On October 27th, Dr. Dennis Gross gave a very informative presentation on the regulatory process. Over the course of two and a half hours, Dennis walked the class through the expensive and time consuming process of developing and approving new products in the US and around the world.
Some governing bodies, such as the FDA and the EU, have rigorous and well defined approval processes, but other markets may have different regulatory bodies with different requirements and timelines. These can significantly delay the approval, thus reducing the lifetime profitability for the drug. Dr. Gross very clearly laid out the challenges that companies face when deciding which markets to enter.
Dr. Dennis Gross is the CEO, Treasurer, and Professor of Pharmacology for the Pennsylvania Drug Discovery Institute. He is the Professor of Experimental Therapeutics and Medicinal Chemistry at the Baruch S. Blumberg Institute of the Hepatitis B Foundation. He is also Faculty in the Jefferson College of Biomedical Sciences and the Sidney Kimmel Medical School of Thomas Jefferson University (TJU).
He retired in 2014 from full-time status at TJU where he was the Associate Dean for Program Development and Assessment and Director for the Professional Science Masters Programs.