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Science

Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist

The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.


Practical, execution-focused, and strategic guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics for biologics, cell and gene therapies, cultivated meat, and biomaterials.


Hosted by Dr. David Brühlmann, CMC strategist, former Bioprocess Innovation Manager at Merck, PhD in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies.


This podcast is for you if:


  • You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnership


  • You are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readiness


  • You are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutiny


  • You are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resources


What you will learn:


CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling, manufacturing economics, continuous manufacturing, digitization, and Industry 4.0 in biopharma.


Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide.


New episodes released weekly. Subscribe and join 400+ biotech leaders already using these insights to accelerate development, reduce manufacturing costs, and de-risk scale-up.


Next Steps:


Get the 5-day CMC email course: https://smartbiotechscientist.com/#cmc


Visit the website: https://smartbiotechscientist.com


Email us: hello@bruehlmann-consulting.com

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  • 21 episodes
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Episodes21

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  • Thursday · 17 min

    276: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 2

    How do you turn a lab-born regenerative medical device into a solution that surgeons actually want to use and investors want to back? The path from academic innovation to clinical adoption is full of practical hurdles and strategic pivots, where compelling science alone isn’t enough. David Brühlmann welcomes back Eva-Maria Balet, whose journey spans tissue engineering research at EPFL to leading Regenosca through first-in-human trials, fundraising, and an executive MBA completed while running the company. This conversation covers the practical realities behind that journey, from quality control to clinical setbacks to investor pitches. Topics discussed: Defining TissueSpan’s regulatory path and quality control as a medical device (02:49) The significance of first-in-human studies and what early clinical experience reveals (04:11) Selecting an initial clinical indication and opportunities for technology expansion (05:50) Realistic assessment of where soft tissue repair technologies apply—and where they do not (07:18) The stepwise progression from in vitro to animal models in product development (08:18) Navigating setbacks, including the impact of Covid-19 on clinical trials, and the value of adaptability (10:36) Bridging science and business in biotech fundraising and communication (12:15) Key takeaways from pursuing an executive MBA alongside building a biotech company (13:42) The importance of collaboration, mindset, and meaningful networks in driving biotech innovation (15:19) Smart insight: The transition from scientist to founder brought its own learning curve. Eva-Maria pursued an executive MBA while running Regenosca, and points to financial and business vocabulary as the skill she'd have built earlier if she could. For a technical founder or CMC lead, the lesson isn't to become a business generalist, it's that the moment you're translating a manufacturing process or clinical dataset into an investor pitch, fluency in the language of accounting, market strategy, and cost structure becomes as load-bearing as the science itself. This week's episode with Eva-Maria Balet steps out of bioprocessing into MedTech, following a collagen scaffold from EPFL lab bench to first-in-human implant. These back-catalog picks cover similar ground: what it takes to win investor buy-in beyond the science, the discipline of turning a lab process into GMP manufacturing, why regulatory classification shapes a product's whole trajectory, and what it really takes to commercialize a lab discovery. Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome Episodes 257 - 258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic Episodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver Kraemer Episodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee Ho Connect with Eva-Maria Balet: LinkedIn: www.linkedin.com/in/eva-maria-balet-72561737 Regenosca website: www.regenosca.com Support the show

  • Tuesday · 16 min

    275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1

    Imagine a wound too large for the body to close on its own. That's the problem Eva-Maria Balet set out to solve, not with living cells, but with a structural bridge that lets the body's own healing mechanisms do the rest. In this episode, David Brühlmann welcomes Eva-Maria Balet, Co-Founder & CEO of Regenosca. Trained at EPFL, Eva-Maria brought her fascination with cellular "factories" from academia straight into entrepreneurship. Rather than chasing elegant science for its own sake, she built her company around a single principle: start with a real clinical need and build backward, collaborating with clinicians from day one so every experiment serves a patient. Highlights & Topics: Why starting with clinical needs—not just scientific excitement—creates meaningful real-world impact in life sciences (02:38) How Eva-Maria’s fascination with biotechnology guided her from cell factories to developing scaffolds for tissue repair (03:51) The unmet challenges in current soft tissue repair treatments and where new solutions are needed (05:51) What makes Regenosca’s fully-engineered collagen implant, TissueSpan, different from existing meshes and biological materials (07:09) The biological mechanisms behind tissue regeneration using a temporary collagen scaffold (08:28) Translating lab-scale research into a robust, scalable, and regulatory-compliant production process (10:34) The practical realities and hurdles of navigating the medical device vs. biologic regulatory pathways (11:59) Advice on building regulatory expertise into your founding team or leveraging consultants effectively (13:31) The importance of interdisciplinary teams and trust when forming biotech startups (14:36) Smart insight: Eva-Maria put it plainly: what works in the lab has to work reliably every single time you produce it for a patient. That shift, from proving a concept to controlling a process, from raw materials through in-process controls to final product testing, is the same discipline any CMC scientist recognizes: science alone doesn't get a product to patients. Reproducibility does. This week's episode with Eva-Maria Balet steps out of bioprocessing into MedTech, following a collagen scaffold from EPFL lab bench to first-in-human implant. These back-catalog picks cover similar ground: what it takes to win investor buy-in beyond the science, the discipline of turning a lab process into GMP manufacturing, why regulatory classification shapes a product's whole trajectory, and what it really takes to commercialize a lab discovery. Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome Episodes 257 - 258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic Episodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver Kraemer Episodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee Ho Connect with Eva-Maria Balet: LinkedIn: www.linkedin.com/in/eva-maria-balet-72561737 Regenosca website: www.regenosca.com Support the show

