Regulatory barriers to the advancement of precision medicine

被引：7

作者：

Pettitt, David ^{[1
,2
]}

Smith, James ^{[1
,3
]}

Meadows, Nick ^{[4
]}

Arshad, Zeeshaan ^{[5
]}

Schuh, Anna ^{[6
]}

DiGiusto, David ^{[7
]}

Bountra, Chas ^{[8
]}

Hollander, Georg ^{[2
,9
]}

Barker, Richard ^{[1
,10
]}

Brindley, David ^{[1
,2
,11
,12
,13
]}

机构：

[1] Univ Oxford, Oxford UCL Ctr Adv Sustainable Med Innovat CASMI, Oxford, England

[2] Univ Oxford, Div Med Sci, Dept Paediat, Oxford, England

[3] Univ Oxford, Nuffield Dept Orthoped Rheumatol & Musculoskeleta, Oxford, England

[4] Kinapse, London, England

[5] Univ St Andrews, Sch Med, St Andrews, Fife, Scotland

[6] Oxford Univ Hosp, Oxford Natl Inst Hlth Res NIHR, BRC, MDC, Oxford, England

[7] Stanford Univ Hosp & Clin, Stem Cell & Cellular Therapeut Operat, Stanford, CA USA

[8] Univ Oxford, Nuffield Dept Med, Struct Genom Consortium, Oxford, England

[9] Univ Oxford, Weatherall Inst Mol Med, John Radcliffe Hosp, Oxford, England

[10] Precis Med Catapult, London, England

[11] UCL, UCL Sch Pharm, Ctr Behav Med, London, England

[12] Harvard Stem Cell Inst, Cambridge, MA USA

[13] USCF Stanford Ctr Excellence Regulatory Sci & Inn, San Francisco, CA USA

来源：

EXPERT REVIEW OF PRECISION MEDICINE AND DRUG DEVELOPMENT | 2016年 / 1卷 / 03期

基金：

英国医学研究理事会;

关键词：

Precision medicine; personalized medicine; regulation; commercialization; regulatory barriers; genomics; companion diagnostics; next generation sequencing; in vitro diagnostics;

D O I：

10.1080/23808993.2016.1176526

中图分类号：

R9 [药学];

学科分类号：

1007 ;

摘要：

Precision medicine utilizes tailored diagnostic, prognostic and therapeutic strategies based on an individual's molecular profile. Although it is gaining considerable traction and high-level political endorsement, it must overcome a number of translational hurdles, including regulatory barriers. At the core of precision medicine lies diagnostic tests and devices, however the regulatory classification of such products varies on a global basis. Navigating these convoluted regulatory pathways can be challenging - exacerbated by asymmetric technological advancement and regulatory progression. Both the EU and US are attempting to address such issues and newer concerns relating to direct-to-consumer testing. Flexible solutions are required to establish regulatory compliance across multiple countries and coordinated cross-collaboration initiatives need to empower technological development and globally harmonized regulation. The wider infrastructure, spanning beyond regulation, must also accommodate these changes and support subsequent clinical adoption, in order to firmly establish precision medicine in modern day medical practice.

引用

页码：319 / 329

页数：11

共 52 条

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