Next week, the IQVIA Institute for Human Data Science will host a multi-stakeholder webinar on 'Strengthening Pathways for Cell and Gene Therapies.' 🗓 September 5 🕙 10:00am - 11:30am EDT Monica Veldman, ARM's Director for Global Regulatory Affairs, will join other industry experts to discuss key challenges, patient access, and the sector's future. Join the webinar here: https://lnkd.in/eXmkyJB6 Full panel: Maria E Santaella, PhD(c), MSN, RN-BC, CPHON VP, Research Strategy National Bleeding Disorders Foundation Mark Trusheim, MS Strategic Director, NEWDIGS Tufts Medical Center Joshi Venugopal, Ph.D. GM and Head of Europe Novartis Gene Therapies Monica Veldman Director, Global Regulatory Affairs Alliance for Regenerative Medicine (ARM) Amritha Jaishankar, Ph.D. Executive Director, Cell and Gene Therapy COE IQVIA Moderator: Murray Aitken Executive Director IQVIA Institute for Human Data Science
Alliance for Regenerative Medicine
Biotechnology Research
Washington, District of Columbia 24,851 followers
We champion the benefits of engineered cell therapies & genetic medicines for patients, healthcare systems & society.
About us
The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization championing the benefits of engineered cell therapies and genetic medicines for patients, healthcare systems, and society. As a community, ARM builds the future of medicine by convening the sector, facilitating influential exchanges on policies and practices, and advancing the narrative with data and analysis. We actively engage key stakeholders to enable the development of advanced therapies and modernize healthcare systems so that patients benefit from durable, potentially curative treatments. As the global voice of the sector, we represent more than 400 members across 25 countries, including emerging and established biotechnology companies, academic and medical research institutions, and patient organizations. To learn more about ARM or to become a member, visit http://www.alliancerm.org.
- Website
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http://alliancerm.org
External link for Alliance for Regenerative Medicine
- Industry
- Biotechnology Research
- Company size
- 11-50 employees
- Headquarters
- Washington, District of Columbia
- Type
- Nonprofit
- Founded
- 2009
Locations
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Primary
1015 18th St NW
Suite 1102
Washington, District of Columbia 20006, US
Employees at Alliance for Regenerative Medicine
Updates
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CAR-T cell therapies can help thousands of patients with few other treatment options. For example, approved therapies provide a durable and effective treatment option that can offer hope to those who are in the later stages of cancer. Learn more about the value of these therapies by reading ARM's CAR-T Therapy for Patients and Society Framework: https://lnkd.in/eX2TJiYf
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This week, momentum continued to build for using CAR-T cell therapy as an earlier line of treatment for blood cancers. The European Medicines Agency validated a Marketing Authorization Application for Bristol Myers Squibb's Breyanzi to treat adult patients with R/R follicular lymphoma who received two or more prior lines of therapy. https://lnkd.in/etAQEKJ5 If approved, the milestone would expand the trend of CAR-T cell therapies being authorized as second and third-line treatments for blood cancers. Looking to stay on top of cell and gene therapy sector news? Subscribe to our Sector Vector newsletter for more weekly cell and gene therapy clinical, business, and manufacturing news. 📩 https://lnkd.in/eD7ZNaU
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Former FDA Commissioner Scott Gottlieb will headline the 2024 Cell & Gene Meeting on the Mesa in Phoenix, AZ, with a fireside chat on October 7! A champion for cell and gene therapies, Dr. Gottlieb played a pivotal role in adapting the agency to the first wave of cell and gene therapy products. Under his leadership, the FDA advanced new frameworks for the modern, safe, and effective oversight of gene therapies, cell-based regenerative medicines, targeted drugs, and digital health devices. As commissioner, Dr. Gottlieb predicted the FDA would approve 10-20 cell and gene therapy products per year by 2025. We are delighted to welcome Dr. Gottlieb to Phoenix and look forward to hearing his insights about the future of these transformative medicines. Want to catch his fireside chat? Register for the Meeting on the Mesa: https://lnkd.in/gisXTCii View our sponsorship opportunities: https://lnkd.in/euPJKGvX #CGMesa24
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A warm welcome to John Aguilar, who joined ARM this week as our Director of Alliance Development. In this role, he will drive strategic engagement for key partnered activities and support the development of coalitions. John has over ten years of experience in healthcare public policy and has held several positions in the non-profit sector. Most recently, he has held public policy positions at the Hispanic Association of Colleges and Universities, the American Academy of Family Physicians, and the American Academy of Otolaryngology-Head and Neck Surgery.
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Which cell and gene therapies have upcoming regulatory decisions? ARM's latest Sector Snapshot on the emerging value of cell and gene therapy highlights what is forthcoming in the clinical pipeline. Dive in today to learn about the upcoming regulatory decisions and check out ARM's latest value frameworks on gene therapy and CAR-T cell therapy. ➡ https://lnkd.in/eX2TJiYf #cellandgenetherapy
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ARM is #hiring an Associate Director of Finance and Operations to join our Finance Department. We're looking for candidates with experience in financial planning and analysis, payroll processing, and operations with the leadership skills to create a culture of continuous process improvement. Does it sound like a good fit for you? Learn more and apply ➡ https://lnkd.in/ek9q5XF
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There remain unique challenges with using gene therapy to treat ultra-rare disorders. A new article in STAT shows how therapies can help patients like Susannah and highlights examples of public-private partnerships and non-profit models that can help patients with no other treatment options access this transformative medicine. https://lnkd.in/eH-NhvBT ARM is working on this issue with our members through initiatives like building blocks or platform technologies for cell and gene therapies and supporting the Bespoke Gene Therapy Consortium. You can read our whitepaper on cell and gene therapy building blocks here: https://lnkd.in/efbJdv3H
A bespoke genetic therapy is helping Susannah. Can similar drugs be made at scale for other rare diseases?
https://www.statnews.com
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What's new in #cellandgenetherapy? This week, the sector showed promising early-stage clinical updates. 🧬1st patient dosed in gene therapy trial to treat Fabry disease 🧫Gamma-delta T-cell therapy has promising effectiveness in treating AML 🔬Cell therapies for multiple sclerosis and progressive myasthenia gravis enter clinical trials Read the full stories below and subscribe to our Sector Vector newsletter for more weekly news on cell and gene therapy clinical, business, and manufacturing. 📩 https://lnkd.in/eD7ZNaU uniQure announced this week that the first patient has been dosed in a Phase I/IIa clinical trial of its gene therapy, AMT-191, for the treatment of Fabry disease, a rare, inherited genetic disease. https://lnkd.in/eMiznUxe IN8bio announced early clinical data that showed 100% of treated AML patients were in complete remission. The company plans to submit an IND application in 2025. https://lnkd.in/eZid5Y3z Precision BioSciences, Inc. and TG Therapeutics, Inc. announced that the FDA has approved an IND application for azer-cel to be used in human clinical trials for the treatment of progressive forms of multiple sclerosis. https://lnkd.in/eR_Rfgcd Kyverna Therapeutics announced that the FDA granted the Regenerative Medicine Advanced Therapy (RMAT) for its autologous, fully human CD19 CAR-T cell product candidate, which will be used to treat patients with progressive myasthenia gravis. https://lnkd.in/eCs5Rryc
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In the context of the EU Joint Clinical Assessment, ARM’s Paolo Morgese and other industry experts discuss in the Financial Times why limiting the use of evidence generated outside randomized control trials would be problematic for rare disease patients with few treatment alternatives. Read it here: https://lnkd.in/gErGqd_4
EU rules threaten to cut new treatments for rare diseases
ft.com