Right Turn: Primers on cell therapy regulation

Understanding cell therapy regulation is an essential component of the bench to bedside pipeline. Without approval from a country’s regulator (Health Canada, FDA, EMA, PMDA, etc.), a product cannot be sold to consumers and the millions invested in research and development, manufacturing and clinical trials is media down the drain.

Cell therapies present a range of challenges for regulators and, of course, for the companies developing them. In advance of an upcoming webinar on cell therapy regulation, hosted by RegMedNet, that same group has produced an infographic on current cell therapies and points of view from the community on this theme. You can see it below.

Log in on June 27 to RegMedNet’s webinar to hear from the following experts:

• Jacqueline Barry, Chief Clinical Officer, Cell and Gene Therapy Catapult
• Patrick Bedford, Manager, Clinical Translation & Regulatory Affairs, CCRM
• Mark W. Sawicki, Chief Commercial Officer, Cryoport
• James L. Sherley, Director, Assymetrex

And if you’re still looking for information or answers on cell therapy regulation (or this timing isn’t convenient), here are three Canadian events, but they require you to attend in person:

• The Business of Regenerative Medicine from July 17-19 in Toronto, Ontario
• Bench to Bedside for Biotherapeutics (B3) on October 5, 2017 in Toronto, Ontario
• Cell and Gene Therapies 101 from November 8-10 in Mont-Tremblant, Quebec

If you prefer self-learning on your own schedule, blogger David Brindley has covered this topic frequently as one of Signals’ commercialization experts. Read his posts here.

This infographic was reproduced with kind permission of RegMedNet. To learn more about cell therapy regulation, visit the spotlight on the challenges of navigating this complex world landscape today.

Our regular feature, Right Turn, appears every Friday and we invite you to submit your own blog to info(at)ccrm.ca. We encourage you to be creative and use the right (!) side of your brain. We dare you to make us laugh! Right Turn features cartoons, photos, videos and other content to amuse, educate and encourage discussion.

As always, we welcome your feedback in the comment section.

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Stacey Johnson

Stacey Johnson is the editor of Signals and a contributor. For 25 years, Stacey has been providing strategic communications counsel to government, corporate, technology and health organizations. She began her career at the CTV Television Network and then moved to Hill & Knowlton Canada where she advised clients in a variety of industries and sectors. Stacey is the Vice President, Communications and Marketing for CCRM, a leader in developing and commercializing regenerative medicine-based technologies and cell and gene therapies. She has a Master's degree in Public Relations. You can follow her on Twitter @msstaceyerin.

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