Exploring the Frontiers of Innovation to Tackle Microbial Threats Proceedings of a Workshop (2020) / Chapter Skim
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6 Breaking Down Barriers and Fostering Partnerships to Enable Innovation
6 Breaking Down Barriers and Fostering Partnerships to Enable Innovation
Pages 79-94
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From page 79... ...
Rajeev Venkayya, president, Global Vaccine Unit, Takeda Pharmaceuticals, remarked on opportunities for partnership models to address unmet needs in global health, particularly in low- and middle-income countries (LMICs)
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From page 80... ...
Its aim is to develop medical solutions by enabling biotechnologies to facilitate rapid response during crises against future threats. He explained that JPEO-CBRND is not responsible for the entire development of a product through its life cycle; rather, it works with partners with government, academia, and the private sector to accelerate products at steady state.
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From page 81... ...
The capacity to conduct clinical trials is being built out further with DoD's aim to improve the ability to have mobile and global outbreak clinical trial capabilities. As an example, Hepburn commended the Congolese volunteers and colleagues from the National Institutes of Health and the World Health Organization, who demonstrated that a randomized controlled trial can be conducted in Ebola treatment units in a conflict zone during a crisis, dispelling the notion that clinical trials are not feasible during an outbreak.
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From page 82... ...
USAID's Approach to Private-Sector Engagement Private-sector engagement is critical to USAID's global health work to combat microbial threats, said Dosani (USAID, 2019a,b)
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From page 83... ...
As an example of the high efficiency and leverage of USAID investments, AMP Health attracted $1.2 million in private-sector funds and an additional $1.3 million in phil anthropic funds to extend impact of $0.8 million in USAID investment in this area. The UBS Optimus Foundation and Merck for Mothers brought in private sector capital to create a development impact bond to address the quality of private-sector facilities in India and improve maternal and child health outcomes.
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From page 84... ...
For example, a private-sector entity can be engaged to co-create a target product profile, test products during research and development, or consider how to bring a product or service to scale. Partnerships start with light touch engagement during an early stage of exploration and can move into a curated stage where engagement is refined, with each partner having set work streams with defined goals.
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From page 85... ...
Adapting and Evolving Partnership Models Dosani highlighted the importance of learning from failure and continuously adapting and evolving partnership models. For instance, AMP Health
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From page 86... ...
PRIVATE-SECTOR PARTNERSHIPS TO ADDRESS GLOBAL HEALTH NEEDS Rajeev Venkayya drew on his range of experiences with the Coalition for Epidemic Preparedness Innovations (CEPI) as a grant recipient from major international funding bodies, and as a contract recipient from BARDA to reflect on some of the opportunities and challenges in forging private-sector partnerships to address unmet global health needs.
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From page 87... ...
During the later stages, vaccine development is a risky, capital-intensive, and lengthy process because the high bar for safety and efficacy requires large clinical trials that can pick up low or infrequently occurring adverse effects that need to be identified before large-scale deployment of a vaccine. For example, the dengue vaccine program is currently being evaluated in a phase 3 trial that has enrolled 20,000 children across 8 countries.
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From page 88... ...
Push funding decreases the risk for companies and incentivizes them to accept the opportunity cost of deploying their resources from more predictable programs to one that has a different risk and investment profile, he noted. For instance, BARDA is providing Takeda Pharmaceuticals with cost reimbursement that allows the company to address public health challenges, such as Zika.
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From page 89... ...
government has improved over the past decade in adopting new and different ways to contract these types of investments with small biotechnical and large pharmaceutical companies. In cases where the opportunity cost for a company would be excessive, he suggested that the government should consider what else it can offer from its toolbox, such as adopting next-generation technology for clinical trials or cost sharing on testing a mutually beneficial vaccine using DoD's global network of clinical trials.
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From page 90... ...
With respect to ideological issues around access, he noted that the Bill & Melinda Gates Foundation's global access policy was pioneering in its focus on getting products for populations in LMICs, which has now expanded to ensure that poor populations in middle- and upper-income countries are also benefiting from the investment. He added that allowing private entities to capture value in other markets with a platform that a funder has helped to develop or reduce risk is an example of how flexibility can engage the private sector while allowing the funder to achieve its aims as well.
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From page 91... ...
Hepburn said that from a DoD standpoint, partnership with the host country is paramount; data are frequently shared, and they ensure that local partners receive first authorship on academic collaborations. DoD works to ensure that host countries benefit from the clinical trials and products being developed, but the complexity of these negotiations makes them challenging.
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From page 92... ...
It is possible to take a risk-based approach to the licensure pathway to accelerate product delivery, while also pacing the rollout to identify safety issues as the product is scaled. Hepburn suggested leveraging the power of next-generation technology, such as cell phones, to capture postmarketing safety data.
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From page 93... ...
Zika vaccine development, for example, had significant epidemiological and market risks. For a venture-backed or public company, the value proposition on a risk-adjusted basis of investing in a Zika vaccine is not attractive relative to other places that capital could be allocated.
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From page 94... ...
The examples she discussed are supported by local governments, local nonprofits, and the local private sector. Andrew Clements, deputy director, Pandemic Influenza and Other Emerging Threats Unit, USAID, commented that in addition to biomedical inventions, there are other valuable preventive measures -- such as infection prevention and control, water and sanitation, and livestock value chain biosecurity -- that could benefit from partnerships with the private sector.
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