International Partnership For Microbicides Inc

TO DEVELOP HIV PREVENTION PRODUCTS AND OTHER SEXUAL AND REPRODUCTIVE HEALTH TECHNOLOGIES FOR WOMEN, AND TO MAKE THEM AVAILABLE AND ACCESSIBLE WHERE THEY ARE URGENTLY NEEDED.

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 THE POPULATION COUNCIL AS PART OF IPM'S DISSOLUTION AND THE ASSOCIATED FUNDING AGREEMENT WITH THE POPULATION COUNCIL.

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 USE (ICH) GUIDELINES, GOOD CLINICAL PRACTICES (GCP), AND ALL APPLICABLE REGULATIONS. VENDOR AUDITS ARE ALSO CONDUCTED WHERE IPM'S CLINICAL, PRECLINICAL, OR CMC WORK IS BEING CONDUCTED. AS OF SEPTEMBER 30TH, 2022, THE REGULATORY AFFAIRS ACTIVITIES TRANSFERRED TO THE POPULATION COUNCIL AS PART OF IPM'S DISSOLUTION AND THE ASSOCIATED FUNDING AGREEMENT WITH THE POPULATION COUNCIL.

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.

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 DEVELOPMENT AND COMPLETION OF THE CLINICAL MODULES AND POST-APPROVAL AMENDMENTS OF THE DVR DOSSIERS SUBMITTED TO REGULATORY AUTHORITIES. PREPARED FOR AND INITIATED THE CLINICAL BRIDGING TRIAL OF IPM'S THREE-MONTH DVR. BUILDING ON THE PROMISE OF IPM'S MONTHLY DAPIVIRINE RING, IPM DEVELOPED THE THREE-MONTH DVR, WHICH IS DESIGNED TO INCREASE CONVENIENCE AND REDUCE ANNUAL COSTS AS COMPARED TO THE MONTHLY DVR. 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) INITIATED IN Q3 2022.SUPPORTED PREPARATIONS AND INITIATION OF A PHASE I 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 BOTH 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 PLANNING STAGES THROUGHOUT 2022 AND INITIATED IN Q3 2022. THIS TRIAL WILL BE CONDUCTED BY THE EUNICE KENNEDY SHRIVER NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT (NICHD). AS OF SEPTEMBER 30TH, 2022, THE CLINICAL AFFAIRS ACTIVITIES TRANSFERRED TO THE POPULATION COUNCIL AS PART OF IPM'S DISSOLUTION AND THE ASSOCIATED FUNDING AGREEMENT WITH THE POPULATION COUNCIL.