Finding the Best Path to a Clinical Protocol Design

in , ,

Can’t get people out of their silos?

You’re not alone.

Problem: An early-stage company needed to demonstrate Proof of Concept for a novel therapy, but the organization could not reach agreement on a clinical protocol design.

My client Peter, the Program Executive, vented his frustration to me:

“Dr. C [the Clinical Director] withdraws, withholds information, doesn’t inform me or the program team about anything, comes up with a suboptimal design, gets his boss on board, the Portfolio Review Committee rejects the proposal, and we end up losing a lot of time. This has happened a couple of times already.”

The Portfolio Committee told the team that the only solution was to bring in outside experts.

Solution: Instead of blaming Clinical, I helped the Program Executive step back. Read more

Innovating In Highly Regulated Settings

in , ,

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.

Read more