CMC Live - Chemistry, Manufacturing & Controls

003 Effective Strategies for Early Stage Drug Development - Judy Magruder

Episode Summary

Design Space InPharmatics Senior Program Management Consultant, Judy Magruder joins the show to share her vast experience consulting with biopharmaceutical product development organizations. In this episode, Ed, Brian, Meranda and Judy discuss how to approach early stage drug development, how to be flexible in the wake of regulatory challenges, instances where companies should pivot and the vital need for effective communication.

Episode Notes

What We Covered

Tweetable Quotes

“Think big picture first and then all the minutia and the smaller, what I call micro-plans, come later. And, I think that when companies take the time to do that upfront and build a registration strategy, ya know, ‘What does the product need to look like when it hits the market,’ all the plans underneath that become that much more valuable and realistic.” 

“So, things change all the time. And so, whether you do a weekly meeting or a daily meeting or a sub-team, I just love that people know number one, what the change is because communication is the key. It’s so multi-disciplinary. All these different disciplines depend on each other, so communicating change in a succinct way is very important.”

“There’s so many different ways to communicate what’s important, what’s the critical path, what are the milestones and what’s important to focus on today.” 

“It’s like anything in life. Unless you have a plan, there’s no guarantee you’re gonna get there. If you want to increase the probability that you’re going to succeed, you need a plan that shows how you’re gonna get there.” 

Relevant Links

International Council fo Harmonisation

Leadership

Design Space InPharmatics - LinkedIn

Design Space InPharmatics - Twitter

Edward Narke on LinkedIn

Judy Magruder on LinkedIn