News: Announcement

The Global Health Technologies Coalition (GHTC) yesterday honored Dr. Anthony Fauci, Senator Sherrod Brown (D-OH), and Senator Todd Young (R-IN) for their leadership in supporting global health research and development (R&D) at the 2022 Innovating for Impact Awards, an annual initiative recognizing US policymakers and partnerships catalyzing global health innovation. Additionally, GHTC recognized the partnership, led by TB Alliance, that developed the breakthrough technology pretomanid and the BPaL regimen—a shortened, simplified, and highly effective therapy for drug-resistant tuberculosis (DR-TB). This year's awards also coincided with GHTC's 15th anniversary—a period over which the global health community has seen incredible innovation and progress.Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases (NIAID) and the chief medical advisor to the President was honored with Innovating for Impact’s first-ever Lifetime of Service Award for his extensive and wide-ranging contributions to advancing global health and global health research, including groundbreaking contributions to HIV/AIDS research that inform our understanding of the disease to this day, inspiring the creation of the US President’s Emergency Plan for AIDS Relief (PEPFAR), leading NIAID for decades, confronting COVID-19 and previously generation-defining health threats, and advising no fewer than seven US presidents. Dr. Fauci’s remarks set the tone for the evening, as he acknowledged the power of partnership in tackling the global health challenges and what can be accomplished with effective collaborations. To underscore this, Dr. Fauci referenced the R&D response to the Covid-19 pandemic, noting "What we're experiencing now with Covid, I think is another really good example of how important it is for groups getting together in a coalition type fashion. And I'm talking about what was accomplished in an extraordinary manner with the development of vaccines for Covid-19. I mean, this could not have been done by any individual component of the coalitions."Senator Sherrod Brown was honored with a Congressional Champion Award, celebrating his contributions to global health research policy, which include spearheading legislation that led to the Tropical Disease Priority Review Voucher Program that has incentivized the development of new, lifesaving global health technologies for more than 25 neglected diseases; encouraging President Obama to release the National Action Plan for Combating Multidrug-Resistant Tuberculosis; and sponsoring the Comprehensive TB Elimination and End Neglected Tropical Diseases Acts. Senator Brown highlighted the tremendous impact commitments to public health have on the world and the key role the advocacy community plays in marshaling political support for global health innovation, “Public health lifts all boats…You do things right, everybody in society gains. And we all live longer, because of the emphasis on public health…We've made huge, huge progress as these awards tonight show, as your activism shows."GHTC also recognized Senator Todd Young with a Congressional Champion Award. Senator Young has supported global health R&D through many pieces of legislation. He co-authored the Pioneering Antimicrobial Subscriptions To End Up surging Resistance Act to bolster the development of antimicrobial innovations for deadly pathogens and infections, introduced the End TB Now Act to support the development of new tools to combat tuberculosis (TB) through the United States Agency of International Development (USAID), and championed a call for innovative tools to end preventable child and maternal deaths through the introduction of the Reach Every Mother and Child Act.In recorded remarks, Senator Young reiterated his commitment to global health technology innovation, stating, “I continue to support robust funding for medical research because sustained investments have enabled critical biomedical innovation and discovery and help to find new tar new treatments and cures fo global diseases.”GHTC presented the Partnership Award to TB Alliance for the development of pretomanid and the BPaL regimen—an innovative treatment for drug-resistant DR-TB. Dr. Mel Spigelman, president and chief executive officer of TB Alliance, accepted the award on behalf of the partners, and joining him on stage were Natasha Bilimoria, deputy assistant administrator of USAID, and Barbara Laughon, senior scientist for TB Drug Development Partnerships at the US National Institutes for Health, representing two key partners in the development of pretomanid. Pretomanid is the first TB drug developed by a nonprofit organization. Pretomanid is part of the three-drug “BPaL” regimen. This innovative new therapy reduces the time needed to treat DR-TB from as long as 18 months or longer to 6 months and the number of pills comprising treatment by nearly 95 percent, all while significantly improving cure rates and toxicity profiles compared to the previous standards of care.In a video exploring the development, benefits, and impacts of pretomanid and the BPaL regimen, Jayshree Rampiar, a DR-TB survivor treated with the regimen, noted, “Before [treatment] had a lot of side effects, and the medication I’m taking now has less. I feel that my future is looking bright, and we can beat TB!”GHTC’s executive director, Jamie Bay Nishi closed the event by reminding us that while there is so much excellent and encouraging progress to celebrate, we still do not have all the tools needed to fully overcome the formidable global health challenges now and on the horizon. Thus, we must continue to strengthen our efforts to ensure more transformative innovations are developed and reach those around the world who need them. The Innovating for Impact Awards will continue to celebrate US commitment to global health R&D and honor the multisector partnerships and policymakers that drive the development of lifesaving technologies for global health challenges both old and new. We thank all those who support global health innovation. As Senator Sherrod Brown noted in his remarks, “None of this [progress] would have happened without the activism of so many of you around the world!”Continue to follow the discussion—and celebration—on Twitter at the hashtag #Innovate4Health.

