010 The White Coat Effect is Real – The Role of Person in Plant Discussion - Daniel Torok
What We Covered00:46 – Daniel Torok joins the show to share his experience as a process chemist and collaborating with CMOs in the pharmaceutical industry 07:54 – Daniel speaks to the importance of bu...
2 Okt 202039min
009 Recipes to Build Towards Your NDA/BLA - Ed Narke, Brian Lihou and Meranda Parascandola
What We Covered00:44 – Ed, Brian and Meranda join the show to share their experiences in all phases of the pharmaceutical development industry5:12 – The process of filing an Investigational New Drug (...
25 Sep 202050min
008 Trust the Process with a CMC Process Champion - Dave Adams
What We Covered01:15 – Dave Adams joins the show to discuss his experience with active pharmaceutical ingredients (APIs) and provides examples of how he’s solved problems with APIs in the past09:41 – ...
18 Sep 202049min
007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer
What We Covered01:32 – Les Mintzmyer joins the show to discuss his background in biologics manufacturing, speak to CMO selection, and break down the RFP process 08:14 – Les speaks to the criteria he u...
11 Sep 202045min
006 Analytical Method Development - Colman Byrne
What We Covered00:43 – Colman Byrne joins the show to discuss his background in analytical chemistry and challenges he’s observed in analytical method development and validation10:27 – Colman’s recomm...
4 Sep 202050min
005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard
What We Covered03:00 – Dr. Catherine Bernard joins the show to discuss her background in regulatory affairs within the pharmaceutical industry07:35 – Dr. Catherine speaks to some of the challenges ass...
28 Aug 202035min
004 Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan
What We Covered02:08 – Bettina Kaplan joins the show to discuss her background in quality assurance, compliance and auditing within the pharmaceutical industry09:43 – Trends in quality auditing that B...
21 Aug 202033min
003 Effective Strategies for Early Stage Drug Development - Judy Magruder
What We Covered02:10 – Judy Magruder joins the show to discuss her background in early stage drug development and best practices for creating integrated product plans06:21 – Judy provides her insights...
14 Aug 202028min
