This 3-part virtual public workshop provided a venue for stakeholders to examine bottlenecks to innovation in drug research and development (R&D) for prevalent chronic diseases and to highlight opportunities for spurring drug R&D in this space. The workshop was hosted by the National Academies Forum on Drug Discovery, Development, and Translation.
This virtual workshop was conducted through a series of public sessions:
- Part One (February 22, 2021) discussed key opportunities and challenges for increasing investment, broadening biospecimen collection or registry use, and supporting innovative discovery and preclinical research in prevalent chronic diseases.
- Part Two (March 1, 2021) considered key aspects and opportunities related to development, translation, regulation, and support for innovative clinical research in prevalent chronic diseases.
- Part Three (March 8, 2021) considered case studies in both discovery and clinical research related to prevalent chronic diseases, and discussed potential cross-cutting applications for other prevalent chronic diseases.
Below are materials for the workshop sessions, including background information, the planning committee, and agenda and briefing book.
For additional information on the workshop, please visit our project page.
Background
Half of all Americans live with at least one chronic disease, such as heart disease, cancer, stroke, or diabetes. These and other chronic diseases are the leading cause of death and disability in the United States and are a leading driver of health care costs1.Yet investment in the leading causes of death and disability, other than cancer, has not kept pace with the public health need. Published data from BIO has shown that venture investment for drug development in areas such as psychiatric disorders, cardiovascular, diabetes, and respiratory diseases has declined over the last decade relative to the prevalence and health care cost of these diseases2. The recent outbreak of Coronavirus Disease 2019 (COVID-19) may further exacerbate the health disparities associated with highly prevalent chronic diseases. A case series on hospitalized COVID-19 patients in the New York City area showed that the most common comorbidities were hypertension, obesity, and diabetes3.
A planning committee of the National Academies of Sciences, Engineering, and Medicine, organized and conducted a public workshop to examine and highlight the bottlenecks to innovation in drug research and development (R&D) for prevalent chronic diseases and to consider challenges and opportunities for spurring drug R&D in this space.
The public workshop featured invited presentations and discussions that:
- Discussed the unique cross-cutting challenges for spurring early stage innovation in drug R&D for prevalent chronic diseases (e.g. do we have promising targets?)
- Considered whether cultural and financial incentives are in alignment for spurring the type of product development that will address unmet need when it comes to prevalent chronic diseases (e.g., do we have the right business models in place?)
- Considered lessons learned from other disease areas (e.g., rare diseases) and/or use cases that could have cross-cutting applications for prevalent chronic diseases.
- Discussed considerations and/or strategies to spur drug R&D innovation for prevalent chronic diseases (i.e., determine whether there are promising avenues forward that merit additional time/effort/funding/attention).
The planning committee organized the workshop, developed the agenda, selected and invited speakers and discussants, and moderated or identified moderators for the discussions. A proceedings of the presentations and discussions at the workshop will be prepared by a designated rapporteur in accordance with institutional guidelines.
Planning Committee
Carlos Garner (co-chair), Eli Lilly and Co.
Anantha Shekhar (co-chair), University of Pittsburgh
Melinda Buntin, Vanderbilt School of Medicine
Grace Colón, InCarda Therapeutics
Bettina Drake, Washington University in St. Louis
Alyson Karesh, Center for Drug Evaluation and Research, FDA
Chronis Manolis, UPMC Health Plan
Phyllis Pettit Nassi, University of Utah
Howard Rosen, BonVelo Ventures/Stanford University
Susan Schaeffer, The Patients’ Academy for Research Advocacy
Amir Tamiz, National Institute of Neurological Disorders and Stroke, NIH
1. National Center for Chronic Disease Prevention and Promotion (https://www.cdc.gov/chronicdisease/index.htm)
2. Thomas and Wessel, 2018 (https://www.bio.org/sites/default/files/legacy/bioorg/docs/BIO_HPCP_Series-Pain_Addiction_2018-02-08.pdf)
3. Richardson et al, JAMA, 2020 (https://jamanetwork.com/journals/jama/fullarticle/2765184)