- Regulatory Strategy Planning
- Orphan Designation Applications
- Break Through Designation Applications
- Pediatric Priority Review Vouchers
- FDA Meeting Preparation and Representation
- Pre-IND
- End of Phase 2
- Pre NDA/BLA
- IND Submission
- NDA/BLA Submission
- Clinical Trials Design and Execution
- EU Orphan Designation Applications
DEMYSTIFYING ORPHANOLOGY WORKSHOP
The regulatory process can be an extremely tedious journey for orphan drug developers with a small margin for error. Gathering all of the insight from his time at the FDA OOPD, Dr. Timothy Coté and his team have developed an on-site seminar, Demystifying Orphanology, to assist the regulatory departments of large pharmaceutical companies. This orphan drug development seminar is a substantive learning tool designed to help companies find and assess regulatory pathways for orphan products, create individualized road-maps based on product readiness, and build on existing in-house regulatory strengths.
During the single-day workshop Dr. Coté engages participants in an academic environment, while also working to expand existing business opportunities. Structured to build upon each individual company’s regulatory knowledge base, the workshop provides training and insider knowledge targeted for regulatory professionals, but accessible for the whole team. The morning modules offer foundational training whereas the afternoon session applies the training in an in-depth portfolio review to strategically assess the most efficient and effective pathway forward for orphan programs.
SEMINAR AGENDA
Didactic Module
Regulatory Landscape Introduction:
A general introduction to the orphan product landscape including trends and recent legislative incentives.
Orphan Product Designation:
A presentation on how and why orphan designation is special and what the necessary components entail.
When the Same Orphan is Different:
An overview of the ways second-to-market orphan products can receive the incentives of orphan designation (exclusivity) by proving clinical superiority.
Plan the Most Effective Pathway for Entrants into the US Market:
Review your ability to achieve orphan designation for your products.
Strategic Planning for FDA Review:
Evaluate your readiness with expert advice to plan your road map, learn timing, criteria, and strategic considerations.
Prepare for Your IND Meeting:
Learn how to integrate and strategically partner with FDA officials and phrase critical questions for optimal results.
