The CMC Team:
● Makes sure manufacturing operations are synchronized with clinical needs (be it for clinical trials or market)
● Manages and controls the CMC budget (which is always insufficient)
● Connects all the dots (and the multitude of experts) from all faucets of product development and translates them to the real life of CMC
● Always keeps direct sight to the Patient needs and safety, with the guidance (and surveillance) of the Regulatory Authorities.
In an ideal world (and mature companies)- there is a team of people in charge of CMC development and operations. But in some start-up companies, it could be as little as ONE person in charge of all the above- and that, ladies and gentlemen, is the CMC Superhero! Look around, she looks just like any one of us....
In the CMC Essentials Training course we got to know the roles of the CMC Leadership in the company, and shared some tips for safe navigation for ultra-small and lean startup operations, relying heavily on a network of service providers...