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Imagine a world where women and girls
are empowered to protect themselves
from unintended pregnancy and
sexually transmitted infections.
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Initiative for Multipurpose Prevention Technologies (IMPT)
Summer 2015 Newsletter
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Happy summer from CAMI Health, Secretariat to the Initiative for Multipurpose Prevention Technologies (IMPT)! We are in the midst of a productive summer, and are preparing for a busy autumn season of technical meetings, conferences, projects, and more. Read on to stay up-to-date on the IMPT's progress!
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MPT Dosage-Form Specific Target Product Profiles (TPPs)
& Technical Brief on TPPs |
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You can now download the MPT Intravaginal Ring TPP and the MPT Long Acting Injectable TPP on the IMPT website. These dosage-form specific TPPs focus on defining the necessary attributes and required supporting data for the successful development of impactful MPT products. We invite our partners to use these tools as guidance in product development and decision-making. You can learn more about TPPs and the development of the MPT Dosage-Form Specific TPPs by downloading our TPP Technical Brief.
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MPT Product Pipeline Table |
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As part of our effort to inform, support, and enable MPT product development, the IMPT Secretariat tracks products currently in development and maintains an online searchable database of MPTs in the development pipeline. An MPT Product Pipeline Table is also available that provides a quick reference guide of the nearly two dozen products currently in development. The table is available on the Initiative website.
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Latin America and the Caribbean (LAC) Regional Webinar on MPTs |
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On 13 May, in collaboration with the Reproductive Health Supplies Coalition (RHSC) ForoLAC, the IMPT hosted the first LAC Regional Webinar on MPTs. This live, Spanish-language webinar contextualized the need for MPTs within regional epidemiological data and the social realities faced by LAC women. We were thrilled to be joined by over 50 LAC-based sexual and reproductive health (SRH) stakeholders and hope to use this as a stepping stone for engaging LAC-based researchers and advocates in the IMPT's work. You can view the presentations on the IMPT website.
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The IMPT aims to provide a platform in which key scientific issues and challenges that inform MPT development and investment decisions can be identified and addressed through an iterative and multi-disciplinary process of stakeholder consultations, field-wide surveys, and technical convenings. Convenings were organized this spring aimed to advance IMPT prioritized issues.
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Round Table Discussion on Commercialization and Social-Behavioral (CSB) Issues for MPTs |
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Clinical trial staff and MPT stakeholders convened at MTN to discuss issues critical to ensuring that MPTs are acceptable and accessible to women and girls worldwide.
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In alignment with recent recommendations from the IMPT Steering Committee and Supporting Agency Collaboration Committee (SACC), the IMPT has prioritized investigating the complex commercialization and social-behavioral (CSB) issues relevant to developing successful MPTs. As part of this effort, the IMPT convened its first in-person Round Table Discussion on CSB Issues for MPTs in conjunction with the Microbicide Trials Network (MTN) Annual Meeting. The meeting brought together MTN clinical trial staff based in sub-Saharan Africa and other MPT stakeholders to prioritize CSB activities to be conducted along the product development timeline. The discussion focused on three main elements critical to ensuring that MPTs meet the needs of women and girls: end-user perspectives, service delivery, and policy and advocacy. The Round Table was the first in a series of small convenings aimed at prioritizing CSB activities in various settings. A summary of the meeting can be found on the IMPT website.
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CCTN and MPT Stakeholder Round Table Discussion on Hormonal Contraceptives (HC) in MPTs |
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CCTN members and MPT stakeholders convened to deliberate around pressing questions related to hormonal contraceptives in MPTs.
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As a follow-up to the September 2014 convening on HC in MPTs, the IMPT, in collaboration with the National Institute of Child Health and Human Development (NICHD), convened a second meeting on HC in MPTs in late May, which brought together members of the Contraceptive Clinical Trials Network (CCTN) and MPT stakeholders in a round table discussion. The convening aimed to drill down on research gaps and challenges identified at the first meeting, and assess the status of ongoing research related to combining HC with ARVs. The group also explored issues related to bleeding patterns and acceptability, and discussed key questions surrounding successful MPT development and uptake. Slides from the meeting are now available on the IMPT website.
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IMPT Joint Steering Committee & Supporting Agency Collaboration Committee (SACC) Meeting
Members of the IMPT Steering Committee and SACC convened in Washington, D.C. on 3 June to discuss some of the key challenges facing the IMPT and the MPT field. The group discussed priority issues for the MPT field, and strategized around funding optimization opportunities. The Executive Summary of the Meeting Report is now available on the IMPT website.
