Insight at Biologics
By biologicsconsulting
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Episodes: 17
Description
Helping you navigate through the maze of drug and device development.
| Episode | Date |
|---|---|
|
16. Bridging Drug Development: Advancing Analytical Methods from Preclinical to Commercialization
|
Jan 27, 2026 |
|
15. Navigating CMC and Nonclinical Challenges with Novel Cell and Gene Therapy Products
|
May 06, 2025 |
|
14. When to take an early FDA meeting, with Aleese Hopkins and Samira Shirwa
|
May 21, 2024 |
|
13. Getting Out of Trouble, with Chris Vessely
|
Apr 16, 2024 |
|
12. Cybersecurity for Medical Devices, With Becky Ditty and DonnaBea Tillman
|
Nov 14, 2023 |
|
11. eCTD 4.0 and standardized data, with Ben Wimmer
|
Jul 18, 2023 |
|
10. Commercial Readiness, with Vince Narbut
|
Jun 20, 2023 |
|
9. Weight of Evidence vs Carcinogenicity Testing Part 2, with Bruce Pearce
|
May 16, 2023 |
|
8. Weight of Evidence vs Carcinogenicity Testing Part 1, with Bruce Pearce
|
Apr 18, 2023 |
|
7. Institutional Memory, with Kerin Ablashi
|
Mar 21, 2023 |
|
6. Potency Assays, with Diana Colleluori
|
Feb 21, 2023 |
|
5. When you should hire a consultant, with HeeSun Smaldore
|
Jan 31, 2023 |
|
4. Assembling Your Non-Clinical IND, with Emily Noonan Place
|
Jan 10, 2023 |
|
3. Gap analysis, with David Pepperl
|
Dec 13, 2022 |
|
2. In vivo cell therapy, with Robert Kutner
|
Nov 22, 2022 |
|
1. What a consultant can do for you, with Debra Barngrover
|
Nov 01, 2022 |
|
Insight at Biologics - Trailer
|
Oct 24, 2022 |