Grail Sipes, OSTP Assistant Director for Biomedical Regulatory Policy
Lizzy Ragan, White House Fellow
COVID-19 has demonstrated the importance of ensuring the U.S. clinical trials infrastructure is prepared to rapidly carry out coordinated, large-scale clinical research in the face of new and emerging health threats. Delays and inefficiencies compound into critical time lost in acquiring actionable information, and ultimately, delay the availability of diagnostics, vaccines, treatments and other tools crucial to outbreak and pandemic response.
The recently updated National Biodefense Strategy and Implementation Plan calls for the U.S. government to strengthen the domestic clinical trials infrastructure to ensure readiness to “expedite the evaluation of safe and effective vaccines, therapeutics, and diagnostics for all segments of the population during a nationally or internationally significant biological incident.” In addition, establishing an emergency clinical trials governance structure, developing the terms of an agreement/framework to accelerate response, and identifying a network of available clinical trial sites that can rapidly pivot for pandemic response are among the key goals of the American Pandemic Preparedness Plan. This plan is a core element of the Administration’s strategy on biodefense and pandemic preparedness, and complements work underway internationally in support of the 100 Days Mission to reduce the impact of further pandemics by making diagnostics, therapeutics, and vaccines available within 100 days.
To advance innovation and enhance the responsiveness of our clinical trials infrastructure, OSTP is soliciting stakeholder input through an active Request for Information (RFI) entitled, “Clinical Research Infrastructure and Emergency Clinical Trials” (further outlined in an earlier OSTP blog post), which is open for responses through January 27th, 2023.*
As part of our outreach and engagement strategy to advance this line of effort, we are hosting a virtual multi-sector roundtable to hear from expert panelists on how we can strengthen the U.S. clinical trials infrastructure. In this discussion, we will cover themes including preparedness, equity, diversity, and reestablishing trust in science.
Preparing U.S. Clinical Trials Infrastructure for Emergencies: A White House Virtual Roundtable Discussion
January 12th from 1:00 – 2:30pm EST
- Stacey Adam, Associate Vice President, FNIH
- Brian Anderson, Chief Digital Health Physician, MITRE Health
- Lindsey Baden, Vice President of Clinical Research, Brigham and Women’s Hospital
- Robert Califf, Commissioner, FDA
- Lisa Fitzpatrick, Founder & CEO, Grapevine Health
- Esther Krofah, Executive Vice President, FasterCures, Milken Institute
- Martin Landray, Professor of Medicine & Epidemiology, University of Oxford
- H. Clifford Lane, Deputy Director for Clinical Research and Special Projects, NIAID
- Vicky Leamy, VP, Therapeutic Strategy, IQVIA
- Shalini Mohan, Executive Director, Head of Health Equity and Inclusive Research, Genentech
- Ramita Tandon, Chief Clinical Trials Officer, Walgreens
The event will be open to the public and participants will be able to engage and pose questions to panelists via a live chat. Views expressed by panelists and participants do not represent the views of OSTP. Live captions will be available and a recording will be posted following the event’s conclusion. OSTP is dedicated to providing a harassment-free event for all participants. For logistical and technical questions or for requests for reasonable accommodation, please contact: email@example.com.
Pre-registration to the event is required. Register here.
Note: Deadline extended to January 27th, 2023, confirmed in the Federal Register here.