Welcome to CMC.LIVE

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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January 25, 2021

Complexity of Project Management in Drug Development with Paul Long

Paul Long is a Project Management Consultant at Design Space InPharmatics. Paul has supervised government regulatory pharmaceutical industries for over twenty years and has a wealth of business knowledge. He knows how to build and lead high-performing, cross-functional teams, how to prioritize and the importance of meeting budgets and targets. In this episode, Paul, Ed, Meranda and Brian discuss the benefits and challenges of virtual project management during the COVID-19 pandemic, integral project management tools and how project management fits into drug development and the overall CMC space.
January 8, 2021

2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola

In this very special episode of CMC Live, hosts Ed Narke, Brian Lihou and Meranda Parascandola provide an in-depth recap of Season One, complete with direct quotes from all of their illustrious guests. Ed, Brian and Meranda reflect on everything from Jim Mencel’s perspective on expedited drug development programs and Dave Adams’ belief in trusting the API process to Daniel Torok’s analysis of the White Coat Effect and Judy Magruder’s effective strategies for early stage drug development. They share insights from David Blasingame on the advantages and disadvantages of manufacturing in China as well as Hedley Rees’ views on the importance of creating a value chain. Finally, Ed, Brian and Meranda discuss topics they’d like to integrate into Season Two and thank the listeners for their support throughout the year.
December 4, 2020
4 Experts, 120+ Years of Drug Substance Experience: Major Trends You Should Know

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

The market for the manufactured and supplied APIs is changing continuously, and there are many factors influencing these changes. Being aware of these changing trends is important. Perhaps what’s even more important is how you leverage the opportunities they bring and how to react to them. In this episode, Ed, Meranda and Brian talk with a group of drug substance services experts about the major trends you should know and be aware of, and how you can use them to your advantage. This panel includes experts who have appeared on the podcast before: David Blasingame, Jim Mencel, Dave Adams and Daniel Torok.
November 20, 2020

Brexit: What You Need to Know for Drug Development

Amber Sheriff is a Senior Regulatory Affairs Consultant at Design Space InPharmatics. With more than 32 years of experience, Amber is an expert in regulatory strategies for orphan drug designation, exclusivity, controlled correspondences, and briefing books, to name a few. In this episode, Amber, Ed, Meranda and Brian discuss regulatory pathways in the European Union (EU), the impact Brexit has had on CMC filings, and the advantages and disadvantages of the three defined procedures to obtain approval for products in Europe.
November 13, 2020

Outsourcing in China: How far can it go?

David Blasingame is a Director of CMC at Rigel Pharmaceuticals and former Senior Consultant at Design Space InPharmatics. David is an accomplished process chemist with over twenty years of experience in process research and development, API and drug product manufacturing and developing cross-functional and external CMO relationships. In this episode, David, Ed, Meranda and Brian discuss the advantages and disadvantages of outsourcing drug manufacturing to China, the value of person in-plant approach, and the importance of communication and trust in building good partnership relationships.
November 6, 2020

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

In this very special and spooky episode of CMC Live, Ed, Meranda and Brian host a happy hour and invite other members of the Design Space InPharmatics team to share the scariest stories from their careers. From walking through a morgue to gain access to medical records to a very noisy liquid oxygen tank, these stories will be sure to raise the hair on the back of your neck!