Bio

I have over 19 years of experience in the In Vitro Diagnostics (IVD) space in developing and supporting diagnostic/companion-diagnostic (CDx) assays with an understanding of industry trends, regulatory environment and market access paths in the CDx space. Currently I am at Genmab as Head of Diagnostics, enabling development of Companion/Complementary diagnostics in Oncology/Immuno-oncology. In this role, I am responsible for providing leadership for all complementary and companion diagnostic activities, which include designing and implementing CDx strategy for various assets, provide CDx expertise and guidance to asset teams, evaluation of Dx platforms, doing due diligence and capability assessment of Dx companies, working with external diagnostic business partners to deliver CDx per asset timelines and overseeing budget for the same. Prior to Genmab, in my ~4 years at Bristol Myers Squibb (BMS), I served as a Pharmacodiagnostic Lead providing leadership in enabling companion/complementary diagnostics solutions in various therapeutic areas like Oncology, Cardiovascular, Fibrosis, and Auto-immune disorders. Prior to BMS, I spent ~16 years at Abbott Laboratories, leading cross-functional teams to develop blood screening diagnostics products for infectious diseases as well as development of molecular assays intended as companion diagnostic (CDx) in the Oncology space with multiple Pharma partners. My experience in a Scientific Affairs role at Abbott gave me a global perspective for diagnostic requirements in US and EU via engagement with KOLs and governing bodies that provide guidance to the Dx industry like NEQAS and CAP. Specialties: Diagnostics development, Complementary/Companion Diagnostics (CDx), Project Management, OEM management, Supplier Relationship Management, BLA Product Support, Diagnostic Product Development, Design Change Control of On-Market Product, Design Change Control for product in Development, Test Method Validations, Process Validations, IVD (Blood Screening/Molecular Diagnostics/Companion Diagnostic) Product development, Scientific Affairs, PMA, Molecular Diagnostics.