Podcasts by CMC Live - Chemistry, Manufacturing

CMC Live - Chemistry, Manufacturing

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.

Further podcasts by Ed Narke, Meranda Parascandola

Podcast on the topic Chemie

All episodes

CMC Live - Chemistry, Manufacturing
Welcome to CMC Live! from 2023-12-12T16:42:53.509784

Enjoying the show? Please leave us a rating and review at http://ratethispodcast.com/cmclive

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CMC Live - Chemistry, Manufacturing
002 Establishing Regulatory Starting Materials&Understanding the ICH - James Mencel from 2023-12-12T16:42:53.502791

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...

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CMC Live - Chemistry, Manufacturing
006 Analytical Method Development - Colman Byrne from 2023-12-12T16:42:53.490676

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 Listen
CMC Live - Chemistry, Manufacturing
010 The White Coat Effect is Real – The Role of Person in Plant Discussion - Daniel Torok from 2023-12-12T16:42:53.469882

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 s...

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CMC Live - Chemistry, Manufacturing
011 - Hey Google, tell me about the importance of living Development Reports with Kyriakos Michailaros from 2023-12-12T16:42:53.463359

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...

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CMC Live - Chemistry, Manufacturing
Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story from 2023-12-12T16:42:53.444495

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 ...

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CMC Live - Chemistry, Manufacturing
017 - 4 Experts, 120+ Years of Drug Substance Experience: Major Trends You Should Know from 2023-12-12T16:42:53.431947

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 ...

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CMC Live - Chemistry, Manufacturing
018 - 2020: A Year in Review with Ed Narke, Brian Lihou&Meranda Parascandola from 2023-12-12T16:42:53.425106

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, ...

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CMC Live - Chemistry, Manufacturing
024 - Quality Management Systems Explained! from 2023-12-12T16:42:53.402839

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 ...

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CMC Live - Chemistry, Manufacturing
025 - The Parenteral Drug Association&Evolution of Drug Development with Michael Carroll from 2021-03-12T11:00

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 ...

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CMC Live - Chemistry, Manufacturing
023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel from 2021-02-26T11:00

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...

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CMC Live - Chemistry, Manufacturing
022 - Filter Validation&How It Impacts Getting Your Product to Market with Shelli Connelly from 2021-02-19T11:00

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  
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CMC Live - Chemistry, Manufacturing
021 - Regulatory Odd Couple with Ed Narke&Meranda Parascandola from 2021-02-12T23:00

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 Q...

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CMC Live - Chemistry, Manufacturing
020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke from 2021-01-29T11:17:59

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 ...

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CMC Live - Chemistry, Manufacturing
019 - Complexity of Project Management in Drug Development with Paul Long from 2021-01-22T11:48:30

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 benef...

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CMC Live - Chemistry, Manufacturing
016 - Brexit: What You Need to Know for Drug Development from 2020-11-20T11:00

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 th...

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CMC Live - Chemistry, Manufacturing
015 - Outsourcing in China: How far can it go? from 2020-11-13T11:00

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 disadvan...

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CMC Live - Chemistry, Manufacturing
014 - Why now is the most important time for selecting a CMO from 2020-10-30T10:00

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 int...

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CMC Live - Chemistry, Manufacturing
013 - A Discussion on CMC Strategy and Submissions with Ed Narke, Brian Lihou&Meranda Parascandola from 2020-10-23T10:00

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 compi...

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CMC Live - Chemistry, Manufacturing
012 - Taking Medicines Back to The Future – A Discussion with Hedley Rees on Value Chain vs. Supply Chain: What's the Difference? from 2020-10-16T10:00

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 t...

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CMC Live - Chemistry, Manufacturing
009 Recipes to Build Towards Your NDA/BLA - Ed Narke, Brian Lihou and Meranda Parascandola from 2020-09-25T10:00:05

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 ...

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CMC Live - Chemistry, Manufacturing
008 Trust the Process with a CMC Process Champion - Dave Adams from 2020-09-18T10:00:16

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...

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CMC Live - Chemistry, Manufacturing
007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer from 2020-09-11T10:00:03

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 – Le...

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CMC Live - Chemistry, Manufacturing
005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard from 2020-08-28T10:00:42

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 ...

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CMC Live - Chemistry, Manufacturing
004 Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan from 2020-08-21T10:00:27

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 – Tren...

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CMC Live - Chemistry, Manufacturing
003 Effective Strategies for Early Stage Drug Development - Judy Magruder from 2020-08-14T11:00:03

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...

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CMC Live - Chemistry, Manufacturing
001 Expedited Drug Development - James Mencel from 2020-07-31T11:53:13

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 d...

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