In case you missed his op ed, here is Pharmatech president Bikash Chatterjee's assessment of pharma, why it needs to change from within, and some of the challenges involved. A brief excerpt below:
So why has our industry, which has prided itself as being scientifically driven, struggled with the concept of QbD? Why has PAT (process analytical technology) not become the ultimate business trump card? Although Big Pharma and Biotech are beginning to embrace these redefined basic principles of process characterization and variation control, the remainder of the industry remains largely uncommitted. Lean Six Sigma initiatives are creeping into process improvement programs but have yet to propagate to the R&D phases of the drug lifecycle.-AMS
