SCOPE Summit 2025: Peter Ronco on the Risks Small Biopharma Companies Face in Clinical Trial Partnerships

ACT: What are the biggest risks small biopharma companies face when partnering on clinical trials, and how can they mitigate them?

Ronco: There are a number of risks. I think being forgotten or being priority number 600 on a large partner’s list of clients is one of them. But this morning, we talked about a couple of others, including the idea that you need to have best-of-breed technology—I have to have the best TMF, the best EDC—and I just don’t think you do. I think you need to ask: What makes sense for my program and my company? From there, you can build a good-enough technology backbone at a lower price point to actually deliver your study.

Another risk we discussed was understanding the core capabilities you have as a company versus where you need to bring in external expertise. There’s no point in hiring if you already have a great statistical or regulatory group—you don’t need to duplicate those efforts. Be clear on what you're outsourcing and why, so you can set the relationship up for success.

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.