003 Effective Strategies for Early Stage Drug Development - Judy Magruder

CMC Live - Chemistry, Manufacturing & Controls

What We Covered

• 02:10 – Judy Magruder joins the show to discuss her background in early stage drug development and best practices for creating integrated product plans
• 06:21 – Judy provides her insights on CMC and the importance of identifying effective ways of executing strategy shifts in this ever-changing industry
• 13:09 – Other communication tools early stage companies can use to meet milestones
• 14:39 – How to manage expectations and risks as a CMO or head of an early stage drug development company
• 21:52 – Judy expounds on CMC regulatory challenges that early stage companies face and the importance of developing a plan
• 26:58 – Ed, Brian and Meranda thank Judy for joining the show

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