Kathy is globally recognized for her effectiveness, having successfully pioneered the first ever FDA clearance for over-the-counter genetic testing, overcoming one of the most publicized FDA warning letters and enabling the relaunch and expansion of the company’s core products. She has successfully managed complex teams under regular and crisis conditions and has negotiated numerous transactions and private and public financings totaling more than $500m. She is active in key industry groups and is a frequent speaker on genomics, privacy and regulation. She sits on the board of Sophia Genetics, Inc. and served on the Board of Decipher Biosciences, Inc. prior to its merger with Veracyte, Inc. During her 20 years’ experience as an executive officer and corporate secretary for two public biotechnology companies, Genomic Health, Inc. and Monogram Biosciences, Inc., Kathy developed her passion for personalized medicine and the power of innovation to improve the lives of patients.
Keith Yamamoto, UCSF
Patient-centric data – Real-World Evidence (RWE) and Real-World Data (RWD) - is becoming instrumental in the drug development process and for health care decisions in general. This data is not only informative for the process from discovery to new indications, clinical trial design, and drug development, it also can be of value to monitor post-marketing drug safety and for decision support in clinical practice. As the data becomes a decision driver, science companies and medical organizations are increasingly focused on leveraging RWD and RWE to not only better understand the patient populations using their drugs and the respective outcomes, but also to accelerate clinical decision support. This session will focus on the various aspects of integrating RWE and RWD to support drug development and clinical decision support