News update from Physiomics March 2024
Leading mathematical modelling company, supporting oncology drug development.
From us to you – curated cutting-edge research and insights. Welcome to our newsletter, where we share the latest updates from Physiomics and offer insights on the pivotal news shaping the dynamic world of drug development.
Top news
Exciting new project with existing large pharma client
Physiomics are pleased to share that we have been awarded a new PKPD modelling project with existing large pharma client to help inform clinical dose and scheduling decisions, adding to our extensive experience in the DNA damage/repair field.
Collaborating with University of Sheffield
Physiomics has been chosen by The University of Sheffield to support a grant funded project developing an insect model of cancer that could be used to screen new drugs prior to pre-clinical testing (potentially reducing number of pre-clinical animal studies required), with a focus on prediction of metastasis.
Industry Insight
FDA’s Clinical Pharmacology Guidance for Development of Antibody-Drug Conjugates & World ADC Event London
This month the Physiomics team attended the 14th Annual World ADC Event in London on 13th and 14th of March 2024, Europe’s definitive Antibody-Drug Conjugate meeting, attended by 600+ experts from the field. It was a great event to meet with leaders of the field and learn about the trends and lessons in this exciting and growing industry. In particular to discuss where quantitative pharmacology and PK/PD modelling expertise can help to inform and de-risk development, in areas such as;
Discovery:
- Model impact of ADC design, including properties such as binding affinity to target, payload release rate, elimination rate, half-life, DAR etc. on payload delivery to the tumour, to inform selection of your lead candidate
Pre-clinical/Translation:
- Predict human PK & PD to select FIH dose and understand optimal dose range in the clinic
Clinical development;
- Understand exposure-response relationships in both safety and efficacy for all components of the ADC (total antibody, ADC, free payload)
- Alter dosing schedule to reduce toxicity
- Define dosing strategies for specific patient populations or sub-groups
For more information on the clinical pharmacology considerations for development of ADC’s, see the Guidance for Industry issued by the FDA’s Center for Drug Evaluation and Research or discuss with the team at Physiomics!
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