

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist
The Go-to Podcast for Biotech Scientists Who Want to Master Biopharma CMC Development and Biomanufacturing.**TOP 10 LIFE SCIENCES PODCAST**Are you ready to simplify bioprocess development and scale with confidence to reduce time to market?Are you feeling overwhelmed by the complexity and guesswork of biologics development and biomanufacturing?Do you wish you had more time to enjoy the beauty of science, without worrying about failing your cell culture process development and commercialization?There's a way to simplify and streamline so you can remove complexity, skip trials and errors, deliver your groundbreaking therapy to clinics and market without delay, and still enjoy every single step.I'm David Brühlmann, a biotech entrepreneur and strategic advisor who partners with C-level biopharma leaders to tackle one of our industry's biggest challenges: reducing manufacturing costs to make lifesaving therapies accessible to more patients worldwide.Through engaging conversations with industry pioneers and practical insights from the trenches, this podcast tackles the critical challenges in bioprocess CMC development and manufacturing of recombinant proteins and cell and gene therapy products. We cut through the complexity so you can:Master bioprocess development with confidence and clarityExcel at scale-up and manufacturing of biologicsTransform your innovative therapy and manufacturing technology into market-ready solutions fasterOptimize manufacturing costs without compromising qualityMake data-driven decisions that reduce the risk of failureI can’t wait to help you do biotech the smart way.Grab a cup of coffee and your favorite notebook and pen. Now is the time to take your bioprocessing game to the next level.Ready to transform your biomanufacturing journey? Let's dive in!Next Steps:Book a free call to reduce biomanufacturing costs and make lifesaving therapies more accessible: https://bruehlmann-consulting.com/call🧬 Ready to accelerate your IND timeline? Get the proven CMC Dashboard that's guided successful mAb programs from chaos to submission: https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-foundersAccelerate biologics development with expert guidance: https://bruehlmann-consulting.comFor sponsorship opportunities, contact us at hello@bruehlmann-consulting.comVisit the Website: https://smartbiotechscientist.comEmail us: hello@bruehlmann-consulting.com
Episodes
Mentioned books

Aug 5, 2025 • 24min
177: Rethinking Cultivated Meat Production: Scale and Media Optimization Strategies Slashing Manufacturing Costs with Richard Alldread - Part 1
What if the secrets to feeding the planet - and democratizing access to future protein - were hiding in the core toolkit of biopharma?The worlds of biopharmaceuticals and cultured food may seem galaxies apart, but at their heart, both rely on remarkably similar technology: media, bioreactors, and cell processing. Yet, as demand grows for sustainable, affordable protein for the masses, innovators are confronting a challenge bigger than scale.This week, host David Brühlmann welcomes Richard Alldread, Chief Technology Officer at The Cultured Hub, a groundbreaking joint venture between three Swiss industry leaders that specializes in developing and scaling cell culture processes for cultivated foods.Most of Richard’s career has been dedicated to leading process and technology development initiatives within the biopharmaceutical industry. He has held key roles at major biotech organizations. He now leads the charge in applying high-tech bioprocessing to the ultimate scale-up: cultivated food. His journey from pioneering life-saving biologics to reimagining food production offers a rare insider’s view of biotech’s next frontier.Here are three reasons you can’t miss this episode:Bioprocessing’s Universal Blueprint: Richard breaks down the striking similarities between pharmaceuticals and food - media, bioreactors, sterility - but reveals why the economics and scale make cultivated food an entirely new beast.From Clinic to Kitchen: Discover how the shift from producing grams of life-saving drugs for the West to tons of affordable protein for global tables flips traditional priorities, pushing innovation in cost reduction, media development, and facility design.The Art of Keeping it Simple: Richard shares a contrarian philosophy: the best processes need fewer high-tech analytics, not more. He weighs in on where digital tools, modeling, and even AI fit into building robust, scalable bioprocesses for the food industry.Curious about how the lessons of biopharma might feed the world? Dive into this episode to uncover the biggest technical, economic, and biological hurdles - and why the next big leap in bioprocessing may end up on our dinner plates.Connect with Richard Alldread:LinkedIn: www.linkedin.com/in/richard-alldread-01923644Website: www.theculturedhub.comWant to hear more perspectives on the future of cell-based food? Don’t miss these previous episodes:Episodes 55-56: Cultivated Meat: A Promising Future or an Inevitable Bubble? with Steven LangEpisodes 45-46: From Lab to Table: The Science Behind Cultivated Meat with Petra HangaEpisodes 15-16: Bacon Without Pigs? Innovations in Cultivated Meat Manufacturing with Beat ThalmannNext 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 CMC roadmap for IND submission.🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

