CORE A ABSTRACT The Administrative Core (Core A) of this grant will provide administrative support for the four scientific projects and two scientific cores for the program entitled, ?Film Antiretroviral Microbicide Evaluation (FAME). This cooperative agreement involves a high degree of collaboration between the scientific projects and cores, between the overall program and the sponsor (NIAID, Division of AIDS), and between the key scientists and the entity (Merck) holding the proprietary rights to the drug being developed within this program. The Administrative Core (Core A) of this grant will provide administrative support for the three scientific projects plus the IND enabling project and two scientific cores for the FAME program. Specifically, the Administrative Core will: 1) provide administrative oversight of the scientific projects and cores in this program; 2) provide fiscal oversight related to the budgets and business agreements between the University of Pittsburgh and the University of Washington (Core B), the University of Colorado and Indiana University (Core C), and the contractors responsible for product manufacturing and IND enabling contracts; 3) collaborate with NIH program staff to review and revise the goals of this cooperative agreement research program to develop and evaluate a coitally independent MK-2048 vaginal film product; 4) plan and coordinate monthly conference calls for the Scientific Steering Committee; 5) plan, schedule and chair the annual meeting in Pittsburgh, PA of Scientific Advisory Panel that is constituted by three to four external advisors; 6) coordinate sharing of data through pre-review of the publication of data in peer-reviewed journals to ensure compliance with the material transfer agreements and clinical trials agreements between Merck, NIAID and Magee-Womens Research Institute; and 7) establish and monitor milestones for each of the projects and cores. This Core, which will be led jointly by Drs. Sharon Hillier and Lisa Rohan, will utilize a flexible, timeline driven administrative model to support all four scientific projects and both scientific cores through the promotion of scientific interactions and collaborations with other investigators engaged in microbicide research.
CORE A NARRATIVE The Administrative and Protocol Management Core will provide administrative and fiscal support for the four scientific projects and two scientific cores which will support the development of film formulation of MK-2048 as an on demand vaginal film for use by women as a vaginal microbicide for prevention of HIV.
| Grab, Sheila; Rohan, Lisa C (2018) A Quantitative Disintegration Method for Polymeric Films. J Pharm Innov 13:321-329 |
