Pharmacokinetic (PK) studies are a key step in the drug development process designed to understand the bioavailability, absorption, and elimination of the compound. PK studies provide data to understand dose exposure, dose response and efficacy across a vast population in late phase clinical trials.
The simplicity of this definition fails to account for the complexity of the drug compound — for example, what impact would a pre-existing immune response to a compound moiety, such as PEG functionality, have on the method and results? In this webinar, the speakers will walk through the progression from PK study to assessing the impact PEG molecules have on immunogenicity with an anti-drug antibody (ADA) assay.
However, the question remains: is looking at the molecule through PK and ADA studies enough? Although it gives a strong foundation for the bioanalytical profile, it lacks any measurement of the clinical response to the treatment. In the third segment of the webinar, we address how biomarkers are an essential complement to PK and ADA assays to understand the therapeutic potential of a compound.
Register for this webinar to hear an explanation of inflammatory biomarkers, validation and results, as well as a discussion of program success through CRO and sponsor collaboration.
Daniel Boster, Principal Scientist, Bioanalytical and Biomarker Sciences, Nexelis
Daniel Boster, Principal Scientist, brings more than 20+ years’ experience of early and late-stage large molecule bioanalytical science to Nexelis. Dan brings novel pharmacokinetic and immunogenicity assay development capability, with experienced troubleshooting techniques, to the regulated GXP environment. Dan’s work in the industry enabled him to gain firsthand experience with CROs: work collaboratively on assay development or validations, review regulated documents, and interpret sample analysis results.Message Presenter
Jennifer Vance, Ph.D., Director, Method Development and Validation, AIT Bioscience, a Nexelis company
Jennifer is the Director of Scientific Services at AIT Bioscience, a Nexelis company. In this role, she leads the LC/MS method development and validation team. She brings strengths in both organic chemistry and analytical method development to her position. At Stanford University, she received a Ph.D. in synthetic organic chemistry with Barry M. Trost. Positions in medicinal and process development chemistry at Eli Lilly and Company, Schering-Plough and ZDye, LLC utilized this skill set while also putting her at an interface with analytical teams and analytical method development.
Her position at Phenomenex chromatography further honed her approaches to LC/MS method development while exposing her to a great range of methods across regulated and non-regulated pharmaceutical, food, environmental, cosmetic and petroleum industries. At AIT Bioscience, Jennifer continues to contribute to the scientific discussion through peer-reviewed journal contributions as well as presenting and volunteering for organizations such as AAPS.Message Presenter
Jordan Jensen, Ph.D., Principal Scientist, Ligand Binding Assays, Nexelis
Jordan Jensen, Principal Scientist for Nexelis, focuses on ligand binding assays carried out at our Indianapolis, IN location. Jordan has had nearly 10 years’ experience within the CRO industry. His scientific roles specialized in monoclonal antibody development, pharmacokinetic and immunogenic preclinical and clinical bioanalytical studies, and studies within the chemistry, manufacture and control phase of development to commercialization.Message Presenter
Who Should Attend?
In the biopharmaceutical industry, this is best suited for:
- Members of the translational science, bioanalytical, biomarker, clinical and preclinical teams
- People whose job function involves research science within the biopharmaceutical industry
- Members of the research and development teams
What You Will Learn
In this webinar, participants will be presented with:
- A comprehensive view of the bioanalytical, immunogenicity and biomarker capabilities at Nexelis, as illustrated through results and applications
- Examples highlighting the nuances of an assay in response to a therapeutic and its molecular complexity
- The synergy of PK, ADA and biomarkers to produce a complete bioanalytical profile
- Strategies for how a CRO can be a key collaborator when constructing a bioanalytical strategy and clinical evaluation plan
- Assay expertise to plan and execute the methods and validations that most effectively support all drug development phases across all modalities
With unrivaled expertise in immunology, five operating sites in North America and Europe, and a translational offer of services covering the needs of the pharmaceutical industry from the lead selection to the late clinical stage, Nexelis is a leading provider of assay development and advanced laboratory testing services in the infectious, metabolic, and oncologic fields. Our versatile team of scientists, working with state-of-the-art technology platforms, were instrumental in the development, qualification, validation, and large-scale sample testing of assays that supported the FDA filing of almost 100 new molecular entities, including blockbuster vaccines and biologics, anti-viral drugs, immunotherapy, and gene and cell therapy products.