New Development Paradigms Workshop

Industry and regulatory agencies are questioning if the linear trial-and-error model that has been used over the past several decades is tenable for the future development of a new medicine. Over the last 5 years the Institute Workshops have suggested a number of approaches to reduce development time and cost, including the consideration of early-release strategies that would offer safe medicines while establishing full therapeutic and benefit-risk profiles. Mechanisms are in place for the early release of certain types of medicines such as cancer therapies under controlled conditions in order to test the medicine in the real world. Now the question is what would be needed, pre- and post-release to provide confidence to the regulators of this approach for a wider set of medicines?

·          Identify current perspectives on the necessary changes to the discovery, development and review model for new medicines that will improve the sustainability of the industry

·          Discuss different strategies and their potential consequences for both regulators and Industry

·          Recommend possible new development approaches to enable regulators to have the confidence in new models being developed, with a focus on early release mechanisms

For more information or to register, contact Gill Hepton at ghepton@cmr.org