FDA Launches Expedited IND Pilot Program to Accelerate Human Trials, Raising IP Considerations for Sponsors
Joseph Mallon, Ph.D. & Susan M. Janicki, Ph.D.
The Expedited Investigational New Drug (IND) Pilot Program is intended to evaluate whether leveraging qualified research institutions (QRIs) and a rolling review process can improve the efficiency of early clinical development.
Before forming a business relationship with a QRI, sponsors should consider steps to protect intellectual property and trade secrets.
FDA Announces New Rare Disease Framework With Potential Implications for IP Strategy
On October 14, 2026, the FDA announced a proposed framework for rare disease drug development that aims to provide greater regulatory flexibility and disease-tailored evaluation. Increased regulatory clarity could influence pharmaceutical and biotechnology companies’ research and development investment decisions, as well as subsequent IP strategies, including patent protection for new therapies.
Subscribe for News and Updates