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.
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.
|Moncla, Bernard J; Chappell, Catherine A; Debo, Brian M et al. (2016) The Effects of Hormones and Vaginal Microflora on the Glycome of the Female Genital Tract: Cervical-Vaginal Fluid. PLoS One 11:e0158687|
|Bunge, Katherine E; Dezzutti, Charlene S; Rohan, Lisa C et al. (2016) A Phase 1 Trial to Assess the Safety, Acceptability, Pharmacokinetics, and Pharmacodynamics of a Novel Dapivirine Vaginal Film. J Acquir Immune Defic Syndr 71:498-505|
|Zhou, Tian; Hu, Minlu; Pearlman, Andrew et al. (2016) Expression, regulation, and function of drug transporters in cervicovaginal tissues of a mouse model used for microbicide testing. Biochem Pharmacol 116:162-75|
|Fan, Maria D; Kramzer, Lindsay F; Hillier, Sharon L et al. (2016) Preferred Physical Characteristics of Vaginal Film Microbicides for HIV Prevention in Pittsburgh Women. Arch Sex Behav :|
|Coleman, Jenell S; Fuchs, Edward; Aung, Wutyi S et al. (2016) Feasibility of radiolabeled small molecule permeability as a quantitative measure of microbicide candidate toxicity. Contraception 93:331-6|
|Moncla, Bernard J; Chappell, Catherine A; Mahal, Lara K et al. (2015) Impact of bacterial vaginosis, as assessed by nugent criteria and hormonal status on glycosidases and lectin binding in cervicovaginal lavage samples. PLoS One 10:e0127091|
|Kramzer, Lindsay F; Cohen, Jessica; Schubert, Jesse et al. (2015) Assessing the potential of the Woman's Condom for vaginal drug delivery. Contraception 92:254-60|
|Hu, Minlu; Patel, Sravan Kumar; Zhou, Tian et al. (2015) Drug transporters in tissues and cells relevant to sexual transmission of HIV: Implications for drug delivery. J Control Release 219:681-96|
|Wang, Linlin; Koppolu, Sujeethraj; Chappell, Catherine et al. (2015) Studying the effects of reproductive hormones and bacterial vaginosis on the glycome of lavage samples from the cervicovaginal cavity. PLoS One 10:e0127021|
|Chappell, Catherine A; Isaacs, Charles E; Xu, Weimin et al. (2015) The effect of menopause on the innate antiviral activity of cervicovaginal lavage. Am J Obstet Gynecol 213:204.e1-6|
Showing the most recent 10 out of 24 publications