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Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture InnovationLanguage: en-us Genres: Life Sciences, Science Contact email: Get it Feed URL: Get it iTunes ID: Get it Trailer: |
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248: Nitrosamine Risk Assessment and CRO Selection: The $6 Million Mistake CMC Teams Must Avoid with Ron Najafi with Ron Najafi - Part 2
Episode 248
Wednesday, 29 April, 2026
Getting an NDA signed shouldn't take weeks. If your CRO needs more than 48 hours to start the paperwork, your project timeline is already moving in the wrong direction.Ron Najafi knows what rigorous analytical work actually looks like under pressure. As founder and CEO of Emery Pharma, he led the investigation that identified NDMA as a degradation product of ranitidine — findings the FDA formally validated and that reshaped how the industry approaches nitrosamine risk assessment. In Part 2, he moves from that scientific foundation into the operational questions that determine whether a CRO partnership accelerates your program or quietly slows it down.If you haven't heard Part 1, it covers Ron's career arc and the technical details of nitrosamine contamination in pharmaceutical development. This episode stands on its own for anyone focused on CRO selection, bioanalytical strategy, and what three decades of building analytical companies actually teaches you.Topics discussed:How to tell if a CRO’s workflow is robust—or just rigid (05:51)The importance of method validation and product stability testing (07:27)Managing expectations and trust-building in client relationships (08:29)Entrepreneurial lessons: raising capital, team-building, and finding the right partners (10:00)The hidden costs of public vs. private biotech ventures (12:31)Reducing bioanalytical costs in biologics through mass spectrometry (13:23)The future of analytical workflows and personalized medicine (14:48)Smart insight:In biotech, success isn’t just about the science—it’s about strategic discipline. Ron emphasizes a few hard-earned principles: raise more capital than you think you’ll need, don’t fixate on valuation, and invest in smart, creative talent. Just as important, real value is unlocked through strong partnerships and the ability to manage collaborations and acquisitions with intention.If this topic resonates with you, here are a few related episodes on building strong CMC foundations and avoiding costly development mistakes:Episodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri KornmannEpisodes 203 - 204: Mastering CRO Selection: Essential Questions for CMC Analytical Development with Daniel GalbraithEpisodes 199 - 200: Mastering Quality by Design: From Product Failures to Commercial Success in Biologics CMC DevelopmentEpisodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later)Episodes 139 - 140: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka ZaibelEpisodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias MüllnerEpisodes 23 - 24: Strategies for Success: Master CMC Development with Gene LeeConnect with Ron Najafi:LinkedIn: www.linkedin.com/in/ronnajafiEmery Pharma: www.emerypharma.comSupport the show
