In my job as a consultant to companies trying to discover and develop new antibiotics, I keep my fingers on the pulse of the industry at least to a certain extent. Today, I wanted to share my growing confusion with all of you. For some reason, I have had a burst of new business both at the beginning of this year and again within the last several weeks. This business is coming from everywhere - large pharma, biotech and investors - wanting everything from on the ground help with discovery and development tasks to evaluations of potential products at various stages of development. But then when I look at the number of large pharmaceutical companies who have abandoned the area and the great difficulties that start-ups are encountering in obtaining funding, I wonder which end is up. Of course, there are still a few (2-4) large companies still pursuing antibiotic discovery and development. There are still a few antibiotic indications where clinical trials remain feasible at the FDA (urinary tract infection, skin infection, intraabdominal infection - although several of these are under review - hold on to your hats).
I think I understand the dynamic here. There is hope. Many very smart people and talented scientists recognize that we cannot go on with no antibiotic pipeline. They realize that the FDA will, therefore, ultimately have to see reason. They also believe that, somehow, a way forward for funding will be found. Perhaps some of them believe that the GAIN act will be a major positive influence (I am not so sure) in terms of providing an incentive for both biotech and their potential partners or even for public markets to finally get back in the act. Maybe some see BARDA as a way forward (although without an ability to fund phase III, I remain skeptical). Nevertheless, hope and optimism are good things. Not only that, but they help keep me in business and, I hope, they will help keep the world supplied with new and needed antibiotics. So today, for me, the glass is half full.
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I received an e-mail from BARDA stating that they do not restrict their funding by phase of development. Therefore, theoretically, BARDA funds could be used for phase III development. They state that this has not yet occurred - but they will let me know when it does. So - I stand partially corrected anyway.
ReplyDeleteGreat call last month on SA getting back into the AB world as evidenced by the deal today.
ReplyDeleteI've been [happily] experiencing an uptick in antibacterial discovery consulting work, too. It's surprising - but hopeful.
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