In evaluating the G20 Bali Leaders’ Declaration, Global Health Technologies Coalition (GHTC) recognizes and applauds several encouraging commitments but urges leaders to walk the walk when it comes to making greater investments in research and development (R&D) and addressing emerging and persistent health threats with greater urgency. Promising support for The Pandemic Fund, ACT-A, and enhancing local capacity GHTC was pleased to see G20 leaders launch The Pandemic Fund in concert with this week’s summit in Bali. We believe this fund will be a critical mechanism for new R&D capacity-building investments and will help facilitate a coordinated and consistent approach to pandemic preparedness and response strengthening. We also echo the declaration’s focus on equity and inclusive membership in The Pandemic Fund’s governance structures, though we remain concerned that concrete targets and accountability provisions should have been included to establish a deeper commitment to diverse representation.  Additionally, GHTC welcomes G20 leaders’ expressed support for the Access to COVID-19 Tools Accelerator (ACT-A), highlighting the continued importance of this cooperative framework to accelerate the development, manufacturing, distribution of, and equitable access to new health technologies in the fight against COVID-19. As the initiative enters a new phase, R&D must continue to be a central pillar to ensure that vaccines, therapeutics, and diagnostics keep up with new variants. While we commend G20 leaders for highlighting the need to draw lessons from ACT-A external evaluations, they did not specify recommendations from those reports that they look to act upon. Several evaluations noted the need for greater integration of lower- and middle-income countries and partners in ACT-A’s model and that a joint platform should be established to coordinate work across product areas. We urge leaders to take tangible steps in advancing these recommendations in the coming months. GHTC was also encouraged to see the G20 articulate the need for strengthening local and regional health product manufacturing capacities and cooperation, as well as sustainable global and regional R&D networks, to facilitate better access to health technologies in lower- and middle-income countries. Insufficient urgency to mobilize against AMR and “the big three” While it was noteworthy to have global health R&D reflected throughout the final communique from G20 leaders, unfortunately the declaration also fell short in several areas. For instance, while GHTC was pleased to see that antimicrobial resistance (AMR) was elevated as part of pandemic preparedness, it was disappointing that countries failed to specify commitments and plans for addressing AMR, including planned investments to strengthen the pipeline of new tools to combat this growing health threat.  Similarly, enduring health challenges such as tuberculosis, malaria, HIV, and neglected tropical diseases did not receive a single mention, reinforcing the perception that they have fallen further off global leaders’ radars, even as new data confirms that the COVID-19 pandemic has eroded hard-won progress in these areas. Continued neglect of these pandemics is a recipe for increased backsliding and puts the goal of universal health coverage at risk. Investment in developing new tools to combat these long-standing threats is key to achieving broad health goals endorsed by the G20 in recent years.  A promising vision must be backed by greater commitment and accountability It was refreshing that this year’s declaration highlighted the importance of global health R&D in several areas, especially in relation to pandemic preparedness, and underscored that R&D investments and prioritization must continue to be a focus of national, regional, and global bodies to combat emerging and ongoing health threats. However, the declaration was light on tangible commitments and failed to address some of the world’s leading and most persistent health threats. To realize the vision of this declaration and the G20’s health goals more broadly, we call on leaders to make specific pledges and be more accountable to the principles outlined in the communique.  

