• California: Sutter Health and Santa Clara University are partnering together to launch the Mark and & Mary Stevens School of Medicine, which will be the first new medical school in the San Francisco Bay Area in over 100 years. The school is being funded in part by a $175 million gift from Mark and Mary Stevens, which is also the largest gift ever given to both Sutter and Santa Clara University. According to Sutter, the new school will be embedded within its integrated health system and build on its current graduate medical education programs, including over 30 physician residency and fellowship programs. Currently, the organizations are working to construct a new 82,000-square-foot facility for the school and will welcome its inaugural class after completing a multiyear accreditation process. (Kuchno, Becker's Hospital Review, 5/15)
• Colorado: In a 5-2 vote, the Colorado Supreme Court has ordered Children's Hospital Colorado to resume providing hormone therapy and puberty blockers for transgender minors. The hospital initially halted gender transition treatments for minors after the Trump administration threatened to cut off funding to hospitals that provided the treatments. Children's Hospital Colorado, along with Denver Health, both paused their gender-related treatments for transgender minors. Four transgender minors and their families sued Children's Hospital Colorado over the pause, saying they had experienced depression and contemplated suicide due to lack of treatment. In its ruling, the Colorado Supreme Court wrote that the hospital's suspension of care left the plaintiffs "suddenly abandoned during a precarious time." In response to the ruling, Shannon Fern, a spokesperson for Children's Hospital Colorado, said hospital officials were "reviewing the court's ruling and assessing our next steps." (Healy, New York Times, 5/18)
• Maryland: FDA has approved Regeneron Pharmaceuticals' new gene therapy Otarmeni for a rare, genetic form of deafness. The approval was granted under FDA's new priority voucher program and is the first gene therapy for genetic hearing loss available on the market. Otarmeni targets otoferlin-related hearing loss, a type of hearing loss caused by variants in the OTOF gene. The condition affects between 20 and 50 newborns in the United States every year. The gene therapy uses an infusion into the cochlea to deliver a working copy of the OTOF gene to replace the non-functional otoferlin protein. "I'd say for the field, it means a new era and thinking about treatments for ​hearing loss - this is ​just the beginning," ⁠said Jonathon Whitton, VP and auditory global program head at Regeneron. According to Regeneron, it will offer the gene therapy for free in the United States. The company is also planning to test the mechanism behind Otarmeni in other forms of inherited hearing loss, as well as other health conditions like obesity and diabetes. (Roy, Reuters, 4/23; Martinez, Wall Street Journal, 4/23)

The pipeline of cell and gene therapies is expanding in both depth and breadth. Healthcare leaders must adapt as competition grows and innovation stretches into new specialties. Find out how new cell and gene therapies will change the status quo and what it means for providers, purchasers, and pharmaceutical manufacturers.