Newsletter | November 15, 2021

11.15.21 -- Expert Insights On Regulatory Interactions, CDMO Capacity, And CMC Developability

New Therapies Require A New Approach To Regulatory Interactions

bluebird bio's Scott Cleve talks about shifting regulatory standards and how biopharmaceutical companies can adapt how they engage with regulators.

How To Apply For A Breakthrough Therapy Designation (And Win It!)

GlaxoSmithKline's Dr.Ira Gupta and Gilead Sciences' Dr. Shanthi Ganeshan break down breakthrough designations, winning them, and bouncing back from rejection.

Perspective On The Importance Of CDMO Capacity For Viral Vectors

Forge Biologics' Dr. Timothy Miller talks about the importance of increasing specialized CDMO capacity for cell and gene therapy applications.

Tips On Achieving Cell And Gene Manufacturing Scalability

Geoff MacKay, president and CEO of AVROBIO, talks about the scale-up obstacles facing the cell and gene therapy space and how AVRO is working to tackle them.

The Importance Of CMC Developability Assessments

Dr. Gene Lee, vice president of technical development at AltruBio, discusses getting the developability question right and why it’s important to understand your end game as early as discovery.