workshop audiences are expected to be similarly diverse, and they will have opportunities to engage in discussion during the workshops.
  • Advancing the Science of Patient Input in Medical Product R&D: Towards a Research Agenda - A Workshop Date: May 9, 2018 (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. These workshops would include presentations and perspectives from thought and knowledge leaders representing a range of disciplines, including but not limited to federal regulatory and funding agencies, clinical and academic medicine and research, medical professional organizations, the regulated biopharmaceutical industry, patients and patient-focused and disease-advocacy organizations, payers, consumer organizations, health systems, and other interested stakeholders that represent the myriad views of those involved in drug, biologic, and device discovery, development, translation, and regulation. The workshop audiences are expected to be similarly diverse, and they will have opportunities to engage in discussion during the workshops.
  • Examining the Impact of Real-World Evidence on Medical Product Development: A Workshop Series | Workshop 2: Practical Approaches Date: March 6, 2018 - March 7, 2018 (8:00 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. These workshops would include presentations and perspectives from thought and knowledge leaders representing a range of disciplines, including but not limited to federal regulatory and funding agencies, clinical and academic medicine and research, medical professional organizations, the regulated biopharmaceutical industry, patients and patient-focused and disease-advocacy organizations, payers, consumer organizations, health systems, and other interested stakeholders that represent the myriad views of those involved in drug, biologic, and device discovery, development, translation, and regulation. The workshop audiences are expected to be similarly diverse, and they will have opportunities to engage in discussion during the workshops.
  • 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.
  • The Drug Development Paradigm in Oncology: A Workshop Date: December 12, 2016 - December 13, 2016 (8:00 AM Eastern)

    This workshop will examine the challenges of improving the efficiency of the drug development and regulatory review process, while ensuring the safety of new therapies.
  • 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.
  • Deriving Drug Discovery Value from Large-Scale Genetic Bioresources: A Workshop Date: March 22, 2016 (8:30 AM Eastern)

    On March 22, 2016, the Roundtable on Translating Genomic-Based Research for Health and the Forum on Drug Discovery, Development, and Translation hosted a one day public workshop to examine and discuss how large-scale genetic data could be used to improve the likelihood of bringing effective and targeted therapies to patients. The goal of the workshop was to address how progress could be made in discovering and validating promising targets and medicines for those targets by using the data collected from large-scale genetic studies. Discussions were held with a broad array of stakeholders which included representatives from pharmaceutical and biotech companies, IT and data science companies, research institutes, investors, providers, patients, payers, and regulators.
  • 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.