Biography
Biography: Rajiv Nayar
Abstract
Demand for drug delivery product in the US will rise 6.1% yearly to $251 billion in 2019. Parenteral products will grow the fastest, driven by monoclonal antibodies and polymer/liposomal encapsulated medicines. Not only are the drugs becoming more complex (e.g. DNA, siRNA, mRNA, cell-based, modified biologicals, etc) but the DDS employ novel materials and configurations (smart polymers, tunable liposomes, mesoporous silica, graphene nanotubes and biosensors, etc). A significant challenge for both drug and drug delivery systems is to produce existing and emerging drug technologies in a manner that improves drug administration for the patients. Advantages of complex drug delivery systems over traditional systems are more convenient routes of administration, rate or efficacy and duration of drug activity, decreased dosing frequency, improved targeting, as well as reductions in toxic metabolites. An equally important consideration is the concept of making the drug delivery system a pharmaceutically acceptable drug product. The challenges involved in making a Drug Product Delivery System (DPDS) are issues that include safety, stability, manufacturability, cost of goods, and being reimbursable. These issues that need to be addressed in CMC of the DPDS will be discussed as they are a critical component in bringing a novel DDS containing a biopharmaceutical to market. Some recent case histories will be discussed as examples.