Scientific Advisory Group
The Scientific Advisory Group (SAG) is an independent multi-disciplinary committee of international experts that conducts unbiased data reviews to help inform prioritization of and decision-making concerning the Collaborative’s product portfolio. In this capacity, the SAG, which meets twice a year, serves as the primary evaluation body for assessing the proposed on- and off-ramping of MATRIX’s critical path products. Importantly, SAG members have no conflict of interest in or direct involvement with MATRIX or MATRIX’s product developer partners. The SAG is a dynamic committee, as members may be added or lost as products advance or are off/on-ramped.
SAG members have expertise in one or more of the following areas: 1) pre-clinical HIV prevention product development; 2) regulatory affairs, including of pre-investigational new drug and investigational new drug critical path efforts with US and/or African regulatory bodies; 3) safety, toxicology and pharmacology, including in hormonal contraception and required animal studies to support regulatory submissions; 4) Chemistry, manufacturing and control and QA/QC standards; 5) Clinical trial design and implementation, in particular, of first-in-human and Phase I, II clinical trials, and design and implementation of clinical trials in sub-Saharan Africa; 6) behavioral research, particularly end-user product preference and acceptability studies for understanding of preferred user characteristics 6) business case development, including marketing in low- and middle-income countries. Additional expertise may be related to behavioral and business case solutions or to a specific device and/or product, formulation or regulatory aspects of a product being considered for on- or off-ramping.