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PODCAST

CMC Live - Chemistry, Manufacturing & Controls

Meranda Parascandola, Ed Narke

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

science chemistry

All Episodes

00:31:51

025 - The Parenteral Drug Association & Evolution of...

CMC Live - Chemistry, Manufacturing & Controls ·

2021/03/12

What We Covered00:55 – 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 – The evolution of regulatory approvals in the pharmaceutical industry 17:34 – Mike describes the influence of the PDA today, given the pandemic 20:18

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00:38:59

024 - Quality Management Systems Explained!

CMC Live - Chemistry, Manufacturing & Controls ·

2021/03/05

What We Covered00:54 – 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 Appropriate as it pertains to QMS23:12 – Identifying which guiding documents to follow 27:29 – The value in having an experience quality professional

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00:43:53

023 - A Broadway Performance Analogy for API Process...

CMC Live - Chemistry, Manufacturing & Controls ·

2021/02/26

What We Covered00:52 – Ed, Meranda and Brian welcome back Jim Mencel who shares his extensive experience with process validation07:46 – 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 and gathering necessary stability data 20:49 – How validation material can be used for launch 24:15 – Jim speaks to the importance of writing a Protocol

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00:32:10

022 - Filter Validation & How It Impacts Getting Your...

CMC Live - Chemistry, Manufacturing & Controls ·

2021/02/19

What We Covered00:51 – 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 same09:03 – The evolution and importance of sizing filters 11:26 – Shelli speaks to the shift to single-use disposable filters 13:05 – Qualifying a filter before validation 16:51 – Shelli explains the Bubble Point test 18:53 – Shelli

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01:00:18

021 - Regulatory Odd Couple with Ed Narke & Meranda...

CMC Live - Chemistry, Manufacturing & Controls ·

2021/02/12

What We Covered00:51 – 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 substances/products and the importance of excipients 37:44 – Ed expounds on the analytical aspect of API and regulatory drug development 46:55 – Ed and

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00:48:13

020 - Lessons Gleaned from Twenty Five Years of a...

CMC Live - Chemistry, Manufacturing & Controls ·

2021/01/29

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 –

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00:43:17

019 - Complexity of Project Management in Drug...

CMC Live - Chemistry, Manufacturing & Controls ·

2021/01/22

What We Covered00:55 – 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 management17:09 – How Paul manages working with clients virtually19:08 – Tools Paul integrates in his project management process21:17 – Paul provides examples of how project management fits into drug development24:52 – Paul shares some project management tools that he utilizes,

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00:52:38

018 - 2020: A Year in Review with Ed Narke, Brian...

CMC Live - Chemistry, Manufacturing & Controls ·

2021/01/08

What We Covered00:43 – Ed, Brian and Meranda introduce today’s 2020 Year-In-Review show and look back on learnings from Jim Mencel, Dave Adams and Daniel Torok10:11 – Ed, Brian and Meranda reflect back on their conversations with Rick Offerman, Les Mintzmyer and Dave Blasingame19:06 – Ed, Brian and Meranda talk about a recent panel discussion they held with other CMC experts21:00 – Ed, Brian and Meranda recap episodes featuring Kyriakos Michailaros, Bettina Kaplan and Colman Byrne31:06 – Ed, Brian

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00:34:30

017 - 4 Experts, 120+ Years of Drug Substance...

CMC Live - Chemistry, Manufacturing & Controls ·

2020/12/04

What We Covered01:03 – 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 expresses their shared concerns over the diminishing number of API manufacturing professionals in the United States 23:53 – The panel provides their

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00:32:41

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

CMC Live - Chemistry, Manufacturing & Controls ·

2020/11/20

What We Covered00:54 – 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 Union06:15 – What CMC drug development looks like in the EU and how it differs from the United States11:24 – Amber breaks down specifics of the centralized filing procedure in the EU15:49 – Amber provides insights on the impact of Brexit on CMC filing in

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00:33:40

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

CMC Live - Chemistry, Manufacturing & Controls ·

2020/11/13

What We Covered00:55 – 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 with employee turnover 17:11 – Facts and myths about America’s dependence on medicine from China, overcoming communications issues and the process of

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00:49:53

Halloween Special – Ghosts, Spirits and CMC...