Jul 31, 2025 • 14min
176: How Virtual Reality Training Solves Europe's Bioproduction Talent Shortage with Sandrine Lemoine - Part 2
What if the missing link to resilient European bioproduction is not just another breakthrough technology, but the ability to continuously learn, adapt, and collaborate?In a rapidly shifting biotech landscape, innovation isn’t only driven by technical prowess. Behind every robust production process and every cutting-edge therapy, there’s a team empowered with both technical expertise and the soft skills necessary to thrive.In this episode, host David Brühlmann explores the human side of bioproduction with Sandrine Lemoine, CEO of Immerscio.bio, who has dedicated her career to transforming talent development in the industry. Sandrine Lemoine brings a unique perspective to biotech training: as both an executive coach and a veteran of pharmaceutical leadership roles, she founded Immerscio.bio to bridge the gap between innovation and workforce development. Her work focuses on immersive, flexible training that prepares biotech professionals - new and experienced alike - for the evolving demands of modern bioproduction, keeping Europe’s talent future-ready.Here are three reasons why you shouldn’t miss this episode:Soft Skills as a Catalyst: Sandrine reveals why leadership, collaboration, and a “co-construction” approach are critical to effective innovation in bioproduction, not just as buzzwords, but as real drivers of successful project delivery.Continuous Learning as a Strategy: Discover how Immerscio.bio’s adaptable training modules keep professionals ahead of the curve in a field defined by fast regulatory shifts, automation, and new therapies - arming teams for every transition, from immunology pivots to advanced manufacturing technologies.Resilience through Workforce Development: As Europe faces unprecedented talent shortages and global competition, Sandrine explains how investing in people and fostering a habit of lifelong learning is key to healthcare sovereignty and the industrialization of scientific progress.Ready to upgrade your own bioprocessing career or build a future-ready team? This conversation will inspire you to see training not as a checkbox, but as your greatest tool for impact in biotech.Connect with Sandrine Lemoine:LinkedIn: www.linkedin.com/in/sandrine-lemoine-ba244a58Website: https://immerscio.bioNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing development and manufacturing: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

Jul 29, 2025 • 20min
175: How Virtual Reality Training Solves Europe's Bioproduction Talent Shortage with Sandrine Lemoine - Part 1
What if the road to bioproduction mastery started not in the lab, but with how you train your people?Traditional biotech education often ends at theory, leaving graduates unprepared for the fast-paced world of manufacturing. But what if the key to faster, safer, and more scalable bioprocessing is digital immersion, letting scientists train in a virtual facility before they ever enter a real one?This week, David Brühlmann welcomes Sandrine Lemoine, CEO of Immerscio.bio, to the Smart Biotech Scientist Podcast. With over 25 years spanning R&D, manufacturing strategy, and executive coaching, Sandrine has seen firsthand the widening gap between academic training and the urgent needs of industry. Now, she’s tackling the bioproduction talent shortage head-on through digital modules, built for skills, not just knowledge. From international team leadership to championing hands-on, immersive learning, Sandrine’s mission is to future-proof the workforce our industry desperately needs.Here are three reasons you should queue up this episode:Immersive Digital Training Meets Industry Demand: Sandrine explains how 100% digital courses - leveraging 3D simulations, serious games, and virtual reality - are bridging the gap between academic theory and operational reality.Collaborating With Industry, Evolving With Technology: Immerscio.bio’s modules aren’t static. Developed by a consortium of major pharma and biotech companies, they’re constantly updated through direct feedback and partnership to keep pace with ever-changing technology and regulations - ensuring every learner gains relevant, up-to-date skills.Beyond Technical Skills: Building the Right Mindset: Technical expertise alone won’t cut it. Sandrine shares how soft skills like critical thinking, autonomy, and quality mindset are intentionally woven into training, preparing new hires and career-changers for the demands of a high-stakes, rapidly evolving field.Curious how digital and AI-supported training could accelerate your team’s readiness and your career? Listen in to discover how Immerscio.bio is redefining workforce development, and get inspired to rethink your own approach to learning.Connect with Sandrine Lemoine:LinkedIn: www.linkedin.com/in/sandrine-lemoine-ba244a58Website: https://immerscio.bioNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing development and manufacturing: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

