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GHTC contributed the below input to a World Health Organization (WHO) Science Division consultation around a new framework to align and expedite the two interrelated processes of prequalifying novel products and issuing technical guidelines to recommend use.GHTC feedback for new World Health Organization Prequalification evaluation procedure for novel productsThe 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. GHTC has been focused on possible improvements to the WHO prequalification program (PQ) for several years and published a report last year together with Duke University that highlighted some of the perceived pain points and areas of opportunity.GHTC welcomes the updated guidance that WHO will apply parallel, rather than sequential processes, in its guidelines development and prequalification and/or emergency use listing (EUL) to all new and novel health products that it needs to assess. Many of our members and partners have outlined the reliance on guidelines being the first step in the process as a major bottleneck for innovative products and highlighted how it adds significantly to timelines, delaying access to critical new health technologies in low- and middle-income countries (LMICs).The following outlines questions GHTC hopes will be answered as part of the consultation process and general feedback on what should be considered as part of this consultation, or where there could be opportunity for additional clarification:Regulatory agencies in LMICs Questions we hope this consultation will address: How will this new procedure intersect with other shifts in the global regulatory ecosystem? How will PQ look beyond the traditional high-income country stringent regulators and start to integrate emerging regulatory authorities with higher maturity levels into this new PQ process?Will WHO work with global procurers to help assess how they can diversify their quality assessment portfolio?Beyond PQ review of dossiers to inform global procurement, and amid national and regional regulatory strengthening efforts, how will PQ reposition its role in assessing products manufactured in one geography for use in other markets (e.g. African made products which might be procured at a national or regional level in Asia)? GHTC contributions:Strengthen other regulatory agencies in LMICs: GHTC continues to hear from partners that they are concerned about additional regulatory barriers coming into play as new bodies, such as the African Medicines Agency (AMA) start to operationalize, and hopes WHO can play an essential role in harmonization (e.g. concerns of a product going sequentially through review by a stringent regulatory authority, PQ, AMA and then a lower maturity regulatory body before a product can be introduced). As WHO PQ develops its new framework for novel products, consideration needs to be given to other regulatory authorities, especially in LMICs, and how their product review can help promote local manufacturing. There could be some countries and regional blocks where WHO Listed Authority (WLA) Level could bypass PQ or significantly expedite PQ approval using maturity levels as markers of expertise. Promoting harmonization and operationalizing of national regulatory efforts (i.e. through AMA) would limit the remit and need for a completely centralized PQ gateway and free up bandwidth within WHO’s PQ team to provide more regulatory technical assistance to national regulatory authorities.Reviewing protocols between global procurers, regulators, and PQ: Across consultations we have done with product developers, national regulators and private sector organizations, there is a lack of consensus on how PQ should interact with global procurers. Some stakeholders are calling on global procurers to diversify the mechanisms to review and approve products. PQ could be one of a menu of mechanisms procurers could leverage for new health products, reducing bottlenecks. On the other hand, many stakeholders see PQ as a critical step before global procurement and would like WHO to update its protocols when working with other regulatory agencies to speed up approvals without sacrificing safety, efficacy, or reviews for programmatic suitability.Limiting the scopeQuestions we hope this consultation will address: How will the WHO PQ team handle prioritization for their pipeline?How can WHO ensure that it reviews based on global needs, and that when products see smaller changes or updates, WHO is not restarting the whole review process (e.g. not going through an entirely new dossier review when the casing of a diagnostic is changed by the manufacturer)?Might there be any types of products that will not require PQ or that can go through an expedited review after being approved through another WLA 3+ body?GHTC contributions:Update protocols for triaging generic versus innovative product dossiers: To ensure that PQ can focus and prioritize products with the greatest need and to fill health product gaps, PQ should work with WLA 3+ regulators to develop a category of health products which may not need to go through a full PQ assessment (e.g. generics where bioequivalents and CNC have been demonstrated). Having a more formalized abridged process for generics would enable PQ to better leverage its technical expertise and limited bandwidth to focus on reviewing novel or innovative product dossiers.Living policy guidelines Questions we hope this consultation will address: How will WHO work internally between the various divisions to ensure clarity for outside stakeholders on the interaction between PQ and policy teams for guidelines?How can WHO ensure that even with the new parallel process, there are no artificial bottlenecks for updating or making changes to guidelines?GHTC contributions:Further develop protocols for living guidelines: To increase uptake of innovative products, support and advise on the expansion of interim or “living” guidelines, similar to those issued recently for COVID-19 therapeutics and treatments for drug-resistant tuberculosis, for other innovator or novel products to expedite opportunities to address real-time needs.