  • July 30 · 16 min

    274: Engineering iPSC Neurons for Parkinson's: From 3% Survival to Durable Graft with Bilal Fares - Part 2

    Building a cell therapy company is hard. Building a genetically engineered iPSC therapy for the brain, on a preclinical budget, is one of the hardest translational problems in biotech. Every experiment has to move the program closer to an IND, or it's motion without progress. That's the operating constraint Bilal Fares faces as CEO and co-founder of AzureCell, the University of Geneva spin-off engineering neuroprotective iPSC neurons for Parkinson's disease. In Part 2, he walks through how his team decides what to build, where AI and synthetic biology genuinely accelerate a CMC roadmap, and the four founder lessons he wishes he'd internalized earlier, including his conviction that scientists who use AI will replace those who don't. Topics discussed include: Strategies for prioritizing experiments and narrowing focus with limited resources (03:33) How business opportunity validation programs helped define a product roadmap (04:08) Integrating AI and synthetic biology into research programs—and where these tools do, and don’t, accelerate development (05:07) Building a cell therapy platform for personalized approaches in neurological diseases beyond Parkinson’s (06:38) Lessons learned in biotech leadership and why tackling big problems matters (08:08) Key advice for aspiring biotech entrepreneurs: kill your own solutions quickly, and learn from others (09:27) The importance of having a strong team and how a powerful mission attracts top talent (12:21) AzureCell’s near-term plans and future goals, including upcoming fundraising and R&D milestones (13:30) Smart insight: What separates successful biotech ventures from the rest? According to Bilal Fares, it is not just technical skill but mindset. First, choose a problem large enough to be worth the struggle. Second, try to “kill your solution as fast as possible”—engage experts, enter competitions, and seek brutal feedback early so you can pivot, improve, or abandon as needed. And finally, plan with the end (approval, patients, impact) always in sight. If you enjoyed this, check out these episodes on cell therapy, where engineered cells can survive and do more than replace what's lost: Michael Rome's investor lens rounds it out for founders facing the same funding realities. Episodes 269 - 270: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo Episodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee Episodes 249 - 250: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale Bernatchez Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome Connect with Bilal Fares: LinkedIn: www.linkedin.com/in/b-fares AzureCell website: www.azurecell.co Email: info@azurecell.co Support the show

  • July 28 · 20 min

    273: Engineering iPSC Neurons for Parkinson's: From 3% Survival to Durable Graft with Bilal Fares - Part 1

    Transplant iPSC-derived neurons into a Parkinson's brain and 97% die before they can restore function. Of the 3% that survive, most face the same pathogenic environment that killed the original neurons. This is the compounded biology and CMC problem defining CNS cell therapy today. Bilal Fares, neuroscience entrepreneur and co-founder of AzureCell, is translating a University of Geneva discovery into a genetically engineered iPSC platform built to solve it: neurons that don't just replace what Parkinson's destroyed, but survive the fire that destroyed them. Topics discussed: Why Bilal believes cell therapy is the future of medicine for brain diseases, and the limitations of other approaches (03:06) Bilal’s personal story and the events that guided his commitment to Parkinson’s research and entrepreneurship (04:03) How cell therapy might move beyond simply replacing lost neurons—using engineered cells to produce therapeutics directly in the brain (09:05) The neuroprotective technology AzureCell is developing, designed to shield transplanted neurons from Parkinson’s disease mechanisms (11:31) The platform approach: combining stem cell technologies, genetic engineering, and allogeneic off-the-shelf cell banks (12:38) Why the blood-brain barrier makes cell therapy a necessary approach for certain conditions (13:26) The current status of Azure’s preclinical and manufacturing development, and their plans for clinical translation (14:31) Why previous therapies for Parkinson’s have fallen short, and how cell therapy might sidestep these limitations (15:57) The potential and challenges of using cell therapy for other brain diseases like Alzheimer’s (18:26) Smart insight: The next generation of CNS cell therapy isn't only about neuron replacement. Bilal's thesis reframes transplanted cells as engineered biological factories inside the brain: producing neuroprotective proteins, modulating disease mechanisms in real time, and eventually enabling preventative treatment as manufacturing costs fall and safety matures. If you enjoyed this, check out these episodes on cell therapy, where engineered cells can survive and do more than replace what's lost: Michael Rome's investor lens rounds it out for founders facing the same funding realities. Episodes 269 - 270: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo Episodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee Episodes 249 - 250: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale Bernatchez Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome Connect with Bilal Fares: LinkedIn: www.linkedin.com/in/b-fares AzureCell website: www.azurecell.co Email: info@azurecell.co Support the show

  • July 23 · 15 min

    272: From Static Scaffolds to Dynamic Matrices: Hydrogels for Animal-Free 3D Cell Culture with Jan Hunik and Matt Baker - Part 2

