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

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

FromCMC Live - Chemistry, Manufacturing & Controls


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

FromCMC Live - Chemistry, Manufacturing & Controls

ratings:
Length:
48 minutes
Released:
Jan 29, 2021
Format:
Podcast episode

Description

What We Covered00:54 – Meranda and Brian flip the script by introducing fellow host, Ed Narke as today’s guest01:56 – Ed speaks to his extensive background in CMC and the importance he places on building relationships based on trust11:06 – Ed expounds on his role at DSI and the impact he, Brian, Meranda and the entire DSI team are having on the CMC industry17:11 – Ed talks about his personal background and roots and the value of being adaptable and the impact COVID-19 has had on his business21:36 – Ed thanks some of the many mentors and friends who have assisted him throughout his career26:48 – Ed provides best practices and advice for operating within the CMC industry30:55 – How Ed strives to build trust in relationships37:27 – Ed shares some of his thoughts on the keys to his success40:32 – Ed answers a listener question about microbiome-based products43:31 – The value of developing powerful, positive routines45:46 – Understanding the urgency of self-improvementTweetable 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 LinksDesign Space InPharmatics – LinkedInDesign Space InPharmatics – TwitterEdward Narke on LinkedIn
Released:
Jan 29, 2021
Format:
Podcast episode

Titles in the series (27)

FDA CMC regulations and guidance simplified through examination, real life experiences and risk-based advice. This podcast hopes to educate sponsors and individuals on agency related regulatory CMC matters. We will focus on the critical CMC issues and build programs that enhance drug development. CMC topics will include Regulatory Starting Materials, API and Drug Product Process, Formulation Development, Supply Chains, Analytical Controls. Advocating and interpreting CMC Strategy, directing CMC Operations and Quality Assurance oversight in conjunction with developing CMC submission content that represents the best interests of emerging biotech. NOT INTENDED TO BE PRESCRIPTIVE ADVICE BUT RATHER INTERPRETATION THAT IS RIGHT FOR YOU. Since 2007 we have provided our partners with innovative strategies and exceptional advice intended to enhance program development, product approval, and marketing presence.