(144h) Why Are We So Risk Adverse?

Authors: 
Fermier, A., Johnson & Johnson
Weber, J., PDMS
Mehrman, S., PDMS
Schaefer, E., Janssen Pharmaceutical Companies of Johnson and Johnson
Harkins, A., Janssen Pharmaceuticals
Cedeno, W., Janssen Pharmaceuticals



Quality by Design is a great concept to drive corporations towards a more streamlined and disciplined mechanism of developing new medicines.  However, it has been a long drawn out conversation with specific case studies, and achieving a sustainable change in this direction is proving difficult.  Is it because we are risk adverse?  Obviously not in our industry with failure rates of molecules reaching >80% from Phase 1 to launch.  We take risks in what we move to the clinic, but how we design and approach our process development one could argue is still very conservative.  The rationale for the conservative approach is the complexity of the manufacturing process itself and substantial consequences of failing ultimately the patient that drives the conservative behavior.  In this presentation we will be discussing our risk based approach we are implementing, our challenges and overall strategy to overcome to help ensure the movement to the risk based approach is a sustainable change.