Precision pathways: Insights and strategies to navigate regulatory requirements for oncology diagnostics

Hakan Sakul is a senior pharmaceutical executive and thought leader with demonstrated achievements in precision medicine. After a stint in biotech, he moved to Pfizer as the head of Clinical PGx and had a 24-year career in leadership positions at Pfizer. He established Pfizer’s Diagnostics group in 2007 and under his leadership through 2023, over 30 drug/diagnostics combination approvals were achieved in global markets for seven oncology drugs. He represented Pfizer as a Scientific Co-Director of BloodPAC (2016-2023), a non-profit offshoot of the Cancer Moonshot, launched to accelerate the development, validation and clinical use of liquid biopsy assays. He is a former member of the Board of The Personalized Medicine Coalition, served as a Scientific Advisor to Luminex Corp, and currently is a Board member of Progentec Diagnostics (US), as well as BASH Biotech (Türkiye), a small molecule therapeutics company. Hakan is an appointed Council Member of California Governor Newsom’s Precision Medicine Advisory Council (CIAPM). He is currently the owner of Precision Dx Strategies Inc, a consulting/advising firm to biotech, diagnostics and pharma companies.

Elaine Katrivanos is Vice President of Regulatory Affairs at Tempus. Elaine previously served  as Regional and Global Regulatory Lead for respiratory drugs and standalone digital health projects at AstraZeneca. Before that, Elaine worked in medical devices and diagnostics at FDA in premarket and post-market device review, bio-research monitoring, manufacturing compliance, policy development, and management. Elaine earned a degree in biomedical engineering from the University of Pittsburgh.

Lauren Silvis serves as Senior Vice President of External Affairs at Tempus, overseeing regulatory, public policy, government affairs and strategic communications. She has held a number of senior career public health roles, serving as a Senior Advisor at the Department of Health and Human Services, Chief of Staff of the Food and Drug Administration and Deputy Center Director for Policy in FDA’s Center for Devices and Radiological Health. She currently serves as a member of the Council of Councils for the National Institutes of Health. During her time in government, she advanced policies to promote innovation in precision medicine, real world evidence, clinical trials and digital health. Lauren serves as Board Vice Chair for the Personalized Medicine Coalition and a board member for the Real-World Evidence Alliance. Earlier in her career, she was a partner at the international law firm Sidley Austin LLP, focusing on regulation of pharmaceuticals and medical devices. Lauren graduated from Duke University and earned her law degree from Georgetown University Law Center.

Dr. Ezra Cohen is a leading medical oncologist and cancer researcher who brings a unique combination of extensive clinical and research experience to Tempus’ leadership team. He was most recently the Chief of the Division of Hematology-Oncology as well as the Associate Director of Clinical Science at UC San Diego (UCSD) Moores Cancer Center. Dr. Cohen also led the Precision Immunotherapy Clinic and co-directed the San Diego Center for Precision Immunotherapy at UCSD. Before UCSD, Dr. Cohen spent 15 years at the University of Chicago, where he was the co-director of the Head and Neck Cancer Program as well as Hematology/Oncology Fellowship Program Director.