Jul 24, 2025 • 21min
174: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist Gernaey - Part 2
How do you transform hybrid model digital twins from promising lab concepts into commercial bioprocessing game-changers that actually deliver ROI?As biotech companies race to implement Industry 4.0 technologies, the critical challenge isn't just developing sophisticated hybrid models - it's deploying them strategically to create user-friendly, cost-effective solutions that genuinely accelerate your path to commercial bioprocessing success.In Part 2 of this essential conversation, David Brühlmann continues his deep dive with Krist Gernaey, Professor of Industrial Fermentation Technology at the Technical University of Denmark. Krist reveals the strategic framework for moving beyond digital twin hype to build hybrid modeling capabilities that scale from lab validation to commercial manufacturing reality.Three Strategic Insights for Commercial Implementation:Digital Twins That Deliver Business Value: Krist cuts through the marketing buzz to define what makes digital twins commercially viable - revealing why true value comes from two-way data exchange and predictive capabilities, not just virtual process copies. Learn the validation strategies that separate successful implementations from expensive pilot projects.Modular Strategy Over Technology Complexity: Forget the "silver bullet" mentality. Krist advocates for strategic building blocks: start with site comparisons and predictive maintenance, then systematically add hybrid modeling complexity as your organization develops the technical capacity and team skills for sustainable commercial success.User-Centric Models for Operational Excellence: The biggest commercial wins aren't always about optimizing yields - they're about creating transparency, robust documentation, and operator-friendly tools that reduce complexity rather than adding it. Discover how to design hybrid model digital twins that empower your manufacturing teams instead of overwhelming them.Ready to develop a strategic roadmap for implementing hybrid model digital twins that drive commercial bioprocessing success? Tune in for Krist's proven framework for avoiding "cauliflower complexity" while building sustainable digital transformation capabilities that scale.Connect with Krist Gernaey:LinkedIn: www.linkedin.com/in/krist-gernaey-591748Website: www.orbit.dtu.dk/en/persons/krist-v-gernaeyIf you’re intrigued by the evolving frontier of bioprocessing, don’t miss these enlightening episodes:Episodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo MorbidelliEpisodes 153-154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago MatosEpisodes 05-06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael SokolovNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

Jul 22, 2025 • 23min
173: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist Gernaey - Part 1
Are you struggling to bridge the gap between lab-scale models and commercial bioprocessing reality? For many biotech innovators, the promise of digital twins meets harsh industrial constraints - where hybrid models that excel in controlled lab environments must prove themselves in the complexity of large-scale manufacturing.This week on the Smart Biotech Scientist Podcast, host David Brühlmann welcomes Krist Gernaey, Professor of Industrial Fermentation Technology at the Technical University of Denmark. With expertise spanning measurement technology development and two decades pioneering hybrid model digital twins for bioprocess applications, Krist reveals the critical gap between digitalization hype and industrial implementation reality.Here are three key reasons this episode will level up your hybrid modelling and digital twin approaches.From Data Overload to Intelligent Control: Raw sensor data means nothing without the right models to interpret it. Krist demonstrates how hybrid model digital twins convert complex bioprocess measurements into actionable control strategies - showing why sophisticated algorithms need simple, robust sensors to succeed at commercial scale.From Individual Genius to Team Implementation: The most elegant digital twin fails without operator buy-in. Krist shares why successful commercial bioprocessing depends on bridging academic innovation with frontline manufacturing expertise - revealing the human factors that make or break advanced modeling initiatives.From Lab Perfection to Commercial Pragmatism: Discover why the most promising hybrid modeling approaches must balance mechanistic understanding with data-driven adaptation. Krist provides a reality check on electrochemical sensors, validation challenges, and the strategic decisions that determine whether digital twins deliver commercial value or remain expensive experiments.Ready to master the art of scaling hybrid model digital twins from promising lab tools to commercial bioprocessing game-changers? Tune in to discover Krist Gernaey's battle-tested strategies for navigating the complex journey from academic innovation to industrial impact.Connect with Krist Gernaey:LinkedIn: www.linkedin.com/in/krist-gernaey-591748Website: www.orbit.dtu.dk/en/persons/krist-v-gernaeyIf you’re intrigued by the evolving frontier of bioprocessing, don’t miss these enlightening episodes:Episodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo MorbidelliEpisodes 153-154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago MatosEpisodes 05-06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael SokolovNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

