• 00:43 – Ed, Brian and Meranda introduce today’s 2020 Year-In-Review show and look back on learnings from Jim Mencel, Dave Adams and Daniel Torok
• 10:11 – Ed, Brian and Meranda reflect back on their conversations with Rick Offerman, Les Mintzmyer and Dave Blasingame
• 19:06 – Ed, Brian and Meranda talk about a recent panel discussion they held with other CMC experts
• 21:00 – Ed, Brian and Meranda recap episodes featuring Kyriakos Michailaros, Bettina Kaplan and Colman Byrne
• 31:06 – Ed, Brian and Meranda highlight a very special external guest, Hedley Rees who spoke with them about how to create a value chain
• 37:39 – Ed, Brian and Meranda speak to their discussions with Judy Magruder and Catherine Bernard
• 43:05 – Ed, Brian and Meranda wrap up this 2020 Year-In-Review, thank the listeners for their support in 2020 and look forward to what 2021 has in store

“One of the things that resonated with me on that particular podcast was how Dave [Adams] took a step back and said, ‘You really can’t underestimate the importance of the skilled technicians that actually run the process.’” 

“The reality is they still need that person-in-plant. So, I think what Dan [Torok] brings to the table is what a lot of clients look for. Some clients don’t have that infrastructure and they blindly trust the CMO – and sometimes not always to the right result.” 

“I think people are now realizing that they do need to take a lot of different factors into consideration when selecting their CMO and they might need that assistance from experts like us.”

“If you know that you have properly identified and characterized the development history of your product, and its pitfalls, and its areas of concern – and you’ve explored those – it really makes for a much more robust filing that stands up to scrutiny.” 

“We had a special external guest, Hedley Rees, who talked a bit about supply chain and how to create a value chain.” 

“Our job as regulatory reviewers, strategists, authors, CMC experts, is to decipher what the data is saying.” 

“I think that’s the experience that Judy brought to bear is that holistic approach to a client’s program.” 

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Taming the Big Pharma Monster

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