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

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.
Support the show

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.
Support the show