Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

• 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) - Part 2

  Still think you can "figure out CMC later"? Your competitors just implemented a systematic framework that cuts their IND timeline in half while you're still debating whether CMC matters.The founders who file INDs predictably aren't smarter than you. They just stopped gambling with ad-hoc CMC approaches and started executing proven systems. While you're wrestling with technical details in crisis mode, they built systematic advantages that turn regulatory complexity into competitive weapons.In this episode, host David Brühlmann delivers the complete five-step framework that transforms CMC from startup-killer into market advantage. This isn't theory. These are the exact systematic approaches helping founders file INDs in 10-12 months while competitors struggle with preventable delays.The strategic reality: Systematic CMC isn't about becoming a technical expert. It's about becoming strategically smart about expert partnerships and execution frameworks. Smart founders focus on "WHO not HOW," building the right team while maintaining strategic control.Three key takeaways that will transform your approach:Start Early, Think Strategically: Early, deliberate CMC planning isn't just for big pharma. Linking your product's clinical goals to quality, process, and regulatory milestones from day one eliminates expensive delays later. Smart founders build systematic CMC advantages while competitors treat it as an afterthought.Quality by Design as Competitive Weapon: Pinpointing critical quality attributes and mapping them to real patient outcomes creates scientific credibility that accelerates every downstream decision. This isn't regulatory box-checking. This is building the foundation that impresses investors, satisfies regulators, and prevents costly manufacturing surprises.Systematic Risk Management as Submission Insurance: A living, well-documented risk register can be the difference between confident IND filing and regulatory rejection. Poor risk tracking is cited by FDA and EMA as a recurring deficiency that leads to clinical holds and expensive delays. Don't become the cautionary tale.This five-step framework creates predictable execution that transforms CMC from crisis management into strategic capability. Instead of reacting to problems, you prevent them. Rather than scrambling under pressure, you scale smoothly from development to commercialization.Ready to bring structure and confidence to your own CMC program? Explore David’s CMC dashboard via the link below , and catch his walkthrough to see the system in action.Solid CMC execution starts with the right conversation.Next step:De-risk CMC development and get decision-making guidance with a new AI platform that transforms CMC overwhelm into predictable development success (launching early 2026). Join the waitlist here: https://david-jkhjdoje.scoreapp.com🧬 Stop second-guessing your CMC strategy before investor meetings. Our 1-Week CMC Assessment reveals your roadmap gaps and transforms uncertain founders into confident presenters who ace investor meetings. Secure your assessment at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-readySupport the show

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• 189: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) - Part 1

  Think you can crack the science first and worry about CMC when you "need it"? That's exactly how promising therapies die in regulatory limbo while patients keep waiting.Your breakthrough discovery means nothing if it's trapped in CMC chaos. While you're perfecting your molecular mechanism, competitors with inferior science but superior CMC strategy are racing past you to IND filing and ultimately, to patients.In this episode, I, David Brühlmann, your usual host, expose the dangerous delusion that's quietly bankrupting biotech startups: the belief that brilliant science automatically translates to successful drug development. Drawing from years of watching founders burn through millions because they treated CMC as an afterthought, I reveal why the smartest scientific minds often make the most catastrophic business decisions.Here's the hard truth you'll confront in this episode:The $50M Misconception: Why "CMC is just manufacturing" thinking destroys companies before they ever reach Phase II. While you're debating molecular targets, smart founders are building systematic CMC advantages that compress timelines and slash costs. The FDA doesn't care how elegant your science is if you can't demonstrate consistent, scalable manufacturing.The Brutal Mathematics of Delay: Systematic CMC approach: 10-12 months to IND, 85% hit timelines. "Figure it out later" approach: 15 months or more, and a much lower success rate. Every month you delay isn't just burning cash. If your therapy could help 10,000 patients annually, that's 833 people per month who don't get treatment because of preventable delays.Three Founder Myths That Kill Programs: The misconceptions about CMC being "basically just manufacturing," bringing in experts "when we need them," and CDMOs handling "the complicated stuff." Each myth leads to the same outcome: brilliant science trapped by business incompetence.Your Four-Action Emergency Protocol: Stop hoping CMC will work out. Start implementing systematic approaches. I give you four specific actions to execute this week, not someday when you're "ready," but right now while you can still prevent the crisis that kills 40% of biotech programs.The competitive reality: While you're listening to this episode, your biggest competitor just moved closer to IND filing. Maybe they completed process validation. Maybe they locked in analytical methods. The question isn't whether CMC matters. It's whether you'll master it before your competitors do.Next step:❗️De-risk CMC development and get decision-making guidance with a new AI platform that transforms CMC overwhelm into predictable development success (launching early 2026). Join the waitlist here: https://david-jkhjdoje.scoreapp.com🧬 Stop second-guessing your CMC strategy before investor meetings. Our 1-Week CMC Assessment reveals your roadmap gaps and transforms uncertain founders into confident presenters who ace investor meetings. Secure your assessment at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-readySupport the show

