Global Health Risk Framework Research and Development of Medical Products: Workshop Summary (2016) / Chapter Skim
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2 Models and Incentives for Engagement
2 Models and Incentives for Engagement
Pages 11-24
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From page 11... ...
Invited speakers and participants discussed partnership approaches, sustainable and effective business models, and existing and promising incentives that support the research and development of medical products for emerging infectious diseases (highlights and main points are summarized in the box below)
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• Incentives for pharmaceutical research and development are needed that delink return on investment from sales/ reimbursement-derived revenues (e.g., prizes and priority review vouchers)
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In its first 2 years, the GHIT Fund invested roughly $43 million in product development, which has been leveraged through a co-funding strategy into a $73 million product portfolio. The current portfolio includes 39 partnerships, with targeted development platforms spanning discovery through clinical development for drugs, vaccines, and diagnostics targeted to malaria, tuberculosis (TB)
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Complementary capabilities of the international development sector that act as incentives for companies to partner with the GHIT Fund include localizing their portfolio mix, branding, and building partnerships across sectors. GHIT is also aligned with the global health policies of the government of Japan, including the Japan Revitalization Strategy, the Healthcare and Medical Strategy, and Japan's Strategy for Global Health Diplomacy.
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MMV uses independent expert scientific review to guide clinical candidate selection and works within a strong contractual framework with its partners to increase access and good governance. MMV is an integrated global effort with about 250 partners, including 28 pharmaceutical companies, 13 biotechnology companies, and a large number of universities, research institutes, clinical sites, and government agencies.
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Ella described a host of other partnerships that have resulted in vaccines for typhoid, Japanese encephalitis, and other threats, as well as ongoing research on vaccines for chikungunya, paratyphoid and non-typhoidal Salmonella, Chandipura virus, malaria, and other infectious diseases relevant to India. Ella highlighted the range of challenges the small Indian company has faced, including legal challenges; purchase commitments that were withdrawn; inconsistent government policies and changing priorities; difficulty securing government loans or venture capital; price competition from cheaper products from China; lack of attention to timelines, resulting in delays; and getting the government to recognize emerging threats.
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From page 17... ...
Pharmaceutical companies are also developing new ways of working together to address global health challenges and drive efficient development of new products. Marks described TransCelerate Biopharma, Inc., a nonprofit initiative that demonstrates a new mindset across industry of working together to improve quality, decrease cost, and reduce redundancy in clinical trial efforts.4 Marks also described a new "biopreparedness organization" (BPO)
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Venkayya mentioned the investments made by BMGF in more than 16 mission-focused product development partnerships. While a company generally leverages its own internal technologies, platforms, and capabilities in advancing a particular product candidate (occasionally licensing in additional capabilities)
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. Marks and Venkayya mentioned priority review vouchers as one example of a pull incentive that could be effective, acknowledging that there are drawbacks (e.g., diverting regulatory agency attention away from more urgent matters to meet the priority review timeline)
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Outterson noted that there is ongoing discussion about a modified version of the Orphan Drug Act for antibiotics, including a refundable or fully transferable tax credit for qualified research and development expenditures. Much of the antibiotic development work is being done in small- and medium-sized enterprises 10 While not presented at the workshop, for further background and criticisms of FDA's priority review voucher program, see Regulatory Explainer: Everything You Need to Know About FDA's Priority Review Vouchers at http://raps.org/RegulatoryFocus/News/2015/03/13/21722/Regulatory-Explainer-Everything-You-Need-to-KnowAbout-FDA%E2%80%99s-Priority-Review-Vouchers (accessed December 2, 2015)
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, whereas a publicly listed company is beholden to the mandate of returning value to shareholders. ELEMENTS OF SUCCESS Venkayya and Mel Spigelman, President and CEO of the TB Alliance, both observed that much has been learned over the past 10 to 15 years of forming public–private partnerships to help address the market failures described by Chan.
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Outterson added that the Chatham House report calls for a global threat assessment to identify and prioritize bacterial pathogens and guide the targeting of incentives. He noted that CDC conducted a U.S.-based threat assessment in 2013, and the European Centre for Disease Control and Prevention is updating its assessment for Europe.
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MODELS AND INCENTIVES FOR ENGAGEMENT 23 Yamada noted that DoD recognizes emerging infections as a U.S. national security issue.
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