Discover a groundbreaking webinar delving into developing and validating liquid chromatography-mass spectrometry (LC-MS) pharmacokinetics (PK) assays for antibody-drug conjugates (ADC). Antibody-drug conjugates are a new class of targeted drugs consisting of “antibodies, cytotoxic drugs and linkers”. The antibody-drug conjugates are designed to increase the specificity and reduce the toxicity of cytotoxic drugs by utilizing antibodies to deliver the drug specifically to target cells (e.g., tumor cells) while avoiding toxicity in healthy cells.
Understanding the PK of antibody-drug conjugates in pre-clinical and clinical studies is critical to inform dose selection and supporting their successful development. Due to the complexity of antibody-drug conjugates, there are several analytes that need to be measured to characterize ADC PK profiles, including free drugs (payloads), drug-conjugated antibodies (intact ADC) and total antibody. Amador Biosciences will share a case study demonstrating the successful development and validation of LC-MS methods for all three assays.
Join this webinar to gain insights into developing and validating LC-MS PK assays for antibody-drug conjugates and their role in advising on antibody-drug conjugates’ stability and dose selection.
Meina Liang, Chief Technology Officer (CTO), President of Bioanalysis & Biomarkers, Amador Bioscience
Dr. Liang is currently the Chief Technology Officer (CTO) and President of Bioanalysis & Biomarkers at Amador Bioscience, leading global strategy to establish cutting-edge bioanalysis capabilities and enhancing Amador’s global-standard services to pharmaceutical companies. She joined Amador with broad experiences in drug development and in global regulatory submissions.
Prior to Amador, Dr. Liang was the Executive Director and global head of Integrated Bioanalysis at AstraZeneca. She led a centralized GxP group with 100+ Scientists across five global sites to support AstraZeneca’s portfolio from discovery to post-marketing across therapeutic areas and drug modalities. Her team is responsible for the assessment of pharmacokinetics, immunogenicity and biomarkers and contributed to MOA investigation, candidate drug selection and companion diagnostics development. She played a key role in a number of successful BLA submissions and market approvals, e.g., IMFINZI and LUMOXITI.
Andrea Ngai, Associate Director, Bioanalysis & Biomarkers, Amador Bioscience
Andrea Ngai is currently an Associate Director in the Bioanalysis and Biomarkers department at Amador Bioscience. She joined Amador as an LC-MS subject matter expert, with an extensive background in large molecule qualitative and quantitative bio-analysis. Andrea is leading a team of PhD and non-PhD Scientists to develop and validate bioanalytical assays for quantitation of large and small molecules.
Prior to Amador, Andrea was an Associate Principal Scientist in the ADME group at Merck, developing LC-MS bioanalysis methods for a range of modalities, including ADCs, mAbs and bispecifics, with a focus on supporting the ADC pipeline. She also led the LC-MS group at DuPont, supporting the development of several products in the global industrial enzymes market. Andrea has a BS and MS in Biology from San Francisco State University.
Who Should Attend?
This webinar will appeal to:
- R&D Scientists
- Biotechnology and pharmaceutical industry professionals
- Academic Scientists and Researchers
- Gene editing and cell and gene therapy professionals
- Biomedical Engineers and Biochemists
- Regulatory affairs personnel
What You Will Learn
Attendees will gain insights into:
- Strategy and considerations when developing and validating liquid chromatography-mass spectrometry (LC-MS) pharmacokinetics (PK) assays for antibody-drug conjugates (ADC): free drugs (payloads), drug-conjugated antibody (intact ADC) and total antibody
- How to apply the PK assay results to inform on ADC stability and dose selection
Amador Bioscience’s Bioanalysis and Biometrics team ensures compliance with international clinical trial standards. We focus on enhancing the success rate of new drugs by scientifically determining the optimal dose, target, and patient population. Our multidisciplinary experts provide comprehensive bioanalytical services, including method development, sample analysis, and result interpretation. Equipped with state-of-the-art facilities in our GLP compliant labs in the United States and China, we deliver accurate data for evaluating drug efficacy, safety, and pharmacokinetics. Our experienced biostatisticians employ innovative methodologies and trial designs to analyze data and generate meaningful insights. By partnering with us, you gain access to a dedicated team committed to supporting your innovative drug discovery projects from pre-clinical research to market approval. We combine scientific excellence, regulatory expertise, and advanced analytics to accelerate your journey toward successful clinical development and commercialization of novel therapies.