An Osteoarthritic Odyssey
Sitting Down With... Mike Clayman, CEO of Flexion Therapeutics, Inc., Burlington, Massachusetts, USA.
How did Flexion Therapeutics come to be?
Neil Bodick (my co-founder at Flexion) and I had previously aggregated about 30 years of experience working at Eli Lilly and Company in various capacities. One of our major achievements during that time was the development of an almost autonomous research and development unit of the Lilly Research Laboratory, called Chorus. With its own funding and around 30 employees, we worked to advance drug candidates from the laboratory to meaningful clinical proof of concept in a fraction of the time and cost of traditional drug development. To provide some context: in the neighborhood of 90 percent of new drug candidates that enter the clinic fail. And those failures are pretty expensive.
The other dynamic to consider is that discovery output always outstrips development capacity, and that forces companies to decide which candidates to pursue further, based solely on pre-clinical data. Unfortunately, pre-clinical data is a poor predictor of what you are likely to see in the clinic. Our aim was to design and conduct the ‘killer’ experiment that would inform whether or not you should continue to work on a compound. Our team found ways to determine that much more efficiently and quickly, while continuing to follow the same levels of safety and compliance from a regulatory point of view. On average, we were progressing new compounds to meaningful clinical proof of concept in less than two years and for between two and five million dollars.
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