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

CMC Live - Chemistry, Manufacturing & Controls

What We Covered

  • 00:54 – Meranda and Brian flip the script by introducing fellow host, Ed Narke as today’s guest
  • 01:56 – Ed speaks to his extensive background in CMC and the importance he places on building relationships based on trust
  • 11:06 – Ed expounds on his role at DSI and the impact he, Brian, Meranda and the entire DSI team are having on the CMC industry
  • 17:11 – Ed talks about his personal background and roots and the value of being adaptable and the impact COVID-19 has had on his business
  • 21:36 – Ed thanks some of the many mentors and friends who have assisted him throughout his career
  • 26:48 – Ed provides best practices and advice for operating within the CMC industry
  • 30:55 – How Ed strives to build trust in relationships
  • 37:27 – Ed shares some of his thoughts on the keys to his success
  • 40:32 – Ed answers a listener question about microbiome-based products
  • 43:31 – The value of developing powerful, positive routines
  • 45:46 – Understanding the urgency of self-improvement

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

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