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• 188: From Biology Is Messy to Designable: The Smart Bioprocessing Transformation with Carmen Jungo Rhême - Part 2

  For too long, biotech innovators have viewed biological systems as inherently messy, unpredictable, and full of “black box” mysteries. But what if, armed with the latest digital tools, AI, and cross-disciplinary thinking, you could transform bioprocessing from a series of trial-and-error experiments to a streamlined, proactive design process?Carmen Jungo Rhême is Full Professor at the University of Applied Sciences in Fribourg (HEIA-FR) and Director of the Biofactory Competence Center (BCC). With 17 years in the pharmaceutical industry at companies like Lonza, Merck Serono, UCB Farchim, and CSL Behring, she specializes in bioprocess development, protein purification, scale-up, and technology transfer. Since joining HEIA-FR in late 2023, she has launched research projects tackling antimicrobial resistance, sustainable food production, and bioprocess digitalization.Here are three reasons why this episode is a must-listen:A Blueprint for Scalable Bioprocessing: Carmen reveals the structured, four-phase approach the BCC uses to help startups and established companies alike, from feasibility and risk assessment, to scalable process design, tailored analytics, and seamless tech transfer to GMP manufacturing.The Future-Proof Skill Set: Discover why data management, digital tool adaptability, and systems thinking are non-negotiable skills for biotech professionals in the next five years and how both newcomers and seasoned scientists can level up.Bioprocessing as Design, Not Chaos: Learn how shifting your mindset from reactive to proactive, and from “biology is messy” to “biology is designable,” can unlock robust processes, faster innovation, and truly sustainable solutions.Ready to smarten up your biotech game? Listen in as Carmen and David unpack practical, actionable strategies for mastering modern bioprocessing—no matter your starting point.Connect with Carmen Jungo Rhême:LinkedIn: www.linkedin.com/in/carmenjungoWebsite: www.heia-fr.ch/en/applied-research/bcc/Next step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call🧬 Stop second-guessing your CMC strategy before investor meetings. Our 1-Week CMC Assessment reveals your roadmap gaps and transforms uncertain founders into confident presenters who ace investor meetings. Secure your assessment at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-readySupport the show

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• 187: From Biology Is Messy to Designable: The Smart Bioprocessing Transformation with Carmen Jungo Rhême - Part 1

