Dr. Stephen Munk, CEO, Ash Stevens
The US FDA Fast Track designation is intended to expedite access to promising new drugs to treat seriously ill patients where there is unmet medical need. To effectively leverage Fast Track status, sponsor pharma companies must rapidly establish excellent communication systems and partnerships with their respective service providers. Of particular urgency, is the development of a scalable manufacturing process to meet the clinical and post-approval demands for API under an accelerated development program. Ash Stevens CEO Dr. Stephen Munk discusses the strategies and tactics his contract manufacturing organization uses to meet the vastly accelerated timelines for Fast Track projects.