Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24) Clinical Trials Not Allowed

FDA's Office of Counterterrorism and Emerging Threats (OCET) is a leader and active participant in the public health community and with the military defense community, helping to advance the development, evaluation, and approval of medical countermeasures to be used against threats involving chemical, biological, radiological, or nuclear (CBRN) agents. In 2010, FDA launched its Medical Countermeasures initiative (MCMi) in response to a report by the Secretary of the Department of Health and Human Services to assess the nation's emergency readiness improve our nation's capacity to respond faster and more effectively to CBRN threats or a naturally occurring emerging disease (e.g., COVID-19 and pandemic influenza). OCET was tasked with leading the implementation of the MCMi. OCET's activities are informed by the knowledge that protecting the civilian, the public, and the warfighter against CBRN agents is a national security priority. A significant area of engagement for OCET is its support of innovative science to advance CBRN countermeasure development with the goal of improving access to safe and effective medical countermeasures, should the need arise. These efforts are central to strengthening national preparedness and security.

Developing medical countermeasures (MCMs) presents unique challenges. For example, limited exposure to threat agents, such as anthrax, often makes it difficult to generate the necessary data from traditional clinical trials to support regulatory review and decision-making. In some cases, clinical trials may not be feasible or are unethical. In these cases, it may be necessary to use data from adequate and well-controlled animal efficacy studies under regulations commonly known as the “Animal Rule”. The Animal Rule' (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products) permits animal models to be used to test the effectiveness of a product when testing in humans is neither possible nor feasible. Under the "Animal Rule,' FDA recommends that pivotal efficacy studies be conducted in accordance with Good Laboratory Practice (GLP) regulations (21 CFR parts 58). Biological threats, such as Ebola virus, Marburg virus, Variola virus, or Lassa fever virus, for which medical countermeasures are needed, require testing in high and maximum biosecurity level (BSL-4) laboratories. These laboratory environments pose daunting challenges to a researcher's ability to meet the standards of GLP regulations. There has been tremendous progress in the development of candidate interventions over the last decade. However, to date there is not a single facility that is capable of performing pivotal studies under GLP at BSL-4. To break the current choke point in the development process for interventions against agents requiring maximum containment, it will be critical for laboratories with BSL-4 capacity to receive the training and develop the capability necessary to routinely perform pivotal studies in accordance with GLP.

OCET therefore seeks applicants who will assist in the effort to research ways to better design a robust, collaborative, and educational program using problem-based learning techniques designed to bring researchers and regulators together to educate each other on the challenges related to these issues and to identify solutions that are acceptable from both scientific and regulatory perspectives. Under this grant, a critical objective is to continue to research ways to deliver this educational program in order to better reach the wide community of stakeholders (research industry, academic, governmental, and international), to better ensure wider distribution of data quality assurance methods in high consequence conditions. By researching these methods, the research and scientific communities will be better able to implement and coordinate medical countermeasure research.

Application Instructions

Please submit:

1. A one‐page letter of intent with a description of proposed aims and approach
2. If the final application requires a diversity statement or statement of broader impacts, please summarize your plans to address the specific requirements on an additional page.
3. CV (not biosketch) of the PI

to limitedsubs@uw.edu by 5:00 PM Wednesday, August 31, 2022. Proposals are due to the sponsor 10/3/2022, so you will need to have your materials in to the Office of Sponsored Programs by 9/22/2022 if given the go‐ahead by the review committee.