Outsourcing Clinical Trials: A Small Biotech Perspective

Robert Dobosz, Director of Clinical Trials Solutions at Ryvu Therapeutics, delivered a thought-provoking presentation at COG Europe 2023, highlighting the unique approach small biotech companies take when outsourcing clinical trials. As a Poland-based biotech developing novel oncology therapies, Ryvu offers valuable insights.

Robert explained that biotech companies face distinct challenges compared to large pharmaceutical firms when designing and executing clinical trials. With limited financial resources, biotechs must be lean and focused in their trial strategy. They strive for speed and flexibility, adapting trial designs rapidly based on emerging data. Biotechs also tend to be more risk-tolerant, willing to pursue novel therapeutic approaches despite uncertainty.

When outsourcing trials, biotechs require CRO partners that understand this nimble, entrepreneurial approach. The best partners go beyond providing services, collaborating as an extension of the biotech's team. Robert emphasized that choosing the right CRO is critical, impacting timelines, costs, and ultimately the viability of the drug and company.

Other key points included:

• Biotechs conduct smaller, targeted trials aimed at demonstrating proof-of-concept vs. the large, extensive trials run by big pharma.

• While big pharma has ample financial resources, biotechs must prioritize spending and often depend on external funding.

• Biotechs are less experienced navigating complex regulations, frequently relying on CROs for regulatory expertise.

• Biotechs are more likely to outsource operational aspects of trials to optimize resources.

In summary, Robert highlighted that although biotechs and big pharma share the goal of bringing new therapies to patients, smaller companies must take a lean, nimble approach to clinical development. Selecting CROs that understand the biotech mindset is key to efficient, cost-effective trials.