CMC Live - Chemistry, Manufacturing & Controls

020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke

Episode Summary

Ed Narke is the co-founder, Principal and Managing Regulatory Director at Design Space InPharmatics. In this episode, Meranda and Brian are turning the tables on Ed and turning him from interviewer to interviewee. Ed touches on his hometown roots, his extensive background in CMC and drug development and lessons learned throughout his career. He expounds on his current role at DSI and the impact his team has had on the industry. Ed lists some of the many mentors-turned-friends he’s had the pleasure of meeting throughout this journey and thanks them for the life lessons they taught him. Finally, Ed talks about the importance of developing powerful, positive routines in order to navigate this virtual new normal in the remote world. Those who embrace change are more likely to experience accelerated growth and wind up ahead of the pack.

Episode Notes

What We Covered

Tweetable Quotes

“I look back on my career and I kind of made a few big mistakes. For example, I went into the office of the Vice President at this company to resign. I was a kid and I was just upset about certain stupid little things. And, when I walked in there, instead of leaving the job, I made a connection with him as another lifelong mentor.” 

“Comparing INDs, NDAs, BLAs, I’ve always had this fascination with putting stuff together into a story.” 

“I hope I look back in fourteen years and say, ‘These are the best days of my life.’” 

“One of the things I have to remind myself every day is that life really hasn’t changed, I have.”

“Everything I learned that is valuable and dicey and on the edge I learned from Dan [Torok].” 

“My goal, hopefully, is to grow CMC Live, make it more interactive and maybe have a live audience with questions.” 

“To truly build trust, I learned it’s better for my colleagues to get to know me as a person.” 

“Two things control the way we operate and who we are: our brains and our gut.” 

Relevant Links

Design Space InPharmatics – LinkedIn

Design Space InPharmatics – Twitter

Edward Narke on LinkedIn