Jul 17, 2025 • 20min
172: Reimagining Chromatography for Advanced Therapies: From Diffusion to Convection with Scott Wheelwright - Part 2
Downstream processing remains one of the most complex and critical steps in biomanufacturing, especially as new therapeutic modalities like cell and gene therapies push current technologies to their limits. The industry faces ongoing pressure to innovate, reduce costs, and improve efficiency, while still ensuring robust and reliable results.In this practical, energetic episode, host David Brühlmann welcomes Scott Wheelwright, Chairman, CTO and Co-Founder of BioChromatographix International (BCI). With a career spanning continents - Asia, Europe, and North America - Scott's perspective is forged from hands-on manufacturing, technology transfer, and building high-growth companies from scratch. He’s not just innovating the science behind chromatography; he’s lived the manufacturing realities, spanning everything from precision antibodies to complex gene therapies, and now leads a team solving the tough purification puzzles holding progress back.Here are three reasons why this episode is a must-listen:Continuous Innovation in Chromatography: Despite a hundred-year legacy, chromatography still holds tremendous untapped potential, especially with new materials and continuous processing, as Scott highlighted with real examples from gene and cell therapy applications.Bridging Lab to Market Needs Customer Focus: Getting new technology into commercial use requires not just technical innovation, but deep user engagement, robust feedback loops, and iterative improvement, plus ongoing education to help users understand new benefits.Embrace Experimentation and Global Collaboration: Whether building companies in Asia, Europe, or the U.S., Scott reminds us that learning from failure, being open to international collaboration, and not being afraid to try new things are essential for long-term growth (and enjoying the biotech journey along the way!).If you’re passionate about downstream processing, tech innovation, or just want to hear inspiring leadership lessons, check out the full episode and connect with Scott Wheelwright or visit the company’s website to follow his team’s advancements.Connect with Scott Wheelwright:LinkedIn: www.linkedin.com/in/scottmwheelwrightWebsite: www.biochromatographix.comCurious about chromatography? Tune in to hear what our previous guests had to say!Episodes 119-120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian GuoEpisodes 61-62: Magnetic Bead Technology: The New Era in Downstream Processing with Nils BrechmannEpisodes 37-38: How to Master Downstream: A Deep Dive Into Bioprocessing Purification with Wei ZhangNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

