nanotoxicity and nanosafety; the nanomedicine perspective recommendations from the nanomedicine...
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Nanotoxicity and Nanosafety; the nanomedicine perspective
Recommendations from the Nanomedicine Community
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Adriele Prine-MelloTrinity College Dublin, Ireland
Chair of Characterization and Toxicology Working Group
Kicking off on the perspective ETPN
Submitted nanoparticle selection
Physical characterization
Chemical characterization
In vitro assays
In vivo assays
Clinical usePre-clinical approval of nanoparticles
Intentional administration
NanoSafetyClusterParticle synthesis
Particle characterization in-situ and ex-situ
Mechanism of interaction
Particle exposure assessment
(in vitro, in vivo, in silico)
NanosafetyImpact of exposure to nanoparticles
Non intentional exposure
7th nanoTOX2014 Antalya 23-26 April 2014
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Everything is Relative
One of the most toxic drugs knownRat i.v. DL50 = 8 mg/kg
Insecticide to treat petDog i.v. DL50 = 7 mg/kg
Ketoconazale , fungicide to treat dandruffMan oral DL50 = 45 mg/kg
Introduction
Toxic drugs knownRat i.v. DL50 = 85 mg/kg
7th nanoTOX2014 Antalya 23-26 April 2014
Improving the Risk-Benefit Ratio…
…of currently-available medical treatment with nanotech is possible!
NanoNano
©TCD 2014
Nanomedicine perspectives
TCD © 2014 – Prina-Mello / Movia
Nanomedicine tiered approach
Tier 2
Tier 3
» Physico-chemical characterisation» Internalization: mechanism and time-dependence» Cytotoxicity» Biodegradation
» Biocompatibility
» Targeted drug delivery
Shell-coated NPs
Purpose-specific functionalized NPs
Risk
Benefit
Adapted from Movia D. et al., Biomaterials, 2014, 35, 9, 2543-2557 ©TCD 2014
WG T&C
WG T&C
Big deals in nanomed in 2013 : > 1 Billion US$
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180M
US$
210M
US$
200M
US$
7th nanoTOX2014 Antalya 23-26 April 2014
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)
Translation process
Design SynthesisClinicaltests
Nanocharacterisati
on
cGMP manufacturin
g
Accelerating translation of engineered nano-products for medicine applications to medicinal products
Proof of concept
• Toxicity• Safety
• PK• PD• Risk/Benefit analysis• Validation to Standards• QC, QA• Certification
NanomedicineCommons
Extras
7th nanoTOX2014 Antalya 23-26 April 2014
Translation process
FullFullcharacterisationcharacterisation
Clinical trialsClinical trials
Scale upScale upManufacturingManufacturing
Approval
Proof of Proof of conceptconcept
NSC:NSC:• DatabaseDatabase• ExpertiseExpertise• ModelsModels• ExperienceExperience• Large EU networkLarge EU network
NSC: NSC: •RegulatoryRegulatory•EHSEHS
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
For more information, contact:For more information, contact:[email protected]@etp-nanomedicine.eu
Consult Consult www.etp-nanomedicine.euwww.etp-nanomedicine.eu to to
•Download reports and documentsDownload reports and documents•Find further informationFind further information•Become a memberBecome a member•……
For more information:
Adriele Prina-Mello, Msc, PhD Andreas Falk, MScE: [email protected] E:
[email protected]. +353 1 896 3259 W: www.bionanonet.at
Linkedin: adriele-prina-mello/1/393/b13Google scholars: Adriele Prina-MelloResearch Gate profile: Adriele_Prina-Mello
Thank you for your attention