Don’t Get Comfortable: 5 Biopharma Flashpoints to Consider in 2015

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its anti-obesity regimens with companion apps. In today’s climate—see Flashpoint #1, above—lower-cost interventions for a high-impact problem like obesity will no doubt get more serious consideration.

5) My final flashpoint, if it happens this year, won’t be as wide-reaching as the others. But it will be fascinating. This might be the year the FDA gets its, well, poop together.

The official word is “stool,” but that doesn’t quite convey a rather radical thing taking place. Very sick people with a gut infection of the bacterium Clostridium difficile can use the poop of healthy people to get better. (C. difficile causes terrible diarrhea and kills 14,000 people a year in the U.S. alone.) The procedure, called fecal microbiota transplantation (FMT), isn’t very complicated, as the scores of D.I.Y. YouTube videos will attest. But a group of young scientists led by MIT microbiologist Mark Smith have created the nonprofit stool bank OpenBiome near Boston to connect patients and stool providers, with a lot of standards and safety checks along the way.

The FDA tried to prevent the practice, but after pressure from doctors and patients, the agency decided to look the other way. If eventually the agency decides stool must be regulated like a drug, OpenBiome and others would be shut down, and for-profit companies like Seres Health would fill the niche with more sophisticated and expensive solutions. (Seres has isolated key bacterial spores from healthy feces and turned them into a treatment that it is moving forward under drug regulations.)

But a ruling that favors OpenBiome, which charges $250 for its service, could make C. difficile treatment a nonprofit, or extremely commoditized, product. They might even knock out some of the antibiotic market. Currently, FMT is only for patients who haven’t responded to antibiotics—those in hospitals who would otherwise die and for “the walking wounded,” outpatients who can’t shake the infection, says Neil Stollman, chief of medicine at Alta Bates Summit in Oakland, CA, and a practicing gastroenterologist who says he’s done more than 100 FMTs for patients. (He’s also an unpaid advisor to OpenBiome.)

But with more safety data, Stollman would have no problem giving it to those in less dire straits. “I already have patients who say, ‘Why are you going to put me through six months of failure [on antibiotics] before you fix me?'” says Stollman.

No one has a clue about the timing of an FDA decision, but Stollman believes the agency will have to show its hand when a related pharmaceutical product is about to come to market. Odds are on Seres, which will start a Phase 3 trial early this year.

Even if a favorable ruling makes C. difficile treatment possible via the power of nonprofit poop, it shouldn’t dissuade for-profit ventures from other microbiome-mediated diseases, which are already proving to be far more complicated than rebooting the biome of a C. diff-infected patient.

I could have included a dozen more things to watch for in 2015, but we’ve all got J.P. Morgan to plan for. If you disagree with my flashpoints or have some of your own to add, start a discussion in the comments or tweet them to me. I’m @alexlash. See you in San Francisco next week.

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3 responses to “Don’t Get Comfortable: 5 Biopharma Flashpoints to Consider in 2015”

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    Follica for 2015? Maybe, maybe?

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