"The only way you survive is you continuously transform into something else. It’s this idea of continuous transformation that makes for an innovation company."
Following completion of postdoctoral training in toxicology, I joined Genentech as a Scientist in 1999. At that time, Genentech was emerging as a biotechnology powerhouse in the pharmaceutical industry and was renowned for innovative approaches to drug development. I have been fortunate to have served as a project team toxicologist where I designed and implemented non-clinical safety studies to support drug research and development efforts. This includes development of drugs for various disease classes including oncology, immunology, pulmonary, cardiovascular and metabolic diseases. I currently serve as Therapeutic Area Lead for metabolic disease and legacy programs and act as an advisor for the Global Technical Development organization.
Toxicol. Sci. 140(2), 470-80.
Design and implement studies to evaluate the preclinical safety of therapeutics for licensure by the Food and Drug Administration and non-US regulatory agencies.
Manage the activities of Development Sciences pharmacology subteams for several drug development efforts.
Genentech Research and Early Development (gRED) lead Subject Matter Expert (SME) in pharmacology-, safety- and immunogenicity-based risk assessment related to Product Technical Development (PTD) aspects (manufacturing, process control strategy, formulation development) of biologics. Various expert assessments enabled PTD organization to make science-based decisions that efficiently balance manufacturing considerations/needs with efficacy and safety concerns and to defend Roche/Genentech’s positions with global health authorities.