Xiao-Yan Cai, Ph.D.

Biography

Dr. Xiao-Yan Cai, MD, Ph.D. is co-founder and CEO of Accurant Biotech, which is a CRO focusing on regulated large molecule bioanalytical services to support pharma and biotech clients for their innovative therapeutic biologics drug development. Under her leadership, her organization’s China labs had successfully supported the 1st domestic CAR-T product Carteyva® approval in China in Jul 2021; and the US lab successfully passed their 1st FDA facility inspection without 483 findings in Aug, 2023.

Prior to co-founding the company about 6 years ago, Dr. Cai was the global head for large molecule bioanalysis at WuXi AppTec’s Global Bioanalytical Services (BAS) from June, 2015 to December, 2017. Prior to that role, she was Director at Merck’s Biologics Bioanalytical Development division and had been with Merck and previously Schering-Plough (merged in 2009) for over 23 years. 

She has extensive Biologics drug development experience and specializes in large molecule bioanalysis. Her team had developed/validated preclinical and clinical PK, PD, ADA and NAb methods to support all Schering-Plough and Merck’s biologics drug development pipeline, including Merck’s blockbuster immune-oncology drug anti-PD1 (Keytruda). She had been on the core BLA filing team for the successful FDA approval of Keytruda for late-stage melanoma in 2014. She is also among the industry leaders for bioanalytical assay development and validation for Biosimilars. Her publications on this topic had been widely cited and considered as guiding white paper in the biosimilar bioanalysis field both globally and in China.

Dr. Cai had been invited to speak at many conferences on numerous topics in the large molecule bioanalytical testing area (e.g. immunogenicity assay challenges for biosimilars, cell-based neutralizing anti-drug antibody assays, overcoming drug tolerance challenges for ADA assays, ultrasensitive PK assays to quantify low concentration of drug in serum samples, regulated large molecule bioanalysis, ADC and biosimilar bioanalysis, etc.). 

Dr. Cai holds a M.D. degree from Beijing Medical University in China (now part of Beijing University) and a Ph.D. in Biochemistry and Molecular Biology from University of Medicine and Dentistry of New Jersey (UMDNJ), which is now part of The Rutgers University in New Jersey, USA.

PUBLICATIONS:

Xu, B., Haley, R., Li, D., Cai, X-Y., Significant Technical Breakthrough of qPCR Method with Consistent LLOQ Sensitivity of 8 copies / mg DNA in a 20 µL Reaction: A Highly Sensitive RCL Activity qPCR Method, WRIB Conference: June 19-23, 2023, Orlando, FL