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IPM Progress Report Year 6

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IPM Progress Report Year 6 IPM Annual Performance Report, Year 1 Cooperative Agreement AID-OAA-A-13-00095 Annual Performance Report, Year 1 Dapivirine Ring Licensure Program 30 September 2013 – 30 September 2014 Cooperative Agreement No. AID-OAA-A-13-00095 Office of HIV/AIDS Submitted 27 October 2014 International Partnership for Microbicides 8401 Colesville Road, Suite 200 Silver Spring, MD 20910 www.ipmglobal.org This report is made possible by the generous support of the American people through the United States Agency for International Development (USAID). The contents are the responsibility of the International Partnership for Microbicides and do not necessarily reflect the views of USAID or the United States Government. IPM Annual Performance Report, Year 1 Cooperative Agreement AID-OAA-A-13-00095 CONTENTS A. EXECUTIVE SUMMARY ........................................................................................................................................1 B. ACTIVITY SUMMARY: YEAR 1 PROGRESS AND PLANS GOING FORWARD ..............................................................2 Activity 1: IPM 027 Phase III Dapivirine Ring Trial Implementation .......................................................................2 Activity 2: IPM 032 Phase IIIb Open-Label Dapivirine Ring Trial ............................................................................4 Activity 3: Preparation and Filing of Regulatory Dossiers .....................................................................................5 Activity 4: Implementation of Cost-reduction Studies ...........................................................................................7 C. GENDER .............................................................................................................................................................8 D. HUMAN SUBJECTS PROTECTION .........................................................................................................................9 E. ENVIRONMENTAL COMPLIANCE ....................................................................................................................... 10 F. SUCCESS STORIES ............................................................................................................................................. 10 G. PRESS & MEDIA ................................................................................................................................................ 11 H. BEST PRACTICES ............................................................................................................................................... 14 IPM Annual Performance Report, Year 1 Cooperative Agreement AID-OAA-A-13-00095 A. EXECUTIVE SUMMARY IPM’s dapivirine ring licensure program is designed to provide the data required for regulatory approval of the monthly dapivirine vaginal ring as a new HIV-1 prevention option for women. Two pivotal Phase III trials are underway: IPM 027 (The Ring Study) conducted by IPM, and MTN-020 (ASPIRE) conducted by the NIH-funded Microbicide Trials Network (MTN). In addition to the Phase III trials, the licensure program also includes other safety studies and clinical trials as required; chemistry, manufacturing and controls (CMC) activities; manufacturing activities (e.g., trial supplies, preparations for commercial production); additional preclinical work on dapivirine ring; and interactions with regulatory agencies and preparations for licensure filings. This Cooperative Agreement comprises the following activities designed to enable IPM to successfully obtain regulatory approval for dapivirine ring: (1) IPM 027 Phase III dapivirine ring trial; (2) IPM 032 Phase IIIb open-label dapivirine ring trial; (3) preparation and filing of regulatory dossiers; and (4) implementation of cost-reduction studies. Progress and Achievements: Year 1 In the first year of this award (30 September 2013 – 30 September 2014), IPM has: Initiated two additional new research centers in South Africa to conduct the IPM 027 dapivirine ring trial Continued participant recruitment/enrollment for IPM 027 Submitted data analyses for IPM 027 Data and Safety Monitoring Board (DSMB) meetings Finalized clinical trial protocol for IPM 032 for submission to regulators Continued conversion of historical documents into electronic dossier format in preparation for filing Following an evaluation based on achieving the technical requirements, cost and ease of regulatory approval, selected a packaging system for the dapivirine ring to progress to launch Issued an RFP to multiple vendors for an environmental risk assessment for dapivirine ring and selected a partner Completed planning activities for process robustness studies and protocol preparation for process validation. 