Desiree Crisolo Genentech

Dez has 20 years of experience in regulatory affairs, with a focus on leading and implementing pre-market and post-market regulatory strategies for combination products (pre-filled syringes, autoinjectors, pen injectors, on-body injectors, and nasal sprays). Her overall experience spans a wide range of areas, including standalone medical devices (510(k), CE-mark), new molecular entities, generics, biosimilars, and medical countermeasure drugs — areas in which she gained experience through positions at Stryker, Genentech, Mylan (now Viatris), Emergent BioSolutions, and Biogen. Throughout her career, Dez has also played an active role in helping to shape and influence important combination-product policy topics, such as regulatory expectations for human factors, device bridging strategies, and access for important emergency use products. In her current role in Genentech, Dez is responsible for developing regulatory strategies for complex programs, shaping regulatory policy, and building organizational device capabilities.