Director Regulatory Affairs, Companion Diagnostics Strategy
Seagen, Inc
As part of the regulatory affairs team at Seagen Inc. I am supporting the development of new generation targeted treatments and companion diagnostics to advance cancer care, with a main focus on implementation of regulatory requirements for clinical studies driven by US and European regulations. Prior roles include Regulatory Affairs Manager at Foundation Medicine Inc. and Roche Tissue Diagnostics supporting development of IVDs and companion diagnostics. I am very passionate about learning and collaborating on tackling complex regulatory issues with colleagues across industry, as well as regulators, and communicating those experiences for the benefit of sponsors of clinical studies and of patients affected by cancer.
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Challenges in Implementation of IVDR Requirements for CDx Clinical Performance Studies
Wednesday, October 4, 2023
4:45 PM – 5:45 PM EDT