1. Production and regulatory issues for theranostics.
- Author
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Giammarile F, Paez D, Zimmermann R, Cutler CS, Jalilian A, Korde A, Knoll P, Ayati N, Lewis JS, Lapi SE, Delgado Bolton RC, Kunikowska J, Estrada Lobato E, Urbain JL, Holmberg O, Abdel-Wahab M, and Scott AM
- Subjects
- Humans, Neoplasms therapy, Precision Medicine, Radiopharmaceuticals therapeutic use, Theranostic Nanomedicine
- Abstract
Theranostics has become a major area of innovation and progress in cancer care over the last decade. In view of the introduction of approved therapeutics in neuroendocrine tumours and prostate cancer in the last 10 years, the ability to provide access to these treatments has emerged as a key factor in ensuring global benefits from this cancer therapy approach. In this Series paper we explore the issues that affect access to and availability of theranostic radiopharmaceuticals, including supply and regulatory issues that might affect the availability of theranostic treatments for patients with cancer., Competing Interests: Declaration of interests RZ reports direct relations with Global Morpho Pharma, Posifit–Nancyclotep, LemerPax, MEDraysintell, Chrysalium Consulting, and Telix Pharma. NA reports having received a travel grant from the Australian and New Zealand Society of Nuclear Medicine. JSL reports research support from Clarity Pharmaceuticals and AVID Radiopharmaceuticals; has acted as an adviser of Boxer, Clarity Pharmaceuticals, Curie Therapeutics, Earli, Evergreen Theragnostics, NexTech Invest, Telix Pharmaceuticals, Suba Therapeutics, inhibrx, Precirix, Alpha-9 Oncology, and TPG Capital; is a co-inventor on technologies licensed to Diaprost, Elucida Oncology, Theragnostics, CheMatech, and Samus Therapeutics; is the co-founder of pHLIP; holds equity in Summit Biomedical Imaging, Telix Pharmaceuticals, and Evergreen Theragnostics; and is supported by National Institutes of Health R35 CA232130. SEL reports research support from Navidea Biopharmaceuticals, Fusion Pharmaceuticals, Cytosite Biopharma, Viewpoint Molecular Targeting, and Genzyme Corporation; has acted as an adviser for NorthStar Medical Radioisotopes and Trevarx biomedical; and is supported by the US Department of Energy as part of the DOE University Isotope Network under grant DESC0021269. JK reports participation on a data safety monitoring board and advisory board for Novartis (personal fees), and an unrestricted grant from Janssen. AMS reports trial funding from EMD Serono, ITM, Telix Pharmaceuticals, AVID Radiopharmaceuticals, Fusion Pharmaceuticals, and Cyclotek; research funding from Medimmune, AVID Radiopharmaceuticals, Adalta, Antengene, Humanigen, Telix Pharmaceuticals, and Theramyc; is a co-inventor on technologies licensed to Humanigen, AbbVie and Life Science Pharmaceuticals; participates on the advisory boards of Imagion and ImmunOs; and is supported by an Australian National Health and Medical Research Council grant number 1177837. CSC is supported by the US Department of Energy under grants Lab 20-2301, DE-FOA-0003063, and DE-FOA-0002532. All other authors declare no competing interests., (Copyright © 2024 Elsevier Ltd. All rights reserved, including those for text and data mining, AI training, and similar technologies.)
- Published
- 2024
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