Patients will benefit if Europe modernizes its policy framework to reflect the distinct promise of cell and gene therapy, the Alliance for Regenerative Medicine will highlight on November 29 European Parliament event

Ppatients will benefit if Europe modernizes his political framework to reflect the distinct promise of cell and gene therapythe Alliance for Regenerative Medicine will highlight in November 29 European Parliament an event

The event will feature the first pediatric patient to receive CAR-T therapy and focus on policy recommendations reverse The decline of Europecompetitiveness

BRUSSEL – 24 November 2022

The European Union can reverse its declining competitiveness and ensure patient access to transformative treatments if it modernizes its policy and regulatory framework to reflect the distinct promise of cell and gene therapies as the future of medicine, the European Union will say. Alliance for Regenerative Medicine (ARM). an event at the European Parliament on 29 November.

WARC and Member of the European Parliament, Dr. Stelios Kympouropoulos of the European People’s Party, will highlight trends in Advanced Therapy Drug Developers (ATMPs), clinical trials and investments in the EU.

“Cell and gene therapies represent huge hope for patients with serious diseases in the EU – but if we don’t act to ensure patient access, hope is all we will have.” said European deputy Kympouropoulos, who lives with spinal muscular atrophy, a rare genetic neuromuscular disease. MEP Kympouropoulos recently signed a letter with 25 MEPs asking the European Commission not to undermine Europe’s pharmaceutical and biotech sectors with its upcoming proposal to revise EU pharmaceuticals legislation.

The November 29 event – The future of ATMPs in Europe — will focus on the first-in-a-generation review of EU pharmaceuticals legislation, the future implementation of the EU Health Technology Assessment Regulation and other policy initiatives keys that will determine the role of cell and gene therapies in the European healthcare landscape for years to come.

“If Europe modernizes its policy and regulatory framework to truly embrace ATMPs as the future of medicine, European patients with cancer, rare diseases and other serious and often life-threatening conditions will benefit enormously,” said Timothy D. Hunt, CEO of ARM. “The same policies and approaches that brought us the biomedical innovation of yesterday simply won’t work for the cell and gene therapies of today and tomorrow. The EU has been in the lead before – and can still be in the lead – but now is the time to act.”

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Seven of the 23 ATMPs approved in the EU have been withdrawn from the market. ARM’s data further illustrates the industry’s struggles in Europe:

• At the end of June 2022, the number of ongoing industrial clinical trials in Europe increased by only 2% and the number of developers headquartered in Europe decreased by 2% compared to five years ago, while the number in North America increased by 41% and 42%, respectively, and the numbers in Asia-Pacific increased by 74% and 271%, respectively.

• Europe accounted for just 11% of new trials from the first half of 2022, with just two phase 1 trials.

More information can be found in ARM’s H1 2022 industry report, « Regenerative Medicine: Pipeline Momentum Builds.”

During the event, ARM will release policy recommendations that would modernize EU regulatory and access frameworks, and encourage cell and gene therapy companies to develop, test and commercialize their therapies in the region.

Other speakers include Emily Whitehead, who was the world’s first pediatric patient to receive CAR-T therapy, an artificial cell therapy that attacks cancer cells. Ten years later, she is considered cured of leukemia.

“Travelling and advocating for this treatment in Europe is an honour,” said Whiteheadnow 17 years old. “I hope that every child in the world can one day have access to these treatments and return to a normal life and be happy and healthy.”

Emily’s father Tom Whitehead, President and co-founder of the Emily Whitehead Foundation, will also speak. “We have heard from many families across Europe since Emily experienced success with CAR-T cell therapy, and we are honored to share our story to hopefully have more access to these new cancer treatments. amazing so that more patients can not only survive their cancer, but thrive in life after.

Media inquiries

For more information or for media inquiries and registration, please contact Stephen Majors, Senior Director of Public Affairs for ARM, at smajors@alliancerm.org.

About the Alliance for Regenerative Medicine

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of Advanced Therapy Medicines (ATMPs). ARM promotes legislative, regulatory, reimbursement and manufacturing initiatives in Europe and internationally to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-engineered therapies. The first products on the market have demonstrated profound, long-lasting and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a strong pipeline of potentially game-changing ATMPs. Over its 13-year history, ARM has become the global voice of the industry, representing the interests of over 475 members worldwide and over 80 members in 15 European countries, including small and large companies, academic research institutes, major medical centers and patient groups. . To learn more about ARM or to become a member, visit http://www.alliancerm.org.