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

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

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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.

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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.

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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.

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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.

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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.

Free 5-day email course, The CMC Failure Chain: the five recurring CMC mistakes that put your promising program at risk → Get it here

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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

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

The "data lake" that was supposed to unify bioprocessing intelligence has, in most companies, become something else entirely: a data swamp, where information goes in and insight rarely comes back out. For anyone trying to deploy AI in GMP manufacturing, that is not a technical problem. It is the problem.

Steffen Kreye has seen it from both sides. As former upstream development lead at Bayer and now Professor of Industrial Biotechnology at Berliner Hochschule für Technik, he brings an unusually grounded perspective on where AI in bioprocessing actually stands, what the next generation of scientists needs to be equipped with, and what industry can do right now to help close the gap.

Key topics discussed:

• How soft skills like teamwork and self-motivation are becoming increasingly important for scientists, and strategies to foster them in education (02:47)
• The reality behind AI and machine learning in biotech today, including current limitations and the true state of industry adoption (05:48)
• Envisioning bioprocessing ten years from now: the potential of continuous manufacturing, digital twins, and automation, and the evolving diversity of bioprocesses (08:09)
• Practical ways industry professionals can support university education—from guest lectures to hands-on lab courses—and why it matters (10:09)
• Motivating students by connecting coursework to real industry roles and contributions (12:10)
• The importance of finding and following individual motivation in science careers (12:41)
• Reflections on moving from industry to academia: autonomy, challenges, and the satisfaction of seeing students grow into scientists (13:22)
• How strong collaboration between academia and industry leads to better innovation and prepares future scientists for success (15:53)

Smart Insight: Most companies talking about AI in bioprocessing are still solving a more fundamental problem: getting their data into a state where AI could use it at all. The breakthrough will not come from the algorithm. It will come from the unglamorous, years-long work of making data accessible, harmonized, and meaningful across sites, systems, and GMP boundaries.

Here are some other guests who touched on similar themes:

• Episodes 175 – 176 : How Virtual Reality Training Solves Europe's Bioproduction Talent Shortage with Sandrine Lemoine — about training the next generation of biopharma talent.
• Episodes 93 – 94: From Lab Coat to LinkedIn: Benjamin McLeod's Journey to Cell and Gene Therapy Influencer — another career pivot story from a scientist who stepped outside the traditional industry path.
• Episodes 111 – 112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars Brandén — very aligned with Steffen's nuanced take that AI is a tool but human expertise in bioprocessing still matters.

Connect with Steffen Kreye:

LinkedIn: www.linkedin.com/in/steffen-kreye-3b531183/

Berliner Hochschule für Technik: www.prof.bht-berlin.de/kreye

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.

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When AI can draft a literature review in minutes, the question bioprocess educators can no longer avoid is this: what does a student actually need to learn?

Steffen Kreye has a clear answer. As Professor of Industrial Biotechnology at Berliner Hochschule für Technik, he trains engineers who step into industry ready to run a bioreactor, not just describe one. His argument is direct: hands-on lab competence is the one thing AI cannot replicate, and it is exactly what underfunding is quietly eroding.

Topics discussed:

• Why Steffen Kreye left his lab head role at Bayer to become a professor and how his career evolved (03:54)
• The unique mission of universities of applied sciences and their close connection to industry needs (11:16)
• Challenges of delivering lab-based education, including funding and equipment constraints (12:32)
• Creative strategies for partnering with biotech companies to sustain practical lab courses (14:34)
• How reading student theses, partnerships, and conferences help Steffen Kreye and his colleagues stay current in a rapidly changing field (17:43)
• The impact of AI and digital tools on research, teaching methods, and student assessment (21:18)
• Why traditional theoretical projects are less relevant, and the growing importance of problem-solving and oral examinations (22:09)

In Part 2, Steffen gives his unfiltered take on where AI in bioprocessing actually stands, which human capabilities are becoming harder to replace, and what a well-prepared bioprocess engineer will need to look like by 2035.

Smart Insight: Once AI can produce a polished report from a well-structured prompt, the only assessment that still reveals genuine understanding is the one a student has to navigate in real time, without a tool to hide behind.

Here are some other guests who touched on similar themes:

• Episodes 175 – 176 : How Virtual Reality Training Solves Europe's Bioproduction Talent Shortage with Sandrine Lemoine — about training the next generation of biopharma talent.
• Episodes 93 – 94: From Lab Coat to LinkedIn: Benjamin McLeod's Journey to Cell and Gene Therapy Influencer — another career pivot story from a scientist who stepped outside the traditional industry path.
• Episodes 111 – 112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars Brandén — very aligned with Steffen's nuanced take that AI is a tool but human expertise in bioprocessing still matters.

Connect with Steffen Kreye:

LinkedIn: www.linkedin.com/in/steffen-kreye-3b531183/

Berliner Hochschule für Technik: www.prof.bht-berlin.de/kreye

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.

Free 5-day email course, The CMC Failure Chain: the five recurring CMC mistakes that put your promising program at risk → Get it here

Support the show