Whale Sharks, Outer Space and the World Stem Cell Summit
by Don C. Reed
Swimming toward me were two of the biggest sharks in the world.
Slow-moving, majestic, totally harmless, (and in any event on the other side of a plate glass window), these were whale sharks, each about 20 feet long. “These are only teenagers, half-grown”, said the diver dressed as Santa Claus, from a microphone inside the tank.
As a former professional diver, I had heard about these gentle giants all my life, and would love to have had a full day to spend at the magnificent Georgia Aquarium.
But I was on a mission.
I stood in awe for just a moment, posed for a souveneir photo that made me look like I was standing in the tank—and rushed back—
To the Atlanta Hyatt Regency, and the beginning of the second decade of the World Stem Cell Summit.
Presented by advocate extraordinaire Bernard Siegel of the Genetics Policy Institute, the Summit takes all year to build and coordinate. It unites advocates, scientists, entrepreneurs and government officials from 35 nations—and this year from outer space too!
Did you know stem cell research will be going on at the International Space Station? The Center for the Advancement of Science in Space (CASIS) is issuing a request for applications to do stem cell experiments in microgravity.
Would stem cells in a petri dish grow faster, or multiply more cleanly, if there was no gravity to squash them down? Only one way to find out—go to the utter blackness of outer space and try!
A more down-to-earth event involved the Food and Drug Administration and the painfully long time it takes for new therapies to get through FDA testing procedures.
The President of the California stem cell program had something to say about that.
Dr. Randy Mills stepped up to the mike.
“There is an excessively long…pathway to get an Investigational New Drug (IND) approval from the FDA (a necessary step to proceed with testing a therapy in a clinical trial). For non-cell therapies it takes 3-4 years to get an IND. For cell therapies it takes 6-8 years, twice as long…
“We have had the current FDA regulatory structure in place for 15 years, and in that 15 years not one stem cell therapy has been approved. Not one…
“We are not anti-regulation, we are not anti-FDA, and we are not calling for the removal of rules and regulations around stem stem cell therapies…
“But right now we are being so careful about safety to ensure patients are not put at risk– while those same patients are dying from their disease.”
–Dr. Randy Mills, President of the California Institute of Regenerative Medicine.
What if that delay could be lessened? Not the safety tests: those are crucial,. But what about removing one of the three required “efficacy” (does it work?) tests? That would shave years off the process, and perhaps save lives.
Two representatives of the FDA spoke, Robert Cailiff and Celia Witten. They shared the vast size of what they are up against—FDA regulations affect approximately 25% of the nation’s gross domestic product!
They did not state the obvious, that every year their budget does not meet the need; their problems increase, but not their ability to deal with them.
These are our friends, and their goal is ours:
“Accelerating translation to yield safe and effective therapies that can be delivered reliably.”
I should mention that I am neither scientist nor doctor, just an informed advocate, trying to understand. For more direct viewpoints, go to the website of the World Stem Cell Summit 2015 headquarters, and listen to some of the speaker videos. Siegel generally posts some of the speakers’ remarks, so even if you could not attend, you can still listen to them, free. What a magnificent gift! When the FDA speeches are posted, you will be able to hear them.
The International component was always absorbing.
Soft-spoken Alain Vertes of Switzerland spoke of the importance of government-sponsored “incubator programs” to help research: Vertes is author and editor of the new book “Stem Cells in Regenerative Medicine: Science, Regulation and Business Strategies”. I just bought a copy. It is pricey ($181 dollars) but contains clearly-written essays by experts on crises faced by regenerative medicine today.
Ave Treves pointed to Israel as a nation has which systematically fostered stem cell research, and recommended a book about his country’s business policy, “Israel, the Start-up Nation”.
Michael May of Canada shared the vision of the Centre for Commercialization of Regenerative Medicine (CCRM), a stem cell research consortium involving nearly 40 companies working together to “bridge the gap between academia and industry and enable promising technologies to reach the market…a global nexus of regenerative medicine commercialization.”
Dr. Yijian Li said China had set up a special fund, so that at least $100 million a year would go into stem cell research, to a maximum of six billion…
So much more, including the latest from Bob Klein, author and first leader of the California stem cell program—
But those are stories for another day.
Don C. Reed is the author of the new book “STEM CELL BATTLES: Proposition 71 and Beyond” How Ordinary People Can Fight Back Against the Crushing Burden of Chronic Disease—with a Posthumous Foreword by Christopher Reeve”, available at Amazon .com.