Landmark Ideas Series: Envisioning Clinical Evidence Generation of the Future (Video Available)

Speaker: Amy Abernethy, MD, PhD; Former Principal Deputy Commissioner and acting Chief Information Officer of Food and Drugs of the US Food and Drug Administration (FDA), at Verily

Date: January 20, 2022 at 4:00PM - 5:30PM

Clinical research is undergoing a major shift, as regulators and sponsors move towards continuous evidence generation to study how interventions perform over time. In this talk, we’ll explore what’s accelerating this trend, how new tools and technologies are advancing the space, and how it can ultimately enable more personalized care.

Dr. Abernethy oversees the overall product vision and related clinical research portfolio at Verily. Dr. Abernethy was most recently Principal Deputy Commissioner of Food and Drugs of the US Food and Drug Administration (FDA) and the agency's acting Chief Information Officer. In just over two years with FDA, Dr. Abernethy is credited with having catalyzed enduring changes in the way the FDA uses data as well as advancing FDA's work in RWE and personalized medicine. She also spearheaded FDA's shift toward cloud-based data interoperability, thereby streamlining the agency's interaction with the health data ecosystem as outlined in the agency's technology and data modernization action plans.


Publications

Chen KY, Borglund EM, Postema EC, Dunn AG, Bourgeois FT. Reporting of clinical trial safety results in ClinicalTrials.gov for FDA-approved drugs: A cross-sectional analysis. Clinical trials (London, England) 2022.

Le Naour J, Sztupinszki Z, Carbonnier V, Casiraghi O, Marty V, Galluzzi L, Szallasi Z, Kroemer G, Vacchelli E. A loss-of-function polymorphism in compromises therapeutic outcome in head and neck carcinoma patients. Oncoimmunology 2022.

Klann JG, Strasser ZH, Hutch MR, Kennedy CJ, Marwaha JS, Morris M, Samayamuthu MJ, Pfaff AC, Estiri H, South AM, Weber GM, Yuan W, Avillach P, Wagholikar KB, Luo Y, Omenn GS, Visweswaran S, Holmes JH, Xia Z, Brat GA, Murphy SN. Distinguishing Admissions Specifically for COVID-19 from Incidental SARS-CoV-2 Admissions: A National Retrospective EHR Study. Journal of medical Internet research 2022.