From The Editor | April 26, 2021

Regulatory Requirements Featuring bluebird bio


By Erin Harris, Editor-In-Chief, Cell & Gene
Follow Me On Twitter @ErinHarris_1


I love when I have the opportunity to guest host my colleague Matt Pillar's Business of Biotech podcast. Just recently, I had the chance to sit down with Matt and bluebird bio’s VP Regulatory Operations and Compliance, Scott Cleve, for a candid discussion on the regulatory trends shaping the advance of bluebird’s pipeline of gene therapies for the treatment of serious, life-altering diseases including Cerebral Adrenoleukodystrophy, Multiple Myeloma, Transfusion-Dependent β-Thalassemia, and Sickle Cell Disease.

Why You Should Listen

The regulatory landscape has seen a lot of change; we talk through some of the biggest changes Cleve has witnessed to date in his career. And, we discuss how and why varying global regulatory requirements (i.e. EMA, FDA, etc.) have exacerbated the challenge of his job.

We talk about the impact COVID has had on regulatory activity, and more specifically, Cleve's relationship with regulators and whether COVID-fueled regulatory trends, such as the speed and agility we’ve seen applied to COVID vaccine and therapeutic approvals, will transfer to other therapeutic areas.

Click here to listen