    How much of your research lives and dies on the bench? Not because the idea isn’t sound, but because building reproducible, scalable biomaterials remains an unsolved puzzle. Jan Hunik and Matt Baker from MosaMatrix discuss the practical challenges and lessons learned from spinning out a biomaterials company from academia. They explore the importance of quality standards in biotech startups, building a team with complementary skills, and the realities of developing reproducible 3D culture systems for modern research. Topics discussed: The critical gap between invention and reliable biomaterial products (00:40) Building company culture around quality standards from day one (02:45) Balancing scientific curiosity and business direction as co-founders (03:51) The impact of university partnerships on early-stage company development (06:02) Funding challenges and strategies for sustaining a biotech startup (06:47) Advice for scientists on addressing real market needs versus pushing technology (07:50) The importance of listening to customers and investors to find product-market fit (09:19) Vision for scaling technology and breaking even in the next two to three years (10:06) New frontiers in engineering living materials and animal-free biomaterials (12:04) Smart insight: The MosaMatrix team believes good materials are key to unlocking advances in drug discovery, cellular agriculture, and engineered living materials. Their story is a testament to how integrating rigorous science, business discipline, and a razor focus on real-world needs can create the foundation for lasting innovation in biotech. If this conversation got you thinking about biomaterials, scale-out manufacturing, and what it takes to turn a chemistry breakthrough into a fundable company, these episodes explore the same ground from complementary angles. Episodes 221 - 222: From 2D Cultures to Advanced 3D Cell Models for Preclinical Research with Catarina Brito Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome Episodes 265 - 266: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan Veraitch Episodes 223 - 224: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven Lang Connect with Jan Hunik and Matt Baker: Emails: matt.baker@mosamatrix.com and jan.hunik@mosamatrix.com Website: www.mosamatrix.com LinkedIn Jan Hunik: www.linkedin.com/in/jan-hunik-0183734 LinkedIn Matt Baker: www.linkedin.com/in/matthew-baker-0abb981b Support the show

  • July 21 · 20 min

    271: From Static Scaffolds to Dynamic Matrices: Hydrogels for Animal-Free 3D Cell Culture with Jan Hunik and Matt Baker - Part 1

    What if the real obstacle in 3D cell culture and tissue engineering isn't the cells, but the very ground they grow on? For years, cell culture has relied on flat plastic and passive scaffolds. But biology doesn't happen on a petri dish—cells live in three dimensions, surrounded by a dynamic environment that talks back, adapts, and shapes development in ways static gels simply cannot. That's the premise behind MosaMatrix, a novel hydrogel platform designed to transform how we grow cells, engineer tissues, and screen new drugs created by CEO Jan Hunik and CTO Matt Baker. Topics discussed: Why traditional flat, 2D cell culture misses the biological mark and what a responsive cell environment really looks like (00:27) The origins of MosaMatrix and the realization that new, adaptive hydrogels were needed for dynamic cell culture (04:45) What makes the MosaMatrix hydrogel different—and why passive scaffolds fall short (06:12) Mechanical and biological characteristics that define hydrogel performance, from stiffness to stress relaxation (07:48) The company's pivot from 3D tissue printing to focusing on high-throughput 3D cell culture for drug discovery (08:42) Advantages of a non-animal-derived, reproducible matrix for research and industry (10:20) Strategies for obtaining real-world customer feedback and working in consortia with academia and industry partners (11:51) Key hurdles in quality control, reproducibility, and measuring success in the emerging field (16:05) Challenges with standardizing organoids and the move to smaller, more automatable culture systems (17:50) The impact of automation and data consistency for scaling up 3D cell culture (18:14) Smart insight: MosaMatrix validates its hydrogel not through internal R&D alone, but through direct collaboration with academic and industry partners — testing performance across cell types and culture media. This includes a ~50-company consortium building next-gen 3D cell culture tools and a new consortium improving kidney dialysis with living human cells. The partnerships surface real variables, like how much culture media composition affects results, that continually shape product development. If this conversation got you thinking about biomaterials, scale-out manufacturing, and what it takes to turn a chemistry breakthrough into a fundable company, these episodes explore the same ground from complementary angles. Episodes 221 - 222: From 2D Cultures to Advanced 3D Cell Models for Preclinical Research with Catarina Brito Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome Episodes 265 - 266: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan Veraitch Episodes 223 - 224: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven Lang Connect with Jan Hunik and Matt Baker: Emails: matt.baker@mosamatrix.com and jan.hunik@mosamatrix.com Website: www.mosamatrix.com LinkedIn Jan Hunik: www.linkedin.com/in/jan-hunik-0183734 LinkedIn Matt Baker: www.linkedin.com/in/matthew-baker-0abb981b Support the show

  • July 16 · 16 min

    270: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo - Part 2

    In the biotech industry, advancing cell-based therapies is not just about innovation. It's about solving real gaps where conventional treatments fall short, especially against complex, aggressive tumors. In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann welcomes Jun Yung Woo, Co-Founder of AGEM Bio, who offers an in-depth look at the science and strategy behind engineered mesenchymal stem cells (MSCs), with a focus on why glioblastoma is the right proving ground for the platform. Topics discussed: Why glioblastoma is the right Phase I indication: infiltrative growth, immunosuppression, and STING pathway deficiencies that make GBM uniquely suited to the platform (02:43) The surgical workflow: intracavity MSC delivery during tumor resection, oral 5-FC administration, and how engineered cells act as local bioreactors in the resection cavity (04:05) Mechanisms by which engineered MSCs target heterogeneous and invasive tumors through shared vulnerabilities rather than antigen recognition (05:58) Overcoming immune rejection with allogeneic therapies and the unique immunological profile of MSCs (07:32) Manufacturing and scale-up: addressing donor variability, GMP production, and building a reproducible process (09:16) Why GMP manufacturing should be designed in from the earliest stages of research (10:50) Beyond glioblastoma: expanding the platform to other solid tumors, regenerative medicine, and chronic inflammatory disease (11:27) Strategies for international trial expansion and partnerships beyond Singapore (12:41) Reframing MSCs from stem cell therapy to programmable delivery platform: the MSC 2.0 thesis (14:10) Smart insight: The shift Jun Yung articulates is from treating stem cells as the therapy to treating them as programmable therapeutic vehicles. Once you can reliably engineer, manufacture, and preserve their function, the limitation is no longer what the cell naturally does. It becomes what biology you can encode into it. Glioblastoma is the proving ground, and the platform's reach extends to liver cancers, sarcomas, peritoneal malignancies, and chronic inflammatory disease. These episodes expand on the same themes of MSC biology, cell engineering, and the challenges of scaling consistent, functional cell therapies: Episodes 179 - 180 : How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davies Episodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee Episodes 125 - 126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei Episodes 129 - 130: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster Connect with Jun Yung Woo: LinkedIn: www.linkedin.com/in/junyungwoo AGEM Bio website: www.agem.bio Email: yung@agem.bio Support the show

