Biomarkers are commonly used in the pharmaceutical industry to evaluate the safety and/or effectiveness of drugs. Biomarkers can also lead to significant cost reductions during drug development by enabling early proof-of-concept studies for novel therapeutic targets, thus reducing costly drug attrition rates. The use of biomarker assays has increased and continues to increase year on year.
However, there are many challenges when analyzing biomarkers. Endogenous targets can be quite different from the recombinant calibrator material used in the biomarker assay to measure target, there is a lack of regulatory clarity with very little biomarker assay regulatory guidance in place at present, and there are many technologies to choose from to assay biomarkers. Due to the huge variability in the types and intended uses of biomarkers, deciding on the right technology and assay acceptance criteria can be extremely difficult.
During this panel discussion our experts will analyze key results from our survey. The panel will also discuss the current issues faced when performing biomarker assays. You will also have the opportunity to pose questions for them to address in the live Q&A session.
What will you learn?
- How to address some of the technical challenges faced when working with biomarkers
- How to deal with the lack of specific regulations for biomarkers
- Biomarker validation notably the tiered approach
Who may this interest?
- Biomarker scientists
- Large and small molecule bioanalytical scientists
- Regulatory scientists
- Method development specialists
Patrick has nearly 30 years of experience in pharmaceutical analysis. This includes Bristol-Myers Squibb Department of Metabolism and Pharmacokinetics, Advion Biosciences (now Quintiles) where he was the Laboratory Director and Tandem Labs where he was Vice President. In 2010, Patrick joined Thermo Fisher Scientific as Director of Global Strategic Marketing within the Chromatography and Mass Spectrometry Division. In 2014, Patrick joined PPD to create a new Biomarker Division, which has dedicated laboratory facilities providing Molecular Genomics, flow cytometry, ligand binding and LC-MS based biomarker services. Patrick earned a BS degree in Toxicology and a MS degree in Pharmacology St. John’s University and an MBA from Syracuse University.
Dr Kyra Cowan is a scientist in the BioAnalytical Sciences department at Genentech (CA, USA), focusing on clinical and nonclinical pharmacokinetic and anti-therapeutic antibody assay method development and validation, bioanalytical strategies, as well as biomarker assay and new technology development. She received her PhD in Chemistry from Carleton University (Canada) and completed two postdoctoral fellowships. The first, at COR Therapeutics (now Millennium) with Dr David Phillips, identifying signalling proteins critical to platelet aggregation, and her second at UCSF, with Dr William Welch, focusing on neurodegenerative disorders and the involvement of molecular chaperones in polyglutamine diseases. Dr Cowan joined Genentech in 2006 and has led and served on several bioanalytical and pharmacology subteams for molecules that target oncology, immunology, ophthalmology, and metabolic disease areas. She has published many first-author articles, reviews and book chapters, and has been an invited speaker at several conferences.
David Lanham, is Principal Scientific Director at Eurofins Pharma Bioanalysis group, Oxford, UK. He has worked in a wide range of areas within the pharmaceutical CRO industry in the UK for over 25 years, including roles in cell-based assay modelling, pre-clinical toxicology assessment and clinical trial bioanalysis. During this time he has developed an interest and expertise around immune function assessment and biomarker analysis. His current role in Oxford focuses on the application of flow cytometry and ligand binding techniques as investigative tools in bioanalysis during pharmaceutical drug development and is a member of the AAPS Flow Cytometry Action Program Committee.
Faye Vazvaei is Senior Principal Scientist, Bioanalytical R&D in the department of Pharmaceutical Sciences at Roche Innovation Center New York (NY, USA). Faye has 20 plus years of experience in the bioanalytical field spanning both pharma and CROs, and managing bioanalytical work globally. Faye is the current chair of the AAPS Bioanalytical Focus Group (BFG). Faye has organized and chaired the Mass Spectrometry Protein Bioanalysis Committee (MSPBC) since 2013. One of the key contributions of this committee has been an AAPSJ white paper entitled ‘Recommendations for Validation of LC-MS/MS Bioanalytical Methods for Protein Therapeutics’. Faye also served on two GBC teams (A3 and A7). She earned her Master’s degree in Biotechnology from Johns Hopkins University in Baltimore (MD, USA) and her Bachelor’s degree in Chemical Engineering from Sharif University of Technology in Tehran (Iran).