8 key arguments, take-homes on day 1 of FDA stem cell meeting

Today was the first part of the FDA’s 2-day meeting on stem cell draft guidances. It was a great meeting I thought.

randy-mills-cirm-fda

Screenshot from video of FDA stem cell meeting of CIRM President Randy Mills speaking.

A few consistent themes and notable things emerged as raised by participants.

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Guide to September 12-13 FDA Stem Cell Meeting: Top 10 bullet points

The FDA is holding a 2-day stem cell meeting starting tomorrow and it promises to be a really big deal. What’s the scoop on this meeting and the attendees?

Who is likely to say what?

Stem cell cartoon

If the deregulatory proponents get their way, could we have stem cell clinics like Starbucks popping up in even more neighborhoods? I have a satirical cartoon from some time ago I drew imagining such a future.

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Blogging today’s FDA stem cell meeting: Part 1

fda-stem-cellsThe FDA is holding its first 2016 stem cell meeting today.

How’s the meeting going?

The meeting start awfully early for us West Coast folks (5:30am) so I didn’t get to see the first few talks. Did anyone else see those and if so, what was your impression?

From the talks I have seen, this meeting is very scientifically focused so far. There has been a lot of clinical trial data presented, which for me as a scientist I really appreciate.

We’ve heard about promise, but also many challenges. One gestalt from the meeting up to this point is that there are a lot of complexities with developing and testing cellular therapies, and the utmost care must be used in this kind of clinical research. It’s not amenable to being rushed. At the same time I think it was Irv Weissman who pointed out that if we are going to see stem cell therapies help many of the patients in need within our lifetimes then there likely need to be some changes.

In the panel discussion before the lunch break, a question from the audience asked about the REGROW Act, but we didn’t hear very much from the panel about in reply that I could gather. If I heard someone on the panel correctly they referred to trying to answer that question as similar to “sticking one’s hand into a bucket of crabs”. However, a few people did indicate they have major concerns on REGROW.

I believe we are going to hear much more about policy in the afternoon session.

FDA stem cell meeting now a 2-day public event in September

FDA stem cell meetingThe FDA stem cell meeting that was supposed to take place in April is now officially going to be a 2-day event in September.

This public meeting is meant to get comments on four draft guidances related to regs on stem cell products and treatments.

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New FDA Interview on April stem cell meeting & draft guidances

FDA draft guidanceBelow is a my interview with an FDA spokesperson on the upcoming April public meeting on the four recent draft guidances related to the regulation of HCT/Ps, including stem cell treatments.

This meeting and the draft guidances could have substantial impact on future regulatory frameworks for stem cell treatments so I thought it important to reach out to the FDA to clarify the process.

  • PK: When the FDA issues draft guidances is it a standard approach to have a public meeting of the kind that will be held in April on the four stem cell-related draft guidances?
  • FDA: No, this is not typical. But with these there has been such strong public interest that we decided to have a Part 15 hearing. This will allow us to hear from interested stakeholders. So for these draft guidances we will both have the docket (the opportunity for written public comments) and the public meeting.
  • PK: Does the agenda include everyone who requested to speak and is that why each speaker gets only about 3 minutes?
  • FDA: We have tried to accommodate everyone who expressed interested in speaking in person at the meeting. Time is limited as a result of the interest.
  • PK: What happens after the meeting and when the written comment period ends?
  • FDA: We will take into consideration and review all the comments as we finalize each of the four draft guidances.
  • PK: Once finalized, what happens next?
  • FDA: These finalized guidances will then reflect the FDA’s current thinking, but the guidances are recommendations and are not binding. Even after we finalize guidance, it can undergo future revision.
  • PK: How do you collate all the comments both in writing and at the meeting, along with the FDA’s own research on the matters at hand? I imagine it could be quite the task with hundreds of potential viewpoints from stakeholders.
  • FDA: Regulatory and policy staff go through all the comments, which is indeed a lot of work. For instance, on the recent review of blood donation deferral, we got something like 700-800 comments that were roughly equally divided. With the four draft guidances related to stem cells, our goal is to provide clarity through the guidance, which we hope will lead to development of safe and effective products.
  • PK: We’ve recently seen a change in Japan as relates to the regulatory scheme for review of stem cell and regenerative medicine products. This has been predicted to speed things up there, but there will be less review before products go into patients. Does the FDA take into consideration paradigms in other countries?
  • FDA: In general we work closely with our regulatory counterparts in other countries.
  • PK: Can you predict a timeline for finalizing these four draft guidances?
  • FDA: I can’t predict the timing. These are a priority though.