FUTURE WEBINAR - 2025, Tuesday, February 18th - Tox By Design: "From Innovation to Market: lessons and challenges from in silico CM&S disruption in Biotech and Pharma's in silico predictive toxicology"
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Abstract
The disruption brought by Computational Modelling and Simulation ("CM&S") is poised to revolutionize the development of pharmaceutical drugs and medical devices.
With CM&S technologies now mature and demonstrating concrete in silico successes, validated models, and initial regulatory acceptance, this field stands at the brink of widespread transformation.
However, to prevent these innovations from becoming short-lived ventures within private startups that fail to sustain growth, CM&S breakthroughs must:
• Address at least one real-world challenge within the biotech or medtech industries;
• Do so in a way that withstands the financial pressures of the private sector to facilitate scalability;
• And adapt to the stringent requirements of pharmaceutical regulatory frameworks.
One early success within the CM&S ecosystem was indeed in silico predictive toxicology through Quantitative Structure-Activity Relationship "(Q)SAR" models.
This application, driven by regulatory and productivity demands, proved essential for this paradigm shift within the industry.
Nevertheless, market potential only surged following an earlier regulatory acceptance.
Moving forward, the establishment of new standards for in silico prediction accuracy will be crucial to support regulatory compliance and drive further advancements in CM&S validated applications.
In this context, let's review the lessons learned and challenges that faced players in the (Q)SAR entrepreneur's journey.
BIO
Matthieu Chareyre, based in Paris, is a serial entrepreneur and investor in the life sciences sector, bringing extensive experience from his leadership roles at Tox by Design, but also Regulaxis & Hephaïstos Biotechs, Zaphyr Pharmaceuticals generics, and Socosur Chem EU API importation and distribution GDP approved,
following his early career at Pfizer and Abbott Laboratories (now AbbVie).
His latest venture, Tox by Design, ranks among the top 3 HBELs regulatory tox experts in Europe, with seven years of commercial success in in silico(Q)SAR methodologies.
Matthieu has also contributed to the European rollout of the initial Good Distribution Practices regulations, which share similarities with the upcoming Good Simulation Practices.
He holds a Doctorate of Pharmacy from Paris-Sud Pharma University and an MSc in Strategic Management from HEC Paris.
With expertise spanning Biotech GMP scale-up, internationalization, corporate strategy, GMP technology transfer, and fundraising, Matthieu looks forward to sharing valuable insights and in-depth industry knowledge with the AA community, inspiring the next generation of innovators as he once was.