David's New Book

Friday, March 31, 2017

CARB-X Rules!

Yesterday CARB-X announced the awards for the discovery and development of products to combat antibiotic resistance.  The awards targeted three potential new classes of antibiotics, included four innovative non-traditional products and seven new molecular targets against the most urgent and deadliest superbugs according to their press release.  The rewards announced yesterday could be for as much as $24 million total if all the awardees reach all the milestones required by CARB-X. And this is only the beginning. Total funding for CARB-X over the next five years could be up to $450 million.  Is this exciting or what??!!!

Now – a cautionary tale and an explanation as to how CARB-X will avoid the pitfalls exemplified by this history.  Does anyone remember the anthrax attacks of 2001? The attacks consisted of letters and envelopes contaminated with highly infectious anthrax spores that infected 17 people and killed 5. Suddenly, biodefense became a high priority for the US government – and rightly so. Part of the response was an effort by the NIH, funded by over $5 billion, to set up centers of excellence in research of special pathogens – those that could conceivably be used in a biological attack. Some of this money went to brick and mortar projects like the establishment of special facilities to allow researchers to work safely with these highly virulent and contagious pathogens. But a significant portion of the money was directed at research designed to provide products that could be used by the government in case of an attack.  Such products included sensors, diagnostics, vaccines, antibodies and therapeutics. I served on the review panels for these grants over several years for NIH. I was one of the very few reviewers in the pharmaceutical industry. The vast majority of the product directed research proposed in these very large requests seemed doomed to failure.  In one study section, the scores were low enough that it wasn’t clear if any of the proposals should be funded.  But, because the NIH had the money and a limited time to spend it (as I understood things then), many of the proposals, even those with relatively low scientific merit, were funded.

Don’t get me wrong.  A great deal of good came out of this effort.  The Centers of Excellence provided new facilities that are still being used for this sort of research.  New fundamental understanding of the pathogenesis of disease caused by these pathogenesis came to light. But on the product side, I am unaware of any vaccines, therapies, diagnostics or devices that were approved for use as a result of this massive effort.  I have asked the NIH to comment – but did not get a reply.  BARDA is unaware of any products resulting from this effort – nor are others I contacted who were involved in other government agencies working on this.

What does this have to do with CARB-X?  Nothing, I hope. I cite this example to make a few points about CARB-X. The NIH grants were just that – grants.  The awardees got the entire budget.  There were no milestones to meet to get more money along the way (as I remember it).  The awardees with collaborating academic institutions, sometimes with connections to industry and sometimes without such a connection. The CARB-X awardees are all companies, all of whom are more capable of carrying out the research than the vast majority of the academic researchers that were applying for the biodefense grants. CARB-X awards its money as a contract using clear milestones.  They try and identify early milestones that can allow both the company and CARB-X to come to go-no-go decisions as early as possible during the award period. At the same time, CARB-X has experts in place that can help companies find the resources they need to advance their products as efficiently as possible – CARB-X wants the projects they fund to succeed.  So do we all. At the same time, we want early decisions on those that will not go forward.

It is of utmost importance that CARB-X be relentless in both its support of awardees and disciplined in coming to clear milestone decisions.  I would even like to see a press release for negative decisions if they should ever occur to demonstrate CARB-X resolve. CARB-X must retain its credibility such that this resource can survive and thrive in an era when funding of efforts combating antibiotic resistance will be more and more critical and endangered at the same time.

In the meantime, we should all celebrate the beginning of the CARB-X era!