Best Ed Narke Podcasts (2025)

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025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll 31:51

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5y ago31:51

31:51

What We Covered 00:55 – Ed, Meranda and Brian welcome today’s guest, Mike Carroll, who speaks to his background in microbiology and product development 04:28 – Mike talks about his involvement in the Parenteral Drug Association (PDA) 07:51 – Lessons Mike has learned throughout his career and expounds on the relevance of PDA technical reports 15:03 …

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024 - Quality Management Systems Explained! 38:59

5y ago38:59

38:59

What We Covered 00:54 – Ed, Meranda and Brian welcome a special panel of guests to break down today’s topic: Quality Management Systems (QMS) Explained! 07:53 – The panel expounds on the timing necessary for QMS and what role the quality manual plays 13:06 – The panel explains the Code of Federal Regulations (CFRs) 17:30 – The panel defines Phase A…

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023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel 43:53

5y ago43:53

43:53

What We Covered 00:52 – Ed, Meranda and Brian welcome back Jim Mencel who shares his extensive experience with process validation 07:46 – The importance of Proven Acceptable Range (PAR) and Critical Process Parameter Program (CPP) 11:14 – The evolution of the batch documentation and the value of critical parameter studies 18:07 – Registration laws …

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022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly 32:10

5y ago32:10

32:10

What We Covered 00:51 – Ed, Meranda and Brian introduce today’s guest, Shelli Connelly, who discusses her background and speaks to some of the elements of filter validation 05:41 – Shelli talks about the process of selecting a filter and why not all filters are the same 09:03 – The evolution and importance of sizing filters 11:26 – Shelli speaks to…

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021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola 1:00:18

5y ago1:00:18

1:00:18

What We Covered 00:51 – Meranda and Ed discuss the Regulatory Odd Couple blog series and constructing the CTD Module 3 11:54 – Ed explains the importance of building the Quality Overall Summary (QOS) and the different starting points for drug process development 19:45 – Ed and Meranda talk about characterization, the process of manufacturing drug s…

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020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke 48:13

5y ago48:13

48:13

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 …

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019 - Complexity of Project Management in Drug Development with Paul Long 43:17

5y ago43:17

43:17

What We Covered 00:55 – Ed, Brian and Meranda welcome to the show Paul Long who shares his well-rounded background as a project management consultant and speaks to some of the benefits and challenges of virtual project management 17:09 – How Paul manages working with clients virtually 19:08 – Tools Paul integrates in his project management process …

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018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola 52:38

5y ago52:38

52:38

What We Covered 00:43 – Ed, Brian and Meranda introduce today’s 2020 Year-In-Review show and look back on learnings from Jim Mencel, Dave Adams and Daniel Torok 10:11 – Ed, Brian and Meranda reflect back on their conversations with Rick Offerman, Les Mintzmyer and Dave Blasingame 19:06 – Ed, Brian and Meranda talk about a recent panel discussion th…

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017 - 4 Experts, 120+ Years of Drug Substance Experience: Major Trends You Should Know 34:30

5y ago34:30

34:30

What We Covered 01:03 – Ed, Brian and Meranda welcome to the show a panel of drug substance services experts, Daniel Torok, Dave Adams, Jim Mencel and David Blasingame who speak to trends they’ve observed in the landscape of API manufacturing 07:04 – The panel speaks to the types of drug manufacturing requests they’ve been seeing 14:42 – The panel …

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016 - Brexit: What You Need to Know for Drug Development 32:41

5y ago32:41

32:41

What We Covered 00:54 – Ed, Brian and Meranda welcome to the show Amber Sheriff who speaks to her background as a regulatory affairs specialist in the pharmaceutical industry and the three procedures for obtaining market authorization in the European Union 06:15 – What CMC drug development looks like in the EU and how it differs from the United Sta…

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015 - Outsourcing in China: How far can it go? 33:40

