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To celebrate Valentine’s Day, GHTC staff embraced our health policy wonkiness by participating in the time-honored beltway tradition: #HealthPolicyValentines. For those who are unfamiliar, this tradition started in 2012 when a former staffer and Twitter aficionado at the US Department of Health and Human Services, Emma Sandoe, became inspired to “tweet one ‘health policy valentine’ every day until Valentine’s Day.” Other health policy experts soon joined in with their own poems and puns related to health care, and an annual tradition was born. Now every February, health policy wonks tweet out their most creative #HealthPolicyValentines. This year, GHTC staff joined in on the fun to share our passion for global health research and development (R&D). Here are our favorites:  Roses are red 🌹 Congress is divided ➗ But if it could deliver strong health R&D funding 💪💰 I’d be delighted 👍#HealthPolicyValentines— Marissa Chmiola (@MarissaChmiola) February 12, 2024 Roses are red Noma’s a place in DC But it was also recognized by @WHO As the latest NTD#HealthPolicyValentines #BeatNTDs— Marissa Chmiola (@MarissaChmiola) February 12, 2024 Roses are red 🌹 CRs are now “laddered” 🪜 Giving more headaches to health wonks 😣Whose brains already feel scattered 🤯#HealthPolicyValentines— Marissa Chmiola (@MarissaChmiola) February 12, 2024 Mosquitoes are spreading Into regions anew #Malaria is not only a threat in Africa It’s hit Maryland too.#HealthPolicyValentines — Philip Kenol (@Phil_kenol88) February 13, 2024 Penicillin was Sir Fleming’s great findThe field of medicine redefinedSo Fleming won a Nobel and changed historyBut the threat of #AMR is now no mysteryWe need new drugs, tests, & vaccines designedA historic poem from our colleague Anum Adrees! #HealthPolicyValentines 🧫💌— GHTC (@GHTCoalition) February 13, 2024 @USAID’s health R&D has saved millionsThat is a fact!But to supercharge it’s workCongress must pass the SIGHT Act#HealthPolicyValentines— Alex Long (@W_AlexLong) February 14, 2024 Roses are redValentine’s Day is blahI don’t get why CongressCan’t just authorize #PAHPA#HealthPolicyValentines— Alex Long (@W_AlexLong) February 14, 2024 From GHTC staff Anum: Valentine’s is in FebruaryMarch is the month afterRemember March 2020?Yeah, that was a disasterOf pandemic threats we should be warySay the disease forecastersSo let’s get pandemic-readyAnd develop those vaccines faster!#HealthPolicyValentines 💝— GHTC (@GHTCoalition) February 14, 2024 The times we live in are rather scaryBut today, we feel quite contraryWe love these #HealthPolicyValentinesThey give us hope that through our work, we can save lives!One last poem from our colleague Hannah! 💌💝— GHTC (@GHTCoalition) February 14, 2024

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Two new reports from the AMR Industry Alliance, a coalition of companies and trade unions in industries working to combat antimicrobial resistance (AMR), highlight both progress and setbacks in the field of antimicrobial resistance research and antibiotic development, as the threat of AMR rises globally. A survey of members demonstrated positive findings, including many industry members having implemented measures to support antimicrobial stewardship and efforts to increase antibiotic access in lower-resource countries, as well as having invested in AMR-relevant R&D. On the other hand, there has been a decline in AMR researchers over the last few decades, leading to less published research on AMR and fewer patents on new antibiotics, the decline particularly acute when compared to cancer and HIV/AIDS. The findings highlight the need for government and private sector incentives to provide adequate funding and investment for AMR research and novel antibiotic development, as well as for efforts to introduce young scientists to the field.The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) recently announced $1.8 million in funding to biotechnology company Visby Medical to develop a portable rapid diagnostic test that detects Neisseria gonorrhoeae, the pathogen that causes gonorrhea, as well as its susceptibility to ciprofloxacin, an oral antibiotic that was formerly a go-to treatment, which can no longer treat resistant forms of the pathogen. The test would allow health care providers to rapidly test and refer patients to the right treatment while hopefully ensuring that ceftriaxone, the only remaining effective antibiotic against resistant N. gonorrhea, is properly managed. The funding will also support the development of a test for N. gonorrhoeae, Chlamydia trachomatis, and Trichomonas vaginalis in men based on urine samples.The Coalition for Epidemic Preparedness Innovations (CEPI) will provide up to $2 million in funding to German biotech company LenioBio GmbH for a preclinical proof-of-concept for using its commercially available, plant-based, and cell-free technology to produce proteins for use in clinical trials testing vaccines against epidemic and pandemic threats in 20 to 40 days. If proven successful, this approach could greatly reduce the time it traditionally takes to manufacture vaccine proteins using other methods, which would be a major boon to CEPI’s 100 Days Mission to develop vaccines against novel pathogens with pandemic potential within 100 days of identification. The easy-to-use technology could also be rolled out for use in remote or low-resource settings, allowing greater availability of and access to future vaccines in those settings. 

Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign up now to receive our weekly R&D News Roundup email. Last Wednesday, the World Health Organization and the Medicines Patent Pool announced a new nonexclusive license agreement with SD Biosensor for the firm’s rapid diagnostic testing technology, which, through a phased technology transfer plan, will allow sublicensees to manufacture the technology, with additional benefits for the broader effort of manufacturing capacity-building in low- and middle-income countries. The agreement was negotiated under the COVID-19 Technology Access Pool (C-TAP), which was launched at the beginning of the COVID-19 pandemic, but it includes a broad range of diseases, including HIV, malaria, and syphilis. The rapid testing technology is the basis of SD Biosensor’s COVID-19 antigen test and is ideal for low- and middle-income countries because it has no equipment requirements and is easy to use with high sensitivity. The announcement also coincided with the unveiling of a new business model, the Health Technology Access Pool, which will succeed C-TAP and address other priority health issues beyond COVID-19.A new project—FLAVIVACCINE—from a diverse consortium of partners aims to increase the European Union’s ability to combat epidemic and viral threats in Europe and globally by supporting the development of a pan-flavivirus vaccine candidate that could protect against multiple flaviviruses, such as dengue, yellow fever, Zika, and West Nile. Beyond seeking a vaccine candidate, the project also aims to provide support across the R&D value chain, offering a boost to the broader global pandemic preparedness and response capability. The project is being organized by public and private institutions, including universities, research institutions, and a vaccine developer, spanning seven countries in Europe and the United States.A new grant to the Drugs for Neglected Diseases initiative (DNDi) from the Bill & Melinda Gates Foundation will support the development of innovative new drugs for sleeping sickness and river blindness. Specifically, the $20 million grant spanning until 2027 will support a single-dose cure for sleeping sickness and a short-course new treatment for river blindness, both diseases with a major footprint in sub-Saharan Africa and for which new tools are urgently needed to accelerate progress toward elimination, despite enormous progress in controlling them in recent years. These investments build on earlier-stage research also supported by the Gates Foundation.

GHTC responded to a public request for comment on the pandemic accord negotiations that was released by the US Department of Health and Human Services' Office of Global Affairs. GHTC's comments focused on the need for the accord to feature provisions that incentivize continuous research and development, facilitate equitable access to medical countermeasures, and strengthen regulatory capacity.Global Health Technologies Coalition Recommendations for US Department of Health and Human Services on the Implications of Access and Benefit Sharing (ABS) Commitments/Regimes and Other Proposed Commitments Being Considered Under a WHO Convention, Agreement or Other International Instrument on Pandemic Prevention, Preparedness and ResponseThe Global Health Technologies Coalition (GHTC) is a coalition of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people.We appreciate the US government, via the Departments of Health and Human Services and State, for providing this consultative opportunity to comment on the ongoing Intergovernmental Negotiating Body (INB) process, the Access and Benefit Sharing (ABS) commitments/regimes, and other research and development (R&D) provisions being considered.Many provisions in the draft agreement are positive, recognizing and affirming key points related to human rights and inclusive provisions that prioritize vulnerable and marginalized populations. The draft recognizes vaccine inequity as a vital concern and affirms key principles of equity and non-discrimination and the need to ensure adequate support for both health workers and the World Health Organization (WHO).However, we believe there are several areas in which the text could be strengthened, particularly when it comes to language around gender equity, a stronger focus of dual-use research and harmonizing pandemic preparedness investments with ongoing efforts to fight malaria, tuberculosis (TB), HIV/AIDS, neglected tropical diseases, and antimicrobial resistance (AMR). There are also ways the draft could be improved to include provisions that address the regulatory ecosystem and the distinct role of WHO.Please find our recommendations below.General CommentsElevate gender equity more broadly throughout the text.The agreement must meaningfully prioritize gender equity. The draft text promotes gender inclusion in areas such as workforce and clinical trials, but it misses other strategic opportunities to advance gender responsive policy essential to equitable pandemic prevention, preparedness and response (PPR). The draft should include specific language affirming the parties’ commitments to collect, report, and analyze data disaggregated by gender, ethnicity, race, and age, and uphold social protections and the full spectrum of essential health services for all during health emergencies.Broaden to all stages of R&D.The text focuses very heavily on later stages of R&D rather than all stages needed for preparation and response. Despite member state