Fraunhofer Institute for Systems and Innovation Research ISIProject
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Background
Advanced Therapy Medicinal Products (ATMPs) provide innovative treatment options for diseases that currently have no adequate standard-of-care options. These breakthrough therapies are available for rare genetic diseases, common immune diseases, cancer and tissue injury. However, scientific, clinical and patient communities and commercial, regulatory and technology-assessing bodies still face significant barriers to ATMP expansion.
Current legal and regulatory frameworks for drug development in the EU have been designed for standard drug production with large patient target groups. Meanwhile, several regulatory, clinical, economic and ethical issues remain unsolved and account for missed opportunities to develop ground-breaking technologies and ATMP success.
To tackle this challenge, the JOIN4ATMP consortium brings together different institutes from the Frauhofer Society with members of the European University Hospital Alliance together with the existing EU-funded T2EVOLVE and RESTORE networks, and with active support from industry partners and patient representatives as core partners. The comprehensive scope of stakeholders involved in the project ensures a holistic assessment of current hurdles and the best way to improve support and regulation of ATMP development and use in the EU and associated countries.
Objective
The JOIN4ATMP project aims to accelerate and de-risk European ATMP development and ensure wide-spread ATMP access. This vision eventually targets ATMP translation through preclinical studies to clinical use and market access. To structure this vision around measurable results, the project aims to achieve three specific objectives: 1) Rigorously map and categorise hurdles in the aforementioned areas, 2) Chart solutions proposed in real-world use cases from ATMP developers or regulators in and outside the EU, 3) Design recommendations for paths forward with regulatory, economics and policy-making advisors.
The Fraunhofer ISI Business Unit Innovations in the Health System is involved in different Tasks within Work Package5 “Increasing ATMP regulatory awareness in producers and ATMP acceptance in patients and healthcare professionals” and will contribute to the achievement of this WP’s main objectives:
- Improve awareness and knowledge of the regulatory processes among academic and SME ATMP developers and manufacturers;
- Introduce improved information exchange to raise ATMP acceptance EU-wide and support equitable ATMP access;
- Involve end-users in the ATMP development process to raise ATMP awareness, acceptance and legitimacy in the lay public.
Results
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