Meetings

  • Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: A Workshop Date: July 16, 2018 - July 17, 2018 (8:00 AM Eastern)

    The National Cancer Policy Forum will hold a public workshop on July 16-17, 2018 to examine the opportunities to improve the clinical development of immune checkpoint inhibitor therapies for cancer, including in the context of site-agnostic indications.
  • 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.
  • Exploring Medical and Public Health Preparedness for a Nuclear Incident: A Workshop Date: August 22, 2018 - August 23, 2018 (8:00 AM Eastern)

    The National Academies of Sciences, Engineering, and Medicine will host a two-day public workshop on August 22-23, 2018 at the National Academies Building (Fred Kavli Auditorium) called Exploring Medical and Public Health Preparedness for a Nuclear Incident. Through this workshop, participants from government, NGO and private sector organizations will explore current assumptions behind and the status of medical and public health preparedness for a nuclear incident, examine potential changes in assumptions and approach, and discuss challenges and opportunities for capacity building in the current threat environment.
  • Transgenic and Chimeric Neuroscience Research: Exploring the Scientific Opportunities Afforded by New Nonhuman Primate Models — A Workshop Date: October 4, 2018 (8:30 AM Eastern)

    The Forum on Neuroscience and Nervous System Disorders proposes to host a public workshop bringing together key stakeholders to advance the discussions that emerged from the three National Institutes of Health meetings scheduled in June and July 2017 to address the opioid epidemic, and examine potential implementation barriers and opportunities related to the proposed approaches discussed.
  • Exploring Sources of Variability Related to the Clinical Translation of Regenerative Engineering Products - A Workshop Date: October 18, 2018 (8:30 AM Eastern)

    Regenerative engineered therapies rely on live cells and/or biologically active scaffolds, thereby creating inherent challenges associated with variability and consistency in source and final products. Each patient, donor, and product application is unique, and therefore, the field faces complexities in the development of new products and therapies that are safe and effective that are not faced by developers of more conventional therapies. To further explore the various factors that contribute to successful regenerative engineering products, the Forum on Regenerative Medicine will hold a one-day workshop in Washington, DC on October 18, 2018. The workshop may discuss factors and sources of variability in the development and clinical application of regenerative engineering products, characteristics of high-quality products, and how different clinical needs, models, and contexts can inform the development of a product. A broad array of stakeholders may take part in the workshop, including academic and industry experts, regulators, clinicians, patients, and patient advocates.
  • Improving Cancer Diagnosis and Care: The Clinical Application of Computational Methods in Precision Oncology: A Workshop Date: October 29, 2018 - October 30, 2018 (8:00 AM Eastern)

    The workshop will be held on October 29 – 30, 2018 to examine the clinical use of high-dimensional omics data and computational methods in precision oncology research and clinical care.