Risultati di ricerca
1 Center for Drug Evaluation and Research, United States Food and Drug Administration, Silver Spring, Maryland. Electronic address: gideon.blumenthal@fda.hhs.gov. 2 Division of Medical Oncology, University of Colorado Cancer Center, Aurora, Colorado. 3 Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.
- Gideon M Blumenthal, Paul A Bunn, Jamie E Chaft, Caroline E Mccoach, Edith A Perez, Giorgio Scagliot...
- 2018
Gideon Blumenthal - Vice President Clinical Development Oncology - Merck | LinkedIn. Vice President Clinical Development Oncology. Silver Spring, Maryland, United States. 2K followers 500+...
- 500+
- 2.1K
- Merck
- Silver Spring, Maryland, United States
FDA. Dr Gideon Blumenthal is a Medical Oncologist and Hematologist who is currently Vice President, Global Regulatory Affairs in Oncology, Merck. Prior to joining Merck in 2020, Dr Blumenthal spent over a decade at the US Food and Drug Administration Oncology office, taking on increasing leadership responsibilities during his time at the Agency.
Gideon M Blumenthal 1 , Paul G Kluetz 2 , Julie Schneider 2 , Kirsten B Goldberg 2 , Amy E McKee 2 , Richard Pazdur 2 3 Affiliations 1 Office of Hematology Oncology Products, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, USA Gideon.Blumenthal@fda.hhs.gov.
- What Are The Key Regulatory Considerations For Liquid Biopsy Tests?
- What Is The Clinical Validity of Very Low Allele Frequency calls?
- Human Genes Referenced
- Author Contributions
- Authors’ Disclosures Or Potential Conflicts of Interest
- Patents
Soma Ghosh: The US Food and Drug Administration has so far approved 2 liquid biopsy ctDNA-based companion diagnostic (CDx) tests, meaning they are essential for the safe and effective use of the corresponding therapeutic: the Roche's Cobas EGFR Mutation Test v.2 that detects EGFR mutations associated with patients with nonsmall cell lung cancer [se...
J. Carl Barrett:Low allele frequency calls can be due to low shedding rates of tumors, to assay sensitivity and to subclonal events in a heterogeneous tumor. As mentioned, CHIP variants should be identified and excluded if based on normal blood sequencing. The clinical validity/utility of low allele, clonal variants is accepted. Subclonal variants ...
KRAS, Ki-ras2 Kirsten rat sarcoma viral oncogene homolog; EGFR, epidermal growth factor receptor; PIK3CA, phosphatidylinositol-4, 5-bisphosphate 3-kinase catalytic subunit alpha; HER2, human epidermal growth factor receptor 2; MET, proto-oncogene, receptor tyrosine kinase.
All authors confirmed they have contributed to the intellectual content of this paper and have met the following 4 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; (c) final approval of the published a...
Upon manuscript submission, all authors completed the author disclosure form. Disclosures and/or potential conflicts of interest:
D.W.Y. Tsui, U.S. provisional Patent Application (Methods for detecting cancer via cfDNA screening.); K. Bramlett, US 10344336.
- Dana W Y Tsui, Gideon M Blumenthal, Reena Philip, J Carl Barrett, Clara Montagut, Kelli Bramlett, Ma...
- 2020
25 mag 2020 · Authors: Yutao Gong, Jeremy Mason, Yuan-Li Shen, Elaine Chang, Dickran Kazandjian, Gideon Michael Blumenthal, Harpreet Singh, Marc Robert Theoret, Shenghui Tang, Richard Pazdur, and Julia A. Beaver Authors Info & Affiliations. Publication: Journal of Clinical Oncology. Volume 38, Number 15_suppl. https://doi.org/10.1200/JCO.2020.38.15_suppl.9541.
8 mag 2020 · May 08, 2020. Vol.46 No.19. BYLINE. IN THIS ISSUE. DOWNLOAD PDF TABLE OF CONTENTS. Gideon Blumenthal was named vice president for Global Oncology Regulatory Affairs at Merck. He is a former deputy director of the FDA Oncology Center of Excellence. Previous Article. Patton named CEO of OneOncology. Next Article.
