Transcript Diapositive 1 - NanoSafety Cluster

Nanotoxicity and Nanosafety;
the nanomedicine perspective
Recommendations from the Nanomedicine
Community
Adriele Prine-Mello
Trinity College Dublin, Ireland
Chair of Characterization and Toxicology Working Group
1
Kicking off on the perspective
NanoSafetyCluster
ETPN
Particle synthesis
Submitted nanoparticle selection
Particle characterization in-situ and
ex-situ
Physical characterization
Mechanism of interaction
In vitro assays
Particle exposure assessment
In vivo assays
Chemical characterization
(in vitro, in vivo, in silico)
Non intentional exposure
Intentional administration
Nanosafety
Clinical use
Impact of exposure to nanoparticles
Pre-clinical approval of nanoparticles
7th nanoTOX2014
Antalya 23-26 April 2014
3
Introduction
Everything is Relative
One of the most toxic drugs known
Rat i.v. DL50 = 8 mg/kg
Toxic drugs known
Rat i.v. DL50 = 85 mg/kg
Insecticide to treat pet
Dog i.v. DL50 = 7 mg/kg
Ketoconazale ,
fungicide to treat dandruff
Man oral DL50 = 45 mg/kg
7th nanoTOX2014
Antalya 23-26 April 2014
Nanomedicine perspectives
Improving the Risk-Benefit Ratio…
…of currently-available medical treatment with nanotech is possible!
Risk
Benefit
TCD © 2014 – Prina-Mello / Movia
©TCD 2014
Nanomedicine tiered approach
Risk
W
G
T
&
C
Safe-by-design
Benefit
» Physico-chemical characterisation
» Internalization: mechanism and time-dependence
» Cytotoxicity
» Biodegradation
Tier 2
» Biocompatibility
Risk
Shell-coated NPs
Tier 3
Purpose-specific
functionalized NPs
» Targeted drug delivery
Benefit
Adapted from Movia D. et al., Biomaterials, 2014, 35, 9, 2543-2557
©TCD 2014
Big deals in nanomed in 2013 : > 1 Billion US$
180M
US$
200M
US$
210M
US$
7th nanoTOX2014
Antalya 23-26 April 2014
6
The European approach to improve translation
…..including toxicity and safety
7th nanoTOX2014
Antalya 23-26 April 2014
ETPN Translational process and focus (WG T&C)
Accelerating translation of engineered nano-products for medicine
applications to medicinal products
Translation process
Proof of concept
Design
Synthesis
Nano
characterisation
Nanomedicine
Commons
• Toxicity
• Safety
Extras
•
•
•
•
•
•
cGMP
manufacturing
Clinical
tests
PK
PD
Risk/Benefit analysis
Validation to Standards
QC, QA
Certification
7th nanoTOX2014
Antalya 23-26 April 2014
Translation process
Scale up
Manufacturing
Full
characterisation
Proof of
concept
Clinical trials
Approval
NSC:
•Regulatory
•EHS
NSC:
• Database
• Expertise
• Models
• Experience
• Large EU network
7th nanoTOX2014
Antalya 23-26 April 2014
ETPN Translation hub
7th nanoTOX2014
Antalya 23-26 April 2014
Impacts on EU
• Economic
– >500 SMEs in nanomedicine in Europe
– Nearly 250 “nano”-products are used or
tested in humans
• Societal
– Diagnostics tools and better healtcare treatments for
• a more targeted and more personalised medicine
• with less side-effects
• for a more cost-effective healthcare
• ETPN Impact on H2020
• White paper
• SRIA
Consult www.etp-nanomedicine.eu to
•Download reports and documents
•Find further information
•Become a member
•…
For more information, contact:
[email protected]
For more information:
Adriele Prina-Mello, Msc, PhD
E: [email protected]
P. +353 1 896 3259
Andreas Falk, MSc
E: [email protected]
W: www.bionanonet.at
Linkedin: adriele-prina-mello/1/393/b13
Google scholars: Adriele Prina-Mello
Research Gate profile: Adriele_Prina-Mello
Thank you for your attention