GHTC responded to Senator Bill Cassidy's (R-LA) request for information (RFI) on modernizing the US Centers for Disease Control and Prevention (CDC).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 US Centers for Disease Control and Prevention (CDC). After navigating the challenges and learning from the unprecedented impact of the recent pandemic, CDC has initiated a series of strategic policy changes and organizational realignments, as well as established new program areas to fortify its preparedness against future threats. These proactive measures directly address perceived gaps in CDC’s capabilities and warrant acknowledgment through robust intergovernmental support and adequate funding. One of CDC's notable strengths lies in the exemplary work of its global health-related program areas. Notable among these are the National Center for Emerging and Zoonotic Infectious Diseases (NCEZID), the Global Health Center (GHC), and the expansive efforts encompassed within the Global Health Security initiatives conducted by the organization. Regarding Fostering Innovation and Collaboration, the CDC should continue and expand its work through GHC. GHC provides expertise on immunizations, disease eradication, and public health capacity-building around the globe through its Global Divisions on HIV & TB, Public Health Protection, and Immunization. Among the far-reaching and high-impact work of GHC, one main priority is to “research, develop, and evaluate new tools and approaches to combat global health threats.” As a global hub for infectious disease research, GHC is uniquely equipped to develop and validate tools for disease surveillance and diagnosis. These tools are critical for both tracking events of public health importance, such as emerging infectious diseases, and monitoring the impact of US global health programs in settings that might otherwise have limited data collection capacity. CDC also provides vital scientific and technical support to interagency initiatives, including the US President’s Emergency Plan for AIDS Relief and the President’s Malaria Initiative. GHC is a great example of, from question 4 under the RFI’s Improving Upon What Works Well, “How can CDC improve linkages between in-country staff and program staff in CDC’s U.S. offices? What would be the benefit of improving these linkages?” Strengthening the global work of CDC would provide US citizens in lower-resourced, remote, and rural settings with health innovations that are fit for use, as well as provide early warning of disease threats that could reach US shores. Similarly, NCEZID and its newest sub-department, previously housed within GHC, the Department of Parasitic Disease and Malaria, uses its globally relevant research and collaborations to inform domestic responses to outbreaks and infections. This work has gained heightened significance in the wake of reports of locally transmitted malaria cases in Florida, Texas, and Maryland. The looming threat of various infectious diseases making their way to the United States underscores the need for continued vigilance. This is a challenge actively monitored by NCEZID, particularly through its Office of Advanced Molecular Detection. Leveraging cutting-edge technologies, such as DNA sequencing and advanced computing, the office delves into the intricate biology of infectious diseases to provide insights pivotal to the development of diagnostics, drugs, and vaccines. For instance, the office has played a vital role in determining the genetics of Ebola and Zika, as well as tracking COVID-19 variants. The agency’s wastewater surveillance programs have also provided pivotal insights into the scale of viral circulation in communities and the spread of COVID-19 variants; yet since this work was funded through emergency appropriations, these programs will run out of funding by fiscal year 2025 unless Congress appropriates sustainable yearly funding. As for Mechanisms to Modernize, the CDC is undergoing rapid and far-reaching improvements and modernization procedures that advocates are excited to see bear fruit. As it stands, the changes are too fresh to reap benefits, but the vision set forth by Dr. Rochelle Walensky and Dr. Mandy Cohen is coming into focus and addresses many of the questions posed in the RFI. One of the changes already mentioned—placing the Department of Parasitic Disease and Malaria under NCEZID – brings the global and domestic portfolios of parasitic diseases together, ensuring that tools and learnings mutually advance protection against parasitic diseases, both globally and in the United States. Other changes highlighted in the RFI like the Data Modernization Initiative and the moves to increase investments in the Epidemiology and Laboratory Capacity Program’s work on electronic laboratory reporting require a longer runway to get off the ground before further policy changes can be seriously considered. While the RFI is well-researched and tackles pertinent issues from multiple angles, the global health community observes the changes being made with optimism, largely predicated on frequent consultation and discussion with CDC officials. It is the advice of GHTC to take these overhauls of past data and lab practices as a clear acknowledgment of the early mistakes made during the COVID-19 response. In addition to the aforementioned changes, CDC is taking on a new approach to how it conducts internal business and presents itself to the public. The idea, dubbed “One CDC,” means to unify what was once a more decentralized organization. By striving to talk with one unified voice, CDC is helping to solve a persistent challenge that the whole of the US government struggled with during COVID-19—unclear and too many streams of communication. Instituting more whole-of-organization approaches to communications around public health emergencies should be considered throughout the government. Ultimately, the pathway for tangible improvements within CDC, as envisioned by GHTC, lies in affording the agency the necessary space and financial resources to attain the ambitious goals set for itself, the United States, and the global community. Recognizing that these investments in CDC's global initiatives directly benefit American global health security is paramount. At a time when global health systems are under immense strain and cumulative gains against persistent threats like HIV/AIDS, malaria, tuberculosis, and neglected tropical diseases risk erosion, safeguarding hard-won advancements demands substantial and sustained funding for all facets of CDC's global health activities. This comprehensive support is not only critical to mitigating potential setbacks but also ensures that Americans are shielded from a spectrum of both enduring and emerging health threats. We appreciate your attention to this matter and would be happy to collaborate further with the Senator’s office as action is taken to modernize CDC. Sincerely,  Alex Long  US Policy & Advocacy Officer  

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).