Clinical and medical affairs: ipm's clinical affairs department is 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 2021 included:- continued support of the monthly dapivirine vaginal ring (dvr) clinical trialsipm worked with its clinical trial partner, the United States (us) national institutes of health (nih)-funded microbicide trials network (mtn) on the subsequent 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, the clinical and medical affairs team supported the regulatory affairs team in developing and completing the clinical modules and post-approval amendments of the dvr dossiers submitted to regulatory authorities. - Clinical trial of ipm's three-month dapivirine ring building on the promise of ipm's monthly dapivirine ring, ipm developed the three-month dapivirine ring, designed to increase convenience and reduce annual costs compared to the monthly dapivirine ring. The clinical affairs team worked across departments and with external partners to develop the protocol for the bridging trial and complete all necessary trial preparations. The bridging trial (ipm 054) was initiated in q3 2022.- Clinical trials of the dapivirine-contraceptive vaginal ring, a multipurpose prevention technology (mpt)the three-month dapivirine-contraceptive ring is designed to provide slow and simultaneous release of the antiretroviral (arv) drug dapivirine to prevent HIV and the contraceptive hormone levonorgestrel to prevent unintended pregnancy. A second phase i clinical trial of the reformulated mpt ring (ipm 056/cctn019b) was in the planning stages throughout 2021 and initiated in mid-2022. This trial will be conducted by the eunice kennedy shriver national institute of child health and human development (nichd).

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