2018 ISPE Pharmaceutical Manufacturing Conference, Managing the Global Pharmaceutical Supply Chain: How Pharmaceutical Quality System (PQS) Ensures Sustainable Compliance, Mumbai, India

In a time that we find ourselves so busy, who has time to attend a conference?  That was my initial thought, but when asked to speak at the conference, it became clear that this would be a unique opportunity to better understand the regulatory landscape while surrounded by members of India pharma and in the presence of key FDA regulators.  

Where There is Smoke, There is Fire!

The FDA’s Douglas Throckmorton, M.D., Deputy Director, Regulatory Programs, in the Center for Drug Evaluation and Research (CDER), gave a presentation on April 12, 2016 entitled, “FDA Regulation of Marijuana: Past Action, Future Plans.”  A key take-away from the presentation was that the Agency supports the development of drugs derived from marijuana (MJ).  This included mention of a guidance on the use of botanicals and the availability of Agency tools for expedited development (i.e.,

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.,