CMC Live - Chemistry, Manufacturing & Controls
27 episodes - English - Latest episode: about 3 years ago -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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Episodes
025 - The Parenteral Drug Association & Evolution of Drug Development with Michael Carroll
March 12, 2021 11:00 - 31 minutes - 29.2 MBWhat 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 – The evolution of regulatory approvals in the pharmaceutical industry 17:34 – Mike describes the influence of the PDA today, given t...
024 - Quality Management Systems Explained!
March 05, 2021 11:00 - 38 minutes - 35.7 MBWhat 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 Appropriate as it pertains to QMS 23:12 – Identifying which guiding documents to follow 27:29 – The value in having an experience qua...
023 - A Broadway Performance Analogy for API Process Validations with Jim Mencel
February 26, 2021 11:00 - 43 minutes - 40.2 MBWhat 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 and gathering necessary stability data 20:49 – How validation material can be used for launch 24:15 – Jim speaks to the importance o...
022 - Filter Validation & How It Impacts Getting Your Product to Market with Shelli Connelly
February 19, 2021 11:00 - 32 minutes - 29.5 MBWhat 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 the shift to single-use disposable filters 13:05 – Qualifying a filter before validation 16:51 – Shelli explains the Bubble Point t...
021 - Regulatory Odd Couple with Ed Narke & Meranda Parascandola
February 12, 2021 23:00 - 1 hour - 55.2 MBWhat 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 substances/products and the importance of excipients 37:44 – Ed expounds on the analytical aspect of API and regulatory drug development ...
020 - Lessons Gleaned from Twenty Five Years of a Regulatory CMC Life with Ed Narke
January 29, 2021 11:17 - 48 minutes - 44.1 MBWhat 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 CMC industry 17:11 – Ed talks about his personal background and roots and the value of being adaptable and the impact COVID-19 has had on his ...
019 - Complexity of Project Management in Drug Development with Paul Long
January 22, 2021 11:48 - 43 minutes - 39.6 MBWhat 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 21:17 – Paul provides examples of how project management fits into drug development 24:52 – Paul shares some project management tools that he...
018 - 2020: A Year in Review with Ed Narke, Brian Lihou & Meranda Parascandola
January 08, 2021 11:00 - 52 minutes - 48.2 MBWhat 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 they held with other CMC experts 21:00 – Ed, Brian and Meranda recap episodes featuring Kyriakos Michailaros, Bettina Kaplan and Colman Byrne 3...
017 - 4 Experts, 120+ Years of Drug Substance Experience: Major Trends You Should Know
December 04, 2020 11:00 - 34 minutes - 31.6 MBWhat 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 expresses their shared concerns over the diminishing number of API manufacturing professionals in the United States 23:53 – The panel provi...
016 - Brexit: What You Need to Know for Drug Development
November 20, 2020 11:00 - 32 minutes - 29.9 MBWhat 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 States 11:24 – Amber breaks down specifics of the centralized filing procedure in the EU 15:49 – Amber provides insights on the impact of Brexit ...
015 - Outsourcing in China: How far can it go?
November 13, 2020 11:00 - 33 minutes - 30.8 MBWhat 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 with employee turnover 17:11 – Facts and myths about America’s dependence on medicine from China, overcoming communications issues and the...
Halloween Special – Ghosts, Spirits and CMC Regulatory, A Halloween Story
November 06, 2020 11:00 - 49 minutes - 45.7 MBWhat 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 – An Excel Horror Story 36:06 – Ed shares a scary email story followed by Dave’s liquid ammonia experience 48:55 – Ed, Brian and Meranda th...
014 - Why now is the most important time for selecting a CMO
October 30, 2020 10:00 - 48 minutes - 44 MBWhat 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 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 mome...
013 - A Discussion on CMC Strategy and Submissions with Ed Narke, Brian Lihou & Meranda Parascandola
October 23, 2020 10:00 - 41 minutes - 38.4 MBWhat 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 25:25 – Brian speaks to the importance of respecting the experience of those that have been working on projects from the jump 28:28 – Ed, Brian...
012 - Taking Medicines Back to The Future – A Discussion with Hedley Rees on Value Chain vs. Supply Chain: What's the Difference?
October 16, 2020 10:00 - 44 minutes - 40.9 MBWhat 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 outsourcing in the pharmaceutical industry 24:07 – Hedley provides his thoughts on Quality by Design (QBD), including changes that must be ma...
011 - Hey Google, tell me about the importance of living Development Reports with Kyriakos Michailaros
October 09, 2020 10:00 - 41 minutes - 38.3 MBWhat 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 risks and concerns as it pertains to drug development programs and what Kyriakos looks for in a comprehensive development report 14:56 – Kyriak...
010 The White Coat Effect is Real – The Role of Person in Plant Discussion - Daniel Torok
October 02, 2020 10:00 - 39 minutes - 36.3 MBWhat 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 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 ...
009 Recipes to Build Towards Your NDA/BLA - Ed Narke, Brian Lihou and Meranda Parascandola
September 25, 2020 10:00 - 50 minutes - 46.5 MBWhat 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 speak to the importance of storyboards and telling a story from the right perspective 28:55 – Ed, Brian and Meranda break down the detailed d...
008 Trust the Process with a CMC Process Champion - Dave Adams
September 18, 2020 10:00 - 49 minutes - 45.3 MBWhat 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 provides his thoughts on sourcing the highest quality raw materials 22:53 – Dave discusses the pilot scale example and the critical role of develo...
007 Selecting a Contract Manufacturing Organization (CMO) - ‘Super’ Les Mintzmyer
September 11, 2020 10:00 - 45 minutes - 41.9 MBWhat 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 the years 24:34 – Challenges of communicating with foreign CMOs, including language and cultural barriers 32:15 – Les provides a brief o...
006 Analytical Method Development - Colman Byrne
September 04, 2020 10:00 - 50 minutes - 45.9 MBWhat 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 parameters that exist for analytical method development and validation for drug development 35:11 – Other physiochemical properties that can a...
005 Pharmaceutical Regulations in CMC - Dr. Catherine Bernard
August 28, 2020 10:00 - 35 minutes - 32.4 MBWhat 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 timelines and target dates 12:58 – Dr. Catherine talks about her experience with breakthrough designations and managing sponsor expectations 2...
004 Quality Assurance and Auditing in the Age of Covid-19 - Bettina Kaplan
August 21, 2020 10:00 - 33 minutes - 30.4 MBWhat 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, such as an analyst or a drug substance chemist, present during an audit 14:42 – Bettina speaks to challenges that Covid-19 has posed to audit...
003 Effective Strategies for Early Stage Drug Development - Judy Magruder
August 14, 2020 11:00 - 28 minutes - 26.3 MBWhat 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 tools early stage companies can use to meet milestones 14:39 – How to manage expectations and risks as a CMO or head of an early stage drug devel...
002 Establishing Regulatory Starting Materials & Understanding the ICH - James Mencel
August 07, 2020 10:56 - 35 minutes - 32.3 MBWhat 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 establishing ideal regulatory starting materials 16:44 – James shares his thoughts on ICH Q11 20:39 – James expounds on the idea behind Quality...
001 Expedited Drug Development - James Mencel
July 31, 2020 11:53 - 18 minutes - 17.3 MBWhat 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 his unique background and experiences with CMC including obstacles and challenges that CMC faces 15:02 – What companies can do to get ahead o...
Welcome to CMC Live!
July 04, 2020 13:47 - 13 minutes - 12.8 MBEnjoying the show? Please leave us a rating and review at http://ratethispodcast.com/cmclive