One of the lesser known activities of
the California stem cell agency is webinars that put researchers
together with the folks who make the federal decisions about whether
stem cell research will be turned into therapies.
parties to get on board.
Cynthia Schaffer, CIRM's contract administrator and compliance officer
had this to say today about the webinars.
“The FDA very graciously donates
their time to speak on these webinars because they too have pledged
to maintain an active dialogue with the industry and provide
education on their regulatory expectations for product development in
the regenerative medicine field. CIRM science officer Kevin
Whittlesey recently
wrote a paper with Celia Witten of the FDA about the role of the
FDA in reaching out to regenerative medicine community, including
webinars such as these.
“In that paper they point out that
the communication goes both ways:
“'Appropriate regulation requires a
strong understanding of the latest scientific developments to meet
current and future regulatory needs and challenges.'
“So the FDA benefits by learning from
the other speakers in the webinar – what is the current state of
the technology, what are investigator’s current thoughts on best
practices and the latest research findings, etc. They also learn what
the industry is facing by listening to the questions asked and the
discussion of the challenges during the Q&A sessions. A group of
FDA employees attend each of these CIRM sponsored webinars, and the
wide variety of other workshops and meetings that CIRM hosts
throughout the year.”
(Editor's note: An earlier version of this item incorrectly identified Cynthia Schaffer as Cynthia Adams.)
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