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

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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 turns 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.

What We Covered

  • 00:54 – Meranda 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… Click To Tweet Comparing INDs, NDAs, BLAs, I’ve always had this fascination with putting stuff together into a story.’ Click To Tweet I hope I look back in fourteen years and say, ‘These are the best days of my life.’ Click To Tweet One of the things I have to remind myself every day is that life really hasn’t changed, I have. Click To Tweet Everything I learned that is valuable and dicey and on the edge I learned from Dan (Torok). Click To Tweet My goal, hopefully, is to grow CMC Live, make it more interactive and maybe have a live audience with questions. Click To Tweet To truly build trust, I learned it’s better for my colleagues to get to know me as a person. Click To Tweet Two things control the way we operate and who we are: our brains and our gut. Click To Tweet

Links Mentioned

Design Space InPharmatics – LinkedIn

Design Space InPharmatics – Twitter

Edward Narke on LinkedIn