15 Navigating CMC and Nonclinical Challenges with Novel Cell and Gene Therapy Products

14. When to take an early FDA meeting, with Aleese Hopkins and Samira Shirwa

13. Getting Out of Trouble, with Chris Vessely

12. Cybersecurity for Medical Devices, With Becky Ditty and DonnaBea Tillman

11. eCTD 4.0 and standardized data, with Ben Wimmer

10. Commercial Readiness, with Vince Narbut

9. Weight of Evidence vs Carcinogenicity Testing Part 2, with Bruce Pearce

8. Weight of Evidence vs Carcinogenicity Testing Part 1, with Bruce Pearce

7. Institutional Memory, with Kerin Ablashi

6. Potency Assays, with Diana Colleluori

5. When you should hire a consultant, with HeeSun Smaldore

4. Assembling Your Non-Clinical IND, with Emily Noonan Place

3. Gap analysis, with David Pepperl

2. In vivo cell therapy, with Robert Kutner

1. What a consultant can do for you, with Debra Barngrover

Insight at Biologics - Trailer