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.
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.
Authors: Robert Farra; Norman F Sheppard; Laura McCabe; Robert M Neer; James M Anderson; John T Santini; Michael J Cima; Robert Langer Journal: Sci Transl Med Date: 2012-02-16 Impact factor: 17.956
Authors: D B Knowles; Irina A Shkel; Noel M Phan; Matt Sternke; Emily Lingeman; Xian Cheng; Lixue Cheng; Kevin O'Connor; M Thomas Record Journal: Biochemistry Date: 2015-05-22 Impact factor: 3.162
Authors: Shawn M Davidson; Oliver Jonas; Mark A Keibler; Han Wei Hou; Alba Luengo; Jared R Mayers; Jeffrey Wyckoff; Amanda M Del Rosario; Matthew Whitman; Christopher R Chin; Kendall J Condon; Alex Lammers; Katherine A Kellersberger; Brian K Stall; Gregory Stephanopoulos; Dafna Bar-Sagi; Jongyoon Han; Joshua D Rabinowitz; Michael J Cima; Robert Langer; Matthew G Vander Heiden Journal: Nat Med Date: 2016-12-26 Impact factor: 53.440
Authors: Sharath K Bhagavatula; Kunj Upadhyaya; Brendyn J Miller; Patrick Bursch; Alex Lammers; Michael J Cima; Stuart G Silverman; Oliver Jonas Journal: Med Phys Date: 2019-09-26 Impact factor: 4.071