Subscribe to Newsletter
Manufacture Advanced Medicine, Standards & Regulation

Introducing a Regulatory Playbook for Gene Therapy

The Bespoke Gene Therapy Consortium has published a regulatory playbook designed to serve as a “Guiding framework for the development and regulatory submission of adeno-associated virus gene therapies for rare diseases.” The playbook is free to access and draws upon publicly available resources, including FDA guidances and other official publications.

To find out more about the inspiration for the playbook, we spoke with Courtney Silverthorn, Vice President, Strategic Alliances and Innovation of the Foundation for the National Institutes of Health’s Accelerating Medicines Partnership Program. She discusses the hurdles to accelerating the development of gene therapy, exciting advances in the field, and how she hopes the playbook will help drug developers. Watch the interview in the video below.

Receive content, products, events as well as relevant industry updates from The Medicine Maker and its sponsors.
Stay up to date with our other newsletters and sponsors information, tailored specifically to the fields you are interested in

When you click “Subscribe” we will email you a link, which you must click to verify the email address above and activate your subscription. If you do not receive this email, please contact us at [email protected].
If you wish to unsubscribe, you can update your preferences at any point.

About the Author
Stephanie Vine

Making great scientific magazines isn’t just about delivering knowledge and high quality content; it’s also about packaging these in the right words to ensure that someone is truly inspired by a topic. My passion is ensuring that our authors’ expertise is presented as a seamless and enjoyable reading experience, whether in print, in digital or on social media. I’ve spent fourteen years writing and editing features for scientific and manufacturing publications, and in making this content engaging and accessible without sacrificing its scientific integrity. There is nothing better than a magazine with great content that feels great to read.

Register to The Medicine Maker

Register to access our FREE online portfolio, request the magazine in print and manage your preferences.

You will benefit from:
  • Unlimited access to ALL articles
  • News, interviews & opinions from leading industry experts
  • Receive print (and PDF) copies of The Medicine Maker magazine