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on the science and technology of drugs and medical devices, including discovery, development, manufacturing, and regulation.

Outbreak! Combating the 2019-Novel Coronavirus (COVID-19)

April 28, 2020
| COVID

Chapter 13 – NIH Foundation is Coordinating a Global Research Effort

This month, NIH launched a public-private partnership to develop an international strategy for the research on the COVID-19 pandemic. Part of the “part of the whole-of-government, whole-of-America response” to the pandemic, the partnership includes NIH, FDA, CDC, the European Medicines Agency (EMA), and 16 pharmaceutical companies, including such leaders as Pfizer, Merck, J&J, Novartis, and Roche. Noticeably absent is Gilead, the sponsor of remdesivir, which has been much in the news lately as a potential COVID-19 treatment undergoing closely watched clinical trials.

Coordinated by the Foundation for the National Institutes of Health (FNIH), the partnership will have four objectives:

  1. Standardize and share preclinical evaluation methods in an open forum that allows for comparison and validation,
  2. Prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential,
  3. Maximize clinical trial capacity and effectiveness, and
  4. Advance vaccine development.

Read the news release for additional detail on the partnership plans and monitor the progress of the research at the NIH COVID web site. NIH Director Francis S. Collins, a leader best known for the NIH effort to map the human genome, said about the partnership, “We need to bring the full power of the biomedical research enterprise to bear on this crisis” and “Now is the time to come together with unassailable objectivity to swiftly advance the development of the most promising vaccine and therapeutic candidates that can help end the COVID-19 global pandemic.”

Reach out to me if you want to know more or discuss your medical product development challenges.

katrina@krogersconsulting.com

linkedin.com/in/katrinarogers

https://calendly.com/katrinarogers

Text Copyright © 2020 Katrina Rogers

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