Jul 15, 2025 • 21min
171: Reimagining Chromatography for Advanced Therapies: From Diffusion to Convection with Scott Wheelwright - Part 1
For decades, chromatographic purification has made use of bead-based diffusion - a reliable but limiting approach, especially as new modalities like gene therapies, mRNA, and viruses push the boundaries of what’s possible. But what if the future of downstream processing lies not in incremental improvement, but in a dramatic reimagining - from slow diffusion to rapid convection?In this episode, David Brühlmann meets Scott Wheelwright, Chairman, CTO and Co-Founder of BioChromatographix International (BCI). Scott brings decades of expertise in biopharmaceutical development and manufacturing. Prior to BCI, he co-founded Biolnno Bioscience, a leading CDMO, and co-founded Innovent Biologics, one of China’s foremost biotechnology companies.Here are three compelling reasons to tune into this episode:Breaking the Mold of Purification: BCI’s AXISFLOW™ Platform moves beyond bead-based processes, using advanced 3D-printed monoliths that enable convective flow, making purification of large biomolecules and viruses faster, more efficient, and better suited for next-generation therapies.Innovation Starts with Imagination (and Measurement): True progress in bioprocessing often hinges not on what we can make, but on what we can accurately measure and imagine. Scott reminds us that advances in analytical testing and creative thinking are the real engines of change.Biotech Demands More than Great Science: Success isn’t just about inventing; it’s about building with the end-user in mind. Scott’s journey highlights the critical role of customer-centric product development, cross-disciplinary teamwork, and regulatory strategy - especially in a conservative, risk-averse industry.Curious how shifting from diffusion to convection could reshape your purification workflow? Listen to this episode and discover how to unlock efficiency, cut costs, and deliver therapies that might otherwise remain out of reach.Connect with Scott Wheelwright:LinkedIn: www.linkedin.com/in/scottmwheelwrightWebsite: www.biochromatographix.comCurious about chromatography? Tune in to hear what our previous guests had to say!Episodes 119-120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian GuoEpisodes 61-62: Magnetic Bead Technology: The New Era in Downstream Processing with Nils BrechmannEpisodes 37-38: How to Master Downstream: A Deep Dive Into Bioprocessing Purification with Wei ZhangNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotechSupport the show

Jul 10, 2025 • 24min
170: Why Your DNA Is a Terrible Disease Predictor (And How Multi-Omics Changes Everything) with Mo Jain - Part 2
For years, disease diagnosis and treatment have focused on a few biomarkers, overlooking thousands of vital biological signals. Despite biotech advances, most therapies are still based on limited data, missing countless breakthroughs.Multiomics changes that. By analyzing tens of thousands of proteins, metabolites, and lipids, it reveals hidden insights, paving the way for smarter, faster, and more effective medical discoveries.In this must-listen episode, David Brühlmann welcomes Mo Jain, founder and CSO of Sapient, a pioneering force in bringing multiomic platforms out of academia and into the heart of drug development. A physician-scientist by training and a visionary entrepreneur by choice, Mo’s journey spans decades at the cutting edge of analytical technologies, culminating in the creation of ultra-high-throughput systems that analyze up to 20,000 biomarkers in a single run for real-world impact.Here are three reasons why this episode needs to be on your playlist:Multiomics at Scale: Mo shares how his team at Sapient turbocharged mass spectrometry, enabling simultaneous measurement of thousands of molecules, transforming routine diagnostics and making previously unimaginable insights accessible to scientists everywhere.Turning Data into Action: Generating vast data is only half the battle. Mo explains how Sapient developed advanced biocomputational teams and frameworks to extract actionable answers, guiding drug developers to faster, smarter decisions and helping avoid the pitfalls that cripple so many omics projects.The Future Is Personalized and Sooner Than You Think: From dramatically earlier disease detection to truly personalized therapies, Mo paints an optimistic picture of a coming era where AI, multiomics, and new therapeutic modalities rapidly accelerate both discovery and delivery, reshaping how biotech companies tackle even the toughest diseases.Ready to break out of the 20-biomarker rut and see what 20,000 data points can reveal? Tune in to discover how you can harness multiomics in your own research and hear Mo’s advice for scientists and entrepreneurs venturing beyond the bench.Connect with Mo Jain:LinkedIn: www.linkedin.com/in/mo-jain-md-phd-373895baWebsite: www.sapient.bioCompany LinkedIn Page: https://www.linkedin.com/company/sapientbioNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