CMC Live - Chemistry, Manufacturing & Controls ·

2020/11/06

What We Covered01:12 – 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 situations21:58 – Paul tells a story of working the graveyard shift at a hospital25:06 – Valerie and Meranda share their own spooky experiences working in pharma35:01 – An Excel Horror Story36:06 – Ed shares a scary email story followed by Dave’s liquid ammonia experience48:55 – Ed, Brian and Meranda thank everyone for

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00:48:01

014 - Why now is the most important time for...

CMC Live - Chemistry, Manufacturing & Controls ·

2020/10/30

What We Covered01:19 – 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 23:14 – Dr. Rick breaks down best practices in cost-control 30:16 – The importance of the project timeline 40:13 – Dr. Rick takes a moment to recognize

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00:41:57

013 - A Discussion on CMC Strategy and Submissions...

CMC Live - Chemistry, Manufacturing & Controls ·

2020/10/23

What We Covered01:16 – Ed, Brian and Meranda take a deep dive into analyzing CMC strategy and submissions11:26 – Ed, Brian and Meranda discuss resources required for compiling CMC dossiers and the importance of understanding roles and responsibilities within this process20:09 – Essential aspects of putting together an effective authoring team25:25 – Brian speaks to the importance of respecting the experience of those that have been working on projects from the jump28:28 – Ed, Brian and Meranda

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00:44:38

012 - Taking Medicines Back to The Future – A...

CMC Live - Chemistry, Manufacturing & Controls ·

2020/10/16

What We Covered00:59 – 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 market09:43 – Hedley speaks to the importance of designing supply chains strategically and why your supply chain is actually your value chain17:51 – Hedley discusses outsourcing in the pharmaceutical industry24:07 – Hedley provides his thoughts on Quality by Design (QBD), including changes that must be made to the

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00:41:49

011 - Hey Google, tell me about the importance of...

CMC Live - Chemistry, Manufacturing & Controls ·

2020/10/09

What We Covered00:53 – 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 risks and concerns as it pertains to drug development programs and what Kyriakos looks for in a comprehensive development report 14:56 – Kyriakos speaks to the

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00:39:40

010 The White Coat Effect is Real – The Role of...

CMC Live - Chemistry, Manufacturing & Controls ·

2020/10/02

What We Covered00:46 – 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 information exchanged in a well-rounded site wrap up report 28:47 – Daniel shares some facts, myths and stories about CMOs 37:47 – Ed, Brian and Meranda thank Daniel

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00:50:50

009 Recipes to Build Towards Your NDA/BLA - Ed Narke,...

CMC Live - Chemistry, Manufacturing & Controls ·

2020/09/25

What We Covered00:44 – Ed, Brian and Meranda join the show to share their experiences in all phases of the pharmaceutical development industry5:12 – 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 speak to the importance of storyboards and telling a story from the right perspective 28:55 – Ed, Brian and Meranda break down the detailed development

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00:49:26

008 Trust the Process with a CMC Process Champion -...

CMC Live - Chemistry, Manufacturing & Controls ·

2020/09/18

What We Covered01:15 – 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 past09:41 – What Dave looks for in a comprehensive, well thought out development program and how he works and interacts with process engineers15:02 – Dave provides his thoughts on sourcing the highest quality raw materials22:53 – Dave discusses the pilot scale example and the critical role of development32:30 –

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00:45:49

007 Selecting a Contract Manufacturing Organization...

CMC Live - Chemistry, Manufacturing & Controls ·

2020/09/11

What We Covered01:32 – 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 the years 24:34 – Challenges of communicating with foreign CMOs, including language and cultural barriers 32:15 – Les provides a brief overview of his

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27 results

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