New development paradigms: Building regulatory confidence for the early release of medicines
11-12th October 2010, Surrey, UK
Over the last 5 years CIRS workshops have suggested a number of approaches to reducing time and cost of medicines development, including considering developing early-release strategies that can make medicines available while establishing their full therapeutic profile and cost benefit. Mechanisms are in place for the early release of certain types of medicines, such as cancer therapies, to gain real-world experience under controlled conditions to expedite patient access to these therapies, while more fully assessing the product’s benefit-risk profile. Therefore, in part because of legal constraints, regulatory agencies have focused on improving the current models and pathways of review leading to early release in lieu of undertaking radical new approval models. In particular, new measures for post-approval monitoring for safety and effectiveness need to be adopted if early release can be applied to a broad spectrum of new medicines. This has in part stimulated the evolution of risk management plans and risk evaluation and mitigation strategies (REMS). Now the question is what would be needed, pre- and post-release to provide confidence to the regulators and payers to apply early-release models to a wider set of medicines?
Workshop objectives
- Identify current companies’ and agencies’ perspectives on the need for a development and review process which has the flexibility to enable early, controlled, real-world access to medicines.
- Discuss different strategies for different medicines and their potential consequences for both regulators and industry.
- Recommend possible new development and review approaches and pre- and post-release requirements to enable regulators to have the confidence in new models being developed with a focus on early-release mechanisms.