Trade association’s CEO says a new strategic planning initiative will consider among other things how gene therapy could fit into the generic industry business model.
Personalized medicine does not immediately fit into the generic industry model of high-volume and low prices, given its goal of providing tailored treatments for a single patient. Still, Association for Accessible Medicines president and CEO Dan Leonard wants the industry to consider its options.
During his 27 May State of AAM address as part of the generics trade association’s annual meeting, Leonard announced the...
In what could amount to a de facto enforcement mechanism, the new draft guidance also “strongly encourages” sponsors to share details about their diversity action plan and enrollment goals with the public.
Long-term follow-up requirements have taken a conservative approach but could be ripe for re-examination and global harmonization given the years of experience with the products, Kite Pharma executive director says; former FDA gene/cell therapy office head Wilson Bryan calls for elimination of the classwide REMS.
Program for collaborative reviews of gene therapy applications is getting under way with the European Medicines Agency. After launch, the pilot could be expanded to earlier discussions around CMC and pharm/tox data requirements, FDA’s Nicole Verdun said.