proposals to widen the focus to include early-stage collaboration, there are no provisions relating to early-stage R&D activities, including discovery research, where investments and collaboration are needed. Specific provisions should be added to Article 9 (Research and Development).Article 9: Research and DevelopmentLeveraging investments for PPR for health systems strengthening.While the agreement includes language that highlights the interconnectedness of health system strengthening and PPR, it lacks provisions that underscore the need to focus on sustainability and “dual-use” R&D capacity and infrastructure that can be leveraged for both pandemic response and longstanding challenges. Article 9 (Research and Development) should therefore add language that explicitly highlights that building clinical trial and laboratory capacity and networks to address ongoing epidemics like HIV/AIDS, TB, malaria, and polio; re-occurring outbreaks of Ebola, Marburg, and cholera; and AMR contributes to both pandemic preparedness and overall health system strengthening.Greater coordination between regulatory authorities and ethics committees for clinical trials.The role of regulatory authorities extends beyond regulatory approvals for market-ready health tools. Conduct of clinical trials requires approvals from regulatory authorities and ethics committees as well. Regulatory authorities and ethics committees, working in a coordinated way to grant approvals, especially during a public health emergency, will speed up the conduct of clinical trials. Article 9 should add a provision under its clinical trials section that promotes greater coordination between ethics committees and regulators. We urge the United States to push for new language encouraging and incentivizing joint reviews of regulatory dossiers, which will maximize opportunities for cooperation between countries and can help optimize review timelines by allowing regulatory authorities to share data, validate findings, and streamline communications with the applicant, thereby expediting market access to the health tools developed.The role of WHO.The pandemic agreement should ensure that WHO is sufficiently empowered to play a strong normative role in helping define a priority research agenda and in coordinating research, building on the R&D Blueprint, to speed innovation and avoid unnecessary duplication and fragmentation of data.Article 10: Sustainable ProductionGoing beyond rapid manufacturing scale-up.Pandemic prevention and response is too often marked by cycles of panic and neglect. While Article 10 (Sustainable Production) outlines provisions that seek to strengthen manufacturing capacity, as well as more diverse and regionally distributed production capabilities to respond during an emergency, the draft currently does not cover incentivizing continuous research to develop vaccines, diagnostics, therapeutics, and other health technologies for epidemic-prone diseases that disproportionately impact low- and middle-income countries. A greater focus needs to be placed at looking beyond just rapid scale-up of production capacity during an emergency, to instead supporting sustained research into disease threats during “times of peace”. Continuous research can yield discoveries that accelerate the development of medical countermeasures for novel pathogens, as was the case when prior research on an mRNA vaccine for HIV contributed to speeding up the development of mRNA COVID-19 vaccines. A provision should be added for supporting such research.Incentivize expanded registration of pandemic tools to accelerate equitable access.To ensure timely global access to health tools developed, manufacturers must seek regulatory approvals or authorizations beyond high-income countries, particularly in developing countries where transmission is high and clinical trials have been conducted, to ensure fair and equitable access to the fruits of research. Therefore, Article 10 (Sustainable Production) should include new text that calls on countries to provide incentives for manufacturers to facilitate this, with a view to achieving a more equitable geographical distribution of the global production of pandemic-related products.Article 11: Transfer of technology and know-howArticle 12: Access and benefit sharingEquitable access to medical countermeasures.The agreement must maintain language on global public health and equitable access at the center of policies, processes, and investments. This means ensuring low- and middle-income countries can create, manufacture, and buy countermeasures when needed and have the resources to respond quickly. Commitments to equitable access in Articles 11, 12, and 13 must be enshrined through robust language on distributed manufacturing capacity, technology transfer, and access and benefit sharing.Regulatory policy that enables innovation and access.The framework should include provisions strengthening the capacity of regional regulatory bodies, like the newly formed African Medicines Agency. Investing in bolstering the regulatory capacity of these regional bodies, and not just promoting harmonization, will help fill gaps for countries with lower regulatory maturity levels. Text should be included that standardizes policies or protocols for the regulation of products during health emergencies. Currently, the draft only highlights general regulatory harmonization and focuses on licensing of pandemic products, without taking into account broader elements of the regulatory ecosystem.