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

Hopper RK, Abman SH, Elia EG, Avitabile CM, Yung D, Mullen MP, Austin ED, Bates A, Handler SS, Feinstein JA, Ivy DD, Kinsella JP, Mandl KD, Raj JU, Sleeper LA, . Pulmonary Hypertension in Children with Down Syndrome: Results from the Pediatric Pulmonary Hypertension Network Registry. The Journal of pediatrics 2022.

Wang X, Zhang HG, Xiong X, Hong C, Weber GM, Brat GA, Bonzel CL, Luo Y, Duan R, Palmer NP, Hutch MR, Gutiérrez-Sacristán A, Bellazzi R, Chiovato L, Cho K, Dagliati A, Estiri H, García-Barrio N, Griffier R, Hanauer DA, Ho YL, Holmes JH, Keller MS, Klann MEng JG, L'Yi S, Lozano-Zahonero S, Maidlow SE, Makoudjou A, Malovini A, Moal B, Moore JH, Morris M, Mowery DL, Murphy SN, Neuraz A, Yuan Ngiam K, Omenn GS, Patel LP, Pedrera-Jiménez M, Prunotto A, Jebathilagam Samayamuthu M, Sanz Vidorreta FJ, Schriver ER, Schubert P, Serrano-Balazote P, South AM, Tan ALM, Tan BWL, Tibollo V, Tippmann P, Visweswaran S, Xia Z, Yuan W, Zöller D, Kohane IS, Avillach P, Guo Z, Cai T, . SurvMaximin: Robust federated approach to transporting survival risk prediction models. Journal of biomedical informatics 2022.

Torous J, Stern AD, Bourgeois FT. Regulatory considerations to keep pace with innovation in digital health products. NPJ digital medicine 2022.

Levy S, Wisk LE, Minegishi M, Ertman B, Lunstead J, Brogna M, Weitzman ER. Association of Screening and Brief Intervention With Substance Use in Massachusetts Middle and High Schools. JAMA network open 2022.

Nielsen M, Presti M, Sztupinszki Z, Jensen AWP, Draghi A, Chamberlain CA, Schina A, Yde CW, Wojcik J, Szallasi Z, Crowther MD, Svane IM, Donia M. Co-existing alterations of MHC class I antigen presentation and IFNγ signaling mediate acquired resistance of melanoma to post-PD-1 immunotherapy. Cancer immunology research 2022.