News & Insights

GHTC responded to Senator Bill Cassidy's (R-LA) request for information (RFI) on modernizing the National Institutes of Health (NIH), highlighting the important globally facing work NIH does.Dear Senator Bill Cassidy, We write to you today representing the Global Health Technologies Coalition (GHTC), a group of more than 45 nonprofit organizations, academic institutions, and aligned businesses advancing policies to accelerate the creation of new drugs, vaccines, diagnostics, and other health tools to bring healthy lives within reach for all people. It is with this perspective that we intend to contribute input on opportunities to continue modernizing the National Institutes of Health (NIH). NIH has long been a cornerstone of basic and early-stage biomedical research, playing a pivotal role in driving scientific discoveries that pave the way for the creation of lifesaving global health technologies by the private sector, nonprofits, and other US agencies. While NIH primarily facilitates basic research on global health challenges through intramural programs and external grants to universities, nonprofits, and other organizations across the United States, its ongoing investments in clinical trials for HIV/AIDS—and increasingly trials for malaria and tuberculosis (TB) products—also makes it one of the biggest global funders of clinical development in each of these disease areas. The foundational research conducted by NIH has been instrumental in facilitating the United States’ COVID-19 response, enabling the nation to lead in the rapid development of new technologies to combat the pandemic. NIH's prior research on coronaviruses, such as SARS-CoV-1 and MERS-CoV, laid the groundwork for understanding these viruses through the development of animal models, scientific techniques, treatments, and vaccines. These past investments enabled NIH scientists to quickly understand and immediately respond to COVID-19 with focused research and accelerated development of diagnostics, therapeutics, and vaccine candidates. Specifically, the National Institute of Allergy and Infectious Diseases (NIAID), in partnership with Moderna, developed one of the initial COVID-19 vaccines, mRNA-1273, and moved the vaccine to human clinical trials just 65 days after the genome of the virus was shared—a record far shorter than any previous vaccine development timeline. This only bolsters the solid track record of NIAID, which also supported, among other breakthroughs, the development of an innovative, automated diagnostic for TB—the Cepheid Xpert® MTB/RIF test; a now-approved Ebola treatment, mAb114, which was found to dramatically improve the survival rate of infected patients in a clinical trial carried out amid the 2018 to 2019 outbreak in the Democratic Republic of the Congo; and the clinical research demonstrating that a combination of two newer drugs, bedaquiline and delamanid, could be safely taken together to treat drug-resistant TB in HIV-positive and HIV-negative individuals. Building upon its leadership in basic research, NIH has also achieved success in driving more directive product development initiatives that should be seen as proof of concepts for the future of US-sponsored targeted research. For example, after COVID-19 emerged, NIH launched and led two public-private partnerships to create new therapeutics and diagnostics for COVID-19: the Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV, and the Rapid Acceleration of Diagnostics initiative, or RADx. What sets these initiatives apart from NIH’s traditional way of funding promising science is the clear focus on a product end goal, the degree of coordination on the research agenda, and the approach of sourcing a portfolio of potential solutions for a problem and flexibly and rapidly infusing funding to speed the development of those that show the most promise as development advances. Expanding these types of more directive, coordinated funding and grant schemes can be particularly valuable for advancing products for diseases that lack a commercial market, including neglected diseases that primarily impact the world’s poorest places and diseases with epidemic potential. Unlike in areas where there is clear profit potential, where companies will build upon NIH-funded basic research discoveries to advance products to market, in these areas, funding basic research alone is not sufficient, and an expanded focus by NIH on targeted product development could help accelerate lifesaving solutions. These initiatives also demonstrate the importance of having a strong overall funding base for NIH, as while ACTIV was eventually powered by significant supplemental funding from COVID-19 relief bills, it was first stood up using the agency’s existing discretionary funding. Another contributing factor to NIH’s success is its ability to create massive impact with constrained resources. The Fogarty International Center (FIC) is a good example of this. With less than one-fifth of one percent of the total NIH budget, Fogarty delivers significant scientific returns for global and American health, forging international partnerships to facilitate truly global research. The center creates a platform for partnerships between scientists in the United States and worldwide. When FIC investments lead to new tools or interventions designed for low-resource settings, these innovations can be deployed back in the United States, where they can drive down costs and improve access to health care in rural settings—an exchange known