ACT: What advice do you have for small biopharma companies looking to scale their clinical programs without overextending resources?
Ronco: The first step is to say your resources are limited, but you can hire some resources internally. Be really choiceful. What are those key roles that you should be investing in up front so that you’d be more successful? I’ve always guided on having a good project manager that knows how to work with outsource providers, having a good statistician that can be by your side throughout the development program, and having an MD and having the support boot on that. But you need to have hose key roles that you can then build upon. I can bring in as a partner. I can bring in additional CRAs. I can bring in data managers. If you have those two core roles, you can really expand out.
Second is investing the time to pick partners that can grow with you. Ideally, you don’t switch partners every study. It’s a pain in the neck. You have to then build the relationships. Ideally, you pick the right partners, and you then grow with them, and as your asset continues to progress or diversify, that partner is able to grow with you.
Full Interview Summary: The session focused on how small biopharma companies can successfully select and collaborate with clinical trial partners despite having limited resources compared to large pharmaceutical companies. Andy Lee highlighted Merck’s approach to clinical trial development, emphasizing that small biotechs must take a different path due to financial constraints and smaller operational teams.
Key considerations for selecting the right clinical trial partners include striking a balance between size and attention—choosing a provider that is large enough to execute the trial effectively but small enough to provide personalized support. Transparency about financial limitations is also critical, as many small biotechs are not aiming for immediate commercialization but rather generating proof-of-concept data to secure further funding or partnerships.
Common risks in partnering include being deprioritized by large CROs, overspending on unnecessary top-tier technology, and failing to clearly define which capabilities should be outsourced versus retained in-house. Companies should invest in core internal roles like project managers and statisticians while leveraging external partners for additional support.
To scale efficiently, small biotechs should focus on selecting long-term partners who can grow with them, reducing the disruption of switching providers between trials. Industry expectations for CROs and trial partners are evolving, with an increasing focus on automation, patient-centric strategies, and diversity in recruitment. For smaller companies, a key differentiator in selecting partners is how quickly and effectively issues are resolved when challenges arise.
Ultimately, success in clinical trial partnerships hinges on strategic partner selection, transparent collaboration, and alignment of capabilities to ensure trial execution remains efficient and goal-oriented.