Reforms to a World Health Organization (WHO) program that focuses on certifying the safety and efficacy of health products have accelerated access to these innovations in low- and middle-income countries (LMICs), yet the program continues to struggle with challenging processes and practices that could lead to unnecessary delays.This is the central finding of a new report released today by the Global Health Technologies Coalition (GHTC) and the Duke Global Health Innovation Center (GHIC) that examines the WHO prequalification program. The program conducts comprehensive reviews of the safety, efficacy and quality of medical products, work that became even more important during the COVID-19 pandemic. Approvals clear the way for procurement of new drugs, vaccines, vector control products and diagnostics by aid agencies and LMICs.“We found that WHO has embraced reforms that can speed access to health technologies through expedited reviews of safety and efficacy,” said Jamie Bay Nishi, executive director of GHTC. “But we also identified issues that can be confusing for product developers and thus impede approvals. They included uncertainties regarding WHO review timelines, data needs and how prequalification is impacted by other WHO processes.”Experts at Duke GHIC and GHTC analyzed the review timelines for two dozen WHO prequalified products. They also conducted interviews with WHO staff, product developers and regulatory experts.  They found a WHO process for expediting reviews of products already approved through the stringent reviews of high-functioning national regulatory agencies substantially reduced the time it took to achieve prequalification — from an average 17 months to just six months. Also, they noted the benefits of a new collaborative registration procedure in which regulatory product reviews conducted by WHO prequalification staff occur jointly with assessments by regulatory officials in LMICs. Regulators in LMICs still conduct their own independent assessments of new medical products regardless of their approval by WHO. But doing this work jointly with WHO reviewers providing technical assistance and guidance allowed the first national product approval following WHO assessment of prequalification to occur within five months, on average, compared to a year lag when they were done separately. The report notes that the faster timelines achieved through the expedited and joint review processes are illustrative of tangible benefits emerging from WHO reforms. It also applauded WHO for piloting procedures to streamline reviews of innovations targeting COVID-19 and drug-resistant tuberculosis, noting the potential to apply these practices more broadly in the future. But the analysis of the prequalification program also revealed a number of pain points in the WHO review process that warrant immediate attention. For example, WHO does not provide estimated review timelines for all product types. This lack of visibility into the process makes it difficult for product developers to anticipate when WHO might reach a decision or request additional data. WHO also does not report performance indicators — data that could reveal whether reviewers are meeting internal expectations for completing product assessments. Furthermore, the report noted product developers were sometimes confused about how WHO was conducting reviews within the parameters of its own stated policies. For example, WHO PQ procedures state that before a product can be prequalified, it already must be included in WHO policy or treatment guidelines. However, there were instances when the processes for developing guidelines occurred either in parallel with prequalification reviews or after the product was prequalified. While this kind of flexibility by WHO could be beneficial for expediting reviews, product developers found the lack of clarity around the process was challenging to navigate. Finally, the report raises concerns that WHO staffing policies are putting a strain on the program’s ability to deliver on its mandate at a time when demands are increasing. The authors identify specific actions that can address inefficiencies and bottlenecks in the prequalification program: Improve reporting and communication to generate greater clarity for stakeholders. This includes publicly releasing performance indicators and launching a public database with complete timeline information on all prequalified products. It also recommends developing additional resources that help product developers navigate the prequalification process and clarifying how it interacts with other WHO treatment and technical guideline development processes.  