MARCH 4-8, 2019
SHORT COURSE: TUESDAY MARCH 5, 6:30PM – 9:00PM

Bioassay Design, Analysis and Specifications

Instructor: Liming Shi, MS, MA, Executive Director, Quality Control, CMAB Biopharma Inc.

Introduction:

This seminar will focus on the fundamentals of biostatistics and simple methodology that are routinely applied in bioassay laboratories. Covered topics will include common mechanisms and principals of bioassays; general statistical concepts and calculations in bioassay; study design during bioassay development and optimization; bioassay validation and regulatory guidance; bioassay acceptance criteria and specification; quantitative quality control of bioassay performance.

Topics to be covered:

• Uniqueness of bioassay, especially cell-based potency assay
• Bioassay measurements and calculations
• Considerations in bioassay development, transfer and validation
• Data driven assay and sample acceptance criteria set up
• Assessment of bioassay results

Who should attend:

• Bioassay development laboratory managers and scientists
• Biomarkers research scientists
• Quality control laboratory managers and analysts
• Regulatory professionals for biological/biosimilar submission
• Scientists in biological/biosimilar development

Instructor Bio:

Liming Shi, MS, MA, Senior Director, Quality Control, CMAB Biopharma Inc.

Liming has more than 20 years’ experience in biopharmaceutical industry. He currently is a senior Director, Quality Control at CMAB Biopharma at Suzhou, China. Prior to that, Liming joined Pfizer as a senior group leader, Bioassay Development at Chicago in 2016 from Eli Lilly. He pioneered and successfully established data driven bioassay system suitability/sample acceptance criteria set-up following USP chapters (1032, 1033, 1034). He first established bioassay Trending program and successfully optimized/qualified qPCR residual HCD method. As an analytical lead he also successfully managed CROs, project timelines, planning/strategy, analytical methods implementation/qualification, transfer/validation, testing/trouble shooting, and all CMC activities. He influenced and implemented many good bioassay practices in the site. Liming joined Lilly from Amylin pharmaceuticals in 2012. He was responsible for bioassay development, transfer and validation for late phase Lilly products. He established and was in charge of bioassay trending programs in Lilly for all third party organizations (TPO). Liming actively involved CMC activities such as IND, IMPD, BLA and MAA. He performed many deviation investigations as principal investigator and primary/corporate reference standard evaluation/re-evaluations for bioassay. Liming had been in Amylin R&D from 2008 to 2012. He was in charge of bioassay development, transfer and validation. He served as bioassay expert to support BLA and IND submissions. He also involved in immunogenicity evaluation and PK studies. Prior to joining Amylin, Liming served as technical scientist, project manager and non-conformance (NC) owner in clinical QC at Amgen for 5 years. He had supported clinical lot release testing and stability program. He also had managed numerous method transfer and validation projects for both late and early phase Amgen products. Prior to that, he had been in Genentech R&D from 1997 to 2002 and conducted virus removal and testing research. Based on his research, he developed and transferred quantitative PCR and quantitative RT-PCR analytical methods for virus removal testing first in biopharmaceutical industry in the world.

Liming holds one Master degree in Biophysics and a second Master degree in Biochemistry. Liming also holds an UCSD Certificate of ADMET Process (Absorption, Distribution, Metabolism, Excretion and Toxicology).