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WASHINGTON, DC – Senator Cory Booker (D-NJ) introduced the Supporting Innovative Global Health Technologies (SIGHT) Act of 2024. The bill would empower the US Agency for International Development (USAID) to boost its research and development (R&D) capabilities for health care technologies in low- and middle-income countries abroad. This bill, S.5278, is a companion bill to H.R.6424, which was introduced in the House of Representatives last November by Representatives Brian Fitzpatrick (PA-01), María Elvira Salazar (FL-27), and Chrissy Houlahan (PA-06)."We applaud Senator Booker for his leadership in advancing next-generation health innovations that are critical for tackling both known and emerging global health challenges by expanding the global health R&D ecosystem within the US government," said Dr. Kristie Mikus, Executive Director of the Global Health Technologies Coalition (GHTC), which represents 49 nonprofit organizations, academic institutions, and aligned businesses dedicated to advancing life-saving innovations globally. "With its extensive presence in low- and middle-income countries and its strong track record of fostering public-private partnerships, USAID is uniquely positioned to drive groundbreaking health innovation. It is encouraging to see congressional leaders in both the House and Senate recognize USAID's potential to embrace new disease-agnostic program areas that will complement the ongoing USAID R&D partnerships that have already been instrumental in saving millions of lives around the world."

The Global Health Technologies Coalitions (GHTC) welcomes the political declaration approved today by the United Nations (UN) High-Level Meeting on Antimicrobial Resistance (AMR) and applauds its commitments to promote the research and development (R&D) of and equitable access to antimicrobials, vaccines, diagnostics, and other products. GHTC especially appreciates the inclusion of concrete targets, such as the goal to reduce AMR deaths by 10 percent by 2030, the commitment to raise $100 million to support the implementation of national action plans against AMR, and support for important new mechanisms like the independent panel for evidence for action against AMR, which will help guide country action and provide both technical support and accountability. GHTC also commends the text’s robust R&D language, which includes many provisions for which GHTC has advocated, such as recognition of the need for stronger local and regional manufacturing capacities and the importance of public-private partnerships (including explicit mentions of our members the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator and the Global Antibiotic Research & Development Partnership), and calls for stronger regional coordination of the licensing and registration of medical products and the use of push and pull incentives.   While GHTC welcomes the strong R&D focus in the political declaration, we believe that there should have been measurable research targets included as well, which would have facilitated better progress tracking and accountability among national governments. We also note with some concern the lack of follow-up outlined in the text, with the next High-Level Meeting on AMR to be held in 2029, providing insufficient time to course correct if inadequate progress has been made.   This political declaration is a laudable step forward, but the true test will be in the implementation of these commitments, as the next few months now become about setting up the right systems and structures to turn principles into action and ensure that this agenda is advanced in other multilateral forums like the G20.   “Antimicrobial resistance poses one of the most pressing threats to global health, and the High-Level Meeting on AMR and its political declaration represent a pivotal moment in our collective response,” said GHTC Executive Director Dr. Kristie Mikus. “We applaud the political declaration’s commitment to promote and invest in R&D in the AMR space, especially in low- and middle-income countries, and to push for a stronger innovation ecosystem for new technologies. As we continue to experience the rising tide of drug-resistant infections and emerging infectious threats, innovation will be more essential than ever before to promote the production of effective, affordable, and accessible health technologies on a global scale.”

GHTC Executive Director Dr. Kristie Mikus issued the following statement in response to the release by the World Health Organization (WHO) of new guidance on best practices in clinical trials. This guidance comes following a two-year development effort prompted by the 2022 adoption of a World Health Assembly resolution on strengthening clinical trial capacity. GHTC has been engaged in robust consultations with the WHO Science Division throughout the process.“Clinical trials are the backbone of medical progress, helping translate promising discoveries from a lab into proven solutions for the patients and communities who need them worldwide. We welcome the release by WHO of new clinical trial guidance, which will support countries, industry, and researchers in conducting better, more inclusive clinical trials during both ordinary times and health emergencies. We particularly applaud the guidance’s focus on strengthening trial infrastructure in low-resource settings and expanding the inclusion of groups traditionally underrepresented in clinical research, including children and pregnant and lactating women and individuals.  Every region should have the capacity to conduct high-quality research, and every person deserves to benefit from the fruits of science. Today’s release of WHO clinical trial guidance is a step forward in realizing that vision.” 