  • July 14 · 25 min

    269: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo - Part 1

    What if the answer to solid tumor therapy isn’t about making immune cells smarter—but about rethinking what a therapeutic cell can do For years, mesenchymal stem cells (MSCs) have turned heads for their ability to home in on damaged tissue, yet their clinical utility has lagged behind the hype. What would it take to transform MSCs from passive healers into precision vehicles for next-generation cancer treatment? This week, David Brühlmann sits down with Jun Yung Woo, Co-Founder of AGEM Bio, who’s devoted nearly two decades to decoding and reimagining the potential of MSCs. From engineering stress-resilient cells to pioneering dual-payload therapeutic platforms, Jun Yung Woo bridges fundamental biology and real-world clinical translation. Topics discussed: The case for understanding cell biology before focusing on process scale-up in bioprocessing (02:38) Jun Yung Woo's personal and scientific journey toward developing engineered MSC therapeutics (04:36) How MSCs sense their environment and exert therapeutic effects via secreted factors, rather than tissue replacement (08:28) Key differences between MSC therapies and immune cell therapies like CAR T cells (10:35) Overview of non-viral engineering platforms, and the importance of intracellular trafficking for modifying MSCs (12:23) Design of AGEM Bio's dual-payload MSC product (cytosine deaminase and interferon beta) to induce highly localized tumor stress and immune activation (14:10) Strategies for controlling MSC targeting and minimizing off-target effects, including the use of prodrug activation and localized cell delivery (17:23) Study results from treating companion animals with engineered MSCs, and observations of tumor regression and possible signs of immune memory (20:29) Open questions about the durability of antitumor responses and future directions for clinical research (22:34) Smart insight: Jun Yung Woo challenges the rush toward bioprocess scale-up, arguing that a deeper understanding of cellular biology should come before manufacturing cells at scale. This episode explores how scaling the wrong biology can derail entire therapeutic platforms—and why aligning process development with cellular function may be critical for clinical success. These episodes expand on the same themes of MSC biology, cell engineering, and the challenges of scaling consistent, functional cell therapies: Episodes 179 - 180 : How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davies Episodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee Episodes 125 - 126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei Episodes 129 - 130: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster Connect with Jun Yung Woo: LinkedIn: www.linkedin.com/in/junyungwoo AGEM Bio website: www.agem.bio Email: yung@agem.bio Support the show

  • July 9 · 20 min

    268: Why Affordable Insulin Is a Money Problem, Not a Science Problem with Eric Moyal - Part 2

    Why does life-saving insulin cost hundreds of dollars a month for patients, when manufacturing costs are just a fraction of that price? What if the nonprofit model could change everything for affordable access? In the pharmaceutical industry, affordability and access remain two of the biggest hurdles for patients, especially when the economics of essential medicines seem stacked against them. Eric Moyal, founder of Project Insulin, is rewriting the rules of biosimilar development. Coming from a fundraising and nonprofit background rather than the pharma inside track, Eric built Project Insulin not to chase profits, but to deliver an essential therapy at a price real people can afford. Topics covered: Key differences between nonprofit and for-profit models in biotech, especially around fundraising, incentives, and revenue (00:02) The intricate balance between development costs, operating expenses, and setting an affordable price point (00:06) Innovative distribution models to eliminate price inflation by middlemen, including direct-to-patient and clinic partnerships (00:08) Major roadblocks in reinventing drug distribution and the importance of building the right partnerships early on (00:10) Advice for founders and scientists exploring solutions to drug affordability, including corporate structure, fundraising, and perseverance (00:12) Lessons learned after five years building Project Insulin, emphasizing the value of assembling the right team and listening to feedback (00:13) Realistic expectations for Project Insulin’s next five years and the primary goals on the horizon (00:16) The broader need for affordable generic drugs and the broken promise of the current patent system (00:17) How to connect with Project Insulin and support its mission (00:18) Smart insight: Generic medicines should be affordable. Ensuring low-cost, accessible generics is essential to restoring the original balance between pharmaceutical innovation and public access, and it requires collective effort beyond any single player. If you enjoyed this episode, you might want to listen to these within a broader set of discussions on biologics affordability, CMC strategy, and bioprocessing realities — from the economic barriers blocking patient access and regulatory decision-making for biosimilars, to CDMO selection for resource-constrained teams: Episode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them) Episodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias Müllner Episodes 103 - 104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma Mostafa Connect with Eric Moyal: Email: emoyal@projectinsulin.org Website: www.projectinsulin.org Instagram: www.instagram.com/projectinsulin LinkedIn: www.linkedin.com/company/82500193 TikTok: www.tiktok.com/@project.insulin YouTube: www.youtube.com/@ProjectInsulin Next step: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode. Support the show

  • July 7 · 18 min

    267: Why Affordable Insulin Is a Money Problem, Not a Science Problem with Eric Moyal - Part 1

