The NIAID Radiation Countermeasures Program Business Model

Hafer, Nathaniel; Maidment, Bert W.; Hatchett, Richard

doi:10.1089/bsp.2010.0041

Cited by 13 publications

(8 citation statements)

References 3 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…• Set R&D priorities and pathogen-specific R&D road maps (World Health Organization 2015; 2016a, b) • Share resources and services around the development of products (Gronvall et al 2007), the purchasing of products (Global Alliance for Vaccines and Immunisation 2014), and the management of partnerships (Hafer et al 2010) Gouglas et al: Setting Strategic Objectives for CEPI INFORMS Journal on Applied Analytics, 2019, vol. 49, no.…”

Section: Resultsmentioning

confidence: 99%

Setting Strategic Objectives for the Coalition for Epidemic Preparedness Innovations: An Exploratory Decision Analysis Process

Gouglas

Hoyt

Peacocke

et al. 2019

INFORMS Journal on Applied Analytics

View full text Add to dashboard Cite

The Coalition for Epidemic Preparedness Innovations (CEPI) was established in 2016 in response to the West African Ebola epidemic. The vision for CEPI is to develop vaccines to prevent future emerging infectious disease outbreaks from becoming humanitarian crises. Leaders from governments, foundations, industry, and civil society convened earlier that year to formulate strategic objectives to support CEPI's first business plan. We demonstrate how decision analysis can support a rational and transparent approach to strategy formulation that accounts for and ranks the preferences of multiple stakeholders in an international coalition setting. We use value-focused thinking to identify and structure objectives and we combine this with an explorative discrete-choice experiment to elicit preferences between objectives. Our findings suggest that decision-analytic methodologies can rationalize strategic objective setting in a highly complex global health research and development planning context characterized by strong stakeholder interests and conflicting priorities.

show abstract

Section: Resultsmentioning

confidence: 99%

Setting Strategic Objectives for the Coalition for Epidemic Preparedness Innovations: An Exploratory Decision Analysis Process

Gouglas

Hoyt

Peacocke

et al. 2019

INFORMS Journal on Applied Analytics

View full text Add to dashboard Cite

show abstract

“…In addition, there is value added to a company that is involved in repurposing. For example, the NIAID wrote about how companies partnering with the U.S. government can achieve a sustainable radiation business model, in which VMI stock bubbles add to the profit from a licensed product (104).…”

Section: Discussionmentioning

confidence: 99%

Challenges and Benefits of Repurposing Products for Use during a Radiation Public Health Emergency: Lessons Learned from Biological Threats and other Disease Treatments

DiCarlo

Cassatt

Dowling³

et al. 2018

Radiation Research

View full text Add to dashboard Cite

The risk of a radiological or nuclear public health emergency is a major growing concern of the U.S. government. To address a potential incident and ensure that the government is prepared to respond to any subsequent civilian or military casualties, the U.S. Department of Health and Human Services and the Department of Defense have been charged with the development of medical countermeasures (MCMs) to treat the acute and delayed injuries that can result from radiation exposure. Because of the limited budgets in research and development and the high costs associated with bring promising approaches from the bench through advanced product development activities, and ultimately, to regulatory approval, the U.S. government places a priority on repurposing products for which there already exists relevant safety and other important information concerning their use in humans. Generating human data can be a costly and time-consuming process; therefore, the U.S. government has interest in drugs for which such relevant information has been established (e.g., products for another indication), and in determining if they could be repurposed for use as MCMs to treat radiation injuries as well as chemical and biological insults. To explore these possibilities, the National Institute of Allergy and Infectious Diseases (NIAID) convened a workshop including U.S. government, industry and academic subject matter experts, to discuss the challenges and benefits of repurposing products for a radiation indication. Topics covered included a discussion of U.S. government efforts (e.g. funding, stockpiling and making products available for study), as well unique regulatory and other challenges faced when repurposing patent protected or generic drugs. Other discussions involved lessons learned from industry on repurposing pre-license, pipeline products within drug development portfolios. This report reviews the information presented, as well as an overview of discussions from the meeting.

show abstract

“…Recent efforts to repurpose drugs with existing clinical indications is an important step toward minimizing the cost and time involved in licensing a product for use during a radiation public health emergency. However, even for other novel compounds, it is critical that a primary, clinical indication is being sought, as it is unlikely that the government could wholly support development costs, and a good business model would not rely on only one purchaser (125). The expectation that complicated polypharmacy approaches may be needed, and the practical impact of an increasingly complex baseline group of therapies that might be required was also discussed.…”

Section: Regulatory Considerationsmentioning

confidence: 99%

Use of Growth Factors and Other Cytokines for Treatment of Injuries During a Radiation Public Health Emergency

et al. 2019

View full text Add to dashboard Cite

Radiation oncology, military medicine, radiation protection a Speakers had the opportunity to review this meeting report prior to journal submission. b CBRNE ¼ chemical, biological, radiological, nuclear and explosive. 2 https://bit.ly/2ZJO9KH. 3 https://bit.ly/2U8OwdE 4 https://bit.ly/2XYai6h. 5 https://bit.ly/2OWDKpK. 6 https://bit.ly/2P28xl9. 7 https://bit.ly/2I8r7aI. 8 https://bit.ly/2uXqrfQ. 9 https://bit.ly/2I6Dq7r. 10 Where pre-publication data are discussed, the first initial and last name of the presenter who provided the information is shown in parentheses.

show abstract

The NIAID Radiation Countermeasures Program Business Model

Cited by 13 publications

References 3 publications

Setting Strategic Objectives for the Coalition for Epidemic Preparedness Innovations: An Exploratory Decision Analysis Process

Setting Strategic Objectives for the Coalition for Epidemic Preparedness Innovations: An Exploratory Decision Analysis Process

Challenges and Benefits of Repurposing Products for Use during a Radiation Public Health Emergency: Lessons Learned from Biological Threats and other Disease Treatments

Use of Growth Factors and Other Cytokines for Treatment of Injuries During a Radiation Public Health Emergency

Contact Info

Product

Resources

About