The Biomarkers and Precision Medicine Community is happy to announce the launch of the "Introduction to Biomarkers" eCourse!
This resource is free for all AAPS members!!
Intro to Biomarkers: Assay Validation/Qualification, Regulatory Guidance and Application | AAPS
Biomarker and translational research play a vital role in drug development to assess target engagement, understand mechanism of action, provide insight on drug safety and efficacy, and expedite the discovery and implementation of new diagnostic tools.
This short course steps through the fundamentals of biomarker assays and their applications in clinical trials. Discussions focus primarily on technologies, key issues in assay development, and regulatory considerations to ensure continuity of experience and best practices, sharing institutional knowledge, and making literature more accessible.
The course is made up of five modules featuring industry and regulatory experts in the biomarker field:
- Module 1: Introduction to the Field of Biomarkers- Mohamed Hassanein, Ph.D. (Pfizer), JP Savaryn, Ph.D. (AbbVie), Iris Qiu, Ph.D. (AbbVie)
- Module 2: Biomarkers Context of Use (COU) and Regulatory Considerations- Steven Piccoli, Ph.D. (SPARC), Abbas Bandukwala, Ph.D. (FDA)
- Module 3: Consideration for LC-MS and LBA Biomarker Assays- Carmen Fernandez-Metzler, Ph.D. (Pharmacadence), Yan Ni, Ph.D. (Passage Bio)
- Module 4: Parallelism, Stability, Endogenous QCs, ISR- Lindsay King, Ph.D. (Pfizer), Sumit Kar, Ph.D. (Revolution Medicines)
- Module 5: Critical Reagents, Commercial Kits and Multiplex Assays- Marianne Scheel-Fjording, Ph.D. (Biolyzer), Amanda Hays, Ph.D. (BioAgilytix)
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Amanda Hays Ph.D.
Scientific Officer
BioAgilytix
Olathe KS
[email protected]Disclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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