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

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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.

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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

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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

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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:

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Can aging be fundamentally slowed or even reversed—not by science fiction, but by harnessing the unassuming power of super-early stem cells?

In Part 1, Yuta Lee, Founder and CEO of Accelerated Bio, walked through the biology, ethical sourcing, and manufacturing profile of human trophoblast stem cells. In Part 2, the conversation shifts to the larger ambition: using those cells not just to treat disease, but to slow, stop, or reverse biological aging itself. The evidence starts with a striking finding from the National Institute on Aging, and it builds from there.

Topics discussed:

• The science and ethics of sourcing stem cells from ectopic pregnancies (03:02)
• Differences in differentiation potential between very early-stage cells and traditional MSCs or iPSCs (05:09)
• The origins of the research focus, driven by NIH/NIA inquiry and lessons from Stanford parabiosis studies (07:27)
• Explanation of senescent cells, inflammation, and disease connections (08:51)
• Potential therapeutic scope, from neurodegeneration to autoimmune diseases, and systemic anti-inflammatory applications (09:26)
• Vision for aging prevention—possibility of maintaining young biological age through regular secretome therapy (10:21)
• Challenges and global differences in regulation, access, and clinical adoption (12:05)
• The realistic limits and potential for reversing versus preventing age-related damage (13:20)
• The future landscape of cell and gene therapy in medicine (14:20)
• Why more investment is needed in longevity science and therapeutics (16:25)
• Practical takeaways for listeners about improving healthspan and longevity today (18:07)

Smart insight:

Prevention is becoming the new frontier of medicine, shifting from treating disease to preserving long-term biological function. Yuta Lee highlights a future where proactive longevity strategies, from lifestyle choices to emerging biotech, could keep us healthier for longer and push toward “escape velocity” against aging.

If you’re interested in how we turn living biology into scalable, reliable, off-the-shelf therapies without losing control of the system, explore these episodes:

• Episodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver Kraemer
• Episodes 147 - 148: Lab-Grown Blood: How Stem Cells Transform Transfusions with Ari Gargir
• Episodes 179 - 180: How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davies
• Episodes 211 - 212: When the Innovator Becomes the Patient: Manufacturing Reality vs. Patient Urgency with Jesús Zurdo

Connect with Yuta Lee:

LinkedIn: www.linkedin.com/in/yuta10

Accelerated Bio website: www.acceleratedbio.com

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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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What if the key to scalable, off-the-shelf cell therapy was hiding in tissue that surgeons discard every day?

Yuta Lee, Founder and CEO of Accelerated Bio, has spent two decades building a cell therapy platform on exactly that insight. Human trophoblast stem cells, sourced from ectopic pregnancy tissue that is otherwise discarded, sit at a unique biological intersection: earlier than MSCs, free from the ethical barriers of embryonic stem cells, expandable to 85 population doublings, and naturally equipped with HLA-G immune modulation that opens the door to allogeneic, off-the-shelf therapy at scale.

Topics discussed

• Common misconceptions and challenges in bioprocess development for biological therapeutics (02:45)
• The origin story behind Yuta Lee's interest in stem cells, including his father’s surgical discovery (04:15)
• A look at the intellectual property strategy that protected and enabled Yuta Lee's company to develop its platform (07:26)
• A clear explanation of different stem cell types (embryonic, trophoblast, mesenchymal, adult, and induced pluripotent) and their sources (09:37)
• Ethical and regulatory issues involved in sourcing stem cells, and how trophoblast cells offer a unique alternative (10:59)
• Discussion of stem cell differentiation, population doubling, and scalability for manufacturing purposes (17:03)
• Importance of immune privilege and HLA-G expression in pre-placental cells for off-the-shelf therapies (20:20)
• Shifts in the industry from autologous to allogeneic therapies, and the role trophoblast cells may play in future treatments (22:00)

In Part 2, Yuta Lee goes into the science of biological aging, the senescent cell secretome findings from the National Institute on Aging, and what a prevention-first therapeutic approach to healthspan extension could look like in practice.

Smart insight:

The scalability ceiling of MSCs is not just a manufacturing inconvenience, it is a strategic constraint. At 25 to 30 population doublings from birth-derived donors, every new donor batch requires revalidation as a distinct biological starting material. Trophoblast stem cells at 85 doublings from a single donor change that equation fundamentally, making true allogeneic scale not just biologically possible but manufacturable.

If you’re interested in how we turn living biology into scalable, reliable, off-the-shelf therapies without losing control of the system, explore these episodes:

• Episodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver Kraemer
• Episodes 147 - 148: Lab-Grown Blood: How Stem Cells Transform Transfusions with Ari Gargir
• Episodes 179 - 180: How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davies
• Episodes 211 - 212: When the Innovator Becomes the Patient: Manufacturing Reality vs. Patient Urgency with Jesús Zurdo

Connect with Yuta Lee:

LinkedIn: www.linkedin.com/in/yuta10

Accelerated Bio website: www.acceleratedbio.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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Are you still using one-factor-at-a-time experiments for biosimilar development, losing months, missing interactions, and risking costly dead-ends?

In this episode, David Brühlmann, host of the Smart Biotech Scientist Podcast, reveals how traditional "one factor at a time" screening in biosimilar development can take over 12 months, while the parallel group design massively accelerates discovery by grouping up to five factors per experiment and applying a multivariate analysis pipeline.

Topics discussed:

• The limitations of traditional and large DoE designs and the advantages of parallel group design (00:08)
• Best practices for grouping compounds by biological mechanism with four essential rules (00:53)
• The importance of anchor compounds, separating strong modulators, and initial univariate screens for unknown compounds (01:43)
• Guidance on managing practical issues, including evaporation, liquid handling, osmolality, and replicating production processes (06:42)
• The use of multivariate analysis tools: Principal Component Analysis, Mahalanobis distance, and decision trees for candidate selection (10:14)
• Key results and outcomes from applying the parallel group method, including faster and more cost-effective quality modulator identification (12:46)
• Three improvements David would recommend today: prequalifying compounds, broader quality analytics, and hybrid modeling integration (13:49)
• The shift in mindset from “time problem” to “information problem” in process development (16:50)
• Extending the parallel group and multivariate approach to other areas like clone selection and scale-up decisions (17:52)

Smart insight:

Process development is fundamentally about generating actionable information, not just running more experiments. The parallel group, multivariate pipeline lets teams ask better questions, in parallel, with dramatically improved data yield. This mindset and methodology extend well beyond biosimilar media development into clone selection, feed design, and process characterization, wherever complexity would paralyze traditional approaches.

If you want more detail, you can read the full article “Parallel experimental design and multivariate analysis provides efficient screening of cell culture media supplements to improve biosimilar product quality” published in Biotechnology and Bioengineering, which outlines the methods and findings behind this approach.

If you’re interested in hybrid modeling, here’s what previous podcast guests have shared on the topic, offering perspectives from fundamentals to real-world applications.

• Episodes 05 - 06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov
• Episodes 99 - 100: From Raw Data to Actionable Insights: Unlocking the Power of Process Models with Fabian Feidl
• Episodes 137 - 138: Skip 90% of Bioreactor Runs: The In Silico Revolution in Bioprocess Development with Yossi Quint
• Episodes 173 - 174: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist Gernaey

Next step: If this was useful, leave a review on Apple Podcasts or Spotify. It helps other scientists find this content, and it genuinely matters.

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