Helping the NIH Redefine their Sepsis R&D Strategy

Sepsis is among the most challenging human illnesses to study and to treat.  Hundreds of thousands of Americans are affected each year.  Sepsis is most often the result of a person’s uncontrolled response to a serious bacterial infection.  The exception is 2020, when SARS-CoV-2 (the cause of COVID-19) has become the most notorious and most lethal cause of overwhelming infection across the planet.

Despite hundreds of millions of dollars of federal research money invested, there has not been a new drug against sepsis brought to the clinic in 30 years  In light of that lack of progress, in 2018 the leadership of the National Institute for General Medical Sciences (NIGMS, the 3rd largest of the institutes at the NIH) reached out for assistance in examining their current funding priorities related to sepsis.  

Over the course of 9 months, Dr. Younger of ArgoPond led a national working group consisting of clinicians, academic researchers, and pharmaceutical industry leaders to assess the institute’s current portfolio and areas of interest, evaluate the research models used to develop treatments, and industry’s stance on the opportunities presented by new agents targeting this lethal condition.

The result was a series of recommendations that prompted an extensive change in research priorities.  Our final video presentation to the National Advisory Council at NIGMS is here.  Our final written report can be downloaded here.

Our broad recommendations were that NIGMS should:

  1. Significantly expand its support of clinical research related to sepsis
  2. Broaden its collaborations with other institutes to support clinical trials in sepsis
  3. Independently sponsor definitive clinical trials only in extraordinary circumstances
  4. Work with the NIH’s Center for Scientific Review to ensure the availability of reviewer expertise
  5. Engage the NIH Office of the Director to conduct a higher-level review of how the NIH can best coordinate efforts across institutes and more fully define NIGMS’s role in order to translate tax dollars into cures.

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