DINNER SHORT COURSE: THURSDAY, APRIL 28 (5:45pm-7:45pm)
Instructor:
Liming Shi, MS, MA, Senior Group Leader, Bioassay Development, Hospira, a Pfizer Company
This course will focus on the fundamentals of statistics and simple methodology that are routinely applied in bioassay laboratories. Covered topics will include review of statistical concepts and calculations, study design, assessing bioassay measurement
quality and comparative studies.
The following topics will be covered:
- Uniqueness of bioassay, especially cell-based potency assay
- Considerations in bioassay development and validation
- Bioassay measurements and calculations
- Quality control of bioassay performance
- Comparative studies for bioassay development and transfer
Instructors Biographies:
Liming Shi, MS, MA, Senior Group Leader, Bioassay Development, Hospira, a Pfizer Company
Liming has
more than 18 years’ experience in biopharmaceutical industry. He specializes in bioanalytical method development, qualification, transfer, and validation. He has lots of GMP and compliance experience and he has been deeply involved in IND and
BLA activities. With thorough statistical knowledge, GMP experience and bioanalytical expertise, he has successfully developed many bioassays, addressed numerous GMP/regulatory issues, managed many transfers and validations and performed a lot of
trouble shootings. He also has experience in immunogenicity evaluation and PK studies. Liming holds a 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).