WASHINGTON, D.C. and BRUSSELS, BELGIUM, Oct. 31, 2019 (GLOBE NEWSWIRE) -- via NEWMEDIAWIRE -- The Alliance for Regenerative Medicine (ARM), the international advocacy organization representing the cell and gene therapy and broader advanced therapies sector, today published a report outlining the latest trends in clinical trials with advanced therapy medicinal products (ATMPs) based in Europe, and its recommendations for how to improve its competitiveness compared to other global regions.
The report, developed following a comprehensive global analysis of all new clinical trials with cell and gene medicinal products initiated between January 2014 to June 2019 and via an online survey with ARM therapeutic developer member organizations, provides detailed insights on clinical trials, including the number, type of technology, phase of development or approval process, specifically within Europe and also compared to other regions in the world.
The fragmentation of regulatory bodies and ethical committees and the lack of harmonization on various aspects (e.g. donor testing requirements, patient information consent forms, contracting agreements) across the different countries may explain the complexity in starting new ATMP clinical trials in Europe, however, other reasons may also contribute, such as the lower levels of investment capital available in the region. The complexity of European GMO (genetically modified organisms) requirements and approval process may contribute to fewer gene therapy trials in Europe.
ARM’s key recommendations (in Europe):
Previous work has shown that the European Clinical Trial Directive 2001/20/EC presented some shortcomings, particularly for trials carried out in several Member States, and was responsible for a decline in the number of clinical trials in the European Union. In view of the sharp increase of the number of ATMPs in development during the last few years, the Alliance for Regenerative Medicine, in this report, has characterized the attractiveness of Europe, including national disparities, for the clinical development of ATMPs, and trends over time compared to other regions.
The implementation of the above recommendations will contribute to maintaining a strong innovation base and important R&D investments in Europe but, most importantly, this will be critical to ensure that European patients with serious diseases and only few or no alternatives can access these new transformative therapies at an early stage through participation in clinical trials.
Janet Lambert, CEO of ARM, commented: “The European advanced therapy space is rich in expertise and innovation, with some individual countries outperforming the U.S. in terms of per capita participation in clinical trials. This research shows that improving the speed of approval and streamlining requirements for European multinational trials with ATMPs are critical to attracting more clinical trials in Europe. Our hope is that regulators and governments across Europe will see the need to reduce barriers while continuing to ensure patient safety and maintaining its level of excellence for clinical research.”
Anne-Virginie Eggimann, M.Sc., Senior Vice President, Regulatory Science at bluebird bio, Inc., commented, “Time is an important driver when choosing a clinical trial location. In the USA, Investigational New Drug (IND) applications and subsequent protocols are reviewed by the FDA within a maximum of 30 days. The longer approval times and their related uncertainty make the conduct of multinational clinical trials in Europe more challenging than in some other regions.”
Dr. Jacqueline Barry, Chief Clinical Officer at UK Cell and Gene Therapy Catapult, commented, “Europe has been at the forefront of innovation with ATMPs as the sector has matured and it is encouraging to see that there are so many potentially life-changing studies taking place across the continent. However, the number of clinical trials with ATMPs is variable from one country to another and we see that countries with shorter approval times, such as the UK, Belgium, Denmark, or Switzerland, attract more clinical trials. It is important to learn from these countries and replicate their performance across Europe. We remain excited by the prospects for the sector in Europe but to maintain its attractiveness and scientific leadership, we support the recommendations of ARM outlined in this report.”
A copy of the full report can be found here.
For more information about the report or media requests, please contact Lyndsey Scull from the Alliance for Regenerative Medicine at email@example.com or Consilium Strategic Communications at firstname.lastname@example.org.
About the Alliance for Regenerative Medicine
The Alliance for Regenerative Medicine (ARM) is an international multi-stakeholder advocacy organization that promotes legislative, regulatory, and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine worldwide. Founded in 2009, ARM works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its 350+ member organizations worldwide. ARM represents the interests of therapeutic developers, academic research institutions, major medical centers, investors, and patient groups that comprise the broader regenerative medicine community and is the prominent international advocacy organization in this field.
ARM has 70+ members across 15 countries in Europe. ARM aims to work closely with European stakeholders, leveraging its membership to create a supportive commercial and regulatory environment to create better conditions for the development and commercialization of ATMPs in Europe; develop strong stakeholder support around proposed solutions to improve patient access to ATMPs; promote clear, predictable and efficient regulatory framework across Europe; and promote international convergence of key regulations and guidance. For more information, visit alliancerm.org.
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