Jul 8, 2025 • 27min
169: Why Your DNA Is a Terrible Disease Predictor (And How Multi-Omics Changes Everything) with Mo Jain - Part 1
What if the secret to truly personalized precision medicine lies not in your genetic code, but in your zip code?For years, biotech has focused on genomics to explain disease and drug response, but DNA only accounts for a fraction of the story. The real breakthrough? Multi-omics: the large-scale analysis of proteins, metabolites, and lipids, powered by advanced mass spectrometry and AI, offering a fuller picture of human health.In this episode, David Brühlmann meets Mo Jain, founder and CSO of Sapient, a leader in multi-omics analytics. With over two decades of experience across physiology, biomedicine, and computational biology, Mo has been at the forefront of developing scalable multi-omics technologies that are changing the way we predict, diagnose, and treat disease. From leading an academic lab to building a pioneering biotech company, Mo’s journey reflects a passion for uncovering the hidden 80–90% of disease risk that lies beyond our genes.Here are three reasons you’ll want to listen to this episode:Your Environment Matters More Than Your Genes: Mo explains why your zip code is a stronger predictor of your health than your genetic code, challenging the industry’s long-held beliefs and opening new avenues for disease prevention and risk assessment.Multi-omics Disrupts Drug Development: Discover how integrating thousands of biological data points can revolutionize drug discovery by identifying novel targets, better predicting drug response, and accelerating therapeutic breakthroughs that were previously out of reach.Big Data Finally Becomes Actionable: Thanks to rapid advances in mass spectrometry and computational power, scientists can now make sense of overwhelming volumes of multi-omic data, turning what was once information overload into actionable insights for diagnostics and drug development.Ready to think beyond your genes? The biotech revolution is here, and it starts in your neighborhood.Connect with Mo Jain:LinkedIn: www.linkedin.com/in/mo-jain-md-phd-373895baWebsite: www.sapient.bioCompany LinkedIn Page: https://www.linkedin.com/company/sapientbioNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show

Jul 3, 2025 • 27min
168: How Generative AI Is Revolutionizing Biotech Regulatory Compliance with Abhijeet Satwekar - Part 2
The promise of generative AI in pharma and biotech is huge, but it's also fraught with complexity, especially when it comes to integrating these systems into highly regulated environments. From monitoring evolving guidelines to balancing operational efficiency and data integrity, the journey from hype to real-world impact is filled with both opportunity and skepticism.In this episode, David Brühlmann sits down with Abhijeet Satwekar, Innovation Manager at Merck Healthcare’s Global Analytical Development. Abhijeet has spent years on the front lines of digital transformation in the biotech sector, and his current mission: implementing generative AI for regulatory guideline monitoring, without giving the quality team a collective heart attack. He offers a no-nonsense roadmap for biotech leaders looking to streamline compliance, harness AI potential, and future-proof their operations.Here are three reasons you should hit play on this episode:From Proof of Concept to Real-World Implementation: Discover how Abhijeet’s team moved beyond early excitement to tackle regulatory, IT, and data privacy requirements, carving a safe and compliant path for bringing generative AI tools into GxP and GMP-adjacent workflows.Human-in-the-Loop Isn’t Optional: Learn why user training, prompt engineering, and close collaboration between scientists and AI are essential for extracting meaningful (and accurate) insights, especially in environments where routine and regulation reign supreme.ROI and Regulation - The Balancing Act: Hear candid perspectives on measuring the return on investment for new digital tools, addressing skeptics closer to manufacturing, and why the real game-changer might just be a community-driven, industry-wide approach to regulatory acceptance.Wondering how to unlock GenAI’s full potential - or just avoid the common pitfalls? Dive into this episode for practical strategies, cautionary tales, and actionable insights from someone who’s actually navigated the compliance minefield.Bring AI into your pipeline with confidence, clarity, and compliance.Connect with Abhijeet Satwekar:LinkedIn: https://www.linkedin.com/in/abhijeetsatwekarNext step:Book a free consultation to help you get started on any questions you may have about bioprocessing development: https://bruehlmann-consulting.com/callDevelop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech🧬 Stop second-guessing your CMC strategy. Get an investor-ready CMC roadmap in 2 weeks, before mistakes cost you $2M+ and 18 months of delays. Secure your spot at https://stan.store/SmartBiotech/p/dont-let-cmc-kill-your-funding-roundSupport the show