5y ago33:40

33:40

What We Covered 00:55 – Ed, Brian and Meranda welcome to the show David Blasingame who speaks to his extensive background as a process chemist as well as the advantages and disadvantages of manufacturing drugs in China 10:20 – The importance of person in-plant activity and the White Coat Effect 11:29 – David speaks to the issues he’s experienced wi…

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Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story 49:53

5y ago49:53

49:53

What We Covered 01:12 – Introducing a very spooky Halloween Special where Ed, Brian, Meranda and the rest of the DSI Team share stories of time spent in creepy labs and other scary situations 21:58 – Paul tells a story of working the graveyard shift at a hospital 25:06 – Valerie and Meranda share their own spooky experiences working in pharma 35:01…

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014 - Why now is the most important time for selecting a CMO 48:01

5y ago48:01

48:01

What We Covered 01:19 – Ed, Brian and Meranda welcome to the show Dr. Rick Offerman who speaks to his experience as a process chemist, the drug development process and what goes into selecting a solvent 15:41 – The importance of selecting the right CMO partner 19:05 – Questions that must be asked in the beginning of the drug manufacturing process 2…

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013 - A Discussion on CMC Strategy and Submissions with Ed Narke, Brian Lihou & Meranda Parascandola 41:57

5y ago41:57

41:57

What We Covered 01:16 – Ed, Brian and Meranda take a deep dive into analyzing CMC strategy and submissions 11:26 – Ed, Brian and Meranda discuss resources required for compiling CMC dossiers and the importance of understanding roles and responsibilities within this process 20:09 – Essential aspects of putting together an effective authoring team 25…

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012 - Taking Medicines Back to The Future – A Discussion with Hedley Rees on Value Chain vs. Supply Chain: What's the Difference? 44:38

5y ago44:38

44:38

What We Covered 00:59 – Hedley Rees joins the show to share his background in the pharmaceutical industry, his thoughts on Big Pharma and issues he’s observed with medicine coming to market 09:43 – Hedley speaks to the importance of designing supply chains strategically and why your supply chain is actually your value chain 17:51 – Hedley discusses…

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011 - Hey Google, tell me about the importance of living Development Reports with Kyriakos Michailaros 41:49

5y ago41:49

41:49

What We Covered 00:53 – Kyriakos Michailaros joins the show to share his background and expertise in the subject matter of drug product services 02:59 – Kyriakos shares his thoughts on appropriate timing for a development report, the validation process and the importance of having your development report be a living document 08:53 – Addressing risk…

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010 The White Coat Effect is Real – The Role of Person in Plant Discussion - Daniel Torok 39:40

5y ago39:40

39:40

What We Covered 00:46 – 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 building trust in order to become an effective in-plant person 19:59 – Daniel details best practices he utilizes for site visits 24:15 – The informatio…

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009 Recipes to Build Towards Your NDA/BLA - Ed Narke, Brian Lihou and Meranda Parascandola 50:50

5+ y ago50:50

50:50

What We Covered 00:44 – Ed, Brian and Meranda join the show to share their experiences in all phases of the pharmaceutical development industry 5:12 – The process of filing an Investigational New Drug (IND) and a New Drug Application (NDA) 18:54 – What it means to have ‘rest-of-world awareness’ as you author an NDA 22:37 – Ed, Brian and Meranda spe…

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008 Trust the Process with a CMC Process Champion - Dave Adams 49:26

5+ y ago49:26

49:26

What We Covered 01:15 – 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 past 09:41 – What Dave looks for in a comprehensive, well thought out development program and how he works and interacts with process engineers 15:02 – Dave prov…

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007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer 45:49

5+ y ago45:49

45:49

What We Covered 01:32 – 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 uses to identify the best CMO to work with and the importance of timely correspondence 18:59 – Lessons Les has gleaned from the RFP process throughout…

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006 Analytical Method Development - Colman Byrne 50:05

5+ y ago50:05

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What We Covered 00:43 – Colman Byrne joins the show to discuss his background in analytical chemistry and challenges he’s observed in analytical method development and validation 10:27 – Colman’s recommendations for method development and validation plans 15:04 – Colman speaks to the commonality of changing methods mid-stream 22:01 – Regulatory par…

