Posted by Maria Codina on December 12, 2017 at 1:19 pm
To support the advancement of a robust pipeline of diverse and effective multipurpose prevention technology (MPT) products serving the broad sexual and reproductive health (SRH) needs of women, the Initiative for MPTs (IMPT) – a product neutral, global collaboration that works to advance MPTs – encourages researchers and product developers to consider entering the MPT development field. Whether your experience is in SRH prevention, drug delivery, novel formulation science, engineering, or polymer chemistry, you will be joining a community of organizations who have paved the way for the promising cadre of first-generation MPT products currently undergoing clinical trials.
While the MPT field is presented with unique technical and market challenges to product development and introduction, the IMPT Secretariat, in collaboration with key partners, has developed a range of resources and tools to advise on various steps of the process – from MPT basics to complex technical considerations.
MPTs are an innovative class of products that deliver varied combinations of HIV prevention, other sexually transmitted infection ( STI ) prevention, and contraception. While the field is currently focused on products that co – formulate contraception and HIV prevention, this is not the only possible MPT combination. MPTs can also deliver HIV prevention and prevention of another STI, or contraception and a non-HIV STI, or prevention of two or more non-HIV STIs.
The only MPTs currently on the market that are effective for more than one indication are male and female condoms, but there are numerous products in development. Access the IMPT’s online product development database for a full listing of MPT products in the pipeline and a table that summarizes the pipeline by indication combination. This database is managed by the IMPT Secretariat.
Given that many MPTs are still not commercially available, it is difficult to fully characterize the market potential for MPTs. Nevertheless, global epidemiological data on overlapping incidences for HIV and other STIs, as well as rates of unintended pregnancy, illustrate a need for more efficient prevention. Moreover, a growing body of literature suggests that many women would prefer taking one multi – indication product over several single – indication products to meet their SRH prevention needs.
Combining multiple drugs in a single product or device opens a host of complex technical challenges, from selection of the active pharmaceutical ingredient and dose, to co-formulation of drugs, to regulatory issues. These complexities notwithstanding, this is a rapidly evolving area of research that is exciting to be a part of, with a collaborative network of stakeholders strategizing and accelerating action around many of these areas.
This 2016 IMPT meeting report examines priority technical questions and challenges specific to MPTs that combine hormonal contraception and HIV prevention MPTs. Another 2016 IMPT meeting report unpacks key issues for MPT clinical trials. Other useful IMP T resources focus on issues surrounding the regulatory pathway for MPTs, including this 2013 report and this live webinar recording on bioequivalence and bioavailability. Whether to be used as guidance for a new MPT product development project or inspiration for a new partnership or collaboration within the IMPT network, these and other technical resources can be found on the IMPT’s online resource center.
There has been an upward trend in MPT R&D investment over the past five years, with MPT – focused RFAs being released with some regularity. Most recently, the National Institutes of Health (NIH) posted several opportunities to develop MPTs: ‘Next Generation MPTs” with applications due on March 19, 2018, and ‘Advancing the Science of MPTs’ with applications due January 22, 2018. Please refer to the NIH postings for project requirements.
In addition to the resources listed above, the IMPT’s generalized Target Product Profiles (TPPs) for intravaginal rings and long-acting injectables are intended to be a starting place for product developers working on those and other dosage-forms. TheIMPT’s report on considerations for an MPT Strategic Evaluation Framework, the market-based complement to a TPP, could be useful as well.