Slots: 1
Deadlines
Internal Deadline: Wednesday, August 10th, 2022, 5pm PT
LOI: August 17, 2022
External Deadline: October 3, 2022
Award Information
Award Type: Cooperative Agreement
Estimated Number of Awards: 1
Anticipated Award Amount: $400,000
Who May Serve as PI: Standard NIH requirements.
Link to Award: https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-23-002.html
Process for Limited Submissions
PIs must submit their application as a Limited Submission through the Office of Research Application Portal: https://orif.usc.edu/oor-portal/.
Materials to submit include:
- (1) Single Page Proposal Summary (0.5” margins; single-spaced; font type: Arial, Helvetica, or Georgia typeface; font size: 11 pt). Page limit includes references and illustrations. Pages that exceed the 1-page limit will be excluded from review.
- (2) CV – (5 pages maximum)
Note: The portal requires information about the PIs and Co-PIs in addition to department and contact information, including the 10-digit USC ID#, Gender, and Ethnicity. Please have this material prepared before beginning this application.
Purpose
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. The educational program envisioned under this grant should also adjust and update training objectives/methods/content in order to provide participants with training and best practices under the 5 key areas below:
1. GLP Natural History Studies in BSL-4 Laboratories
Natural history studies are performed to establish the dose of the disease agent, the route of exposure, and to study the pathogenicity of the disease agent in the animal model. Results of these studies help determine which animal model best describes the disease in humans. Examples of challenges in meeting GLP standards include appropriate data recording, record keeping, inspections, and equipment validation. Training on the development of strategies to meet GLP standards in high and maximum biocontainment laboratories can be realized when everyone has a common understanding of the challenges and standards. In such a case, the scientific validity and regulatory acceptance of a study can be ensured early on, reducing the need for repeat studies, thereby reducing the numbers of animals needed to address the scientific and regulatory objectives. Once the natural history of the disease in the animal model has been established, it can be used to test the efficacy of antibiotics, vaccine, or other therapies as described in the “Animal Rule.’
2. GLP Animal Efficacy Studies in BSL-4 Laboratories
Animal efficacy studies are performed in accordance with the “Animal Rule’ to test the effectiveness of a medical countermeasure against a specific threat agent in an animal model that best models the disease in humans. Results from these studies also help determine the dose of the medical countermeasure that will be effective in humans.
3. Good Clinical Practices to maintain data quality in maximum containment infectious disease settings
Over the course of the training program to date (2012-2022), FDA has regularly worked with grantees and SMEs in government, academia, and industry to identify and incorporate updated or additional guidance. This includes the additional of a training module to provide best practices during clinical trials undertaken in maximum containment environments (i.e. “clinical sites”) or high consequence pathogen environments. This component elaborates on the challenges of maintaining data quality at clinical sites, and best practices for mitigating risks to data quality (such as appropriate data recording, record keeping, onsite training, and validation techniques). This course module, which was initiated during the prior grant (2017-2022) has been a successful addition to the program and will remain a priority for the next grant.
4. One Health:
One Health is a collaborative, multisectoral, and transdisciplinary approach that works at the local, regional, national, and global levels to achieve optimal health outcomes for human, animal, and environmental domains. Because FDA is aware of the value of One Health in solving public health issues, FDA cultivated an agency-wide One Health Initiative in 2019. The dynamic landscape of CBRN events is seldom separate among human, animal, and their shared environment requiring a collaborative, multidisciplinary, and multisectoral approach to detect, prepare, prevent, and respond to CBRN threats. Naturally occurring, accidental, or deliberate threats with CBRN agents have no boundaries and can adversely impact any habitat or geographical location presenting significant public health challenges in all three domains. Utilizing a diverse scientific undertaking to enhance agency regulatory decisions and relevancy of policy development, the One Health concept can be utilized to establish partnerships, share knowledge with internal and external stakeholders, and facilitate mechanisms that can inform the development, regulatory review, and use of medical countermeasures. FDA can also utilize the One Health concept to analyze and resolve health disparities relevant to pre-clinical and clinical studies for FDA-regulated MCM products for both human and animals. Considerations for socio‐cultural and socio‐economic factors have helped gain various perspectives to geographic variation of pathogens in animal and non‐animal sources to better understand the environment’s relationship of various adverse impacts and outcomes of both animals and people.
5. Diversity, Equity, Inclusion and Accessibility:
Diversity, Equity, Inclusion, and Accessibility (DEI&A) is a concept supported within all levels of government to include FDA advocating for broader participation, more attention to diverse perspectives, and opportunities allowing equal and accessible provisions. Although DEI&A has been a public health concern for many years, the topic is still at a starting point, and discussions have only scratched the surface of its suitability for product development for underserved communities including MCMs. Research, technology, and innovation disparities that limit the generalizability of data are likely to widen racial, ethnic, socioeconomic, and gender treatment gaps, health inequities, or unintentional harmful results. DEI&A adds to the robustness of data generated from studies which would otherwise limit public health progress with FDA-regulated products including MCMs. This is one reason why the 1993 NIH Revitalization Act was developed to ensure women and minorities were included in clinical research. Preclinical animal studies were not immune to underrepresentation. Therefore, in 2015, sex as a biological variable was extended to vertebrate animal studies to factor in sex differences in research design, analysis, and reporting. Embracing DEI&A concepts and practices greatly increases the scope of gaining new perspectives and finding resolutions to ongoing public health CBRN and emerging threat issues for underserved communities critical for regulatory science interpretations, validation, and generalizability of data generated. As health issues continue to emerge, DEI&A needs to continue expanding its applications in the MCM realm.
Visit our Institutionally Limited Submission webpage for more updates and other announcements.