Limulus Bio Coffee Break –highlights from Biocompatibility Matters 2022, a delegates perspective ??
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Biocompatibility Experts - Biocompatibility and toxicology consultancy and training, with a global perspective
Ulrika Carlander, Toxicologist and investigator at Swedish MPA and Associate researcher in Nanotoxicology at Karolinska Institute was our guest. It was interesting to hear her views as she has earlier been deeply involved in standardization during more than 10 years. Especially her reflection about new young people that participated and presented their work, together with the development of new alternative methods, looks really promising for the future to come.
“As a researcher and regulator, I feel trust when I see that new developing standards are based on science and that results are published.?My belief is that standard test methods must be validated and built on science else it is difficult to build trust among regulators. Methods must also address specific requirements in regulation to facilitate regulator’s market surveillance.”
Ulrika also mentioned the 3R:s; Refine, Replace and Reduce. To get there, NAMs are necessary. How can we build trust in new alternative methods? What is needed? Education, validation, use new methods in parallel with existing over a transition period, other suggestions?
What is really needed when it comes to validation of New Alternative Methods (NAMs) is a tricky question, and the outcome of the discussion is perhaps that founding is extremely important. It was highlighted that there are work going on for specific type of device, for example Personal Lubricants. Maybe public private partnerships for founding, as within Cosmetic industry, could be an alternative for Med Tech as well?
Another topic was initially raised by Arthur Brandwood at BM2022:?“Does ISO 10993 aim to address safety, or safety and performance? Are more device specific standards required or is ISO 10993 sufficient?”. Maybe ISO 10993 just answers specific safety questions? Jeremy Tinkler raised the importance of a risk management process. There are examples of device problems that might not have been picked up by the way ISO 10993 has been followed, but the situation is better now due to the requirement of performing thorough material characterizations.
The next challenging field Ulrika choose was endocrine disruptors presented by Hedwig M Braakhuis. How do we address endocrine disruptors? What shall be the test strategy? Maybe there was a consensus at the Coffee Break to leave this subject for now (or maybe forever)…
A last reflection. Material characterization is becoming common practice but is still challenging to use in risk assessment. Best practices are evolving and in silico tools are developing with aim to predict toxicity. How do we build trust in using material characterization and in silico tools in toxicological risk assessments? And with the extreme sensitivity reached by analytical instruments today, when is enough enough? How do we balance the risk?
In conclusion, we think the BM2022 raised some important issues. We hope that all who attended have got something that they can use in their daily life, and further, that the standards are developed in the right direction. With that said, with real science behind.
Thanks to all who joined us and hope to see you at BM2023, stay tuned!
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The next Limulus Bio Coffee Break is with Emanuela Corsini, discussing on the topic Immunotoxicity.?Emanuela is Professor of Toxicology at the University of Milano. Grab a cup of coffee and join our informal discussion.
See you?Wednesday November 30 at 3 pm CET. To get an invitation with Teams link, send an email to:?[email protected]. You may also ask to be added to the standing invitation list to get invitations to later Coffee Break discussions as well.
The Limulus Bio Coffee Breaks are informal discussions, free of charge and held in English.
Welcome!