Big Pharma Embraces Microbiome Research; Partnering Poised To Follow
Microbiome-based research is gaining credibility as a means to discover novel therapeutics. Now big pharmas like J&J and Pfizer are evaluating partnering opportunities in the burgeoning field – with potential therapies starting to enter the clinic – as they look to strike the appropriate balance between internal and external research.
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FDA's regulatory pathway "for development of probiotic drugs is reasonably clear. But the road to develop probiotic foods, supplements or microbiome-based dietary strategies to compensate for deficient microbiota is less so," says the International Scientific Association for Probiotics and Prebiotics. FDA's Center for Biologics Evaluation and Research is conducting Sept. 17 workshop to exchange information with the scientific community about the clinical, manufacturing and regulatory considerations associated with live microbiome-based products administered to treat a disease.
With an emphasis on early disease intervention, J&J’s Janssen R&D unit launched three new research platforms – disease prevention, disease interception and the microbiome.
Biogen will purchase GSK spinout Convergence to bolster its pain portfolio, while Tekmira and OnCore are merging to create a new company focused on hepatitis B. Two J&J units struck deals during the week in Alzheimer’s and gastrointestinal indications, as Lilly teamed up with Merck and Bristol for combo trials to keep its drugs relevant in the PD-1 world.