An estimated 257 million women globally who want to avoid pregnancy are not using safe, modern contraceptive methods, leading to around 121 million unintended pregnancies globally every year—nearly half of all pregnancies. Ensuring all who wish to use contraception have access to safe, effective, and acceptable options can enable all people of reproductive potential to enjoy greater autonomy over their lives and health. To meet the diverse needs of people of reproductive age, we need a variety of new contraceptive choices, including options that are longer-lasting, more discreet, have fewer side effects, and require fewer visits to a health care provider, as well as additional options for men to take more of the burden of pregnancy prevention off the shoulders of women. In recognition of this year’s World Contraception Day, GHTC is highlighting six technological solutions in the pipeline that could enable greater access to contraception by breaking down barriers, especially for underserved populations and those in low-resource settings. 1. Next-generation contraceptive vaginal rings   Intravaginal rings—flexible silicone rings that are self-inserted into the body and release contraceptives—offer an easy-to-use, convenient, and discreet contraceptive option for many women worldwide. Today, women can choose from either a monthly or a yearly ring—the latter of which was developed by Population Council and first approved by the US Food and Drug Administration (FDA) in 2018. However, both ring options use a combination of the same estrogen hormone, ethinyl estradiol, and different types of progestin hormones. While these hormone options work well for many individuals, for others, they can cause side effects or risks, creating a need for rings with alternative hormones and rings that are nonhormonal. Thankfully, several next-generation rings are on the horizon.These next-generation options include two rings under development by Population Council, which use alternative hormones. The first, the three-month Nestorone®/estradiol intravaginal ring uses a form of estrogen that, unlike ethinyl estradiol, is not associated with an increased risk of blood clots in the veins among women with a higher body mass index—who account for 15 percent of adult women. It is currently being evaluated for use in women with a higher body mass index in a Phase 2b study.  The second, the Nestorone®-only vaginal ring, has no estrogen, offering an alternative for those who have estrogen sensitivities, those who are at higher risk of blood clots, and postpartum breastfeeding mothers, who are often advised against using hormonal contraception that contains ethinyl estradiol due to its effect on milk production and composition. The ring will soon undergo a Phase 2 dose-finding study.On the nonhormonal front, Daré Bioscience is developing Ovaprene®, a monthly vaginal ring which uses a “semi-permeable polymer mesh barrier” to physically stop sperm from entering the cervical canal. Early clinical studies found that the ring is well-tolerated and acceptable to sexually active women and their partners. Additional clinical trial results announced in 2024 also demonstrated safety and efficacy, paving the way for a Phase 3 trial now underway.2. Biodegradable contraceptive implant  Today’s contraceptive implants are small, flexible rods inserted under the skin that continuously release hormones for pregnancy prevention. While they are safe and long-lasting, after three years, they must be removed by a medical provider. That can be an issue, particularly in low-resource settings worldwide where fewer trained health care workers, distance, and cost can serve as barriers to care. Biodegradable contraceptive implants, which dissolve into the body, offer promise as a more convenient option that could improve access by cutting out the need for a trip to a medical facility for device removal.FHI 360 and development partners pH Sciences and Gesea Biosciences, with funding from the Bill & Melinda Gates Foundation, developed a biodegradable implant called Casea S, which can provide protection against unintended pregnancy for 18 to 24 months. The implant is now being tested in a Phase 1 clinical trial, the first trial for a biodegradable contraceptive implant in more than 20 years.3. Microneedle contraceptive patches   Many women choose to use injectable forms of contraception for long-acting protection, but, for others, the need for regular shots and visits to a health care provider can make this a less desirable choice. But imagine if these injections were pain-free and did not require leaving home. That is the promise of microneedle or microarray patches, which are small Band-Aid-like patches that contain hundreds of microneedles that slowly release drugs into the body when pressed against the skin. The new technology, which is also being developed to deliver vaccines and therapeutics, could offer a discrete, user-controlled, and less painful option that could either be self-administered or administered by a health care provider with minimal training.  