PDA Letter Article

How to Get Your ATMP From the Lab to the Market

by Andy Fry, Team Consulting

What is actually involved in taking an advanced therapy medicinal product (ATMP) from a brilliant idea in the lab to a successful product on the market? Is it similar to the development of a combination product? Or a monoclonal antibody? Just how difficult can it be? The level of activity surrounding ATMPs has been increasing, with some remarkable therapeutic opportunities currently being explored.