1. Pink Sheet

BIO Notebook Day 3: ARM Launches Foundation To Educate Public About Gene And Cell Therapies

 
• By Joseph Haas and Sue Sutter

Alliance for Regenerative Medicine initiative seeks to explain gene and cell therapy to the general public. Also, EY's Giovannetti says strategic decisions, not tax reform, should drive deal-making; FDA's Woodcock touts benefits of new drug review office overhaul; and Siga Technologies eyes priority review voucher upon approval of Tpoxx for smallpox.

BIO International 2018 Notebook

The potential for gene and cell therapies may seem limitless and exciting, but a flip side of that story can be fear generated by the unknown. That is the issue the Alliance for Regenerative Medicine (ARM) decided to address by launching a non-profit foundation June 6 – with an announcement at the 2018 BIO International Convention in Boston – to increase the public’s awareness of and understanding about gene and cell therapy.

As a 501(c)(3) non-profit affiliated with ARM, the ARM Foundation for Cell and Gene Medicine will begin with three primary...

More from Cell & Gene Therapies

More from Advanced Technologies

UK’s Decentralized Manufacturing Rules Designed To Allow For ‘Future Developments’

 
• By Eliza Slawther

The UK drug regulator acknowledges that technology will “move on” and, as such, has designed its decentralized manufacturing regulation to be as “enduring” as possible. Experts from the MHRA explain what products are covered by the new framework and how it has been future-proofed.

Profit-Sharing AI Model Proposed To Boost Korean Drug R&D

 
• By Jung Won Shin

A differentiated profit-sharing model to accelerate the use of AI in drug development using clinical and patient data is being proposed in South Korea, but the idea faces multiple practical challenges

US FDA’s Top Cell and Gene Therapy Regulators Forced Out

 
• By Sarah Karlin-Smith

Office of Therapeutic Products Director Nicole Verdun and her deputy Rachael Anatol were escorted out of FDA headquarters on June 18. Disagreements over CAR-T regulation and Capricor’s DMD treatment may be to blame.