as reciprocal innovation. By looking at the successes of NIAID, FIC, and the flexible and targeted funding calls, the future of NIH’s work looks bright, as low resource innovation and dynamic funding mechanisms are prioritized throughout the institutes. It should be noted that, while done in good faith, further scrutiny of NIH for the sake of transparency should be measured so as not to interfere with the flow and cadence of ongoing research. One way to mitigate disruption is to work with NIH principal investigators, administrative staff, directors, and all those impacted to roll out new oversight measures with clear deliverables through a transparent process to instill trust in the process and the people. We appreciate your attention to this matter and would be happy to further collaborate with the Senator’s office as action is taken to modernize NIH. Sincerely,  Alex Long  US Policy & Advocacy Officer  

The Honorable Xavier Becerra Secretary of the Department of Health and Human Services The U.S. Department of Health and Human Services 200 Independence Avenue, S.W. Washington, D.C. 20201 RE: Support for an FDA Emerging Pathogens Preparedness Program Dear Secretary Becerra, We thank you for your leadership and contribution towards the United States’ pandemic preparedness strategy. In light of the reauthorization of the Pandemic and All-Hazards Preparedness Act (PAHPA), we write to express our strong support for the FDA’s proposal to create an Emerging Pathogens Preparedness Program within the FDA's Center for Biologics Evaluation and Research (CBER). The FDA’s Summary of FY 2024 Legislative Proposals puts forward a plan for an Emerging Pathogens Preparedness Program that would “defend against emerging pathogens so the agency is better positioned to respond to identified threats of concern and focus experienced resources to work quickly on medical countermeasure development.” The increased regulatory capacity CBER provided to review COVID-19 vaccines was crucial to the success of Operation Warp Speed. According to Paul Mango’s Warp Speed memoir, CBER director Peter Marks “restructured his team and its internal processes to work around the clock to accelerate the evaluations.” A permanent office within CBER to handle preparedness and response would enhance this capacity for future pandemics. The reauthorization of PAHPA offers the perfect opportunity to do so, by embedding the regulatory successes of Operation Warp Speed in a more sustainable way. An IMF paper recently estimated that each day of the COVID-19 pandemic in 2020 and 2021 cost the U.S. economy $26 billion. 1 The massive value of preventing or shortening pandemics makes it critical to prepare for “Disease X” – a future catastrophic biological risk that could in theory be far worse than COVID. This has led to proposals by the G7 2 and the Coalition for Epidemic 2United Kingdom Cabinet Office. (2021). 100 Days Mission to Respond to Future Pandemic Threats. 1Baker, J., Chaudhuri, A., & Kremer, M. (2021). Accelerating Vaccinations. Finance & Development, 58(1). Preparedness Innovations 3 for a “100 Day Mission” to roll out vaccines and other countermeasures within a hundred days of the start of the next pandemic. To do this will require conducting early clinical trials on prototype vaccines against pathogen families with pandemic potential before an emergency occurs. These trials will need close supervision by the FDA and proactive guidance of how their data would be used in the event of a pandemic. Providing dedicated regulatory capacity at the FDA for this purpose is crucial to achieving these important goals. Finally, a dedicated CBER office could be used to facilitate future programs in the model of Operation Warp Speed. By ensuring rapid regulatory decision-making for target product categories whose social value greatly exceeds their market value, the proposed office could build a “warm base” of regulatory capacity that could be drawn on in the event of an emergency. We have been excited to see the announcement of President Biden’s “Project NextGen.” Creating an office like the one described can ensure that the next generation of coronavirus vaccines receive the same regulatory capacity and accelerated development that was so crucial to vaccines approved during Operation Warp Speed. The anticipated annual cost of an office to support the FDA’s proposed program is about $10-15 million, but its value in supporting preparation and response for the next pandemic is immense. Merely providing 1% of Project Next Gen’s $5 billion would ensure strong coronavirus vaccine review capacity for the next several years. Therefore the signatories below express our strong support for the program’s creation and funding. Sincerely, 1Day Sooner American Society for Microbiology BIO Coalition to Stop Flu Critical Path Institute Federation of American Scientists Global Health Technologies Coalition Infectious Diseases Society of America Institute for Progress International Vaccine Institute 3 Coalition for Epidemic Preparedness Innovations. (2022). CEPI 100 Days Report: Building a More Prepared World to Stop Pandemics. Medical Countermeasures Coalition National Foundation for Infectious Diseases Research!America Technologies for Pandemic Defense CC: Major General (ret) Paul Friedrichs Inaugural Director of the Office of Pandemic Preparedness and Response Policy (OPPR) and Principal Advisor on Pandemic Preparedness and Response. CC: Ms. Dawn O’Connell Assistant Secretary for Preparedness and Response (ASPR).