    Insulin was first discovered over a century ago—yet in the United States, 1 in 5 insulin-dependent patients still ration their lifesaving supply. Why is a molecule so essential, and so well understood, still so out of reach for so many? Eric Moyal, founder of Project Insulin, decided to challenge not just the science, but the business model itself. With a background in nonprofit fundraising—not drug development—he’s building a biosimilar insulin glargine and promising to sell it directly to patients at cost, insurance or not. Topics discussed include: The origins of the insulin affordability crisis and the impact of profit-driven healthcare systems (04:27) How over a million Americans are forced to ration their insulin every month, and the broader impact on patients’ (lives 06:37) The advantages and challenges of approaching drug development with a background outside of biotech (08:37) The fundraising-focused strategy for overcoming scientific and technical hurdles in developing biosimilar insulin (09:17) Technical details on Project Insulin’s development process, including selection of CDMOs, importance of analytical data, and process challenges like reverse-phase cleaving and crystallization (11:16) The impact of recent FDA regulatory changes on the development and approval pathway for biosimilars in the U.S. (15:45) Smart insight: A nonprofit approach to essential medicines could reshape the future for patients who depend on them. By removing shareholder expectations and focusing on affordability and access, leaders like Eric Moyal are proving new paths are possible—not through incremental science alone, but through bold re-imaginings of how science serves the public. If you enjoyed this episode, you might want to listen to these within a broader set of discussions on biologics affordability, CMC strategy, and bioprocessing realities — from the economic barriers blocking patient access and regulatory decision-making for biosimilars, to CDMO selection for resource-constrained teams: Episode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them) Episodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias Müllner Episodes 103 - 104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma Mostafa Connect with Eric Moyal: Email: emoyal@projectinsulin.org Website: www.projectinsulin.org Instagram: www.instagram.com/projectinsulin LinkedIn: www.linkedin.com/company/82500193 TikTok: www.tiktok.com/@project.insulin YouTube: www.youtube.com/@ProjectInsulin Next step: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode. Support the show

  • July 2 · 21 min

    266: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan Veraitch - Part 2

    The cell and gene therapy industry faces massive hurdles—cost, scalability, and the need for highly skilled operators have historically limited the reach of these transformative treatments. advanced therapy medicinal products manufacturing innovation is urgently needed to overcome these challenges and unlock broader global access. Farlan Veraitch, founder and Chief Scientific Officer at Ori Biotech, is leading the way in reimagining manufacturing platforms using automation, modularity, and digital transformation. His vision is redefining how cell and gene therapies are produced—from research labs to point-of-care hospital settings. What’s inside: The use and adaptation of the paper pull tab sterile connection system—miniaturized and multiplexed—to ensure reliable material transfer in the manufacturing process (06:36) How modular and stackable system design supports scale-up and scale-out, increasing manufacturing capacity and flexibility (09:17) Full digitization of the Ori platform, including setting up digital twins, integrating sample prep automation, and capturing data for QA/QC in real time (10:11) Deskilling bioprocess operations, reducing the need for highly trained cell culture staff, and enabling broader use in both centralized facilities and hospitals (14:02) The logistical benefits of separating material prep (like buffer and virus formulation) from the manufacturing site to streamline point-of-care applications (15:39) Farlan’s vision for an accessible, profitable, globally distributed manufacturing platform to support new treatment pipelines (17:14) Driving down cost and improving scalability as key challenges to unlocking the potential of cell and gene therapies (18:49) Strategic insight: The cell and gene therapy field needs to lower manufacturing costs and increase production. Focused, practical approaches are required to make these life-changing therapies more efficient, scalable, and accessible to more patients around the world. Listen for practical perspectives on automation, digital tools, manufacturing infrastructure, and the future possibilities for decentralized, scalable cell and gene therapy production. Connect with Farlan Veraitch: LinkedIn: www.linkedin.com/in/farlan-singh-veraitch-a677112 Email: farlan.veraitch@oribiotech.com Ori Biotech: www.oribiotech.com Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

  • June 30 · 22 min

    265: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan Veraitch - Part 1

    What if the simple act of opening an incubator could undermine the consistency of your cell therapy manufacturing process? Unlike traditional biologics, the moment cells leave their incubator, subtle shifts in temperature, CO₂, and pH can spiral into mission-critical variability, jeopardizing everything from product yield to therapeutic potency. This episode features Farlan Veraitch, founder and Chief Scientific Officer of Ori Biotech. Trained at UCL’s Department of Biochemical Engineering, Farlan blends a bioprocess engineer’s mindset with hands-on experience scaling monoclonal antibodies, before pioneering the first-ever automation platform for embryonic stem cell culture. His drive for eliminating variability and designing systems that scale seamlessly from bench to bedside has informed ORI’s approach to modular cell therapy manufacturing. What you’ll hear in this episode: The importance of controlling pH, temperature, and shear forces in cell therapy manufacturing (00:36) Lessons learned from scaling monoclonal antibody production and its impact on biotech business models (05:23) The unique sources of variability in primary and stem cells, and why automation is essential (11:16) Strategies to minimize human-induced variability in sensitive cell cultures (12:59) How exposure to ambient oxygen and CO₂ during manual processing affects cell viability (14:13) The logic behind Ori Biotech’s modular design to solve environmental control issues (19:04) Strategic insight: As cell and gene therapies push boundaries, manufacturing must keep pace with exponentially tighter requirements. Farlan’s journey highlights a universal lesson for scientists and engineers: process control is not just a technicality, but a necessity for reproducible, scalable, and commercially viable therapies. If you’re grappling with process variability or looking for fresh strategies in cell and gene therapy development, this episode offers an inside view from a scientist who’s worked at the intersection of bioprocess, automation, and commercial translation. Connect with Farlan Veraitch: LinkedIn: www.linkedin.com/in/farlan-singh-veraitch-a677112 Email: farlan.veraitch@oribiotech.com Ori Biotech: www.oribiotech.com Next step: Need fast CMC guidance? → Get rapid CMC decision support here Support the show

