Innovations in the development of advanced therapies have yielded new and dynamic solutions for the prevention and treatment of diseases where none existed previously. However, compared to traditional small molecules, advanced therapies present unique CMC challenges that may complicate development. Effective CMC strategies are crucial to the successful development and lifecycle management of these products. Leveraging advances in technology as well as accelerations in development due to the pandemic will enable us to bring even more products to market.

The DIA Advanced Therapies: Innovations in CMC conference will explore common CMC challenges posed by the development of these increasingly complex products. The use of multi-stakeholder perspectives and relevant case studies will provide solutions to enable regulatory compliance, shorter review timelines, and support post-approval maintenance.