Developing Multipurpose Reproductive Health Technologies: An Integrated Strategy
Table 1
Study design components.
Teams and associated activities*
Tasks and deliverables
Data collection approach
Participants
Process contributions (summary conclusions/material outputs)
CAMI Advisory Committee and Core Management Group
Overall design and management of strategic process
Regular telephonic and internet consultation, document preparation, and review
(i) Core strategy management group () (ii) Entire CAMI Advisory Committee ()
Series of meeting reports, circulation of survey findings, web posting of presentations, conference convening
Think Tank*
Answer 2 questions: (i) Is MPC concept scientifically feasible? (ii) If so, what is most logical and effective way to organize and prioritize the scientific agenda for MPT R&D? (Results to be discussed at International MPT Symposium, November 2011)
Document review and consultation (May 2011) (i) Review of ideal characteristics for populations most likely to benefit from MPTs (ii) Review of pipeline of relevant technologies (iii) Preliminary definition of research needs, gaps, obstacles for each MPT component
28 representatives from businesses, foundations, universities, nonprofit organizations, US government agencies (USAID, NIH, FDA)
Conclusions: (i) MPTs deemed feasible, though scientifically challenging (ii) Recommended adoption of Target Product Profile methodology for MPTs (iii) Agreed to form two teams to develop specific TPPs for (a) combination drug and drug/device MPTs and (b) multipurpose vaccines
Drug-Drug and Drug-Device Working Group
Implement strategy to: (i) Select and refine TPP critical attributes and appropriate parameter ranges for high-impact MPTs in these product categories (ii) Expand understanding of regional needs and priorities for MPT development
“Snowball” series of surveys, ePolls, qualitative interviews, consultations, invited presentations, consultations, and reviews of successive iterations of TPP parameters and criteria (March 2011–January 2012)
Key populations: reproductive health and HIV research experts and advocates from Asia, Africa, Europe, United States, including (i) 593 US health care providers (Association for Reproductive Health Professionals (ARHP) 2011 Conference) (ii) 289 African health care providers (International Family Planning (ICFP) 2011 Conference) (iii) ~120 participants, MPT 2011 Symposium
Consensus derived from each survey analyzed to construct consensus TPP for presentation, discussion, feedback from participants in International MPT Symposium (November 2011, Washington, DC) and >60 participants at Global Forum on Multipurpose Prevention Technologies (London, UK, January 2012)* for discussion
Multipurpose Vaccine Working Group
(i) Elicit ideas for multipurpose reproductive health vaccines (ii) Develop consensus Target Product Profile (iii) Discuss timeline for MPT vaccine development
(i) “Request for MPT Concepts” formulated, reviewed, emitted (ii) Teleconference process to develop Target Product Profile for MPT reproductive health vaccines
MPT vaccine researchers and potential developers
13 submissions received based on active immunization, passive immunization, adenovirus-vectored antibodies, and MPT vaccine development strategies
Scientific Agenda Working Group (SAWG)
(i) Use TPPs developed by the product-specific working groups as framework for (ii) Characterizing the MPT pipeline from discovery through regulatory approval (iii) Prioritizing promising candidates
(i) Agenda-driven conference calls to review successive iterations of TPPs and survey responses (ii) Convening of experts charged with critiquing and debating SAWG draft to formally review SAWG recommendations
(i) Respondents to MPT Product Profiles Survey (ii) 35 experts from pharmaceutical companies, academic institutions, national regulatory authorities, global drug delivery
(i) SAWG recommendations and priorities endorsed (ii) Feedback and recommendations regarding challenges, risks, and strategies to be considered
(iv) Analyzing overall pipeline status and gaps (v) Exploring associated regulatory implications
Efforts, and countries with greatest need for MPT products (Product Prioritization Stakeholder Meeting, October 2012)
