Enabling all stakeholders to consult on the value of a drug early in development could dramatically improve the drug development process. In 2010, this idea sparked a new pilot process for testing multi-country, multi-stakeholder consultations in drug development.
This pilot initiative brings together leaders of healthcare institutions representing the European Union (EU) and five of its Member States. It represents a first-ever collaboration of regulators, health technology assessors, payers, patients, and medical experts from across Europe to inform a pharmaceutical company’s development decisions regarding an early-stage medicine.
The pilots provide a forum for medicine developers to receive integrated feedback on the expected value of a medicine in the pipeline and how best to demonstrate that value. Participating stakeholders inform each other’s perspectives on these issues.
Participating stakeholders and Tapestry jointly designed this process, with guidance from existing early advice processes and input from key European healthcare leaders. The pilots provide a shared basis of knowledge and experience regarding the benefits and limitations of a multi-constituent approach to informing drug development.
The antibiotics development pilot
The prevalence of bacterial infections that cannot be treated with existing antibiotics is increasing at an alarming rate. The rising tide of bacterial resistance threatens to undo many of the medical advances of the past 70 years. Previous efforts to build a stronger consensus on the need to manage resistance have failed to address the full range of action needed. Tapestry Networks believes that a successful policy approach will require key stakeholders to co-design a new model for the assessment, appropriate use and reward for innovation in antibiotic R&D. Learn More