The Preclinical and Clinical Developmental and Regulatory Evaluations Core (Core B) will be responsible for the provision of test materials for use by all components of the Program, including subcontractors performing animal modeling and toxicology studies, as well as overall Project Management of the regulatory development of the final ring products. Thus, ImQuest BioSciences staff will coordinate the synthesis, storage and shipping of compounds required for evaluation, the interactions with a regulatory consultant responsible for providing advice on the development of the ring product, the performance of safety pharmacology and toxicology testing, including irritation and absorption studies, the synthesis of GMP material for use in the ring product and for submission of the pre-IND and IND documents leading to the pre- Phase 1 human clinical trial.

Public Health Relevance

The Preclinical and Clinical Developmental and Regulatory Evaluations Core will provide all required expertise and capability to lead the product devlopment efforts through the IND-enabling studies and result in the submission of an IND to the FDA for approval to conduct a pre-Phase 1 human clinical trial to test the safety of an intravaginal ring product.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Research Program--Cooperative Agreements (U19)
Project #
5U19AI076980-04
Application #
8380241
Study Section
Special Emphasis Panel (ZAI1-BP-A)
Project Start
Project End
2014-08-31
Budget Start
2012-09-01
Budget End
2014-08-31
Support Year
4
Fiscal Year
2012
Total Cost
$301,809
Indirect Cost
$86,545
Name
Albert Einstein College of Medicine
Department
Type
DUNS #
110521739
City
Bronx
State
NY
Country
United States
Zip Code
10461
Rastogi, Rachna; Su, Jonathan; Mahalingam, Alamelu et al. (2016) Engineering and characterization of simplified vaginal and seminal fluid simulants. Contraception 93:337-46
Keller, Marla J; Mesquita, Pedro M; Marzinke, Mark A et al. (2016) A phase 1 randomized placebo-controlled safety and pharmacokinetic trial of a tenofovir disoproxil fumarate vaginal ring. AIDS 30:743-51
Teller, Ryan S; Malaspina, David C; Rastogi, Rachna et al. (2016) Controlling the hydration rate of a hydrophilic matrix in the core of an intravaginal ring determines antiretroviral release. J Control Release 224:176-83
Smith, James M; Srinivasan, Priya; Teller, Ryan S et al. (2015) Tenofovir disoproxil fumarate intravaginal ring protects high-dose depot medroxyprogesterone acetate-treated macaques from multiple SHIV exposures. J Acquir Immune Defic Syndr 68:1-5
Nixon, Briana; Jandl, Thomas; Teller, Ryan S et al. (2014) Vaginally delivered tenofovir disoproxil fumarate provides greater protection than tenofovir against genital herpes in a murine model of efficacy and safety. Antimicrob Agents Chemother 58:1153-60
Teller, Ryan S; Rastogi, Rachna; Johnson, Todd J et al. (2014) Intravaginal flux controlled pump for sustained release of macromolecules. Pharm Res 31:2344-53
Srinivasan, Priya; Dinh, Chuong; Zhang, Jining et al. (2014) Pharmacokinetic evaluation of tenofovir disoproxil fumarate released from an intravaginal ring in pigtailed macaques after 6 months of continuous use. J Med Primatol 43:364-9
Herold, Betsy C; Dezzutti, Charlene S; Richardson, Barbra A et al. (2014) Antiviral activity of genital tract secretions after oral or topical tenofovir pre-exposure prophylaxis for HIV-1. J Acquir Immune Defic Syndr 66:65-73
Nixon, Briana; Stefanidou, Martha; Mesquita, Pedro M M et al. (2013) Griffithsin protects mice from genital herpes by preventing cell-to-cell spread. J Virol 87:6257-69
Mesquita, Pedro M M; Srinivasan, Priya; Johnson, Todd J et al. (2013) Novel preclinical models of topical PrEP pharmacodynamics provide rationale for combination of drugs with complementary properties. Retrovirology 10:113

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