2013 2014 Year 1 STATUS Dapivirine Ring Licensure Program: Workplan Timeline, Year 1 Q4 Q1 Q2 Q3 OVERVIEW Activity 1: IPM 027 Phase III Dapivirine Ring Trial Implementation -- Initiation of new research centers Achieved: Q1 2014 Continued participant recruitment/enrollment and adherence monitoring Ongoing Data analyses submitted for DSMB meetings Achieved / Ongoing Activity 2: IPM 032 Phase IIIb Open-Label Dapivirine Ring Trial -- IPM 032 protocol finalized* Achieved: Q3 2014 Submissions to appropriate regulators and ethics committees* Ongoing Activity 3: Preparation and Filing of Regulatory Dossiers -- Continued dossier development, legacy document conversion, etc. Ongoing Activity 4: Implementation of Cost-reduction Studies -- Packaging engineering / shipping studies Ongoing Environmental impact studies Ongoing Process robustness / equipment validation studies Ongoing *Originally scheduled as a Year 2 activity; not included in Year 1 work plan. Obstacles and Challenges: Year 1 In Year 1, IPM encountered obstacles and challenges as described below. Although adherence is a well-known challenge for microbicide trials, an unexpectedly high level of ring non- adherence was observed at one specific research center (RC) participating in IPM 027. IPM consulted with regulators and made a decision to discontinue all participants from the identified RC, and to add 300 participants to the trial (for a total of 1950 participants) to restore the power of the trial to detect efficacy and safety; these changes were approved by the South Africa Medicines Control Council (MCC) in October 2013. Enrollment is now slated to run through Q4 2014, with participant visits expected to conclude in Q4 2016. IPM Page 1 IPM Annual Performance Report, Year 1 Cooperative Agreement AID-OAA-A-13-00095 has also proposed to regulatory authorities to add statistical analyses with and without the discontinued RC to its dossier package. Participant retention can also be challenging for prevention trials, as IPM experienced during December 2012/January 2013 with higher numbers of missed clinic visits during the holiday season. Applying lessons learned from the prior year, IPM continued to proactively address this potential risk by working with RCs to fine- tune their retention plans for the December 2013/January 2014 holiday season with the key focus on ring adherence and visit schedules, including dispensing of additional rings. An improvement was observed across all RCs as a result. The FDA informed IPM in July 2014 that they have classified dapivirine vaginal ring a drug-device product which expands the regulatory requirements for the application. The planning for the environmental impact studies for dapivirine ring was delayed following the departure of IPM’s Senior Director of Analytical and CMC. Now that this critical staff position has been filled at IPM, a comprehensive evaluation has been completed of potential vendors for this activity and a subaward is targeted for Q4 2014. Process robustness studies and process validation have required significant collaboration with QPharma to achieve an agreed approach and cost certainty, which has taken longer than originally planned. QPharma proposed that a multi-variant analysis (MVA) of the clinical batch manufacturing data should be completed and reviewed prior to finalizing robustness and validation protocols. Both the MVA and protocols have now been completed which has allowed cost certainty for the completion of this activity. Optimization of packaging has required input from potential commercial manufacturing partners, particularly with regard to their current capability and views on what are the most cost effective options to manufacture; this delayed progress on the selection of a packaging system until more progress was made selecting a commercial manufacturing partner. B. ACTIVITY SUMMARY: Year 1 PROGRESS AND PLANS GOING FORWARD This section describes progress made in meeting Year 1 objectives during the performance period (30 September 2013 – 30 September 2014), with an overview of planned activities for the next performance period (01 October 2014 – 30 September 2015). Activity 1: IPM 027 Phase III Dapivirine Ring Trial Implementation Primary Countries of Activity: South Africa, Uganda, US Period: 2012–2016 Technical Coordinator: Annaléne Nel, IPM Chief Medical Officer Implementers: IPM; RCs; other contractors Objective: The objective of this activity is to successfully complete IPM 027 (The Ring Study), IPM’s Phase III dapivirine ring trial currently underway at RCs in South Africa and Uganda, with ongoing and expanded adherence measurements. This activity is an integral part of the overall dapivirine ring licensure program, which is being conducted by IPM in partnership
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