This book covers the unique application of flow cytometry in drug discovery and development. The first section includes two introductory chapters, one on flow cytometry and one on biomarkers, as well as a chapter on recent advances in flow cytometry. The second section focuses on the unique challenges and added benefits associated with the use of flow cytometry in the drug development process. The third section contains a single chapter presenting an in depth discussion of validation considerations and regulatory compliance issues associated with drug development.
Table of Contents
Dedication (Virginia Litwin).
Forward (J. Paul Robinson).
Acknowledgements (Virginia Litwin).
Section A: Introduction-Overview (Philip Marder and Virginia Litwin).
- 1 Introduction to Flow Cytometry (Elizabeth Raveche, Fatima Abbasi, Yao Yuan, Erica Salerno, Siddha Kasar and Gerald Marti).
- 2 Recent Advances in Flow Cytometry: Platforms, Tools and the Challenges for Data Analysis (Paul J Smith, Roy Edward, Rachel J Errington).
- 3 Introduction to Biomarkers (Ole Vesterqvist and Manjula Reddy).
Section B: Flow Cytometry in the Drug Development Process-Overview (Virginia Litwin and Philip Marder).
- 4 HTS Flow Cytometry, Small Molecule Discovery, and the NIH Molecular Libraries Initiative (Larry A. Sklar and Bruce S. Edwards).
- 5 A Multiparameter Approach to Cell Cycle Analysis as a Standard Tool in Oncology Drug Discovery (Carmen Raventos-Suarez and Byron H. Long)
- 6 Flow Cytometry in Pre-Clinical Toxicology/Safety Assessment Environment (David McFarland and Kristi Harkins)
- 7 Use of Flow Cytometry for Defining and Validating the Molecular Mechanism of Anti-cancer Drugs in Humans (David W Hedley).
- 8 CD4 T cell Assessments in Evaluation of HIV Therapeutics (Thomas N. Denny, Raul Louzao, John Wong and Brooke Walker).
- 9 A Translational Medicine Approach to Monitoring the Immune System during Clinical Trials (Virginia Litwin and James Andahazy).
- 10 Immunogenicity Testing Using Flow Cytometry (Denise M. O'Hara and Valerie Theobald).
- 11 Pharmacokinetics by Flow Cytometry: Recommendations for Development and Validation of Flow Cytometric Method for Pharmacokinetic Studies (Yuanxin Xu and Susan M Richards).
Section C: Validation and Regulatory Compliance: Overview (Virginia Litwin and Philip Marder).
- 12 Validation and Regulatory Compliance (Carla Hill, Dianna Wu, John Ferbas, Virginia Litwin, Manjula Reddy).
- 13 Instrument Validation for Regulated Studies (John Ferbas and Michelle Schroeder).
Section D: Future Directions-Overview (Virginia Litwin and Philip Marder).
- 14 Probability State Modeling: A New Paradigm for Cytometric Analysis (Bruce Bagwell).
- 15 Phospho Flow Cytometry: Single Cell Signaling Networks in Next Generation Drug Discovery and Patient Stratification (Peter O. Krutzik, Sean C. Bendall, Matthew B. Hale, Jonathan M. Irish, Garry P. Nolan).
Virginia Litwin is a Principal Scientist at Covance Central Laboratory Services. After numerous years in the pharmaceutical/biotechnology industry, she has become a leader in the application and validation of flow cytometric methods in drug discovery and development. She founded the Flow Cytometry Subcommittee of the Ligand Binding Assay Bioanalytical Focus Group within the American Association of Pharmaceutical Scientists (AAPS). She is an active contributor to the International Clinical Cytometry Society (ICCS) and the International Society for Analytical Cytology (ISAC). She received her bachelor's from the University of California and her doctorate from the University of Iowa.
Philip Marder was internationally distinguished for his leadership in the application of flow cytometry in early drug discovery and development. He was a key contributor to the scientific community as an active member of ISAC and AAPS. After receiving both his bachelor's and master's degrees from The Ohio State University, he had a distinguished thirty year career at Eli Lilly and Company.