Conducting the advanced therapy supply chain orchestra is more than waving a stick at people — it is an end-to-end, complicated, interrelated system that requires controlled, consistent management. Following are some things you need to think about to develop the capability to provide a harmonious supply chain management system.
While the potential for advanced therapies to provide curative treatments to patients around the world is very exciting, the pricing strategies and reimbursement models to support this innovation are quite complicated. This article explores the cost vs. price paradigm through a supply chain lens, highlighting hidden costs and their impact on reimbursement potential.
Due to the short shelf life and clinical criticality of advanced therapies, their supply chains are often highly complex. Once efficacy and safety is demonstrated, the focus of advanced therapy developers moves to controlling cost. However, the biggest cost within the supply chain is caused by its complexity. Learn why the advanced therapy supply chain is so complex and how this complexity correlates to cost.
The RMAT designation gives the sponsor of a new drug access to increased meeting opportunities with the FDA, in a manner comparable to those offered to sponsors of breakthrough-designated therapies. In fact, the RMAT may be considered as analogous to the breakthrough designation for regenerative medicine drugs.