CMC Live - Chemistry, Manufacturing & Controls

CMC Live - Chemistry, Manufacturing & Controls

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.

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Episoder(27)

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

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

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 obser...

4 Des 202034min

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

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

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 f...

20 Nov 202032min

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

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

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 manufacturi...

13 Nov 202033min

Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story

Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story

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 – Pa...

6 Nov 202049min

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

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

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 solven...

30 Okt 202048min

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

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

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 imp...

23 Okt 202041min

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

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

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 – Hedl...

16 Okt 202044min

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

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

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 timi...

9 Okt 202041min

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