Rapid Medical Countermeasure Response to Infectious Diseases Enabling Sustainable Capabilities Through Ongoing Public- and Private-Sector Partnerships: Workshop Summary (2016) / Chapter Skim
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7 Sustainable Business Models to Ensure Rapid and Nimble Responses
7 Sustainable Business Models to Ensure Rapid and Nimble Responses
Pages 79-98
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From page 79... ...
There are challenges not only in sustaining product development and production, but also in sustaining partnerships, networks, people, and expertise. ADDRESSING "MARKET FAILURES" IN GLOBAL HEALTH AND BIODEFENSE Venkayya of Takeda Pharmaceuticals shared his personal perspective on lessons from global health, government, and industry that may apply to the biodefense and MCM enterprise for emerging infectious diseases.1 Prior to 2000, research on agents of bioterrorism and neglected diseases in global health was limited to small groups of passionate, poorly funded researchers.
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Venkayya observed a pervasive ideology in the global health community and in governments that companies should not be allowed to make undue profits. This impedes fully tapping into the innovation that exists in the world, he claimed.
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Push incentives help to provide a clear, de-risked pathway to the market through investment and by providing key capabilities. Pull investments essentially guarantee a market, which is especially important in places where the commercial potential is not apparent.
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One existing operating model described by Venkayya is the approach used by the biotechnology company Celgene. The Celgene business model makes targeted limited investments in acquiring promising technologies and candidates.
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WHAT MOTIVATES COMPANIES? : LESSONS FROM ANTIBACTERIAL DRUG DEVELOPMENT The efficacy of antibacterial drugs is currently threatened by increasing antimicrobial resistance, said John Rex of AstraZeneca.2 CDC estimates that 23,000 deaths per year in the United States are attributable to antimicrobial resistance.
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The global antibacterial community has been working to move the economic models back into consistently positive territory through a range of initiatives, incentives, and new regulatory guidance. As an example, Rex described the New Drugs for Bad Bugs initiative that was created under the auspices of the EU Innovative Medicines Initiative, a public–private partnership between the European Commission and the European Federation of Pharmaceutical Industries and Associations
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Flexibility in the approach of incentive programs is essential, including flexible partnering mechanisms. Because of this, 4 The EFPIA is the trade organization representing EU-based pharmaceutical companies.
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. Larsen acknowledged that, in order to respond to an emerging infectious disease, alternative business models will likely be required to incentivize industry, and a mix of push and pull mechanisms need to be considered and implemented, especially when considering how to appeal to both small, nimble companies and larger companies with more resources and capabilities.
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From page 87... ...
that a company would win upon getting the product to end of Phase I • Would still require follow on infrastructure to respond to an emerging infectious disease event SOURCE: Larsen presentation, March 27, 2015. During the discussion, Venkayya observed that the incentive programs all had a reward (cash payment, investment by the government)
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From page 88... ...
Rex noted that the previously mentioned Drive-AB project is meant to precipitate a very public conversation about the true value of an antibiotic, both an antibiotic correctly used, and an antibiotic available but not used, which will be a long process working in many directions. One participant suggested that through future meetings, the Academies could consider a similar approach to increasing understanding of the true value of MCM development -- separate from the typically understood "market value." Venkayya also observed that, in addition to the palatability of cash rewards, there is a level of uncertainty in some of the pull incentives discussed.
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VIRAL HEMORRHAGIC FEVER CONSORTIUM: A UNIVERSITY-BASED MODEL Robert Garry, professor of microbiology and immunology at Tulane University School of Medicine, and program manager for the Viral Hemorrhagic Fever Consortium (VHFC) , described how a modestly funded university-based consortium was able to quickly develop an Ebola rapid diagnostic test.
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The assay requires a skilled technician and laboratory with electrical power, PCR machines, and centrifuges. The lateral flow immunoassay rapid diagnostic test developed by VHFC requires only a finger stick, minimal training to collect the drop of blood, a 15-minute assay, and minimal training to perform the assay, which requires no power or laboratory equipment.
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From page 91... ...
government of the need to stockpile this product for future outbreaks, or convincing wealthy countries or foundations to buy or subsidize the product when there is no immediate demand. Garry also suggested implementing orphan drug– type incentives5 as a potential approach to encourage development of MCMs for emerging infectious diseases.
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Resources would need to be combined to make true progress. In 2009, the Gates Foundation partnered with the TB Alliance and the Critical Path Institute to operationalize this public–private partnership and create a neutral third party, with regulatory authorities participating actively from the start.
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This includdes biomarrkers needed to support efffective decission making aand de-risk thhis costly process, esp pecially whenn transitioninng from earlyy- to late-staage clinicaal trials, and when relyingg on combinaation studies. CPTR workked througgh a formal drug develop pment tool aand biomarkeer qualificatiion processs that has beeen defined byb both EMA A and the FDDA.
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Hanna noted that several of the major pharmaceutical partners have completely divested their anti-infective research and development, which has had a very serious impact in the TB drug development space. Although not part of the original focus, advocacy and incentive development for pharmaceutical companies to stay in antibiotic drug development is becoming a priority for the consortium going forward.
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Another element is the co-creation aspect of shared value. The shared-value business model usually requires that the company partner with different types of organizations (e.g., nongovernmental organizations, government, foundations)
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Rex of AstraZeneca suggested that, overall, that amount is relatively inexpensive in terms of maintaining the infrastructure and ability to make an immunoassay lateral flow test for a new pathogen. Sustaining Clinical Trial Capabilities Rex noted that CPTR now has clinical trials capabilities in place, which can be viewed as a tool for rapid MCM development, but ensuring those capabilities are maintained in different locations around the globe can be difficult as well.
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The existence of the clinical trials network will not necessarily make product development less expensive, she said, but there is a potentially large cost advantage to having capabilities available to pull together, and to be able to start clinical trials more quickly. The key with product development partnerships, Hanna noted, is showing flexibility in how they partner with and reward pharmaceutical companies to bring in drugs from their pipeline.
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For example, the NIH budget has been relatively flat for the past 10 years, which is an actual decrease in real funding of at least 25 percent over that time. Larsen of BARDA suggested that, from a policy standpoint, a framework of prioritization for emerging infectious diseases would be valuable, so that the list is manageable and tangible in terms of product development and all partners are clear on priorities.
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