The World Stem Cell Summit in San Diego was a great meeting this past week. It was my 3rd straight Summit and the best of all. It’s a unique mix of science, medicine, and policy that links together key players from every corner of the field.
I talked stem cells one-on-one or in small groups with more than 100 people in our diverse field during the meeting. It was remarkable.
Some patterns emerged in terms of the topics on the most people’s minds.
Based on these interactions and the talk in the stem cell field the last few weeks that I’ve heard, below are the top 10 questions for the stem cell field looking to 2014. Stay tuned in the next week or so for my predictions for the stem cell field in 2014 and a look at how my predictions for this year turned out.
- 10. Will will happen on the SVF front given the current uncertainty and rapid expansion of clinics using it without FDA approval?
- 9. Will BioTime get the ES cell-based clinical trial for spinal cord injury up and running again in 2014?
- 8. What will be the verdict in the US v. Regenerative Sciences Appeal?
- 7. Will the Japanese IPSC-based clinical trial for macular degeneration, which starting enrolling patients on Aug. 1, transplant RPEs into its first patients in 2014?
- 6. Any major news from ACT’s clinic trials?
- 5. Will a Medical School or Hospital have the vision to start the first ever real fellowship or subspecialty training program for physicians in stem cell regenerative and cellular medicine in 2014 to address the huge need for doctor education in stem cells?
- 4. Who will be the new CIRM President & will the agency find a new source of funding for beyond 2017?
- 3. Will we see a blockbuster adult stem cell clinical paper in 2014?
- 2. Will one or more labs produce SCNT hESCs as Shoukhrat Mitalipov reported in 2013? If so, how will the cells compare?
- 1. Will the FDA finally approve at least one cellular therapy using the breakthrough designation?
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Elitists at Princeton Allowed to Take Vaccine Not Approved by the FDA
Students at Princeton University received meningitis vaccines this week after the Centers for Disease Control ruled that they could be given a vaccine as yet unapproved by the Food and Drug Administration. The strain of the disease affecting the campus, the B serogroup, is rare and no FDA-approved vaccine protects against it. The vaccine is approved for use in the European Union but not in the United States.
Jared Meyer comments:
If the CDC circumvents the FDA’s approval process for a group of Ivy League students, then the drug is clearly not dangerous—even for those not receiving an Ivy League education. If it is safe enough for the 500 million residents of the European Union, it should be allowed in America as well[…]Asking this question seems ridiculous, but this is a reality faced by millions daily. Cancer patients, diabetics, and those with heart problems or Alzheimer’s are all offered limited treatment options because of the FDA’s refusal to approve promising treatments[…]The FDA’s outdated ways harm people. It is time to stand up for medical advances and put an end to destructive policies that cause needless suffering. Everyone, not only Princeton students, should be able to take advantage of the latest in pharmaceutical innovation.
http://www.economicpolicyjournal.com/2013/12/elitists-at-princeton-allowed-to-take.html#comment-form
I guess some animals are more equal than others…
C’mon #2!!!
Nobody asked about Blastocyst complementation? Unbelieveable.