Francis KalushBSc, MSc, PhD
Dr. Francis Kalush is the Health Programs Coordinator in the Professional Affairs and Stakeholder Engagement (PASE) at the Office of the Center Director, Center for Drug Evaluation and Research (CDER ), Food and Drug Administration (FDA). She provides a focal point for advocacy, to enhance two-way communication and collaboration with healthcare professionals, patients, patient groups, and others on CDER issues concerning drug development, drug review, and drug safety. Dr. Kalush provides leadership and strategic planning direction for educating, developing, communicating, implementing, and assessing advocacy and stakeholder relations strategy for CDER. She is CDER’s Network of Experts Coordinator.
Before joining CDER, Dr. Kalush was a Senior Science Health Advisor at the Office Center Director at the Center for Devices and Radiological Health (CDRH) at FDA. She directed and managed center wide initiatives, led the development of a FDA National Medical Device Curriculum Program, enhanced communication and transparency by leading outreaching activities to patient advocates consumers and professional associations.
As the Diagnostics and Personalized Medicine Network Leader at CDRH, she planned, managed and coordinated the activities for the Network, encompassing premarket, post market, compliance, science, personalized medicine collaborations and communications to enhance safety of medical devices within the total product life cycle. She is the Healthy People 2020 Medical Product Safety Workgroup Coordinator.
Dr. Kalush was the representative to the Global Harmonization Task Force (GHTF) In Vitro Diagnostics working group. Playing an important role in the international regulatory arena, she assisted COFEPRIS, Ministry of Health, Mexico on setting up their new regulatory reform for medical devices and over the counter medicines. Francis was essential on setting up Pharmacogenomics guidances and roundtable meetings with industry organizations and FDA to address the regulatory, scientific and co-development concerns of drug-diagnostics targeted therapies in Personalized Medicine.
Before Joining FDA, Dr. Kalush was the Director, Pharmacogenomics at Celera Genomics. She was responsible for the development of Celera SNP Databases, online support for Applera Projects. Oversaw input from academic and commercial markets and public health programs for the development of Pharmacogenomics, Toxicogenomics and Genetics products.
She is the author of multiple publications including “The Sequence of the Human Genome “and she is a well-known international speaker. Dr. Kalush holds a Ph.D in Chemical Immunology from the Weizmann Institute of Science, MSc. in Human Microbiology from Sackler Schoold of Medicine, Tel Aviv University and BSc. in Chemistry and Biology from the Hebrew University, Jerusalem.