Analytical Pharmacology

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Abstract Shared Resource 02: Analytical Pharmacology (AP-SR) The Analytical Pharmacology Shared Resource (AP-SR) provides comprehensive analytical and consultative services to COHCCC Members in a GLP-compliant environment. The AP-SR assists with the design and implementation of pharmacokinetic, pharmacodynamic, and biomarker correlative studies for clinical and preclinical investigations of small molecules and biologic agents. The AP-SR also provides GLP-compliant quality control release testing of CC manufactured cell therapies. Specific Aims of AP-SR: Aim 1. Provide support for clinical investigators and trainees requiring expertise in pharmacokinetics, pharmacodynamics, and molecular correlative laboratory studies. Aim 2. Facilitate preclinical cancer-focused research to support basic, translational, and population scientists and trainees who require analytical services. Aim 3. Perform GLP-compliant quality control (QC) in-process and final product release testing and provide correlative analyses in support of the COHCCC Cellular Therapy Program. Services include: 1) initial consultation on research projects; 2) study design and protocol review, including collaboration with biostatisticians; 3) development, implementation, and validation of analytical methods; 4) sample acquisition, tracking, and storage; 5) sample analysis (e.g., LC-MS/MS, ICP-MS, HPLC, Luminex, ELISA, FACS, and qPCR); 6) QC final product release testing (e.g., mycoplasma, endotoxin, cell potency and identity, cell counting and viability, cell specific lysis); 7) pharmacokinetic programming and data analysis; and 8) participation in collaborative writing for manuscripts and grant proposals. The AP-SR is directed by Dr. Timothy Synold and is supported by 13 FTEs. Members Utilization by %Revenue 2017–21: 93.8 Total (4.3 MCBC, 25.3 DCT, 22.2 CI, 35.8 HM, 6.2 CCPS) Publications by Members: 44, 12 with Impact Factor >10 Grants Supported: 52 Total (9 CIRM, 1 DoD, 2 LLS, 20 NCI of 34 NIH ( 20R01, 4U01))