Developing Drugs For Developing Countries

Ridley, David B.; Grabowski, Henry G.; Moe, Jeffrey L.

doi:10.1377/hlthaff.25.2.313

Cited by 162 publications

(127 citation statements)

References 23 publications

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“…One strategy may be to formulate a new regulatory pathway to accelerate novel organ engineering while simultaneously enhancing transparency and post market reporting [21•]. Another strategy may be to expand the priority-review voucher model [22,23], which was established to incentivize industry to develop therapies for neglected diseases. Expanding this incentive to regenerative medicine-based breakthrough therapies such as bioengineering organs could have profound effects.…”

Section: Commercialization Strategies For Enabling Bioengineering Of mentioning

confidence: 99%

Bioengineering Priorities on a Path to Ending Organ Shortage

Hunsberger

Neubert²,

Wertheim

et al. 2016

Curr Stem Cell Rep

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This perspective article covers current successes in and continuing challenges remaining in eliminating the growing organ shortage. We specifically cover data from a workshop entitled BOrgan Bioengineering and Banking Roadmap Workshop^funded by the National Science Foundation (NSF) and the Methuselah Foundation in Washington, D.C. on May 27, 2015, and a subsequent Roundtable held at the White House Office of Science and Technology Policy (OSTP) on May 28, 2015. We address four parallel and potentially cooperative approaches for bioengineering tissues and organs. The first approach is bioprinting of tissues and organs. The second approach encompasses recellularization strategies, which can involve either developing tissue scaffolds from non-transplantable human (or xenogenic) organs or tissues and then reconstituting these templates with human cells to create a functional tissue/organ or seeding synthetic biodegradable scaffolds with human cells. The third approach is optimization of cellular repair and regeneration with strategies that include shifting the balance away from maladaptive processes that lead to chronic scarring. The fourth approach is xenotransplantation, which involves developing functional tissues for human use in transgenic animals whose cells are modified to prevent immune rejection. Current challenges and limitations are addressed, which include mapping, cell sourcing and manufacturing, immunosuppression, integration, and vascularization. We identify commercialization strategies that will make these approaches economically feasible. We present solutions toward a vision to one day ending the current organ and tissue shortage, and the impact this will have on treating disease and providing indirect economic benefit by decreasing the disease burden on society and improving quality of life.

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Section: Commercialization Strategies For Enabling Bioengineering Of mentioning

confidence: 99%

Bioengineering Priorities on a Path to Ending Organ Shortage

Hunsberger

Neubert²,

Wertheim

et al. 2016

Curr Stem Cell Rep

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“…Based on a concept by Ridley, Grabowski, and Moe, 14 in 2007 the US Government created a mechanism by which a pharmaceutical company that gains US Food and Drug Administration (FDA) approval for a new molecular entity "for which there is no significant market in developed nations and that disproportionally affects poor and marginalized populations" is granted a tradable voucher for a priority review by FDA of another drug of its choice. 15 In this case, the voucher granted for the approval of the drug for the developing world would provide a decreased time to market for a highly-profitable drug for the rich world, thus providing a clear financial incentive for the development of the former.…”

Section: Priority Review Voucher (Prv)mentioning

confidence: 99%

Implications of public-health insecticide resistance and replacement costs for malaria control: challenges and policy options for endemic countries and donors

Miller

Tren

2012

RRTM

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Abstract:Millions of people rely on public-health insecticides for malaria prevention. Yet growing insecticide resistance may threaten malaria control programs through decreasing e ffectiveness and possibly unsustainable cost-increases. Insufficient investment by s takeholders in the search for new public-health insecticides in recent decades has left malaria control programs with limited alternatives with which to manage resistance and maintain program effectiveness. While alternative insecticides are available, short of an unforeseen, significant increase in funding, their higher cost would compel programs to reduce malaria control coverage, leading to increased mortality and morbidity. In order to limit these negative effects on cost and coverage, we propose that policymakers and malaria stakeholders consider adoption of existing policies from successful efforts to secure reduced prices and increased access to other essential health interventions.

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“…Finally, it deserves to be mentioned the Priority Review Vouchers (suggested by Ridley et al [11] and later adopted by the Food and Drug Administration of the USA, in the year 2008) that provide incentives to invest in drugs for neglected tropical diseases. Companies that obtain approval for a treatment of a neglected disease are given a transferable voucher that allows them a priority review process for the authorisation of another agent.…”

Section: New Initiatives For Making Drugs More Accessible For Allmentioning

confidence: 99%