2022
Dominas, Christine; Bhagavatula, Sharath; Stover, Elizabeth; Deans, Kyle; Larocca, Cecilia; Colson, Yolanda; Peruzzi, Pierpaolo; Kibel, Adam; Hata, Nobuhiko; Tsai, Lillian; Hung, Yin; Packard, Robert; Jonas, Oliver
The Translational and Regulatory Development of an Implantable Microdevice for Multiple Drug Sensitivity Measurements in Cancer Patients Journal Article
In: IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING, vol. 69, no. 1, pp. 412–421, 2022, ISSN: 0018-9294, 1558-2531, (Num Pages: 10 Place: Piscataway Publisher: Ieee-Inst Electrical Electronics Engineers Inc Web of Science ID: WOS:000733943200045).
Abstract | Links | BibTeX | Tags: Animals, Biomarkers, biomaterials, Biomedical engineering, CANCER, clinical trials, drug delivery, drug discovery, Drugs, implants, In vivo, Medical treatment, Testing, Tumor Microenvironment, Tumors
@article{dominas_translational_2022,
title = {The Translational and Regulatory Development of an Implantable Microdevice for Multiple Drug Sensitivity Measurements in Cancer Patients},
author = {Christine Dominas and Sharath Bhagavatula and Elizabeth Stover and Kyle Deans and Cecilia Larocca and Yolanda Colson and Pierpaolo Peruzzi and Adam Kibel and Nobuhiko Hata and Lillian Tsai and Yin Hung and Robert Packard and Oliver Jonas},
doi = {10.1109/TBME.2021.3096126},
issn = {0018-9294, 1558-2531},
year = {2022},
date = {2022-01-01},
journal = {IEEE TRANSACTIONS ON BIOMEDICAL ENGINEERING},
volume = {69},
number = {1},
pages = {412–421},
abstract = {Objective: The purpose of this article is to report the translational process of an implantable microdevice platform with an emphasis on the technical and engineering adaptations for patient use, regulatory advances, and successful integration into clinical workflow. Methods: We developed design adaptations for implantation and retrieval, established ongoing monitoring and testing, and facilitated regulatory advances that enabled the administration and examination of a large set of cancer therapies simultaneously in individual patients. Results: Six applications for oncology studies have successfully proceeded to patient trials, with future applications in progress. Conclusion: First-in-human translation required engineering design changes to enable implantation and retrieval that fit with existing clinical workflows, a regulatory strategy that enabled both delivery and response measurement of up to 20 agents in a single patient, and establishment of novel testing and quality control processes for a drug/device combination product without clear precedents. Significance: This manuscript provides a real-world account and roadmap on how to advance from animal proof-of-concept into the clinic, confronting the question of how to use research to benefit patients.},
note = {Num Pages: 10
Place: Piscataway
Publisher: Ieee-Inst Electrical Electronics Engineers Inc
Web of Science ID: WOS:000733943200045},
keywords = {Animals, Biomarkers, biomaterials, Biomedical engineering, CANCER, clinical trials, drug delivery, drug discovery, Drugs, implants, In vivo, Medical treatment, Testing, Tumor Microenvironment, Tumors},
pubstate = {published},
tppubtype = {article}
}
Objective: The purpose of this article is to report the translational process of an implantable microdevice platform with an emphasis on the technical and engineering adaptations for patient use, regulatory advances, and successful integration into clinical workflow. Methods: We developed design adaptations for implantation and retrieval, established ongoing monitoring and testing, and facilitated regulatory advances that enabled the administration and examination of a large set of cancer therapies simultaneously in individual patients. Results: Six applications for oncology studies have successfully proceeded to patient trials, with future applications in progress. Conclusion: First-in-human translation required engineering design changes to enable implantation and retrieval that fit with existing clinical workflows, a regulatory strategy that enabled both delivery and response measurement of up to 20 agents in a single patient, and establishment of novel testing and quality control processes for a drug/device combination product without clear precedents. Significance: This manuscript provides a real-world account and roadmap on how to advance from animal proof-of-concept into the clinic, confronting the question of how to use research to benefit patients.