Pre-congress Workshops

Pre-congress Workshops Nov 6

09:00

Morning Pre-congress Workshops

Dr Renato Dellamano

Workshop A (9am-1pm): Pricing, Reimbursement and Market Access Challenges for Orphan Drugs and Cell and Gene Therapies

  • Orphan Drugs and Advanced Therapy Medicinal Products (ATMPs) in the EU: Pricing, reimbursement and market access challenges
  • Guided panel discussion – What pricing, reimbursement and market access models for Orphan ATMPs?
  • Unique challenges in the manufacturing and commercialization of gene therapies for rare diseases
  • Building a value dossier for personalized gene / cell therapies for rare diseases
Daniel O'Connor

Workshop B (9am-1pm): Drug Repurposing – A Sufficient Business Model to Drive Orphan Drug Development?

  • What is a sustainable approach to repurposing generic drugs for rare diseases?
  • Can repurposing truly deliver a transformational therapy?
  • How can this be incorporated into a drug development business model and strategy?
  • How to get national healthcare providers and regulators on-board? Are there gaps in the regulatory frameworks
  • Considerations: How does drug repurposing differ? The more obvious benefits and lesser known challenges
  • What about off label repurposing?
13:00

Networking Lunch Break

14:00

Afternoon Workshops

Dr William C. Maier
Sheela Upadhyaya

Workshop D (2pm-5pm): Managed Access…Are they the holy grail?

  • How will the development of the EUnetHTA initiative support the managed entry agreement development and data collection, can it become a joint European venture too?
  • Success stories and learning from a variety of jurisdictions, discuss best practices from multiple perspectives and provide a hands-on opportunity to craft MEAs for specific therapies
Inneke Van De Vijver, Acting President - Taskforce Managed Entry Agreements, N.I.H.D.I.
17:00

End of workshops and welcome drinks Hosted by ICON

last published: 19/Oct/18 16:45 GMT

 

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