Cell Therapy Manufacturing & Gene Therapy Digital Week – A Closer Look at Orphan ATMP Development, Incentives and Similarity.
Clinical Development for Cell, Gene and Immunotherapies
A Closer Look at Orphan ATMP Development, Incentives and Similarity.
Alex Bloom of Cell Medica presented at Cell Gene Digital Week.
Watch the on-demand webinar here http://spr.ly/60108gWqn
With an estimated 8,000 rare diseases identified and worldwide sales expected to exceed $175bn by 2020, commercializing new orphan medicines is highly attractive. The development of orphan ATMPs combines the incentives offered by orphan drug legislation with the specific expertise foreseen by the ATMP regulations.
This talk takes a closer look at:
• The development advantages associated with orphan ATMPs
• How to successfully prepare an orphan drug designation package, including common pitfalls
• Orphan similarity and market exclusivity as applied to ATMPs