The European Commission should exempt advanced therapies from Genetically Modified Organism (GMO) legislation, which hurts Europe’s ability to attract clinical trials and delays patient access to transformative medicines, said the Alliance for Regenerative Medicine (ARM), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and the European Association of Bioindustries (EuropaBio) in a paper published online yesterday in the journal Human Gene Therapy.
The Alliance for Regenerative Medicine (ARM) – the global voice of the regenerative medicine and advanced therapies sector – welcomes the Council of the European Union’s support for EU-level joint clinical assessments. If adopted, joint clinical assessments can eliminate duplicative reviews of transformative Advanced Therapy Medicinal Products (ATMPs) across member states, reducing the time and cost required to bring durable, and potentially curative, cell, gene, and tissue-based therapies to patients anywhere in the EU.
The regenerative medicine and advanced therapies sector raised a record $19.9B in funding in 2020, fueling the broader biotech sector and driving a rapidly advancing pipeline of potentially transformative therapies, according to the Alliance for Regenerative Medicine’s (ARM) 2020 Annual Report released today.
WASHINGTON, DC and BRUSSELS, BELGIUM
The Alliance for Regenerative Medicine (ARM) – the ‘global voice’ of the regenerative medicine and advanced therapies sector – applauds the EU Beating Cancer Plan’s identification of Advanced Therapy Medicinal Products (ATMPs) as part of a comprehensive cancer solution. ATMPs include cell and gene therapies that have already revolutionized the treatment of some aggressive forms of blood cancers and hold great promise for addressing other types of cancer.