Amanda Hays is a Scientific Officer and Senior Director at BioAgilytix Laboratories. She offers more than a decade of lab experience in multiple fields, including pharmacology, drug metabolism, immunoassays, immunogenicity, biomarkers, flow cytometry and qPCR and has supported programs through all stages in drug development. In her current role, she 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 Ph.D. in Pharmacology from the University of Kansas Medical Center in Kansas City, KS.

Kelly Colletti, PhD, MBA is the Director, Preclinical Bioanalytics at Beam Therapeutics. She oversees the development and validation of bioanalytical assays supporting IND submissions for all therapeutic areas. She has over 14 years experience designing and troubleshooting ligand binding assays in bioanalysis and has more recently contributed to the validation principles for qPCR assays. Kelly has been highly engaged as an AAPS member with a passion for mentoring students and scientists. She received her PhD in cellular and molecular biology in 2005 from the University of Nevada Reno, where she also completed an MBA. Kelly lives in Reno, Nevada with her family where she enjoys recreation in the Sierra Nevada mountains.

Niketa Jani, Ph.D., Manager I, BioAgilytix Laboratories offers more than 5 years lab operation experience managing projects for fit-for-purpose molecular biology assays in accordance with applicable regulatory guidelines. She has led projects under GMP, GCP, GCLP, or RUO regulatory compliance for AAV based gene therapy and other drug modalities and for studies such as biodistribution, vector copy number analyses, vector shedding assays and gene expression assays and has supported programs through all stages in drug development. She has more than 4 years of lab operation experience overseeing molecular biology assay validation, implementation and CLIA regulatory compliance of Lab Developed Tests for infectious diseases. She earned her Ph.D. in Molecular Biology from Wayne State University in Detroit, Michigan.