Bioanalytical strategies for oncolytic virus therapeutics
Oncolytic viruses for the treatment of cancer and genetic disease has been an area of active study for decades. Testing strategies for monitoring efficacy and safety of such therapeutics includes biomarker, biodistribution, viral shedding and infectivity assays.
Assessing the risk level for individual programs can drive the use of these bioanalytical methods and help shape overall strategy. Logistics for sample collection and handling, as well as the use of the data for these tests, are critical for understanding preclinical and clinical oncolytic virus programs.
This webinar covers each of these topics, highlighting current expectations from regulatory agencies.
What will you learn?
- To recognize the applications of oncolytic viruses for therapeutic use
- To identify testing strategies to support safety and efficacy of oncolytic therapeutics
- To understand common challenges and regulatory expectations for bioanalysis in support of these programs
Who may this interest?
- Bioanalytical scientists
- Clinical virologists and lead scientists
- Clinical study project managers
Speakers
Michelle Miller, PhD, DABT
Scientific Officer, Director
BioAgilytix (NC, USA)
Dr. Miller has over a decade of experience working in the fields of immunology and toxicology. With a strong background in project management, Dr Miller previously served as an Associate Director of Bioanalytical Operations at BioAgilytix.
Prior to BioAgilytix, Michelle worked as a study director leading GLP toxicology and immunotoxicology studies as a lead investigator in the toxicology field developing high throughput screening assays, and as an R&D scientist in the pharmaceutical industry.
She is a current diplomate of the American Board of Toxicology. Michelle earned her BA in Chemistry, BS in Zoology and PhD in Immunology with a minor in Biochemistry from North Carolina State University (USA).
Stephanie Hamilton
Director Scientific Operations,
360biolabs, a BioAgilytix company (Melbourne, Australia)
Stephanie serves as Director of Scientific Operations at 360biolabs. Her previous roles include Scientist within Influenza Operations at Sequirus (Parkville, Australia) and as a Senior Research Scientist at Aviragen (GA, USA). She earned her Masters in Public Health from Monash University (Melbourne, Australia).
Amanda Hays, PhD
Scientific Officer, Senior Director
BioAgilytix (KS, USA)
Dr. Hays offers more than a decade of lab experience in multiple fields, including pharmacology, drug metabolism, immunoassays, immunogenicity, biomarkers, flow cytometry and qPCR.
She has particular expertise leading programs through all stages in the drug development process. In her current role, she serves as a Scientific Officer and provides global scientific leadership and technical guidance at BioAgilytix.
Dr Hays is the Chair of the AAPS biomarkers and precision medicine community and the AAPS qPCR working group, among other volunteer leadership positions. She earned her PhD in Pharmacology from the University of Kansas Medical Center in Kansas City (USA).
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