Innovating In Highly Regulated Settings

Find it hard to innovate in the strictly regulated environment of drug development?

You’re not alone.

Problem: Recently, a client company faced a competitive threat to their leading product. The FDA issued new manufacturing guidelines that would have taken three years to implement, while their competition had already complied. The PD (process development) team proposed an innovative method that would cut two years out of implementation and save $10 million. The problem was that their executive team said it was too risky to recommend to the FDA.

Solution: In the words of Clayton Christensen, Harvard Business School Professor and authority on disruptive innovation, “Management teams aren’t good at asking questions. In business school, we train them to be good at giving answers.” Instead of trying to convince the executive team to their point of view, I coached the PD team on how to clearly articulate the scientific questions and ask the C-Suite members, “What data would be compelling for you to take the risk?”

Result: With the responses to their questions in hand, the PD team designed and executed a study that produced robust data to support their innovative method. Executives agreed to their approach and conducted a successful meeting with FDA, who approved their method.