Summary of DIA workshop on Co-Development of personalized medicine and in vitro diagnostic companion devices

Lisa Palladino Kim; Jeffrey N. Stuart; Daniel Schultz; James A. Boiani

doi:10.1177/2168479013483136

Summary of DIA workshop on Co-Development of personalized medicine and in vitro diagnostic companion devices

Lisa Palladino Kim, Jeffrey N. Stuart, Daniel Schultz, James A. Boiani

School of Health Professions, Biomedical Informatics

Research output: Contribution to journal › Article › peer-review

1 Scopus citations

Abstract

The pairing of personalized medicine, including targeted drug therapy, and in vitro diagnostic (IVD) companion devices (ie, "companion diagnostics") allows treatment decisions to be tailored for each patient. However, development of companion diagnostics and personalized medicine still faces challenges in clinical development as regulatory policy tries to keep up with and accommodate this growing field. To assist industry and regulators, the DIA provided a forum for the discussion of current challenges and opportunities for progressive alignment approaches to regulating personalized medicine and IVD devices.

Original language	English (US)
Pages (from-to)	294-298
Number of pages	5
Journal	Therapeutic Innovation and Regulatory Science
Volume	47
Issue number	3
DOIs	https://doi.org/10.1177/2168479013483136
State	Published - May 2013

All Science Journal Classification (ASJC) codes

Pharmacology, Toxicology and Pharmaceutics (miscellaneous)
Public Health, Environmental and Occupational Health
Pharmacology (medical)

Keywords

Alignment between development and regulatory requirements
Co-development
Companion diagnostics
DIA
In vitro diagnostic (IVD) companion devices
Personalized medicine

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Summary of DIA workshop on Co-Development of personalized medicine and in vitro diagnostic companion devices

Abstract

All Science Journal Classification (ASJC) codes

Keywords

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