Biosimilar Development Stage-Gate Governance

Course Summary

Biosimilar development requires coordination across multiple scientific, regulatory and operational workstreams, including molecule selection, clone development, upstream and downstream process development, analytical comparability, clinical readiness, technology transfer, PPQ and global dossier preparation.

This half-day program provides a practical framework for establishing stage-gate governance across the biosimilar development lifecycle. Participants learn how to define decision checkpoints, establish readiness criteria, manage cross-functional dependencies and create governance mechanisms that enable timely and compliant program execution.

The program focuses on real execution challenges faced by biologics and biosimilar teams, including delayed process development, comparability gaps, technology-transfer risks and leadership decision-making requirements.

Who Should Attend

• Mid-level Project Managers managing biologics/biosimilar programs
• R&D Leads and Development Scientists
• CMC Professionals
• Regulatory Affairs Program Teams
• Portfolio Managers
• MSAT Professionals
• Manufacturing and Technology Transfer Teams
• QA Professionals involved in product-development governance

Business Outcomes

Participants will be able to:

• Establish a structured stage-gate framework for biosimilar development programs.
• Improve alignment between technical teams, project teams and leadership stakeholders.
• Define clear ownership, milestones and governance cadence.
• Strengthen risk-based decision-making for timelines, cost, quality and regulatory readiness.
• Identify development bottlenecks early and create mitigation plans.
• Convert complex technical updates into leadership-ready decision documents.
• Improve execution discipline while maintaining compliance requirements.