  • June 25 · 15 min

    264: Why AI and Automation Tools Won't Deliver Until Your Lab's Data Is Connected with David Hardy - Part 2

    Digital transformation in biotech is no longer just about adopting new tools, it's about building a foundation where automation, data standardization, and AI integration actually lead to real value and long-term success. For today’s episode, David Brühlmann is joined by David Hardy, a leader at Thermo Fisher Scientific. With years spent guiding automation and digital lab transformation projects around the globe, David’s perspective is equal parts pragmatic and visionary. He’s watched automation go from pilot to scale, advised on the messy realities of lab data, and seen firsthand what separates science fiction from science fact in fully connected labs. In this episode: Bottlenecks in lab automation, especially the challenge of scaling data volume and adapting processes (02:26) Differences between machine learning (ML) and generative AI in lab contexts, and why ML remains central to value extraction (04:17) The key requirements for successful AI adoption: quality data, robust data checking processes, and a cyclical approach to model training (05:25) The vision for an AI-enabled, fully connected lab and the role of predictive maintenance and data quality checks (07:24) Data governance strategies: balancing access and security, and the case for data democratization within organizations (09:32) How data standardization paves the way for better AI and smoother connectivity (11:25) The necessity of treating digital transformation as an ongoing journey, not a one-time project (12:15) Smart insight: digital transformation is not a one-off project but a long-term journey. The most important takeaway for any scientist or leader? Prioritize good quality, standardized data; invest in the foundational work; and foster a culture of collaboration and learning. The connectivity problem doesn't stop at the data layer. These episodes tackle the automation failures, digital infrastructure decisions, and AI readiness questions that determine whether your lab's data ever becomes an asset. Episodes 215 - 216: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya Burkov Episodes 233 - 234: Why Most Bioprocess Automation Projects Fail Before the Robot Is Even Ordered with Anthony Catacchio Episodes 153 - 154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago Matos Episodes 17 - 18: How Extracting Gold From Your Data Accelerates Process Development with Ioscani Jiménez del Val - Part 1 Connect with David Hardy: LinkedIn: www.linkedin.com/in/david-hardy-46331823 Thermo Fisher Scientific website: www.thermofisher.com Next: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode. Support the show

  • June 23 · 16 min

    263: Why AI and Automation Tools Won't Deliver Until Your Lab's Data Is Connected with David Hardy - Part 1

    Despite cutting-edge equipment and brilliant minds, biotech labs often find half their data trapped in difficult-to-access spreadsheets or isolated in silos, making true digital transformation a major, industry-wide hurdle. David Hardy, a leading market and innovation strategist at Thermo Fisher Scientific with 25 years of experience at the intersection of data, automation, and laboratory science, is helping organizations bridge the gap between data chaos and actionable insight. Topics discussed: David Hardy’s early experiences managing NMR data at AstraZeneca and the origins of his interest in data management (03:46) Lessons from retail analytics and returning to scientific data challenges (05:21) Identifying the persistent problem of data connectivity in labs, despite growing data volumes and new technologies (06:40) The most common pushbacks to digital solutions: long-term commitment and culture change (07:38) What mindsets and leadership approaches support successful digital transformation (08:43) Recognizing fragmentation and spotting “hidden” data silos in biotech labs (10:06) Where data fragmentation hurts the most—especially for cross-disciplinary questions and CMC reporting (11:06) Build vs. buy: deciding whether to create in-house digital tools or work with external vendors (13:50) The importance of adaptable systems and preparing for inevitable change in biotech data management (14:43) Smart insight: True digital transformation is not a project, but a process—a way of working that requires vision, patience, and continual adaptation. The labs that break down data silos and connect their digital resources are better positioned to unlock the full promise of biotech: faster discoveries, more robust compliance, and therapies delivered to patients without unnecessary delay. The connectivity problem doesn't stop at the data layer. These episodes tackle the automation failures, digital infrastructure decisions, and AI readiness questions that determine whether your lab's data ever becomes an asset. Episodes 215 - 216: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya Burkov Episodes 233 - 234: Why Most Bioprocess Automation Projects Fail Before the Robot Is Even Ordered with Anthony Catacchio Episodes 153 - 154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago Matos Episodes 17 - 18: How Extracting Gold From Your Data Accelerates Process Development with Ioscani Jiménez del Val Connect with David Hardy LinkedIn: www.linkedin.com/in/david-hardy-46331823 Thermo Fisher Scientific website: www.thermofisher.com Next step: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode. Support the show

  • June 18 · 15 min

    262: How to Stop Defaulting to CHO: An Evidence-Based Host Selection Framework for Biologics

