Today is part of 4 (the last) of my interview with Dr. Arnold Caplan, MSC godfather and guru.
In this post I focus on my discussion with Caplan on translation of stem cells to patients and the FDA.
During our conversation we talked about some of the challenges facing the efforts to make safe and effective stem cell therapies (including those based on MSCs) available to patients.
Of course one key element is regulatory oversight, which is important for protecting patients, but which, according to some in the field, is too onerous and slows everything down far too much.
When I asked Caplan about the FDA, he said, “There is no sinister plot.” What he was referring is the ubiquitous, but false claim by some in the non-compliant stem cell sector that the FDA and Big Pharma (and some academic scientists) are engaged in a plot to kill stem cell therapies because they are supposedly a threat to the profit stream of Big Pharma.
However, Caplan continued, “The FDA is inhibitory to translation of stem cell therapies to patients. There is no sense in regulating MSCs as a drug.”
Caplan went on to describe an interesting, new proposal that he is working on with Mike West and Andy VonEschenbach (former FDA commissioner, 2006-2009 and now a proponent of FDA reform, exemplified by his widely read editorial in the WSJ). In the new framework envisioned in the proposal, there would be progressive approval and after early phase success companies could get FDA approval to get paid for patient treatment as part of the process. Another element overall would be a greatly streamlined overall process that gets stem cell-based medicines to patients more quickly.
This priority fits with the results so far of my blog’s poll on FDA reform (still time to participate) where the top pick amongst respondents for a reform at the FDA in the stem cell field was speeding up the clinical trials process.
Caplan concluded on the FDA with a powerful overall take-home message, “A test of any civilization is laws and we need the FDA, but we also need faster access for patients to stem cell therapies.”
I really enjoyed talking with Dr. Caplan (thank you!) and I hope you enjoyed this series of blog posts on the interview.