Effective Strategies for Early Stage Drug Development with Judy Magruder
Establishing Regulatory Starting Materials & Understanding the ICH with James Mencel
August 7, 2020
Quality Assurance and Auditing in the Age of Covid-19 with Bettina Kaplan
August 21, 2020
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.
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… Click To Tweet 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… Click To Tweet 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. Click To Tweet 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. Click To TweetLinks Mentioned
International Council fo Harmonisation
Design Space InPharmatics – LinkedIn
