Strategies for Orphan, Breakthrough and Fast Track Designated Development Programs
Presenter: Richard J. Holl and Todd Stutzman
Summary: There are critical unmet needs to get new drugs to market in order treat life threatening diseases. Accelerated regulatory pathways of fast track and breakthrough designations can often shave years off the approval process. Richard J. Holl, PhD and Todd Stutzman, Pharm.D., Directors at Catalent discuss how different development approaches and solutions can save time and accelerate your project from development to commercialization.