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CAMI Health welcomes new Research Associate!
We are thrilled to welcome Vanetta Thomas to the CAMI Health team, who recently joined as our new Research Associate. Vanetta earned her Master of Public Health at Emory University, Rollins School of Public Health. She will be assisting with research, and will take a lead role in the planning and implementation of several upcoming technical projects. Welcome, Vanetta!
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In the Foreground of the Field
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The IMPT Secretariat strives to keep Initiative stakeholders informed of the most recent MPT developments, research, and issues in the field. You should be receiving our monthly "MPTs: Articles from the Field," with journal articles and other resources distributed to over 1,000 IMPT supporters. See back issues.
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Keeping on Track: IMPT Network of Experts Quarterly Update
Each quarter, the IMPT hosts updates on the Initiative for our stakeholders around the world, otherwise known as our Network of Experts (NoE). The last convening took place on 11 May, with over 30 MPT stakeholders from around the world. Several participants provided updates on exciting MPT-related research and activities, including: |
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AVAC Communications & Fellows Program: AVAC's Communication Working Group convened in April to discuss trial design and conduct from a communications perspective. The AVAC Advocacy Fellows 2015 class recently commenced their work and attended the African Advocacy Partners Forum in March. 2014 Fellow Everlyne Ombati will continue her work on MPT messaging in Kenya as part of the IMPT, through support from KEMRI and the IMPT.
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CONRAD MPT Ring Acceptability Study: The Phase I study of CONRAD's MPT intravaginal ring is currently underway, and is expected to be complete in January 2016. The study is assessing safety, acceptability, and pharmacokinetics / pharmacodynamics. CONRAD is also working to develop an IUD for the sustained delivery of an ARV that will work as an MPT.
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IMPT Funding Optimization Strategy: The IMPT Secretariat has been working toward strengthening the sustainability of the Initiative. This includes the development of the Global MPT Funding Optimization and Enhancement strategy, a proposed multiyear approach aimed at supporting optimal use of current MPT funding and expanding the financial resources available to the MPT field.
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IMPT Priority Issues Identification Exercise: Based on recommendations from the IMPT Steering Committee and SACC, the IMPT Secretariat conducted a Priority Issues Identification Exercise, aimed at pinpointing priority issues for IMPT follow-up. To this end, the Secretariat developed an online survey, which was distributed to members of the Network of Experts. A small, neutral review committee convened to analyze survey data and make recommendations, which were approved by the IMPT Steering Committee and SACC. The IMPT Secretariat is now developing an MPT Field Wide Investment Guide that will identify and inform potential activities that could advance the field.
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IPM MPT Ring Program: IPM's MPT Ring Program, whose rings combine dapivirine and levonorgestrel (LNG), has transferred its technology to a manufacturer and clinical rings will be made this summer. The MTN will run the first clinical study on IPM's ring, a double-blind study looking at a combination of safety and PK data. Recruitment will begin in 2016.
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Mapp Biopharmaceutical Plantibodies: In collaboration with Johns Hopkins University, Brown University, Emory University, Boston University, Kentucky Bioprocessing, and Oakcrest, Mapp Biopharmaceutical is close to submitting an IND for the Phase I clinical trial of their antibody-based MPT film with HSV and HIV indications. In addition, colleagues at the University of North Carolina recently conducted a study regarding providers' attitudes towards multipurpose vaccines. The study was conducted among providers in Argentina, Malaysia, South Africa, South Korea, and Spain, who showed substantial interest in the concept. The abstract is posted on the Initiative website.
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RTI International TRIO Study: RTI Women's Global Health Imperative recently announced the launch of the TRIO Study (Tablets, Rings, and Injectables as Options for women) in South Africa and Kenya, a two-year project that will evaluate the preference and acceptability of three potential multipurpose prevention technologies (MPTs) for prevention of HIV and unintended pregnancy. Funded by the Bill & Melinda Gates Foundation, this study will evaluate a vaginal ring, an injectable, and a daily oral tablet using only placebo products.
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Cayaź Diaphragm Now Available in the United States: The United States Food & Drug Administration recently approved Cayaź for marketing in the U.S. Developed by PATH, CONRAD, and other research partners, this one-size-fits-all diaphragm was created with the input of women. Read the press release here.
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Coming this Summer/Winter
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Indian Society for the Study of Reproduction & Fertility (ISSRF) Newsletter
We are excited that the forthcoming ISSRF Newsletter will focus exclusively on MPTs and will also feature articles by IMPT members. Edited by IMPT Steering Committee member Nomita Chandhiok, the Newsletter will be circulated to 1,200 ISSFR members, as well as Indian medical schools and research organizations.
