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Will focus on advanced therapy medicinal product development.
May 30, 2023
By: Anthony Vecchione
Vinnova, Sweden’s Innovation Agency, has granted funding to establish a national cluster for commercialization of advanced therapies. The Centre for Commercialization of Regenerative Medicine (CCRM) Nordic will be located at GoCo Health Innovation City in Mölndal. CCRM Nordic is backed by an industry consortium that will contribute to establishing the center as an organization with specialized infrastructure and expertise focused on Advanced Therapy Medicinal Product (ATMP) development, based on the successful CCRM model founded in Toronto, Canada. The project is being coordinated by the recently formed not-for-profit CCRM Nordic AB (svb) and gathers engaged stakeholders to move the initiative forward. “A lot is happening within the ATMP field both nationally and internationally and I’m therefore very excited about the opportunity to manage the CCRM Nordic initiative from the establishment phase and onwards,” said Fredrik Wessberg, CCRM Nordic CEO. “It is inspiring to see such great interest from developers and industry who are part of this consortium.” ATMP is the European Medicines Agency (EMA) classification of cell and gene therapy drugs, and tissue engineered drugs. These products must be produced to Good Manufacturing Practice (GMP) standards and complete clinical trials before applying for market approval and becoming available to patients. Organizations like Canada’s CCRM ensure ATMPs are manufactured and controlled according to the required quality standards, strengthening the chances these novel therapeutics will make it to patients. “I am delighted that Vinnova is committed to supporting this consortium to develop a CCRM hub for Sweden and its neighbors,” said Michael May, President, and CEO of CCRM, Toronto. “CCRM believes global collaboration is needed to maximize the health and economic benefits of ATMPs, and we have sought to partner with like-minded organizations with substantial activities and investments in regenerative medicine and cell and gene therapy. I am confident a CCRM Nordic will expedite the development of durable treatments for some of the world’s most debilitating and devastating diseases.” CCRM Nordic will be established as a new entity with national infrastructure for development, manufacturing, and commercialization of ATMPs, and will be accessible by stakeholders from academia, industry, and the health-care sector. In addition, the initiative has strong support from industry with major Swedish ATMP organizations such as AstraZeneca, CombiGene, Cytiva, Getinge, Takara Bio Europe, TATAA Biocenter and Verigraft, as well as local innovation actors such as GoCo Health Innovation City and GU Ventures. As host, GoCo will construct a purpose-built facility that is expected to be operational in 2026 and will provide temporary offices and labs until then. “At AstraZeneca, we recognize the potential of cell and gene therapies to slow, stop and even cure diseases where significant unmet need still exists,” said Regina Fritsche Danielson, senior vice president and head of research and early development, cardiovascular renal and metabolism, BioPharmaceuticals R&D, AstraZeneca, and CCRM Nordic board member. “The facility being established by CCRM Nordic in Gothenburg will create a center of scientific excellence that we hope enhances collaboration, knowledge and skill sharing, and drives innovation in this rapidly advancing field. It will help ensure that the right infrastructure is in place to deliver the next wave of innovative therapies for patients.” “Cell and gene therapies have the potential to transform global health care and cure once incurable diseases. Establishing a CCRM facility in Sweden will help create the infrastructure that is needed in the Nordic region to ensure these therapies are developed using GMP standards,” said Emmanuel Abate, president, Genomic Medicine, Cytiva.
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