    Host David Brühlmann returns for a focused solo episode to provide an honest, data-driven perspective on the evolving landscape of host selection for biologics manufacturing. Building on part one, David reviews five alternative expression platforms and offers a clear, practical framework for scientists navigating host cell decisions today. David Brühlmann moves past simplistic "replacement" narratives to instead examine where each technology, from plant farming to cell-free systems, fits in today’s market and production realities. Key topics discussed Why asking if a novel host will "replace CHO" is the wrong question for scientists and manufacturers (00:11) Critical dimensions to evaluate: cost structure, speed, and intrinsic product quality (01:20) Review of five alternative platforms with current clinical and regulatory status: Plant farming for speed and decentralization (03:42) Insect cells for VLPs and complex proteins (05:00) Cell-free protein synthesis for ADCs and unique conjugation requirements (06:23) Moss for monoclonal antibodies with distinct glycosylation patterns (07:50) Filamentous fungi for high secretion and thermotolerance (08:47) A practical host selection framework by molecule type and manufacturing context (09:59) Detailed constraints and advantages of each platform, including cost, infrastructure, timeline, and product attributes (10:09) Analysis of silkworm production as a disruptive possibility for future biologics manufacturing (13:09) The evolving toolkit available to bioprocess scientists—and why "CHO replacement" is a distraction from more relevant questions (12:06) Smart insight: The real development over the past decade is that bioprocess scientists now have a credible, validated toolkit of alternatives for specific molecules in specific contexts. The practical implication: know this landscape well enough to ask the right host selection question at program initiation, before you've built months of process development around a platform you chose by default. Here are the episodes referenced: Episodes 163 - 164: How Moss Enables Production of Unproducible Protein Therapeutics with Andreas Schaaf Episodes 141 - 142: How Microalgae Cuts Antibody Costs by 70% and Redefines Biomanufacturing with Muriel Bardor Episodes 235 - 236: Plant-Based Biomanufacturing: How Molecular Farming Produces Biopharmaceuticals in Weeks, Not Months with Waranyoo Phoolcharoen Episodes 217 - 218: Silkworm Biomanufacturing: From Ancient Silk Production to Phase I Vaccine Trials with Masafumi Osawa Episodes 229 - 230: Cyanobacteria Biomanufacturing: Achieving Carbon-Neutral Production at Lower Cost Than Fermentation with Tim Corcoran Next: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode. Support the show

  • June 16 · 20 min

    261: Why CHO Is Still Winning (and the 5 Platforms That Beat It in Specific Contexts)

    In this solo episode, David Brühlmann explores the evolving landscape of biologic manufacturing platforms beyond CHO (Chinese hamster ovary) cells. Drawing from previous interviews with platform pioneers and rigorous data analysis, David examines where established and emerging hosts find their strengths—and their limits—in today’s biomanufacturing environment. Topics Discussed The historical dominance of CHO cells and what’s changed in the last decade (00:08) Three critical areas where alternative hosts might outperform CHO: cost, speed, and intrinsic product quality (04:52) Moss as a production platform: regulatory advantages, glycosylation, and oncology antibodies (05:47) Microalgae’s carbon-negative potential and the current 1000-fold yield challenge (08:28) Molecular farming (plant-based production): timelines, case of the Medicago COVID-19 vaccine, and overcoming political—not technical—barriers (10:41) Silkworm-based production: infrastructure cost, individual variability, and progress in vaccines (13:07) Cyanobacteria: promise of photosynthetic biomanufacturing and current limitations for clinical use (15:06) The pattern emerging among all alternative platforms: finding niche advantages rather than universally replacing CHO (18:25) A framework for evaluating novel hosts moving forward (19:14) Part 2 examines whether “Will it replace CHO?” is the right question to be asking at all, and introduces an alternative framework for evaluating the issue more effectively. Smart insight: None of the “novel hosts” are universal CHO replacements. Winners emerge in narrow niches: plant farming for pandemic-scale vaccines, silkworms in veterinary and oral applications, and cyanobacteria as a long-term bet for sustainable production. Here are the episodes referenced: Episodes 163 - 164: How Moss Enables Production of Unproducible Protein Therapeutics with Andreas Schaaf Episodes 141 - 142: How Microalgae Cuts Antibody Costs by 70% and Redefines Biomanufacturing with Muriel Bardor Episodes 235 - 236: Plant-Based Biomanufacturing: How Molecular Farming Produces Biopharmaceuticals in Weeks, Not Months with Waranyoo Phoolcharoen Episodes 217 - 218: Silkworm Biomanufacturing: From Ancient Silk Production to Phase I Vaccine Trials with Masafumi Osawa Episodes 229 - 230: Cyanobacteria Biomanufacturing: Achieving Carbon-Neutral Production at Lower Cost Than Fermentation with Tim Corcoran Next: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode. Support the show

  • June 11 · 21 min

    260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome - Part 2

    Funding novel therapeutics isn’t just “harder than ever”—the rules have changed entirely. The wild rush of capital into early-stage biotech during 2020–2021 gave way to a drought, making investor priorities sharper and startup hurdles higher than most founders realize. Michael Rome, Managing Director at Foresite Capital, joined the Smart Biotech Scientist Podcast to dissect what’s really driving funding decisions today, and what early-stage founders must do to stand out. Key topics discussed: The financial cycle of biotech investment before, during, and after the COVID-19 boom (02:47) Why investors are now focused on clear pathways to approved drugs and how founders should frame their proposals (06:10) The evolving importance of CMC expertise and manufacturing readiness for startups at different stages (07:44) Leadership traits and execution qualities investors appreciate in biotech founders and teams (09:18) Promising scientific and market areas including small molecule oncology, degraders, and heterobifunctional molecules (11:24) Practical advice for founders preparing for fundraising: focusing on unmet medical needs and market analysis (14:55) The impact of recent M&A activity and regulatory challenges at the FDA on the future of biotech investment (16:27) The importance of open communication and collaboration between scientists and investors (18:47) Smart insight: For those preparing their next fundraising push, Michael advised: Start with the end in mind: Outline the unmet need, the clinical and market pathway, and the product vision first Reverse engineer your innovation: Work backwards from market and regulatory needs to inform your technical approach, not the other way around. Frame your business case: Make it obvious to investors how your solution advances value in the ecosystem If you want to go deeper into the themes from this conversation with Michael Rome—how investors evaluate biotech companies, why CMC and execution matter, and how founders can better frame their science for funding—these episodes are a strong next listen: Episodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) Episodes 165 - 166: Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It) Episodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee Ho Episodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann Connect with Michael Rome: LinkedIn: https://www.linkedin.com/in/michael-rome-5067616b/ Foresite Capital website: www.foresitecapital.com Next: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode. Support the show

