GMP Inspection Deficiency Data Trends for 2016 – Who is Minding the Store?

With the recent publication of the GMP Inspection trends for 2016 from the MHRA (here) and the FDA (here), companies involved with the observations might want to reconsider their internal audit processes.

If you evaluate the examples of the issues observed, you would question why internal audit programs do not catch many of the issues cited as most frequently encountered.

Getting a CRISPR View – Genetic Editing: Medical Frontier

Most of us in the pharmaceutical industry have heard the phrase “targeted therapy”.  Targeted therapies are drugs or other substances specifically designed to prevent cancer cells from dividing or destroying them directly, and are intended to target only cancer cells.  While standard chemotherapy may affect all cells in the body (including healthy, non-cancerous tissue), targeted therapy uses drugs or other specially created substances (e.g.,