Understanding the pharmaceutical product development process is the key to maximizing the value of your new drug or dosage form. Ensuring that you are on the proper product development path will increase the likelihood of success, whether out-licensing technology or taking a product to market. This workshop will provide an overview of the pharmaceutical/ biologic development process – from discovery to marketing authorization by the FDA. Particular focus will be placed on early stage activities required for an IND application. Programs designed to get products to market faster such as the Orphan Drug Act, Fast Track, Priority Review, Accelerated Approval and RAID will be discussed as well.
