- Metabolic Stability
- CYP Interaction
- Permeability & Transporters
- Physicochemical Properties
- Protein Binding
Discovery PK and Toxicology
The emergence of global pandemics has led to an expansion of studies focused on vaccine development for infectious agents. Moreover, breakthroughs in understanding the immune system in recent years have brought a new wave of treatments using immune system modulators and immunotherapies. The ELISpot assay is a powerful tool in addressing the bioanalytical needs of vaccine development, immunotherapies, and gene therapies. Tremendous global harmonization efforts have been carried out to create optimized protocols and guidelines for ELISpot assays. Successes in these efforts are now being transferred to other areas in which there is an urgent need for compliant, high-throughput image acquisition and analysis systems.
What will you learn?
* Applications and advantages of ELISpot assays
* ELISpot platforms currently available
* Benefits of readily-available characterized PBMC
* Introduction of CTL FluoroSpot Analyzers
* Compliance requirements for data acquisition and handling
* Viral / Bacterial Neutralization Applications
Speaker: Chenyi Pan, Associate Director of Biologics Services, Frontage Laboratories, Inc. (PA, USA)
Dr. Chenyi Pan is an Associate Director of Biologics Services at Frontage Laboratories, Inc (PA, USA). He received his BS from Zhejiang University, China, and his Ph.D. in Biology from Georgia Institute of Technology (GA, USA). His Ph.D. research was focused on the epigenetic regulation of stem cells and cancer. Before joining Frontage in 2017, Dr. Pan worked as an NSF EBICS postdoctoral fellow in biomedical engineering at Georgia Tech, where he developed novel biosensor systems to monitor intracellular redox status during stem cell differentiation. At Frontage, Dr. Pan is leading the efforts in developing and validating bioanalytical assays for biomarkers, oligonucleotides and gene and cell therapies. He has strong expertise in PK, immunogenicity, and biomarker assays based on various platforms, including ELISA, MSD electrochemiluminescence, Quanterix Simoa, Ella, flow cytometry, and qPCR. Being working in a GLP- and CLIA-regulated environment, he has been helping biopharmaceutical companies on preclinical and clinical drug development in various therapeutic areas.
Speaker: Tameem Ansari, Director of Global Sales, CTL (OH, USA)
Tameem Ansari has been the Director of Global Sales at CTL (OH, USA) for over 10 years where he has witnessed the growth of ELISpot in the fields of immuno-oncology, vaccine development, and immune monitoring. Tameem’s knowledge and technical experience in ELISpot are highly respected in the industry. In his role at CTL, Tameem is exposed to the latest advancements in ELISpot and FluoroSpot, giving him unique insights to help find the best solutions for prospective clients. Prior to his current position at CTL, Tameem held various critical positions within the CTL organization since its inception over 20 years ago.
As biotech and pharma companies have become more streamlined and “virtual”, the use of CROs to conduct and/or manage portions of, or all of, a complete IND-enabling program has become common practice. However, the complexity of such programs, involving expertise in drug synthesis, regulatory, CMC, bioanalysis, toxicology, chemistry, pathology, and related disciplines makes management of these many inputs very challenging and subject to risks of poor execution or delayed submissions. This webinar, presented by a CRO-industry veteran, will provide insights on best practices, highlight common pitfalls, and identify “trade secrets” that can benefit industry newcomers, as well as more seasoned professionals. Topics addressed in this webinar include CRO qualification/selection, contracts, scheduling, protocol/program design, study conduct and monitoring, data and report review, and more. The session is intended to help participants interact more effectively and constructively with their CRO partners and ultimately save time, money & headaches in their development programs.
Speaker: Glenn Washer, President, Frontage Laboratories North America and Executive Vice President for Global Safety and Toxicology, Frontage Laboratories, Inc.
Glenn is a board-certified toxicologist, with >35 years in the industry. Prior to Frontage, he headed Charles River’s North America preclinical businesses and earlier served in executive roles in international CROs & Biotechs. He served as Faculty for the Pharmaceutical Education & Research Institute, as an Editorial-board-member of the International Journal of Toxicology, and lecturer for the Society of Toxicology, Drug Information Association, Society of Quality Assurance, McGill University and Universite de Montreal. He has also served on multiple corporate and industry boards.