  • June 9 · 25 min

    259: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael Rome - Part 1

    Strong science alone won’t get your biotech startup funded—investors are sizing up much more than just your molecule. Michael Rome, who leads therapeutics investing at Foresite Capital, brings a rare dual lens as both scientist and investor. Having trained as a Caltech biochemist and incubated dozens of biotech companies, he’s seen first-hand how world-class discoveries become market-ready solutions—or get left behind. Topics discussed: Why strong science isn't always enough to secure funding (00:25) Insights on diverse biotech investing strategies, time horizons, and mandate differences between venture firms (02:44) The advantage of Foresite’s multi-stage and cross-sector investment model (03:32) Michael’s journey from science and math enthusiast to biotech investor (04:49) The importance of founding team track records and repeat entrepreneurs in early-stage company building (12:53) The evolving global landscape: company formation, investment, and biotech innovation in Asia (with a focus on China) (15:56) Effects of shifting geopolitical and regulatory landscapes on US, European, and Asian biotech partnerships (20:25) The practicalities and tradeoffs of outsourcing drug development, R&D, and manufacturing overseas (22:04) Smart insight: Engage with investor perspectives early: align your work to real market needs. Seek partnerships with industry leaders and proven entrepreneurs, embrace global resources, networks, and collaborations to maximize both scientific and commercial potential. If you want to go deeper into the themes from this conversation with Michael Rome—how investors evaluate biotech companies, why CMC and execution matter, and how founders can better frame their science for funding—these episodes are a strong next listen: Episodes 189 - 190: Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) Episodes 165 - 166: Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It) Episodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee Ho Episodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann Connect with Michael Rome: LinkedIn: https://www.linkedin.com/in/michael-rome-5067616b/ Foresite Capital website: www.foresitecapital.com Next: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode. Support the show

  • June 4 · 24 min

    258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 2

    What happens between scientific discovery and clinical trials? For too many drug candidates, the answer is “failure”—not because the idea lacked merit, but because the critical handoff between discovery and IND-enabling studies gets overlooked, rushed, or under-resourced. This episode features Milan Tomic, whose journey stretches from nucleic acid chemistry to leading GMP manufacturing and biodefense initiatives with hundreds of millions in US government support. Milan’s focus lies in streamlining drug development, from rapid molecule design to building manufacturing infrastructure, all grounded in holistic, systems-level thinking. Topics discussed: Why so many promising programs fail between discovery and the clinic, and how to close this gap through early, iterative design and testing (02:52) The practical advantages and considerations of cell-free protein synthesis for rapid prototyping and testing during development (07:30) How to decide when to deploy cell-free production versus traditional CHO systems (08:29) Recommendations for resource-constrained startups: what to focus on first and why stability and documentation matter most (10:55) Consistent success factors across Milan’s experiences, from government contract projects to launching his own company (13:54) Candid stories of setbacks and lessons—such as the critical importance of safety in development and the impact of overlooked technical details like facility lighting (15:30) The importance of linking drug design decisions to target patient needs and regulatory considerations, thinking holistically, and using target product profiles to guide development (20:22) Smart insight: Perhaps the most powerful takeaway isn’t technical, but personal. Staying curious, open-minded, and deriving enjoyment from the process is vital for sustaining the drive necessary for biotech’s long and often unpredictable journey. The best way to bridge the valley of death in biotech is through rigorous iterative design, early testing of critical attributes, holistic planning, and a relentless commitment to learning. If you enjoyed this episode you might also like listening to: Episodes 189 - 190 : Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) Episodes 123 - 124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan Sharfstein Episodes 213 - 214: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe Licari Episodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann Connect with Milan Tomic: LinkedIn: www.linkedin.com/in/milan-tomic-phd Albrem Biopharma: www.albrem.com Next Step: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode. Support the show

  • June 2 · 23 min

    257: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan Tomic - Part 1

    The gap between a “drug” and a true “product” is where many therapies fail. Milan Tomic, biotech veteran, GMP manufacturing expert, and founder of Albrem, has spent 30 years turning promising science into scalable, executable products that can actually reach patients. His experience spans everything from antibody development to building large-scale GMP facilities. Today, he helps biotech teams align scientific innovation with the operational and regulatory realities needed for successful commercialization. Topics discussed: Milan’s path from curiosity-driven research in molecular biology to biotech industry leadership (05:24) The importance of integrating work-life factors into career decisions, and balancing scientific depth with operational and business responsibilities (08:22) The unexpected role that salesmanship plays for scientists moving into entrepreneurship (10:40) Lessons from transitioning between scientific disciplines, including dealing with setbacks like unpublished graduate work (12:57) How curiosity led Milan to oversee the redesign of a 2,000-liter GMP manufacturing facility (16:16) Key advice for scientists on process design and scaling up, especially for those involved in CMC (20:18) Smart insight: A promising molecule isn’t enough—successful drug development requires designing early for scalability, GMP compliance, and real patient need. Companies that align science with manufacturability and market fit are far better positioned to advance, attract investors, and secure partners. If you enjoyed this episode you might also like listening to: Episodes 189 - 190 : Why Smart Biotech Founders Plan CMC First (While Competitors Burn Cash Later) Episodes 123 - 124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan Sharfstein Episodes 213 - 214: From Developability to Formulation: How In Silico Methods Predict Stability Issues Before the Lab with Giuseppe Licari Episodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri Kornmann Connect with Milan Tomic: LinkedIn: www.linkedin.com/in/milan-tomic-phd Albrem Biopharma: www.albrem.com Next Step: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode. Support the show