Insight at Biologics

Helping you navigate through the maze of drug and device development.

Episodes

Feb 21, 2023

24 min

How well does it work and how can you illustrate that? Diana Colleluori explains potency assays and best practices with them.

Jan 31, 2023

15 min

HeeSun Smaldore discusses the intricacies of deciding when to hire an outside consultant.

Jan 10, 2023

15 min

The regulatory agency doesn't get a lot of time with your IND submission. To figure out how to make the most of that time, we talk with Emily Noonan Place.

Dec 13, 2022

21 min

You may not have everything that you need when it comes to making a drug or device submission. How do you know? With a gap analysis. David Pepperl explains it in our conversation.

Nov 22, 2022

20 min

Using your own cells to help you heal isn't science fiction anymore. Robert Kutner takes us into the world of in vivo cell therapy.

Nov 1, 2022

13 min

Bringing a drug or device to market can be arduous. In this interview with Debra Barngrover of Biologics Consulting, we learn how a consultant can help bring your picture into focus.Guest: Debra BarngroverHost: James C. Taylor

Oct 24, 2022

15 sec

A little bit about the show. 

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