L Alonso-Alconada1, J Barbazan1, S Candamio1, J L Falco2, C Anton3, C Martin-Saborido3, G Fuster4, M Sampedro5, C Grande6, R Lado6, L Sampietro-Colom7, E Crego8, S Figueiras9, L Leon-Mateos9, R Lopez-Lopez1, M Abal10. 1. Translational Medical Oncology, CIBERONC, Health Research Institute of Santiago (IDIS), University Hospital of Santiago (SERGAS), Trav. Choupana s/n, 15706, Santiago de Compostela, Spain. 2. Antares Consulting, Barcelona, Spain. 3. UETeS, Universidad Francisco de Vitoria, Madrid, Spain. 4. Hoffmann Eitle, Madrid, Spain. 5. Department of Innovation and Transfer, Ramon Dominguez Foundation, Santiago de Compostela, Spain. 6. Medical and Health Technology Innovation Platform (ITEMAS), Galician Network, Santiago de Compostela, Spain. 7. Health Technology Assessment Unit, Clinic Hospital, Barcelona, Spain. 8. EFT Consulting, Santiago de Compostela, Spain. 9. Health Knowledge Agency (ACIS), Galician Health System (SERGAS), Santiago de Compostela, Spain. 10. Translational Medical Oncology, CIBERONC, Health Research Institute of Santiago (IDIS), University Hospital of Santiago (SERGAS), Trav. Choupana s/n, 15706, Santiago de Compostela, Spain. miguel.abal.posada@sergas.es.
Abstract
PURPOSE: Management of metastatic disease in oncology includes monitoring of therapy response principally by imaging techniques like CT scan. In addition to some limitations, the irruption of liquid biopsy and its application in personalized medicine has encouraged the development of more efficient technologies for prognosis and follow-up of patients in advanced disease. METHODS: PrediCTC constitutes a panel of genes for the assessment of circulating tumor cells (CTC) in metastatic colorectal cancer patients, with demonstrated improved efficiency compared to CT scan for the evaluation of early therapy response in a multicenter prospective study. In this work, we designed and developed a technology transfer strategy to define the market opportunity for an eventual implementation of PrediCTC in the clinical practice. RESULTS: This included the definition of the regulatory framework, the analysis of the regulatory roadmap needed for CE mark, a benchmarking study, the design of a product development strategy, a revision of intellectual property, a cost-effectiveness study and an expert panel consultation. CONCLUSION: The definition and analysis of an appropriate technology transfer strategy and the correct balance among regulatory, financial and technical determinants are critical for the transformation of a promising technology into a viable technology, and for the decision of implementing liquid biopsy in the monitoring of therapy response in advanced disease.
PURPOSE: Management of metastatic disease in oncology includes monitoring of therapy response principally by imaging techniques like CT scan. In addition to some limitations, the irruption of liquid biopsy and its application in personalized medicine has encouraged the development of more efficient technologies for prognosis and follow-up of patients in advanced disease. METHODS: PrediCTC constitutes a panel of genes for the assessment of circulating tumor cells (CTC) in metastatic colorectal cancerpatients, with demonstrated improved efficiency compared to CT scan for the evaluation of early therapy response in a multicenter prospective study. In this work, we designed and developed a technology transfer strategy to define the market opportunity for an eventual implementation of PrediCTC in the clinical practice. RESULTS: This included the definition of the regulatory framework, the analysis of the regulatory roadmap needed for CE mark, a benchmarking study, the design of a product development strategy, a revision of intellectual property, a cost-effectiveness study and an expert panel consultation. CONCLUSION: The definition and analysis of an appropriate technology transfer strategy and the correct balance among regulatory, financial and technical determinants are critical for the transformation of a promising technology into a viable technology, and for the decision of implementing liquid biopsy in the monitoring of therapy response in advanced disease.
Authors: Daniel F Hayes; Massimo Cristofanilli; G Thomas Budd; Matthew J Ellis; Alison Stopeck; M Craig Miller; Jeri Matera; W Jeffrey Allard; Gerald V Doyle; Leon W W M Terstappen Journal: Clin Cancer Res Date: 2006-07-15 Impact factor: 12.531
Authors: Steven J Cohen; Cornelis J A Punt; Nicholas Iannotti; Bruce H Saidman; Kert D Sabbath; Nashat Y Gabrail; Joel Picus; Michael Morse; Edith Mitchell; M Craig Miller; Gerald V Doyle; Henk Tissing; Leon W M M Terstappen; Neal J Meropol Journal: J Clin Oncol Date: 2008-07-01 Impact factor: 44.544
Authors: Eric Van Cutsem; Henk M W Verheul; Patrik Flamen; Philippe Rougier; Regina Beets-Tan; Rob Glynne-Jones; Thomas Seufferlein Journal: Cancers (Basel) Date: 2016-08-31 Impact factor: 6.639
Authors: Yolanda Vidal Insua; Juan de la Cámara; Elena Brozos Vázquez; Ana Fernández; Francisca Vázquez Rivera; Mª José Villanueva Villanueva Silva; Jorge Barbazán; Laura Muinelo-Romay; Sonia Candamio Folgar; Alicia Abalo; Rafael López-López; Miguel Abal; Lorena Alonso-Alconada Journal: Int J Mol Sci Date: 2017-06-13 Impact factor: 5.923
Authors: Johann S de Bono; Howard I Scher; R Bruce Montgomery; Christopher Parker; M Craig Miller; Henk Tissing; Gerald V Doyle; Leon W W M Terstappen; Kenneth J Pienta; Derek Raghavan Journal: Clin Cancer Res Date: 2008-10-01 Impact factor: 12.531