Access to drug substance and formulated drug product are required for the successful completion of this Center Grant application. In addition, all required regulatory documentation must be properly completed and filed with the FDA to test the film and gel formulations into Phase 1 clinical testing. The overall goal of the Pharmaceutical and Regulatory Core (Core C) is to provide pharmaceutical product and regulatory support for Projects 1, 2, 3, and 4 and Core B of this grant application. The Core will coordinate the acquisition, distribution, and/or manufacture of UC781 and tenofovir (TFV) drug substance, UC781 and TFV gel product, and UC781 and TFV GMP film for all projects and cores. The Pharmaceutical Core will assist in coordination of the manufacture, packaging, and labeling of clinical supplies for Projects 3 and 4. GMP gel products containing UC781 or TFV will be supplied through CONRAD from existing clinical supplies. GMP film product will will be manufactured at a suitable contract manufacturer such as MonoSol Rx or LTS Lohmann. Core C will manage preparation of batch records, manufacturing of films, release testing, and supporting stability studies. Core C will also manage GLP animal toxicology studies with film products to support Phase 1 clinical testing. CONRAD currently holds one of the INDs for TFV gel and also holds the IND for UC781 vaginal gel. Core C will compile all required data and protocols to file amendments with the FDA for each drug in support of all clinical trial activity planned under this Center Grant application. Finally, Core C will provide assistance with clinical protocol development as well as patient safety monitoring for all human studies in Projects 3 and 4. CONRAD has significant experience in all planned activities within Core C. The activities of Core C will ensure thorough and timely completion of targeted milestones.

Public Health Relevance

A successful product development program is an essential component to any drug product entering clinical trials. The Pharmaceutical and Regulatory Core provides key components required to bring tenofovir and UC781 pharmaceutical products from the bench to the clinic.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Research Program--Cooperative Agreements (U19)
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Special Emphasis Panel (ZAI1)
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Magee-Women's Research Institute and Foundation
United States
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