Steven Hirschfeld MD PhD

Education

MD, Columbia University College of Physicians & Surgeons
PhD New York University (Cell Biology)
Pediatric Residency, University of California, San Francisco
Immunology Fellowship, National Institue of Child Health and Human Development
Hematology/Oncology Fellowship, National Cancer Institute

Biography

Dr. Steven Hirschfeld is a decorated military veteran and a pediatric hematologist-oncologist. He has served in multiple capacities within the Departments of Health and Human Services, Homeland Security, and Defense. He held leadership positions in all agencies including Oncology Team Leader at the Food and Drug Administration, Associate Director for Research at the Eunice Kennedy Shriver National Institute of Child Health and Human Development, Assistant Vice President for Research Initiatives and Compliance at the Uniformed Services University of the Health Sciences (USUHS) and Chief Medical Officer, Operations Chief, and Deputy Team Commander for Rapid Deployment Force-1 in the US Public Health Service. He served at the rank of Captain (O-6) and was deployed on humanitarian and disaster response missions for 27 years.

His professional interests and experience include immunology beginning with a Fellowship in Experimental Immunology at the National Institute of Child Health and Human Development followed by a Clinical Fellowship at the National Cancer Institute. His clinical experience with immunocompromised patients due to either congenital, acquired or iatrogenic treatment related causes and the attendant infectious complications, graft versus host disease, participation in a global consortium to establish guidelines for testing vaccines in pregnant women, and participation in several World Health Organization working groups on pediatric health and treatment. He was the Director of a national birth cohort study for five years and a co-founder of an international birth cohort consortium to study environmental influences on human development. He led an international pediatric terminology initiative for pediatrics and pregnant women that was integrated into MedDRA and published by the Enterprise Vocabulary Services of the National Cancer Institute. He contributed to development of the Clinical Data Interchange Standards Consortium (CDISC) standards and served on the CDISC Board of Directors as well the Site Accreditation Standards Initiative (SASI) and serves on the SASI Board of Directors.
 
A major interest has been the development of new therapeutics, particularly for children. He was a major co-author of the Pediatric Research Equity Act and contributed to the Best Pharmaceuticals for Children Act and the Pediatric Medical Device Safety and Improvement Act. He was a co-author of the adaptation of the pediatric component, subpart D, of the Common Rule adaptation to FDA regulated products and contributed to the revisions of the HHS Common Rule. Dr. Hirschfeld served as the co-lead for the Pediatric Component of the NIH funded Clinical and Translational Science Awards consortium, and developed new models for network based studies resulting in the NICHD Pediatric Trials Network, the European Commission Global Research in Paediatrics network, for which he served as a co-chair, and contributed to the formation of Conect4Children, a pan European clinical trials network, which he served as the Chair of the External Advisory Board during its startup phase. He served as consultant or working group member to the World Health Organization (Geneva). European Commission (Brussels) European Medicines Agency, Pharmaceutical and Medical Devices Agency (Japan), Organization for Economic Co-operation and Development (Paris), governments of Australia, Finland, France, Germany, Italy, Japan, Poland, Serbia, and Taiwan.
 

Career Highlights: Positions, Projects, Deployements, Awards and Additional Publications

Attending PHysician, National Cancer Institute

Medical Officer and Team Leader, Food and Drug Administration

Associate Director for Clinical Research, Eunice Kennedy Shriver National Institute for Child Health and Human Research

Assistant Vice President for Research Initiatives and Compliance, Uniformed Service University of the Health Sciences

Clinical Trial Consultant, National Institute for Deafness and Other Communicaiton Disorders

Professor of Pediatrics, Uniformed Services University of the Health Sciences