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STI MPT Panel at ISSTDR, 13-16 September; Brisbane, Australia
In collaboration with the World Health Organization, UCSF Bixby Center for Global Reproductive Health, and the Australian Sexual Health Alliance, the IMPT is co-sponsoring an exciting session on STI MPTs at the 21st meeting of the International Society for Sexually Transmitted Diseases Research (ISSTDR) in Brisbane, Australia. Panelists will give an overview of MPTs in the pipeline that are relevant to STI prevention, as well as the epidemiological need for MPTs with STI indications. The discussion will focus on engaging STI researchers, clinicians, product developers and advocates in the MPT field. In addition, IMPT Steering Committee member Professor Helen Rees (Wits Reproductive Health and HIV Institute) will be giving a keynote lecture on STIs and the Sustainable Development Goals, where she will highlight STI MPTs as promising developments in addressing the multiple SRH needs of women.
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Technical Convening on Clinical Trial Design Issues for MPTs, Date TBD (Autumn/Winter 2015); Washington, D.C. area
MPT clinical trial design issues were highlighted as a critical issue among stakeholders who took part in the IMPT Priority Issues Identification Exercise. As an initial step in assessing these challenges, the IMPT will be convening a technical meeting in autumn or winter 2015, aimed at engaging funders, trial design experts, and product developers in these issues. Meeting participants will examine issues such as single trials per indication versus combined indication; bioequivalence options for MPTs; strategies for using PK/PD data; placebo control versus superiority or non-inferiority trials; and addressing drug-drug interactions between ARVs and hormonal contraceptives. This effort is being led by a multi-disciplinary planning committee, which convened in June and early July for initial planning meetings.
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General Membership Meeting of the Reproductive Health Supplies Coalition, 5-9 October; Oslo, Norway
IMPT Secretariat staff looks forward to connecting with other SRH partners at the 16th General Membership Meeting of the RHSC, which will take place in Oslo, Norway. A session panel submitted by the IMPT is under review for presentation at this meeting. Stay tuned for more details.
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International Conference on Family Planning, 9-12 November; Nusa Dua, Indonesia
We are thrilled to announce that the IMPT's panel, "Multipurpose prevention technologies (MPTs): a promising response to current challenges around hormonal contraceptive methods and HIV," was recently accepted as part of the program at the International Conference on Family Planning in Nusa Dua, Indonesia. The panel will provide an overview of research assessing whether various hormonal contraceptive methods impact the risk of HIV acquisition, and will explore research gaps related to combining hormonal contraceptives and HIV drugs in MPTs. The session also aims to engage new stakeholders in the IMPT's efforts to address critical MPT research gaps.
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North American Forum on Family Planning, 14-16 November, Chicago, IL, USA
MPTs will be featured in two sessions at the North American Forum on Family Planning in Chicago. The first will give a general overview of the status of MPT development, and the second will give technical insight into combining hormonal contraceptives with HIV prevention drugs in MPTs. More details are forthcoming.
If you are aware of other conferences where MPTs will be highlighted or where colleagues can submit abstracts, please write to us with the details.
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NIAID Division of AIDS Announces RFA Supporting Comprehensive Resources for HIV Microbicides and Biomedical Prevention
NIAID Division of AIDS recently announced a request for proposals on preclinical product development services for candidate products for HIV prevention. Successful contractors will fill task orders in preclinical gap-filling services, HIV animal models supporting product development, bioanalytical support services, product manufacturing, and scientific and quality/regulatory support services. Read the solicitation for more information. Proposals are due 24 September 2015.
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STAR STI CTG: Call for Concept Proposals
The Concept Proposal Solicitation period for the 3rd quarter of 2015 is now open. The STAR STI CTG is a NIH-sponsored clinical trials group that supports large, randomized, clinical trials in the field of prevention, diagnosis and treatment of STIs. Concept proposals along with the requested information included on the website must be submitted by 1 September 2015.
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Join the Network of Experts (NoE)
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The NoE is a multidisciplinary, international group of experts working in sexual and reproductive health, all of whom are committed to making MPTs a reality. NoE members have access to up-to-date news and resources, quarterly update webinars, and other critical MPT-related convenings. Become a member of the IMPT NoE today!
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Thanks for Your Continued Support!
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Write to us with any feedback or suggestions to improve our quarterly newsletter.
Best,
CAMI Health Staff
Join us to make MPTs a life-saving reality-- your contributions will help advance
MPT development and increase MPT support-- and it is tax deductible.
Visit http://www.cami-health.org/support
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