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005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard 35:21

5+ y ago35:21

35:21

What We Covered 03:00 – Dr. Catherine Bernard joins the show to discuss her background in regulatory affairs within the pharmaceutical industry 07:35 – Dr. Catherine speaks to some of the challenges associated with preparing a CMC dossier 10:38 – Dr. Catherine speaks to the vital role project management plays in submissions and explains realistic t…

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004 Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan 33:15

5+ y ago33:15

33:15

What We Covered 02:08 – Bettina Kaplan joins the show to discuss her background in quality assurance, compliance and auditing within the pharmaceutical industry 09:43 – Trends in quality auditing that Bettina observed before the shutdown and strategies to ensure a successful audit 12:48 – Bettina expounds on when it’s appropriate to have an expert,…

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003 Effective Strategies for Early Stage Drug Development - Judy Magruder 28:41

5+ y ago28:41

28:41

What We Covered 02:10 – Judy Magruder joins the show to discuss her background in early stage drug development and best practices for creating integrated product plans 06:21 – Judy provides her insights on CMC and the importance of identifying effective ways of executing strategy shifts in this ever-changing industry 13:09 – Other communication too…

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002 Establishing Regulatory Starting Materials & Understanding the ICH - James Mencel 35:16

5+ y ago35:16

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What We Covered 00:54 – James continues his discussion of expedited drug development programs, focusing on the importance of establishing regulatory starting materials 07:34 – James provides best practices for working with clients who don’t want to approach the FDA proactively and curating fallback plans 11:45 – James speaks to strategies for estab…

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001 Expedited Drug Development - James Mencel 18:51

5+ y ago18:51

18:51

What We Covered 00:23 – James discusses regulations and the importance of starting with big ideas when it comes to expedited drug development programs 05:44 – Breakthrough designations that occur as a result of expedited drug development programs 08:20 – When a sponsor should consider applying for expedited drug development 11:14 – James speaks to …

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Welcome to CMC Live! 13:59

5+ y ago13:59

13:59

Enjoying the show? Please leave us a rating and review at http://ratethispodcast.com/cmcliveBy Ed Narke, Brian Lihou, Meranda Parascandola

Ed Narke Podcasts

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CMC Live - Chemistry, Manufacturing & Controls

Meranda Parascandola, Ed Narke

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025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll 31:51

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024 - Quality Management Systems Explained! 38:59

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023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel 43:53

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022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly 32:10

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021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola 1:00:18

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020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke 48:13

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019 - Complexity of Project Management in Drug Development with Paul Long 43:17

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018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola 52:38

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017 - 4 Experts, 120+ Years of Drug Substance Experience: Major Trends You Should Know 34:30

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016 - Brexit: What You Need to Know for Drug Development 32:41

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015 - Outsourcing in China: How far can it go? 33:40

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Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story 49:53

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014 - Why now is the most important time for selecting a CMO 48:01

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013 - A Discussion on CMC Strategy and Submissions with Ed Narke, Brian Lihou & Meranda Parascandola 41:57

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012 - Taking Medicines Back to The Future – A Discussion with Hedley Rees on Value Chain vs. Supply Chain: What's the Difference? 44:38

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011 - Hey Google, tell me about the importance of living Development Reports with Kyriakos Michailaros 41:49

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010 The White Coat Effect is Real – The Role of Person in Plant Discussion - Daniel Torok 39:40

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009 Recipes to Build Towards Your NDA/BLA - Ed Narke, Brian Lihou and Meranda Parascandola 50:50

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008 Trust the Process with a CMC Process Champion - Dave Adams 49:26

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007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer 45:49

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006 Analytical Method Development - Colman Byrne 50:05

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005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard 35:21

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004 Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan 33:15

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003 Effective Strategies for Early Stage Drug Development - Judy Magruder 28:41

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002 Establishing Regulatory Starting Materials & Understanding the ICH - James Mencel 35:16

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001 Expedited Drug Development - James Mencel 18:51

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Welcome to CMC Live! 13:59