Microbicide Research, Development, and Introduction, Round 2: Thin-Flim Polymer Device for Microbicide Delivery

To develop a novel microbicide sustained-release delivery system in the form of a subcutaneously injected and biodegradable thin-film polymer device that improves on the effectiveness, acceptability, usage, and accessibility of existing microbicide delivery systems.

To test the safety, pharmacokinetics (PK), pharmacodynamics (PD), and acceptability of ARVs systemically delivered through the novel TFPD by conducting IND-enabling pre-clinical and Phase I clinicalstudies.

This project includes the following activities:.Identification of lead and back up ARV candidate and technology development; Pre-IND/preclinicalresearch; IND regulatory activities; Pilot product manufacturing and clinical translation; and, Phase I clinical work.