Regenerative Outcomes

04/26/2018

Friends and Followers,

This page will be suspended effective June 15, 2018. To continue sharing our passion for aiding access to safe, effective cell therapies for patients, as well as the providers who wish to provide them responsibly, I invite you to our page for The Regenerative Outcomes Foundation:

The Regenerative Outcomes Foundation is a 501(c)3 tax-exempt charitable organization that serves both patients seeking healing through regenerative medicine and the providers seeking to provide it.

11/16/2017

CBER is clearly holding the line on regulation, including and especially SVF. RMAT designation FDA trial will be key tool, as will the national registry for RWE, RWD and post-market approval.

FDA announces comprehensive regenerative medicine policy framework to spur innovation, efficient access to potentially transformative products, while ensuring safety and efficacy.

09/07/2017

The first of what I suspect will be several incremental releases over the next months.

08/28/2017

Clinics: Time to Pay Attention...

https://twitter.com/douguglee/status/902209965070446592

“ https://t.co/aPe3RKFC0k Impacts patients. Time for unity w/balance ”

06/21/2017

Much more to come about my upcoming meetings in DC!

“For upcoming meetings scheduled with CBER officials... https://t.co/Ustg25gVQs”

04/25/2017

Humbled and honored to be the new contributor on the block...

Everybody loves a good story. It doesn’t really matter if it’s true or false or somewhere in between. For stories, the truth is found in the telling – in the narrative.

04/09/2017

Why The Needle May Not Matter...

I travel to many provider cross-training events where physicians teach each other about the techniques, protocols and technology involved in offering

03/15/2017

Very productive week in D.C. Met with Dr. Collins (NIH), Dr. Seiving (NEI), and many researchers and regenerative medicine providers. The research being done for eye diseases is amazing. Could there be research opportunities for The Regenerative Outcomes Foundation in the near future? We'll see!

01/06/2017

Had good results in DC.

Lengthy conversations with both head of NIH (Dr. Collins) and FDA (Dr. Califf). Hopeful for continued dialog with them and top policy-makers... not to "lobby", but to simply ask what their vision, (professional and personal) is for patients. Let's see what happens...

Reception went well. Lots to share...

01/05/2017

On my way to D.C. today. Privileged (and I have to say, pretty excited), to attend a celebration reception for legislators and staff, regulatory officials, and Bipartisan Policy Center leaders involved in the development of the 21st Century Cures Act! A rare opportunity to meet top folks, and spread the love. Peace...

10/21/2016