ACT Brief: Single Pivotal Trial Stakes, Configurable FSP Strategy, and G-CSF Biosimilar Portfolio Expansion

This is the Applied Clinical Trials Brief—your fast track to the latest insights shaping clinical operations and drug development.

• In part one of a new interview, Gaynor Anders, chief delivery officer at Trialbee, explained how the FDA's shift toward single pivotal trials is raising the stakes on recruitment quality, feasibility precision, diversity, and retention. Sponsors now operate with reduced margin for error, making site selection, enrollment strategy, and participant engagement more critical to overall program success, fundamentally changing how they approach trial planning and execution.
• In a new contributed article, Nicole Duffey examined how FSP should be viewed as a configurable continuum rather than a binary outsourcing decision, challenging persistent misconceptions that FSP requires mature infrastructure or precludes hybrid approaches. Strategic deployment requires honest assessment of functional complexity, internal capacity maturity, and strategic priority, enabling sponsors to tailor engagement models to their specific needs without wholesale operational restructuring.
• FDA approved Accord BioPharma's Ennumo for febrile neutropenia prophylaxis in patients receiving myelosuppressive chemotherapy, including pediatric populations. The approval completes Accord's three-product G-CSF biosimilar portfolio and positions the company toward its goal of launching 20 biosimilars by 2030, expanding access to supportive care therapies across oncology practices.

That's all for today's ACT Brief. Join us next week for more updates shaping clinical operations and drug development. Thanks for listening.