Check In, Coffee & Refreshments
1.00 – 2.00
2:00 - 4:00 pm
Exploring Regulatory Law & IP Considerations for Peptide Drug Product Formulation & Reformulation to Ensure Patent Application Success
Understanding the intellectual property (IP) and regulatory implications of making formulation or chemical changes to peptide drugs is critical to ensuring smooth market access for your product.
Join this collaborative space to learn about the steps, frameworks and data requirements needed for submitting successful patent and regulatory packages for your novel peptide drug.
This workshop will gather experts to:
- Outline the IP implications for making changes to peptide drugs
- Understand when an old molecule becomes a new molecular entity with new IP
- Define the data packages required to be sufficient for IP submission and abide by regulatory law if formulation or chemical changes are made

Workshop Leaders
Mi Cai
Associate & Registered Patent Attorney
Foley Hoag