Premier Perspectives

The blog for insider insights in clinical development

Recent Posts

Learn more about the latest events and updates.

Medical and Regulatory Affairs

How COVID-19 Is Making Operationalizing Gene Therapy Trials Even Tougher – And How We Handled It

January 14, 2021

Medical and Regulatory Affairs

Site Selection, Manufacturing & Long-Term Follow-Up: Looming Challenges for a Rescue Phase 1/2 Gene Therapy Trial

January 12, 2021

Consulting

How to Navigate Global Regulatory Frameworks & Expedited Programs for Gene Therapy Development in the U.S., EU, & Japan

December 21, 2020

Clinical Research: Phase 1 - Phase 4

Choose the Right FDA Program to Expedite Your Rare Oncology Trial

December 2, 2020

Consulting

Beware of Underestimating the Value of a Pre-NDA Meeting

November 18, 2020

Clinical Research: Phase 1 - Phase 4

Adaptive Design Methods Offer Rapid, Seamless Transition Between Studies

November 17, 2020