Halloran's Regulatory Lens – What We're Watching In 2025

By Shawn Roach, PhD, RAC

As the regulatory environment evolves in 2025, product developers face increasing complexity driven by external pressures such as tariffs and internal shifts like FDA personnel changes. Halloran’s regulatory team, led by Shawn Roach, PhD, is closely monitoring these developments and providing strategic guidance to mitigate risk and maintain momentum. Imminent tariffs on imported materials—particularly from Canada, the EU, and China—pose a significant threat to biopharmaceutical supply chains. Small and mid-sized companies may be especially vulnerable, making proactive risk assessment and alternate sourcing strategies essential.

Halloran continues to emphasize the importance of robust planning across all phases of development—from early research to NDA/BLA submissions—anchored in realistic funding strategies and agile risk management. The firm urges companies to shift away from milestone-based fundraising and adopt long-term strategic planning that aligns with regulatory and market dynamics. Throughout 2025, Halloran will publish ongoing insights and actionable recommendations to help sponsors adapt to the shifting regulatory landscape, manage uncertainty, and remain competitive in a challenging development environment.