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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 in 29 November EU Parliament event

Pcustomers will benefit from this if Europe modernizes to be policy framework to represent the clear promise of cell and gene therapywill highlight the Alliance for Regenerative Medicine in November 29 European parliament event

Event will be the first pediatric patient to receive CAR-T therapy and focus on policy recommendations backwards The Fall of Europecompetitiveness

BRUSSELS – 24 November 2022

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

ARM and Member of the European Parliament Dr. Stelios Kympouropoulos from the European People’s Party will focus on trends for advanced therapy drug (ATMP) developers, clinical trials and investments in the EU.

“Cell and gene therapies offer huge hope for patients with serious diseases in the EU – but if we don’t do something to ensure patients have access, hope is all we’ll have,” said MEP Kympouropoulos, who lives with spinal muscular atrophy, a rare genetic neuromuscular disease. MEP Kympouropoulos recently issued an a letter with 25 MEPs asking the European Commission not to undermine Europe’s pharmaceutical and biotechnology sectors with its forthcoming proposal to review EU pharmaceutical legislation.

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

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

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

  • As of the end of June 2022, the number of ongoing industrial clinical trials in Europe is up just 2% and the number of developers headquartered in Europe is down 2% compared to five years ago, while the number in North America is up 41% and 42%, respectively, and numbers in Asia Pacific were up 74% and 271%, respectively.

  • Europe accounted for just 11% of new trials starting in the first half of 2022, with only two Phase 1 trials.

More information can be found in ARM’s H1 2022 Sector Report, “Regenerative medicine: pipeline momentum is building.

At the event, ARM will issue policy recommendations that modernize the EU’s 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 engineered cell therapy that attacks cancer cells. Ten years later, she is considered cured of leukemia.

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“It’s an honor to travel and advocate for this treatment in Europe,” Whitehead saidnow 17. “I hope that every child in the world can one day access these treatments and return to their normal lives and be happy and healthy.”

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

Questions from the media

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 delivering on the promise of advanced therapy drugs (ATMPs). ARM promotes legislative, regulatory, reimbursement and manufacturing initiatives in Europe and internationally to advance this innovative and transformative sector, which encompasses cell therapies, gene therapies and tissue-engineered therapies. Early market products have demonstrated profound, sustainable, and potentially curative benefits that are already helping thousands of patients around the world, many of whom have no other viable treatment options. Hundreds of additional product candidates add to a robust pipeline of potentially life-changing ATMPs. In its 13-year history, ARM has become the global voice of the industry, representing the interests of 475+ members worldwide and 80+ members in 15 European countries, including small and large companies, academic research institutions, major medical centers and patient groups. For more information about ARM or to become a member, visit http://www.alliancerm.org.

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