Hot Topic ‘Choose Europe’ - How pharma & biotech can make the most of the EU Biotech Act and FAST-EU

Day 1

• The EU Biotech Act: Unleashing Europe’s Innovation Potential.
  
  The background and purpose of the EU Biotech Act designed to boost investment and ensure future breakthroughs are "Made in Europe."
  
  Jakob Bjerg Larsen, Head of Clinical Trials and Pharmaceutical Manufacturing Policy, The Danish Association of the Pharmaceutical Industry (Lif).
  
  
• The EU Biotech Act: Impact on pipeline, footprint and speed-to-patient:
  
  In this session, the proposal will be translated into practical implications for pharma & biotech companies working across health biotechnology - from R&D and clinical development to scale-up, manufacturing and data/AI-enabled innovation - including:
  
  • Opportunities to accelerate and strengthen EU-based projects through “strategic project” designation.
  • A potential ‘Made in EU’ incentive, including the possibility of 12 months additional protection for particularly innovative medicines
  • Faster and clearer trial pathways by shorter approval timelines, regulatory sandboxes and a single authorisation route for trials combining medicines with medical devices/IVD
  • Simplification and harmonisation across key areas affecting development and scale-up (clinical trials, ATMPs, SoHO, GMOs, VMPs and food)
  • Increased focus on AI and data to enable and accelerate biotechnology
  • A proposed 2-year EU Health Biotechnology Investment Pilot designed to support companies across their lifecycle
  
  Louise Bertelsen Forman, Partner, Bech-Bruun & Emil Bjerrum, Senior Associate, Bech-Bruun
  
  
• FAST-EU – Paving the Way for Expedited Multi-National Trials Across EU
  
  • As a first step to prepare and implement the future EU Biotech Act, the FAST-EU pilot was recently launched to harmonise and accelerate clinical trial approvals across 24 member states.
  • Get a deep dive into the Danish Medicines Agency’s role in the initiative, their expectations for the process, and how they support sponsors to drive clinical innovation.
  Lene Grejs Petersen, Special Adviser at the Danish Medicines Agency
  
  
• Industry Readiness: Pharma & Biotech Perspectives on the Biotech Act & FAST-EU
  
  Panel discussion between:
  
  • Christina Balslev Rindshøj, Vice President, Head of Regulatory Affairs, Zealand Pharma
  • Dorte Klokker, Country Head, PD Global Clinical Operations, Roche
  • Jakob Bjerg Larsen, Lif (Denmark)
  • Lene Grejs Petersen, Special Adviser at the Danish Medicines Agency
  • Louise Bertelsen Forman, Partner, Bech-Bruun
  
  Moderated by: Elisabeth Gammelgaard Ludvig, Journalist