Current trends and challenges in the clinical translation of nanoparticulate nanomedicines: Pathways for translational development and commercialization

Susan Hua (Corresponding Author), Maria B.C. de Matos, Josbert M. Metselaar, Gert Storm

Research output: Contribution to journalReview articleAcademicpeer-review

23 Citations (Scopus)

Abstract

The use of nanotechnology in medicine has the potential to have a major impact on human health for the prevention, diagnosis, and treatment of diseases. One particular aspect of the nanomedicine field which has received a great deal of attention is the design and development of nanoparticulate nanomedicines (NNMs) for drug delivery (i.e., drug-containing nanoparticles). NNMs are intended to deliver drugs via various mechanisms: solubilization, passive targeting, active targeting, and triggered release. The NNM approach aims to increase therapeutic efficacy, decrease the therapeutically effective dose, and/or reduce the risk of systemic side effects. In order to move a NNM from the bench to the bedside, several experimental challenges need to be addressed. This review will discuss the current trends and challenges in the clinical translation of NNMs as well as the potential pathways for translational development and commercialization. Key issues related to the clinical development of NNMs will be covered, including biological challenges, large-scale manufacturing, biocompatibility and safety, intellectual property (IP), government regulations, and overall cost-effectiveness in comparison to current therapies. These factors can impose significant hurdles limiting the appearance of NNMs on the market, irrelevant of whether they are therapeutically beneficial or not.

Original languageEnglish
Article number790
JournalFrontiers in pharmacology
Volume9
Issue numberJUL
DOIs
Publication statusPublished - 17 Jul 2018

Fingerprint

Nanomedicine
Government Regulation
Pharmaceutical Preparations
Intellectual Property
Nanotechnology
Nanoparticles
Cost-Benefit Analysis
Medicine
Safety

Keywords

  • Biological
  • Challenges
  • Clinical translation
  • Commercialization
  • Drug delivery systems
  • Nanomedicine
  • Nanoparticles
  • Regulations

Cite this

@article{bf5e34360e0541b9a80f81bc564677e7,
title = "Current trends and challenges in the clinical translation of nanoparticulate nanomedicines: Pathways for translational development and commercialization",
abstract = "The use of nanotechnology in medicine has the potential to have a major impact on human health for the prevention, diagnosis, and treatment of diseases. One particular aspect of the nanomedicine field which has received a great deal of attention is the design and development of nanoparticulate nanomedicines (NNMs) for drug delivery (i.e., drug-containing nanoparticles). NNMs are intended to deliver drugs via various mechanisms: solubilization, passive targeting, active targeting, and triggered release. The NNM approach aims to increase therapeutic efficacy, decrease the therapeutically effective dose, and/or reduce the risk of systemic side effects. In order to move a NNM from the bench to the bedside, several experimental challenges need to be addressed. This review will discuss the current trends and challenges in the clinical translation of NNMs as well as the potential pathways for translational development and commercialization. Key issues related to the clinical development of NNMs will be covered, including biological challenges, large-scale manufacturing, biocompatibility and safety, intellectual property (IP), government regulations, and overall cost-effectiveness in comparison to current therapies. These factors can impose significant hurdles limiting the appearance of NNMs on the market, irrelevant of whether they are therapeutically beneficial or not.",
keywords = "Biological, Challenges, Clinical translation, Commercialization, Drug delivery systems, Nanomedicine, Nanoparticles, Regulations",
author = "Susan Hua and {de Matos}, {Maria B.C.} and Metselaar, {Josbert M.} and Gert Storm",
year = "2018",
month = "7",
day = "17",
doi = "10.3389/fphar.2018.00790",
language = "English",
volume = "9",
journal = "Frontiers in pharmacology",
issn = "1663-9812",
publisher = "Frontiers Media S.A.",
number = "JUL",

}

Current trends and challenges in the clinical translation of nanoparticulate nanomedicines : Pathways for translational development and commercialization. / Hua, Susan (Corresponding Author); de Matos, Maria B.C.; Metselaar, Josbert M.; Storm, Gert.

In: Frontiers in pharmacology, Vol. 9, No. JUL, 790, 17.07.2018.

Research output: Contribution to journalReview articleAcademicpeer-review

TY - JOUR

T1 - Current trends and challenges in the clinical translation of nanoparticulate nanomedicines

T2 - Pathways for translational development and commercialization

AU - Hua, Susan

AU - de Matos, Maria B.C.

AU - Metselaar, Josbert M.

AU - Storm, Gert

PY - 2018/7/17

Y1 - 2018/7/17

N2 - The use of nanotechnology in medicine has the potential to have a major impact on human health for the prevention, diagnosis, and treatment of diseases. One particular aspect of the nanomedicine field which has received a great deal of attention is the design and development of nanoparticulate nanomedicines (NNMs) for drug delivery (i.e., drug-containing nanoparticles). NNMs are intended to deliver drugs via various mechanisms: solubilization, passive targeting, active targeting, and triggered release. The NNM approach aims to increase therapeutic efficacy, decrease the therapeutically effective dose, and/or reduce the risk of systemic side effects. In order to move a NNM from the bench to the bedside, several experimental challenges need to be addressed. This review will discuss the current trends and challenges in the clinical translation of NNMs as well as the potential pathways for translational development and commercialization. Key issues related to the clinical development of NNMs will be covered, including biological challenges, large-scale manufacturing, biocompatibility and safety, intellectual property (IP), government regulations, and overall cost-effectiveness in comparison to current therapies. These factors can impose significant hurdles limiting the appearance of NNMs on the market, irrelevant of whether they are therapeutically beneficial or not.

AB - The use of nanotechnology in medicine has the potential to have a major impact on human health for the prevention, diagnosis, and treatment of diseases. One particular aspect of the nanomedicine field which has received a great deal of attention is the design and development of nanoparticulate nanomedicines (NNMs) for drug delivery (i.e., drug-containing nanoparticles). NNMs are intended to deliver drugs via various mechanisms: solubilization, passive targeting, active targeting, and triggered release. The NNM approach aims to increase therapeutic efficacy, decrease the therapeutically effective dose, and/or reduce the risk of systemic side effects. In order to move a NNM from the bench to the bedside, several experimental challenges need to be addressed. This review will discuss the current trends and challenges in the clinical translation of NNMs as well as the potential pathways for translational development and commercialization. Key issues related to the clinical development of NNMs will be covered, including biological challenges, large-scale manufacturing, biocompatibility and safety, intellectual property (IP), government regulations, and overall cost-effectiveness in comparison to current therapies. These factors can impose significant hurdles limiting the appearance of NNMs on the market, irrelevant of whether they are therapeutically beneficial or not.

KW - Biological

KW - Challenges

KW - Clinical translation

KW - Commercialization

KW - Drug delivery systems

KW - Nanomedicine

KW - Nanoparticles

KW - Regulations

UR - http://www.scopus.com/inward/record.url?scp=85050118384&partnerID=8YFLogxK

U2 - 10.3389/fphar.2018.00790

DO - 10.3389/fphar.2018.00790

M3 - Review article

VL - 9

JO - Frontiers in pharmacology

JF - Frontiers in pharmacology

SN - 1663-9812

IS - JUL

M1 - 790

ER -