Ursula Jeffry

• Participated in development management leadership team, overseeing pharmacology, toxicology, pathology, bioanalytics, and clinical pharmacology / PKPD. • Served as member of global project teams for immune oncology, autoimmune, metabolic disease, and ophthalmology projects and responsible for development of drug candidates from research through clinical trials. • Managed health authority interactions involving early development, pharmacology, PKPD, and nonclinical safety. • Led planning, monitoring, and analyzing nonclinical studies ranging from proof of concept / efficacy studies in primates and rodent disease models in house to GLP-compliant, IND-enabling studies at contract research organizations.

• Operated as member of preclinical development leadership team as toxicology and immunology expert and member of several global project teams responsible for development of drug candidates through clinical trials. • Oversaw all health authority interactions involving preclinical safety; authoring toxicology sections for US, European, and Asian regulatory submissions; responding to health authorities’ (HA) questions; and representing company at meetings with regulatory agencies. • Organized, monitored, and analyzed preclinical toxicology studies with contract research organizations, as well as organized and analyzed proof of concept / efficacy studies in primates and rodent disease models at contract research organizations.

• Integral member of the global Novartis Oncology Strategic team as the biologic’s expert and member of several global project teams responsible for the development of a drug through clinical trials. • Led antibody drug conjugate (ADC) preclinical safety assessment initiative, overseeing novel toxin evaluation as well as development of known toxin-linker ADC programs. • Managed health authority interactions involving preclinical safety, authoring toxicology sections for US and European regulatory submissions, responding to HA questions, and representing Novartis at meetings with regulatory agencies. • Led preclinical safety teams assigned to each potential drug candidate (antibodies, biologics, and small molecules), including pathology and investigative safety for issue resolution and deeper understanding of safety profile of candidate molecules in various phases of development spanning research to post-IND stage.