Research output per year
Research output per year
Personal profile
Biography
USPHS Officer for 28 years, retired O-6. Pediatric oncologist with basic and clinical research experience including all phases of therapeutic development, regulatory (FDA employee, EMA consultant), industry, and policy expereince. (co-authored laws, regulations, guidance documents, and policy). Contributed to international standards (ICH, CDISC, MedDRA, SASI) and leadership experience (FDA, NIH, USU). Served on multiple disaster response deployments in leadership positions, developed and published response guidance. Experience and expertise in ethics, informatics, and scientific strategy.
External positions
Advisor to the Director, National Institute on Deafness and Other Communication Disorders (NIDCD)
Keywords
- RM Therapeutics. Pharmacology
- RA0421 Public health. Hygiene. Preventive Medicine
- BJ Ethics
- KF United States Federal Law
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Collaborations and top research areas from the last five years
Recent external collaboration on country/territory level. Dive into details by clicking on the dots or
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ENTRÉE Lung Platform Trial Sub-study 1: Phase II Randomized Efficacy and Safety Analysis of Feladilimab Plus Docetaxel Versus Docetaxel Monotherapy in Advanced/Recurrent NSCLC
Garassino, M. C., Cousin, S., Besse, B., Sacher, A., Orlov, S., Schenker, M., Felip, E., Gladkov, O., Messina, C. H., Majumdar, A., Wu, Z. J., Karpinich, N. O., Hirschfeld, S., Ballas, M. & Reck, M., 2026, In: Clinical Lung Cancer. 27, 5, p. 65-76.e2Research output: Contribution to journal › Article › peer-review
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Addressing the Health Care Needs of Displaced Populations Following a Disaster: Development of Clinical Tools and Tracking Methods
Hirschfeld, S., Coppola, D. & Kopp, J., 4 Sep 2025, In: Disaster Medicine and Public Health Preparedness. 19, e248.Research output: Contribution to journal › Article › peer-review
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Addressing the Healthcare Needs of Displaced Populations with Chronic Illness Following a Disaster: Examples from the US Public Health Service Federal Medical Station Experience
Hirschfeld, S., Coppola, D., Beck, D. & Kopp, J., 4 Sep 2025, In: Disaster Medicine and Public Health Preparedness. 19, e247.Research output: Contribution to journal › Article › peer-review
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First-in-human phase 1 study of the ICOS agonist feladilimab on patients with advanced solid tumors
Maio, M., Moreno, V., Martin-Liberal, J., Opdam, F., Hansen, A., Bauer, T. M., Le Tourneau, C., Italiano, A., Rischin, D., Ellis, C., Turner, D., Yadavilli, S., Zhou, H., Hirschfeld, S., Ballas, M., Diaz-Padilla, I. & Angevin, E., 11 Aug 2025, In: Journal for immunotherapy of cancer. 13, 8, e011475.Research output: Contribution to journal › Article › peer-review
Open Access3 Scopus citations -
Commentary on Hey, Hunter, Muller et al. A Never-ending Story: Evaluating Evidence in Medicinal Product Decision Making
Hirschfeld, S., Mar 2024, In: Clinical Therapeutics. 46, 3, p. 300-302 3 p.Research output: Contribution to journal › Article › peer-review
1 Scopus citations
Press/Media
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Comparative evaluation of Pediatric Drug Regulation in US, Europe and India
16/09/21
1 item of Media coverage
Press/Media