Ppurchasers will profit if Europe modernizesure its coverage framework to replicate the distinct promise of cell and gene remedythe Alliance for Regenerative Medication will spotlight in 29 november EU Parliament occasions
Occasion will function first pediatric affected person to obtain a CAR-T remedy and give attention to coverage suggestions to reverse Europe’s declineing competitiveness
B.RUSSELS – two4 November 2022
The European Union can reverse its declining competitiveness and guarantee affected person entry to transformative therapies if it modernizes its coverage and regulatory framework to replicate the distinct promise of cell and gene therapies as the way forward for drugs, the Alliance for Regenerative Medication (ARM) will say throughout an occasion on the EU Parliament on 29 November.
ARM and Member of the European Parliament Dr. Stelios Kympouropoulos of the European Folks’s Occasion will spotlight regarding traits for superior remedy medicinal product (ATMP) builders, scientific trials, and funding within the EU.
“Cell and gene therapies symbolize great hope for sufferers with critical illnesses within the EU – but when we do not act to make sure sufferers have entry, hope is all we may have,” stated MEP kympouropoulos, who lives with spinal muscular atrophy, a uncommon genetic neuromuscular illness. MEP Kympouropoulos just lately signed a letter with 25 MEPs asking the European Fee to not undermine the European pharmaceutical and biotechnology sectors with its upcoming proposal to revise the EU prescribed drugs laws.
The 29 November occasion – The Way forward for ATMPs in Europe — will give attention to the first-in-a-generation revision of the EU prescribed drugs laws, the long run implementation of the EU Regulation on Well being Expertise Evaluation, and different key coverage initiatives that may decide the position of cell and gene therapies in Europe’s healthcare panorama for years to return.
“If Europe modernizes its coverage and regulatory framework to really embrace ATMPs as the way forward for drugs, European sufferers residing with most cancers, uncommon illnesses, and different critical and sometimes life-threatening issues will profit tremendously,” stated Timothy D. Hunt, chief government officer of ARM. “The identical insurance policies and approaches that introduced us yesterday’s biomedical innovation merely is not going to work for the cell and gene therapies of at this time and tomorrow. The EU has led earlier than — and may lead as soon as once more — however the time to behave is now.”
Seven of the 23 ATMPs which have been permitted within the EU have been withdrawn from the market. ARM’s knowledge additional illustrates the sector’s struggles in Europe:
As of the top of June 2022, the variety of ongoing business scientific trials in Europe elevated by simply 2% and the variety of builders headquartered in Europe declined by 2% in comparison with 5 years in the past, whereas the numbers in North America elevated by 41% and 42%, respectively, and the numbers in Asia-Pacific elevated by 74% and 271%, respectively.
Europe accounted for simply 11% of latest trials beginning within the first half of 2022, with solely two part 1 trials.
Extra info could be present in ARM’s H1 2022 Sector Report, “Regenerative Medication: The Pipeline Momentum Builds.”
In the course of the occasion, ARM will launch coverage suggestions that may modernize the EU’s regulatory and entry frameworks, and encourage cell and gene remedy firms to develop, take a look at, and commercialize their therapies within the area.
Different audio system embrace Emily Whitehead, who was the primary pediatric affected person globally to obtain a CAR-T remedy, an engineered cell remedy that assaults most cancers cells. Ten years later, she is taken into account cured of leukemia.
“Attending to journey and advocate for this remedy in Europe is an honor,” stated Whiteheadnow 17. “It’s my hope that each baby on the earth can sometime have entry to those therapies and get again to their regular lives and be completely satisfied and wholesome.”
Emily’s father, Tom Whitehead, President and co-founder of the Emily Whitehead Basis, will even communicate. “We now have heard from many households from Europe since Emily had her success with CAR-T cell remedy, and we’re honored to share our story to hopefully get extra entry to those new wonderful most cancers therapies so extra sufferers cannot solely survive their most cancers however thrive in life after.”
For extra info or for media requests and registration, please contact Stephen Majors, Senior Director of Public Affairs for ARM, at firstname.lastname@example.org.
In regards to the Alliance for Regenerative Medication
The Alliance for Regenerative Medication (ARM) is the main worldwide advocacy group devoted to realizing the promise of superior remedy medicinal merchandise (ATMPs). ARM promotes legislative, regulatory, reimbursement and manufacturing initiatives in Europe and internationally to advance this progressive and transformative sector, which incorporates cell therapies, gene therapies and tissue-engineered therapies. Early merchandise to market have demonstrated profound, sturdy and probably healing advantages which are already serving to hundreds of sufferers worldwide, lots of whom haven’t any different viable remedy choices. A whole bunch of further product candidates contribute to a strong pipeline of probably life-changing ATMPs. In its 13-year historical past, ARM has grow to be the worldwide voice of the sector, representing the pursuits of 475+ members worldwide and 80+ members throughout 15 European international locations, together with small and enormous firms, educational analysis establishments, main medical facilities and affected person teams. . To be taught extra about ARM or to grow to be a member, go to http://www.alliancerm.org.