Alliance for Regenerative Medicine

What does strengthening the manufacturing process for cell and gene therapies look like? Rita Johnson-Greene, MBA, ARM's Chief Operating Officer, sat down with Scott Broughton, Chief Commercial Officer at Ascend Advanced Therapies, at ARM Studios during our 2024 Cell & Gene Meeting on the Mesa to gain his insight of how the sector is moving towards industrialization.

Registration is now open! Join us on January 13, 2025, for our annual Cell & Gene State of the Industry Briefing at the Biotech Showcase in San Francisco during #JPM2025. Our briefing, which is free to attend, will feature ARM’s annual update on the progress of the cell and gene therapy sector, followed by two sessions featuring sector leaders and executives. Learn more and register here ?? https://lnkd.in/gU_sJjg Please note that in-person attendance is for ARM Members, Biotech Showcase attendees, investors, and the?media only. Virtual attendance is free and open to the public. #CGSOTI25

What is the industry sentiment, and what are the big threats and opportunities facing the cell and gene therapy industry? TLDR Biotech compiled 43 industry interviews with senior leaders and executives at ARM's Meeting on the Mesa 2024 to provide a deep look at the current industry trends. Dive into the insights here: https://lnkd.in/e-Jppbrw #cellandgenetherapy #CGMesa24

This week, there has been more regulatory and business news?from the cell and gene therapy sector. ?? New gene therapy acquisition deal worth $1.1 billion ?? FDA approves cord blood cell therapy product to treat blood and immune system disorders ?? Gene therapy to treat Duchenne muscular dystrophy moves into pivotal stages and doses first patient Read the full stories below and subscribe to ARM's Sector Vector newsletter for more weekly news on cell and gene therapy clinical, business, and manufacturing. ?? https://lnkd.in/e9H6syK6 This week, Novartis acquired Kate Therapeutics to further enhance and strengthen gene therapies for patients in a deal worth up to $1.1 billion. https://lnkd.in/eAz_97mT The FDA has approved StemCyte Inc.'s product REGENECYTE, a cord blood stem cell therapy for transplantation in patients with blood and immune system disorders. https://lnkd.in/eb2tHg_g REGENXBIO announced that its gene therapy for Duchenne muscular dystrophy has advanced to pivotal phase trials and dosed its first patient. The pivotal trial is expected to support a BLA submission using the accelerated approval pathway in 2026. https://lnkd.in/efSsHHws

Calling all future #cellandgenetherapy leaders! ARM is accepting host company?and?intern?applications for the GROW Internship Program. This program provides crucial, early-career paid opportunities in the regenerative medicine sector to talented undergraduate and graduate students whose backgrounds and life experiences have shaped their unique perspectives. The application deadline is February 15, 2025, with the early selection deadline being December 15, 2024. All majors are encouraged to apply. Learn more: https://lnkd.in/eM5EzPsT #RegenerativeMedicine #GROWRegenMed

Last night, ARM joined senior leaders and policy leaders in the European Parliament for our reception "How to cure the incurable? The promise of ATMPs and overcoming patient access challenge," co-hosted by MEP Stine Bosse and MEP Romana Jerkovi?. Our thanks to the hosts, speakers and attendees for convening to share their perspectives on the unique promise of advanced therapies and how we can ensure access for patients in Europe.

ARM’s Q3 2024 cell and gene therapy sector data is now available! Dive in to view our figures highlighting clinical trials, the number of therapeutic developers, and total sector investment. One new trend to highlight: ?? Sector investment through Q3 2024 has now surpassed total sector investment in all of 2023 View the complete data on our website. ?? https://lnkd.in/ebVuvmKK

Happening today - Commercial Strategies for Cell and Gene Therapies ??? ?? 11:00am - 12:00pm ET Join ARM and Catalent Pharma Solutions for our last Building the Future of Regenerative Medicine webinar of the year. This live webinar will discuss the critical steps required to successfully bring cell and gene therapies to market. Register here to tune in: https://lnkd.in/gEG8xKXe Moderator: Delara Motlagh Ph.D. Vice President, Global Cell Therapy and Plasmid DNA, Catalent Pharma Solutions Featured Speakers: Rob Allen, Ph.D. Managing Partner and General Manager Europe, Dark Horse Consulting Group Inc. Sarah Creviston Global Vice President, Patient Advocacy and Public Affairs, Novartis Gene Therapies John King Chief Commercial Officer and Head of Business Development, Vor Bio Kristin Yarema, Ph.D. President and CEO, Poseida Therapeutics, Inc.

Our next Scientific Exchange is about to start! Looking to explore ways to advance gene editing platforms? You'll be able to view today's event virtually at no cost. Tune in today at any time by registering here: https://lnkd.in/eMp5gZwZ The event is co-organized by ARM, ISCT, International Society for Cell & Gene Therapy, and Danaher Corporation. It will convene key stakeholders, including senior leaders from the FDA. The 2024 Scientific Exchange seeks to make progress on therapeutic development for rare conditions that are scientifically feasible but commercially non-viable.

We’re thrilled to welcome Tay Salimullah as a fellow in the ARM Fellowship Program, where he will bring invaluable insight to our work on critical topics in Cell and Gene Therapy Ethics and Society. Tay will provide strategic counsel on pivotal areas including pricing, value, and access, advancing industrialization for global reach, addressing ultra-rare disease challenges, and fostering scientific engagement in advanced MedTech. Currently a Venture Partner at 4BIO Capital, Tay previously served on the executive team at Novartis Gene Therapies, where he was instrumental in establishing global, industry-leading capabilities for pioneering a multi-billion-dollar gene therapy and rare disease business. He was also recently appointed to the Board of Directors at Trogenix, a company developing a breakthrough Synthetic Super-Enhancer platform, Odysseus, to enable unprecedented precision in targeting aggressive cancers. We’re eager to collaborate with Tay to drive forward meaningful conversations and leadership on the field’s most complex issues.