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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