Clinical development strategy is often shaped long before a study begins.
Early decisions around trial design, endpoint selection, data strategy, and regulatory planning can influence not only execution, but also how well a program adapts as complexity increases.
For small and mid-sized biotechs operating under tight timelines and resource constraints, misalignment across clinical, data, and regulatory functions can create downstream challenges that are costly and difficult to resolve later in development. Global considerations across regions such as the US and EU can add further complexity.
This webinar will explore how more integrated approaches to clinical development can help reduce fragmentation, improve visibility across functions, and support key milestones such as First Patient In (FPI). Through a cross-functional discussion, attendees will gain practical insights into identifying early sources of risk and strengthening the foundation of their development strategy.
Attendees will learn how to:
Identify early sources of strategic and operational misalignment
Evaluate how clinical, data, and regulatory decisions impact execution later in development
Strengthen development planning to better support key milestones, including first patient in
Assess how integrated operating models can help reduce downstream risk
Thermo Fisher Speaker Details
Gerri Baer, MD, FAAP
Vice President, Strategic Scientific Solutions at PPD
TJ Stalvey
Vice President, Neurosciences at PPD
Ariel Berger, MPH
Executive Director, Integrated Solutions, Real-World Data & Scientific Solutions at PPD
Shyam Banuprakash
Vice President, Data Science & Data Delivery for Medical Imaging at Clario