CMC Live - Chemistry, Manufacturing & Controls

What We Covered00:43 – Colman Byrne joins the show to discuss his background in analytical chemistry and challenges he’s observed in analytical method development and validation10:27 – Colman’s recommendations for method development and validation plans15:04 – 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 affect method

What We Covered03:00 – Dr. Catherine Bernard joins the show to discuss her background in regulatory affairs within the pharmaceutical industry07:35 – Dr. Catherine speaks to some of the challenges associated with preparing a CMC dossier10:38 – Dr. Catherine speaks to the vital role project management plays in submissions and explains realistic timelines and target dates12:58 – Dr. Catherine talks about her experience with breakthrough designations and managing sponsor expectations20:59 – The

What We Covered02:08 – Bettina Kaplan joins the show to discuss her background in quality assurance, compliance and auditing within the pharmaceutical industry09:43 – Trends in quality auditing that Bettina observed before the shutdown and strategies to ensure a successful audit12:48 – Bettina expounds on when it’s appropriate to have an expert, such as an analyst or a drug substance chemist, present during an audit14:42 – Bettina speaks to challenges that Covid-19 has posed to auditing and how she

What We Covered02:10 – Judy Magruder joins the show to discuss her background in early stage drug development and best practices for creating integrated product plans06:21 – Judy provides her insights on CMC and the importance of identifying effective ways of executing strategy shifts in this ever-changing industry13:09 – Other communication tools early stage companies can use to meet milestones14:39 – How to manage expectations and risks as a CMO or head of an early stage drug development

What We Covered00:54 – James continues his discussion of expedited drug development programs, focusing on the importance of establishing regulatory starting materials07:34 – 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 by Design

What We Covered00:23 – James discusses regulations and the importance of starting with big ideas when it comes to expedited drug development programs05:44 – Breakthrough designations that occur as a result of expedited drug development programs08:20 – When a sponsor should consider applying for expedited drug development11:14 – James speaks to his unique background and experiences with CMC including obstacles and challenges that CMC faces15:02 – What companies can do to get ahead of the curve when

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