Agenda for Day 2 - Tuesday 10 November, 2026
How will the GPL and the Biotech Act create additional incentives for market access?
Implications of initiatives on regulatory data protection and market exclusivity
Navigating changes to Supplementary Protection Certificates (SPCs) and their impact on market exclusivity
Regulatory strategies to maximise available incentives
Comparing key global differences in approaches to incentives
- Hugh Pullen - Chair, EuropaBio Healthcare Council and VP, Head of Public Affairs Region Europe, Novartis
Examining the enhanced incentives under updated GPL regulations
Understanding the baseline for data protection measures
How to qualify for rewards attached to new indications with significant clinical benefits
Analysing breakthrough definition for extending exclusivity periods
Key updates tailored to paediatric medicine advancements
- Katherine Tyner - Senior Director, Regulatory Policy Leader, EMEA & CMC, Johnson & Johnson
Regulatory pathways and benefits available for unmet medical need targeted products, and how can they accelerate development and approval?
How do you define unmet medical needs and that are the thresholds? Navigating the challenge of variable regulatory interpretations across diseases and therapeutic areas
Case study insight into different conditions and how they qualify for Unmet Need
Have the changes in the GPL really moved the needle when it comes to stimulating development for unmet medical needs?
- Sara Escola - Regulatory Affairs Europe Head, PTC Therapeutics
- EMA guidelines to operationalise the implementation
Adapting to the evolving EMA network and its role in shaping GPL processes
Understanding the key changes under GPL and their impact on your regulatory approval
Practical scenarios: share different perspectives, identify readiness challenges, and discuss recommendations and next steps
- Virginia Acha - Associate VP, Global Regulatory Policy, MSD
Latest developments in EMA’s regulatory sandbox and the potential for innovation
Leveraging the IHI BRIDGE project to advance innovative healthcare technologies
MHRA’s AI airlock sandbox expansion and its implications for biotech innovation
Evaluating the potential of in-silico technologies to replace pre-clinical and phase I testing
- Dominika Misztela - Director, Global Regulatory Affairs Science, Policy, and Intelligence – Europe, CSL Behring
Understanding the impact of the EU Biotech Act, ATMP, and SoHO Regulations on ATMP development and Biosimilars
Building a unified approach to Hospital Exemption to accelerate ATMP access and drive Europe's innovation and competitive edge forward
Comparing the EU regulatory framework with the MHRA Rare Therapies Launch Pad and its support for innovation
Exploring the FDA’s framework for accelerating individualized therapies and its implications for global competitiveness
Identifying key strategies for biotech manufacturers to adapt to evolving regulatory requirements and seize new opportunities
- Simon Bennett - Director, Regulatory Policy Europe, Canada and Partner Markets, Biogen
Examining the current state of EU CTR and upcoming changes under the EU Biotech Act
Comparing the key differences across the US, China, and UK
Assessing practical impacts on regulatory approval processes and timelines for clinical trials
Navigating divergent regulatory feedback: understanding similarities and differences in how key global regulators engage with sponsors throughout the regulatory journey
- Christine Mayer-Nicolai - VP, Global Regulatory and Scientific Policy, Merck Serono
- Anna Litsiou - Senior Director, International Regulatory Policy & Intelligence, AstraZeneca