Workshop Nanomedicine

The international standardisation roadmap for nanomedicine

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Nanomedicine and nano-enabled medical devices therapeutics (defined here as nanotherapeutics) are innovative solutions for tackling several health challenges, by delivering therapeutic agents to specific targeted sites in a controlled manner. 
The international community recently started to work on the development robust and validated analytical methods, fit for purpose reference materials and formally recognised consensus standards for the assessment of their quality and safety.

Objectives of the day

The intent of the workshop is to:

• share information on existing (pre)-standardisation initiatives ongoing at the European and international level (OITB, Euramet, VAMAS, EDQM, ASTM E56, ISO/TC 229, CEN/TC 352)
• identify and prioritise specific measurement and standards needed to facilitate preclinical development and regulatory approval moving forward.

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The workshop is co-sponsored by the 22HLT04-MetrINo project and the NanoMeasure France association.

Program

09h00 | Welcome of the participants

09h25 | Introduction of the day

G. Favre, Directeur Institut LNE Nanotech

Pre-standardisation activities : the EU perspective

9h30 | “Advancing characterization methods and standards for nanotechnology based medical products”

Dr. Luigi Calzolai, European Commission, Joint Research Centre (JRC), Ispra, Italy

09h55 | “The SAFE-N-MEDTECH-Open innovation test bed for Safety Testing In The Life Cycle Of Nanotechnology-Enabled Medical Technologies For Health”

Dr. Adriele Prina Mello, Trinity College Dublin

10h20 | “PHOENIX - Pharmaceutical Open Innovation Test Bed for GMP Manufacturing of Nanopharmaceuticals”

Dr. Nazende Günday-Türeli, MyBiotech GmbH

10h45 | “Multi-detector Field flow fractionation for liposomes and RNA-LNPs: from the lab to Standardization.”

Dr. Jeremie Parot, SINTEF Industry, Biotechnology and Nanomedicine department

11h10 | coffee break

EU metrology strategies and activities

11h40 | “International and EU metrology strategies and activities”

Dr. Paola Fisicaro, LNE (Laboratoire national de métrologie et d'essais)

12h05 | “MetrINo-Metrology for nanotherapeutics”

Dr. Fanny Caputo, LNE

12h30 | Lunch break

13h30 | Round-table part 1 : Industrial needs, identified priories

Ongoing Standardisation projects part 1

14h00 | “Standardising nanomedicine at ISO/TC 229: one particle at a time”

Denis Koltsov, chair of ISO/TC 229

14h25 | “Assuring quality of nanomedicines: activities at the European Pharmacopoeia”

Gerrit Borchard, School of Pharmaceutical Sciences of Western Switzerland (ISPSO), University of Geneva, Switzerland

14h50 | “Overview of VAMAS interlaboratory comparisons relevant to nanomedicine and future outlook”

Dr. Caterina Minelli, NPL - National Physical Laboratory

15h15 | Coffee break

Ongoing Standardisation projects part 2

15h45 | “Total lipid quantitation in liposomal-based drug formulations”

Bryant Nelson, NIST – Material Measurement Laboratory, Gaithersburg, MD USA and ASTM International, E56.08 Subcommittee on Nano-Enabled Medical Products, Conshohocken, PA USA

16h10 | “Certified Reference Materials for Lipid-Based Nanocarriers”

Shan Zou, Team Leader for Nanoscale Measurement, Metrology Research Centre, National Research Council Canada

16h35 | Round table part 2 : How can EU be part of the game?

Define practical approaches for collaboration and harmonisation of activities among the metrology community and the standardisation bodies active in the field of Nano medicine at the European Level.

17h30 | End of the day

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Registration

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