INTERNATIONAL PARTNERSHIP FOR MICROBICIDES INC

Programs

1. The product development (pd) division led non-clinical, formulation, manufacturing, chemistry manufacturing and controls (cmc), analytical, and material planning and supply activities for ipm's products. This division remained responsible for product supply and associated activities (including product manufacturing, packaging, labeling, distribution, stability) as well as the post-use testing of dapivirine rings to support adherence assessments during clinical trials. In 2022, the pd team also continued efforts related commercial manufacturing of the dvr. This included completing capacity planning with critical vendors such as the dvr product manufacturing partner, dapivirine drug substance manufacturing partners and silicone manufacturing partner. Additionally, pd supported the completion manufacturing scale-up (1x to 5x) process validation. The 5x process validation successfully completed in 2022 and will be used as the dvr manufacturing scale going forward. Further to this, the pd team continued cmc, formulation and analytical activities related to the development the three-month dvr and the mpt ring. As of september 30th, 2022, the product development activities transferred to…

   $4,542,294 spent
   57% of program spending

2. The regulatory affairs team oversaw the monthly dvr regulatory process, providing leadership in dossier preparation, filings and post-approval maintenance in europe, the united states, south africa and other target african countries, where preparations are ongoing for dvr market introduction. Importantly, in 2022, the regulatory affairs team managed all post-authorization measures related to the ema positive scientific opinion of the monthly dvr. This division also supports all regulatory efforts for other ipm products on the product development pathway; this support includes submission and maintenance of investigational new drug (ind) documentation and conducting regulatory agency interactions related to new protocols for upcoming clinical trials. In partnership with the regulatory affairs team, the quality assurance (qa) team ensures product development and clinical studies are conducted in compliance with all applicable drug and safety laws. Audits are conducted during the conduct of clinical trials to provide assurance of protocol compliance, and compliance with international conference on harmonization of technical requirements for registration of pharmaceuticals for human…

   $1,931,196 spent
   24% of program spending

3. Program support & access: in 2022, ipm continued to build awareness globally about microbicides and create a favorable environment in support of microbicide product development and introduction. This is achieved by informing, educating, and building support for ipm's work through communication materials, advocacy and direct stakeholder engagement. In conjunction with these efforts, ipm also continued work to ensure that the dvr can quickly reach the women in developing countries, who face the highest risk of hiv. This work includes partnering with a global network of organizations, including government, pharmaceutical, health services, civil society and academic sectors, to strategically plan for affordable access to the dapivirine ring. As of september 30th, 2022, the program support & access activities transferred to the population council as part of ipm's dissolution and the associated funding agreement with the population council.

   $1,121,147 spent
   14% of program spending

4. Ipm's clinical affairs department remained responsible for quality control and compliance, medical safety, pharmacovigilance, medical affairs, clinical operations, biometrics, public affairs, community public affairs and socio-behavioral sciences for the clinical trials conducted on ipm's products. Key activities in 2022 included:support of the monthly dapivirine vaginal ring (dvr) clinical trials. Ipm worked with clinical trial partner, the united states (us) national institutes of health (nih)-funded microbicide trials network (mtn) on the following clinical trials of the dvr:o mtn-034 (reach): a phase 2a crossover trial evaluating the safety of and adherence to a vaginal matrix ring containing dapivirine and oral emtricitabine/tenofovir disoproxil fumarate in an adolescent and young adult female populationo mtn-042 (deliver): phase 3b, randomized, open label safety trial of dapivirine vaginal ring (vr) and oral truvada use in pregnancyo mtn-043 (b-protected): phase 3b, open-label, safety and drug detection study of dapivirine vaginal ring and oral truvada in breastfeeding mother-infant pairsfurther to this, the clinical affairs team supported the regulatory affairs team in…

   $332,387 spent
   4% of program spending

The 4 programs described on its FY2022 Form 990, listed largest first by expense. Program spending in total: $7,927,024.