With support from the US Agency for International Development through the US President’s Emergency Plan for AIDS Relief, PATH is developing an easy-to-use, discreet, and self-administered contraceptive patch that could provide protection against unintended pregnancy and HIV, which is currently in preclinical development.FHI 360, in partnership with Population Council and the Georgia Institute of Technology, is also developing a three- to six-month, biodegradable, and progestin-only patch currently in the preclinical phase, with support from the US Agency for International Development and the Gates Foundation.4. Longer-acting contraceptive injectablesThe most commonly used contraceptive injection, depot-medroxyprogesterone acetate (DMPA), approved by FDA back in 1992, offers a longer-lasting option than the daily pill, with a three-month period between injections. However, DMPA requires users to return often to their health care providers, and it has the highest discontinuation rate among contraceptives in the United States due to unpleasant side effects like menstrual irregularities, weight gain, and bone density loss.FHI 360 is in the midst of a Phase 3 trial testing a six-month version of DMPA that is injected under the skin rather than into the muscle, which could offer a longer-lasting, lower-dose option that is more convenient and presents a lower risk of side effects for users. The product, which is the furthest-along six-month injectable in the pipeline, could be approved as early as 2025 or 2026 if trials prove successful.  FHI 360 is also developing a six-month self-injectable contraceptive that uses levonorgestrel rather than DMPA and is being advanced through Phase 1 clinical trials in collaboration with the Shanghai Institute for Biomedical and Pharmaceutical Technologies, with funding from the Gates Foundation. This product could offer another longer-lasting option with potentially fewer side effects and the convenience of using it at home.  5. Male contraceptivesThe need for male contraceptive options beyond condoms and vasectomy to allow men to more equally share the responsibility of contraception has been widely and increasingly recognized. There are a number of technologies in development, including technologies that use hormones to disrupt the sperm creation process. Population Council has developed a novel, easy-to-use, and reversible gel hormonal contraceptive method that is applied daily to the shoulders and, if approved, would be the first-of-its-kind option for men. Early studies showed that it is well tolerated and causes no serious adverse events. A Phase 2b study yielded promising results, with a second part of the trial now underway. The gel, which could enter the final phase of testing in 2025 with the go-ahead from FDA, has made it excitingly far in a pipeline lacking in male contraceptive technologies beyond the preclinical stage.While hormonal strategies require a long time to start and stop working because of the considerable months-long sperm development process and could have side effects due to hormone disruption, there are also nonhormonal technologies in early-stage development. These nonhormonal strategies target specific processes later in sperm development and could start and stop working more quickly, perhaps even to the point of an on-demand product taken right before intercourse. One recent study in mice identified a new nonhormonal, reversible method that targets a protein complex important during sperm production, with the drug successfully stopping the process without producing side effects or causing irreversible effects. Another recent study in mice identified a different protein target necessary for fertility, finding similarly positive results.  Contraline and Next Life Sciences are also developing nonhormonal products that work by blocking the vas deferens, the tube in the male reproductive system that transports sperm, with an injectable gel. Contraline announced positive interim results from a first-in-human trial earlier this year. 6. Dual-use technologies for HIV, STI, and pregnancy preventionMultipurpose technologies that protect against unintended pregnancy, HIV, and other sexually transmitted infections (STIs) could be a game-changer in opening up access to prevention tools, particularly in low-resource settings, by reducing the burden on users and the health care system.In addition to the aforementioned microneedle patch for HIV and unintended pregnancy prevention, Population Council is developing several dual-use products. The two products likely to reach market fastest are a dual-use pill, which reformulates already approved medicines for oral pre-exposure prophylaxis and oral contraceptives into one tablet to be taken daily, and the dapivirine-levonorgestrel vaginal ring, which builds on the successful development of the one-month dapivirine ring for HIV prevention with a three-month ring that slowly releases the antiviral drug dapivirine and the contraceptive hormone levenorgestrel, drugs already approved in other forms. Other products in early development include a nonhormonal vaginal ring and a nonhormonal fast-dissolving vaginal insert, both designed to provide crosscutting protection against unintended pregnancy and STIs.Currently, contraceptive research and development is greatly underfunded, and there is an urgent need for new and improved products to better serve particular populations and those living in low-resource settings. The contraceptive technologies detailed above and others in the pipeline offer hope that we will in the future have a robust array of contraceptive options to ensure everyone globally who wants to use contraception has access to a product that works for them.