Support the expanded use of interim or “living” guidelines for other novel products. The report notes that WHO recently relied on early or interim evidence to issue interim treatment guidelines for COVID-19 therapeutics and the treatment of drug-resistant tuberculosis. The report calls for expanding this practice. It’s a faster way to provide real-time information to health decisionmakers and reduces delays in the prequalification process.Provide greater opportunities for external stakeholder to inform prequalification processes and strategy. The report urges WHO to improve platforms and consultation processes for gathering ongoing feedback from product developers, regulators and product access ecosystem actors. It also recommends new efforts focused on expanding country and product developer participation in WHO’s collaborative registration procedure, given its success in speeding regulatory approvals.Adopt a new policy to enable the prequalification program to hire additional permanent staff and reduce reliance on consultants. The report explains that this would require WHO member states to approve changes to existing staffing policies, which currently limit the number of permanent staff that can be hired at WHO headquarters.“Our research unearths important advances the WHO prequalification program has made in enabling greater access to lifesaving health products in low-income countries, said Elina Urli Hodges, assistant director of programs at Duke GHIC. “But by adopting additional stepwise changes to the way it communicates and engages with developers and regulators, we believe the program can better deliver on its mission to make quality essential medical products available to all who urgently need them.”###The Global Health Technologies Coalition (www.ghtcoalition.org) works to save and improve lives by encouraging the research and development of essential health technologies. We bring together more than 40 nonprofit organizations, academic institutions, and aligned businesses to advance policies to accelerate the creation of new drugs, vaccines, diagnostics, and other tools that bring healthy lives within reach for all people.The Duke Global Health Innovation Center (www.dukeghic.org) supports the scaling of health care delivery and policy innovations through applied research and education to improve health worldwide. Duke GHIC links global health, health policy, and health innovation efforts across Duke University, and partners with Innovations in Healthcare, a Duke-hosted non-profit that aims to increase access to quality, affordable health care worldwide by scaling leading innovations.

The Global Health Technologies Coalition (GHTC) welcomes the decision this week by the Global Health Security Agenda (GHSA) Steering Committee to make permanent its pilot Research and Development (R&D) Task Force. This important decision gives the task force—which was launched in June 2021 as a one-year pilot effort focused on improving R&D readiness—a mandate to continue its work through the current GHSA strategic framework, which runs through 2024.In response to the decision, GHTC Executive Director Jamie Bay Nishi said, “GHTC and our members applaud the GHSA Steering Committee for making permanent the R&D Task Force—an action that not only enables it to continue its vital work, but also cements R&D capacity strengthening as a central part of GHSA’s broader mission to prevent, detect, and respond to health threats.”“The COVID-19 pandemic has made clear the importance of investing in R&D of medical countermeasures to combat health threats. But it has also exposed systemic gaps in the R&D capabilities of many nations—including limited surveillance, clinical research, manufacturing, and regulatory capacity—which have contributed to gross inequalities in access to health technologies between rich and poor nations. As a country-led collaborative effort, the GHSA R&D Task Force is uniquely positioned to play a leadership role in closing these gaps—and in just one year has already achieved important first steps toward that aim.”“Later this year, the task force will unveil a new tool designed to support countries in self-assessing their R&D capabilities, which aligns with and complements the International Health Regulations (IHR) and Joint External Evaluation (JEE) process. GHTC believes that at a local level, this tool can help GHSA nations identify country-specific R&D capacity gaps to address through their national preparedness plans, and at a global level, this evidence can inform the adoption of new indicators within the IHR or JEE to better address R&D readiness, as well as strategically guide the disbursement of funding from international mechanisms like the new World Bank prevention, preparedness, and response fund.”“Closing R&D capacity gaps is not a problem that will be solved overnight, but it is vital to bolstering the world’s pandemic defenses. We thank the GHSA Steering Committee for their vote of confidence to continue the task force’s work and their continued leadership and commitment to advancing a world better equipped with the R&D capabilities to prevent the next pandemic.”For more information on the GHSA R&D Task Force’s accomplishments and future vision, view its one-year progress report.