Thursday, October 10, 2013

CIRM's board gets some strategic advice and ponders conflicts of interest rules

As you get older you tend to focus more on how much time you have left and how best to use that time. It’s true in life, and it’s equally true in business. That’s why some time ago our President, Alan Trounson, put together a Scientific Advisory Board to help advise us on how best to use the existing money.

That Scientific Advisory Board met recently and its report was one of the major elements under discussion at the meeting of our governing Board, the Independent Citizens Oversight Committee, in Burlingame on October 9.

The SAB as it has come to be known – everything in science and government ends up with an acronym – sprang out of a recommendation from the Institute of Medicine (IOM – see, what I mean about acronyms) which said we should pull together a blue ribbon panel of experts in “scientific, clinical ethical, industry and regulatory aspects of stem cell biology.”

We did just that and recruited eight distinguished experts from all over the world, chaired by Sir John Bell of Oxford University in the UK (the full list of SAB members is in this presentation to the board). The goal they were set was to look at what we had done, how much money we had left and to give us a high level view of how best to use that money to live up to our mission.

The SAB met on August 23rd and answered a series of questions about our overall goals and some questions about more specific areas. They weren’t asked to identify particular projects we should focus on, or specific dollar amounts to spend, instead we asked them to take a high level view about what we are doing as we reach a pivotal point in our work and how we can get the best bang for our taxpayer bucks.

In short, they suggested we;
  • Focus on 6 to 8 projects that have clear relevant to our mission and that we should set aside sufficient funds to help these get to Phase I/II clinical trials
  • Continue funding our training programs to develop a workforce of highly trained individuals
  • Discontinue our funding of shared labs but that those labs should learn how to operate independently
  • Continue funding basic research
  • Continue working hard to attract the highest quality individuals to our review panels
  • Continue working hard to establish strong ties between CIRM, academia and the commercial sector
  • Increase efforts to get wider recognition for our scientific achievements
The report was literally hot off the press. Our senior leadership only got a copy of it two days before the Board meeting so they had only a very short amount of time to go through the recommendations and draft some preliminary responses. Those were mostly supportive with a few caveats (the full responses are in the board presentation)

One question the SAB didn’t weigh in on was when they were asked if there was anything we had missed, any opportunities we were failing to grab. They didn’t identify anything. Of course, the SAB is going to be meeting three or four times a year (at least one in person) so they may find something in the future, but the fact that they didn’t have anything immediately identifiable this time was an encouraging sign.

The goal of the presentation was not to say what the agency will do in response but to share with the Board the recommendations and management’s initial response, and for the Board to have a chance to think about them. The Board will come back at its December meeting for a more in-depth discussion of the report and how best to respond.

The Board also considered what is something of a hot button issue: conflict of Interest. In the past we have been criticized for having policies that, even if they didn’t violate conflict of interest rules, could at least have given the perception that they might potentially violate those rules. We have made several changes to our governing structure to address some of the stronger criticisms, and at this meeting the Board considered some proposals to clarify the language used to identify what constitutes a conflict of interest. Highlighting what a thorny issue this is and how difficult it is to strike a balance between strong and over burdensome rules, there was no agreement on the new language. There was however, agreement on the need for a more detailed look at all our rules to make sure they matched those of other institutions, such as the NIH. (You can read our current conflict of interest regulations on our website.)

So, it was decided to hold more meetings at the committee level to come up with a more comprehensive look at our COI rules and bring those back to the Board at a future meeting.

Kevin McCormack

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