  Almost every corner of modern medicine and sustainable food production today is facing a massive challenge: how do we outpace drug-resistant “superbugs” and create food for a growing population using fewer resources? The answer, it turns out, may come down to how well we understand and control the biomanufacturing processes underpinning these biomaterials and biomolecules.In this episode, David Brühlmann speaks with Carmen Jungo Rhême, Full Professor at the University of Applied Sciences in Fribourg, Switzerland and Director of the Biofactory Competence Center. With years in the pharmaceutical industry at Lonza, Merck Serono, UCB Farchim, and CSL Behring, she now tackles global challenges like antimicrobial resistance, sustainable food, and digitalization. From her beginnings in chemical engineering at EPFL to leading at the nexus of academia and industry, Carmen is helping shape the future of smarter, more robust biotech.Here are three reasons why this episode is a must-listen:Antimicrobial Resistance - Smarter Solutions: Carmen explains how phage therapy, recombinant proteins like endolysins, and smart bioprocess design are helping outmanoeuvre drug-resistant pathogens. In partnership with the University Hospital in Lausanne, her team is developing GMP-ready phage production using quality-by-design methods from mainstream recombinant protein manufacturing, bringing phages back into clinical relevance.From Cheese Whey to Microalgae: Applying pharma-grade principles to food, BCC is turning Swiss cheese by-products into nutrient-rich microalgae, offering a new path for sustainable protein and lipid production while transforming food waste into valuable resources.Digitalization - The Connecting Thread: Mapping and controlling hundreds of process parameters is key to robust, reproducible innovation. Carmen shows how data-driven process characterization links antimicrobial strategies and sustainable food production through the power of digital analytics.Curious about how smarter bioprocesses could help you solve tomorrow’s biggest biotech challenges? Tune in to hear how Carmen’s approach could transform your perspective on both health and food security.Connect with Carmen Jungo Rhême:LinkedIn: www.linkedin.com/in/carmenjungoWebsite: www.heia-fr.ch/en/applied-research/bcc/Next step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call🧬 Stop second-guessing your CMC strategy before investor meetings. Our 1-Week CMC Assessment reveals your roadmap gaps and transforms uncertain founders into confident presenters who ace investor meetings. Secure your assessment at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-readySupport the show

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• 186: How Generative AI Accelerates Protein Design for Biotech Discovery with Elise de Reus - Part 2

  Imagine unlocking a world where designing custom proteins is not only feasible - but faster, smarter, and more powerful than ever before, thanks to artificial intelligence.As the promise of programmable biology takes center stage, AI-driven protein engineering is rapidly moving from theoretical dream to industry standard.In this episode, David Brühlmann sits down with Elise de Reus, co-founder of Cradle, whose ground-breaking platform has become a go-to for luminaries at pharma giants, as well as leaders in agriculture and industrial biotech. Elise’s journey bridges hands-on scientific discovery with entrepreneurial vision, and she’s on a mission to make biology a foundational pillar of a more sustainable and equitable world.Here are three reasons you can’t miss this episode:AI Unmasks the Black Box: Elise explains how Cradle’s platform isn’t just about predictive power - it offers transparency and actionable insights, allowing scientists to see why models perform as they do, and how to interpret and trust their outputs.From Hype to Real-World Impact: You’ll hear real examples of AI accelerating everything from pandemic preparedness and antivenom development, to sustainable raw materials - plus candid advice on scaling AI adoption across diverse project teams.Blueprints for Biotech Founders: Elise shares hard-won lessons on transforming scientific innovation into a thriving company, including the counterintuitive power of targeting “mission impossible” challenges and the priceless value of early, unfiltered feedback.Ready to future-proof your protein engineering with generative AI? Press play to take home Elise’s practical framework for evaluating tools, overcoming organizational hurdles, and crafting a winning adoption strategy, before the innovation curve pulls away.Wondering how Generative AI is transforming the biotech landscape? From accelerating regulatory workflows to reinventing protein purification, AI is driving breakthroughs across the industry. Explore these standout episodes to hear from experts leading the charge:Episodes 77-78: Cell Factories Explained: How Synthetic Biology and AI Revolutionize Protein Production with Mauro TorresEpisodes 119-120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian GuoEpisodes 123-124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan SharfsteinEpisodes 167-168: How Generative AI Is Revolutionizing Biotech Regulatory Compliance with Abhijeet SatwekarConnect with Elise de Reus:LinkedIn: www.linkedin.com/in/elise-de-reus-77b83a24Website: www.cradle.bioNext step:Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call🧬 Ready to eliminate CMC chaos and hit your IND timeline with absolute certainty? Get the complete Notion CMC Dashboard at https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders - the proven roadmap that's guided successful mAb programs to hit their IND submission deadlines.🧬 Stop second-guessing your CMC strategy before investor meetings. Our 1-Week CMC Assessment reveals your roadmap gaps and transforms uncertain founders into confident presenters who ace investor meetings. Secure your assessment at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-readySupport the show

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