September 26, 2017

Recently, I taught a module on regulatory trends and RMAT strategy at a hands-on weekend clinical training event in Austin, one of those events at which clinicians planning to integrate cell-based therapy within their current practices learn the basic theory, principle...

August 3, 2017

I’m very positive about the future role of the FDA in ensuring that stem cell and related therapies are safe and effective.

And, because of that, I believe now is the appointed time for both patients and therapy providers to be intentional in helping to rewire their own...

July 27, 2017

I am always challenged and intellectually stimulated when I feel as though I’ve identified a pattern, practice, or even consequence of doing business that reveals itself as I observe the fledgling industry that we’ve alchemized and branded here in the U.S. as our versi...

July 11, 2017

Throughout the week of August 7th, I have visits in DC with top policymakers and regulators, politicians, stem cell industry leaders, researchers and CBER officials. We specialize in guiding providers wishing to conduct RMAT-Designated trials.

April 30, 2017

In case you haven’t heard, last December, with the passage of the 21st Century Cures Act, Congress provided an avenue for FDA reform that has opened an opportunity to talented, research-oriented cell therapy providers to become investigators and conduct clinical trials...

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Regenerative Outcomes, LLC, Achieves Rapid Growth, as Demand for RMAT Consultancy Expands – Interview with Megan Moneypenny, CEO

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