Working for a large biotech company I was assigned to a product development team that was given the challenge of getting a first-in-man drug into a Phase-1 trial using the minimalist amount of resources and shortest amount of time. The project was named after the 1980s TV series hero MacGyver who applied his scientific knowledge to ordinary items (e.g. Swiss Army knife) to create for him and others a means of escape from impending doom and in the process save the world.
The team success would be measured against already established budget, resource and timeline metrics for other first-in-man Investigative New Drug applications (IND). As the regulatory representative on the team, my challenge was to ensure that there was just enough regulatory compliance with current regulations … Read more »