Beyond the Blueprint: Executing Europe's Bio-Manufacturing Vision

07/10/2026 11:35am - 12:20pm

Contributors

Claire Skentelbery : Director General - EuropaBio

Wallace Lin : Secretary General  - Taiwan Bio Industry Organisation (Taiwan BIO)

Michael Kocher : CEO - Xellia

Christian Houborg : Senior Vice President, Denmark • Global Operations & Quality - FUJIFILM Biotechnologies

While Biotech Act II establishes the legislative framework, successful implementation requires coordinated action across manufacturers, regulators, investors, and biotechs. This panel examines the practical execution challenges: how companies are navigating regulatory pathways, structuring partnerships, and building manufacturing capability under the new policy environment—and where structural barriers persist despite legislative intent.

Key Discussion Points:

• Regulatory Navigation: How manufacturers and biotechs are leveraging streamlined approval pathways and harmonised frameworks in practice—including early experiences, implementation gaps across Member States, and where regulatory coordination still creates bottlenecks.
• Manufacturing Partnership Models: Moving from transactional CDMO relationships to integrated co-development frameworks that align with Biotech Act II's innovation funding priorities—what works, what doesn't, and how capital discipline is reshaping collaboration structures.
• Infrastructure vs. Execution: Where policy incentives are successfully driving facility investment and capability building, and where economic realities, workforce constraints, or cross-border regulatory friction undermine legislative ambition.
• Stakeholder Coordination: Practical governance frameworks for aligning manufacturers, regulators, investors, and market access considerations from discovery forward—addressing the disconnect between policy goals and operational feasibility.