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The Alliance for Regenerative Medicine (ARM) used its welcome remarks at the Cell & Gene Meeting on the Mesa in Phoenix on Monday, October 5, 2026 to make the case that conditions for the sector are improving, with CEO Tim Hunt telling members that “the FDA has stabilized” and that ARM is preparing changes to its membership dues.
Hunt was speaking in a 9:00am session listed on the agenda as the ARM board vote and welcome remarks, alongside ARM chairman Bob Smith of OrbiMed. Hunt, CEO since September 2022, said there are “really meaningful opportunities” for the field “if we all work together as one big community”.
Hunt points to seven more blockbusters
Hunt said that “for many, many years, we had two blockbuster products”, that three more had followed in the last couple of years, and that Wall Street data now point to seven more.
ARM’s second-quarter sector snapshot names the five as Zolgensma/Itvisma, Yescarta, Carvykti, Breyanzi and Elevidys. An ARM deck dated October 2 says about seven more are expected by 2031, citing analyst consensus data from GlobalData compiled by Guidehouse. The same deck puts total sector financings at more than $11.3 billion through the third quarter of 2026, up 43% on the same period of 2025, and notes that the third-quarter data are preliminary.
A new plan, and changes to dues
ARM said the same day that its new multi-year strategic plan is organized around four pillars: regulatory modernization, improving the commercial model and access, sector sustainability, and strategic global positioning. Hunt said the planning process involved 200 leaders across ARM’s membership.
Hunt said the fourth pillar covers how ARM thinks about Asia, the Middle East and China, and indicated that the work would take time.
Hunt also said ARM will soon announce changes to how its membership dues are structured. The aims, Hunt said, include “lower barriers to entry for small and mid-sized organizations” and to “ensure sufficient resources to advance the sector going forward”.
Gene editing playbook and CAR-T access
Hunt highlighted a gene editing document ARM “rolled out on September 29th”, published as A Platform Framework for Gene Editing Drug Development. “It’s a blueprint developed by leading practitioners in the field,” Hunt said, describing it as a 100-page technical document covering preclinical and clinical considerations, and as “a little bit of a regulatory guidance in a box”.
Hunt pointed members to a new website from the ARM-convened CAR-T Access Coalition, communitycart.org, calling it “a resource to help community physicians”. The site states that just 25% of eligible patients receive CAR-T.
Policy and ethics
On policy, Hunt said ARM regards price controls as a “terrible idea”, and said: “We need to fight bad policies that we’ve seen in D.C. and beyond.” Hunt cited ARM’s push for the Accelerating Kids’ Access to Care Act, which became law in February as part of the Consolidated Appropriations Act, 2026, and a recent meeting with the UK’s MHRA on rare diseases and platform technologies.
Hunt also trailed that afternoon’s ethics panel, which the agenda lists Hunt as chairing, saying it would take on “controversial things”, including China and recent deaths in clinical trials. Hunt did not name any company, product or trial. ARM’s Ethics & Society project, which Hunt said launched in January 2024, was set up to discuss “pricing and value and sustainability of health systems”. ARM says it holds annual meetings with the Vatican’s Pontifical Academy for Life.
“We need to focus on building the future of cell and gene therapy,” Hunt said. The address was followed by a keynote from Karim Mikhail, director of the FDA’s Center for Biologics Evaluation and Research, which Onyx has reported separately.
About the Alliance for Regenerative Medicine
Founded in 2009 and based in Washington, D.C., ARM is an advocacy organization for engineered cell therapies and genetic medicines. ARM says it represents more than 400 members across 25 countries. ARM organizes the Cell & Gene Meeting on the Mesa, held on October 5-7 at the Arizona Biltmore.
Onyx spoke with ARM’s Stephen Majors at the Cell & Gene Meeting on the Med in April, and has also reported from this week’s meeting on Arbor Biotechnologies and Rocket Pharmaceuticals.
Sources: ARM welcome remarks, Cell & Gene Meeting on the Mesa, October 5, 2026; Meeting on the Mesa agenda; ARM press release (October 5, 2026); ARM Reasons to Believe deck (October 2026); ARM Q2 2026 sector snapshot; ARM gene editing playbook; CAR-T Access Coalition; ARM statement (February 2026); ARM Ethics & Society; ARM CEO appointment press release (August 2022)
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