COVANCE - Key Persons

Job Titles:

• Scientist, Molecular Bioanalysis

Dr. Agnes Zybura has extensive knowledge in the fields of molecular neurobiology, pharmacology and biochemistry with expertise in signal transduction pathways, sodium channel biology, electrophysiology, fluorescent imaging techniques, cell culture and PCR-based assays. She serves as a QC scientist within the Molecular Bioanalysis group at Labcorp (Greenfield) where she is responsible for developing and validating qPCR-/dPCR-based assays in support of biodistribution and vector shedding studies in accordance with applicable regulatory guidelines (e.g., GLP, GCP/CLIA). Together with her team in Molecular Bioanalysis, Agnes supports a wide variety of projects in the cell and gene therapy space ranging from early development to regulated clinical trials. Prior to joining Labcorp Biopharmaceutical CMC Services, Agnes earned her PhD in medical neuroscience at the Indiana University School of Medicine where she discovered a novel mechanism involving kinase regulation of a voltage-gated sodium channel in modulating neuronal excitability. Her work continued as a postdoctoral researcher at Indiana University-Purdue University Indianapolis investigating neuronal effects and potential therapeutic treatments of epilepsy-associated genetic mutations. Agnes' work is published in several peer-reviewed publications and has been presented at international meetings.

Job Titles:

• Senior Manager, LC - MS Bioanalytical Services

Dr. Brendan Powers joined Labcorp Bioanalytical Services in 2018 and has more than 10 years in biological and analytical research. In his current role as senior manager, Brendan manages a team that undertakes original research that includes developing and confirming highly sensitive, reliable assay methodologies for fast and accurate analysis of pharmaceuticals and biopharmaceuticals in biological fluids and tissues. In addition, he is a subject matter expert and global innovation leader for LC-MS analysis of biopharmaceuticals (biologic therapeutics). His key areas of expertise include hybrid IA-LC-MS/MS, regulated LC-MS/MS, molecular biology and large molecule bioanalysis. Brendan is an author or co-author of more than a dozen peer-reviewed publications and industry presentations. His work can be seen in several leading publications, including the Journal of Cell Science and the Journals of Biochemistry and Molecular Cell, among others. He holds a BS in biochemistry from the University of Illinois and a PhD in biochemistry from Purdue University.

Job Titles:

• Executive Director, Global Immunochemistry Bioanalytical Services

Dr. Daniel Sikkema brings more than 25 years of experience in the biopharmaceutical, vaccine and cell/gene therapy fields supporting oncology, neurosciences, respiratory, immunology and infectious disease. He has held positions of increasing responsibility at leading pharmaceutical and diagnostic instrumentation companies. In his career, he has contributed to the licensure of numerous vaccines and biopharmaceuticals, as well as the world's first ex vivo cell/gene therapy product, leading to more than $150 billion in sales. He has also worked with the World Health Organization, National Institute for Biological Standards and Controls, U.S. Centers for Disease Control and Prevention, FDA and EMA in roles as an invited expert and as an advisor (specifically for gene therapy approaches for hemophilia for FDA). Daniel holds a BS in medical technology from Northern Michigan University and a PhD in microbiology and public health from Michigan State University, College of Medicine. He was a postdoctoral fellow in infectious disease at SUNY at Buffalo, School of Medicine, and a research assistant professor in infectious disease at SUNY in Buffalo. Additionally, Dan is a registered medical technologist with the American Society for Clinical Pathology. He has chaired Division V (Clinical and Diagnostic Immunology) for the American Society for Microbiology and was coordinator for an Innovative Medicine Initiative project ABIRISK, the largest funded project to study immunogenicity of biotherapeutics. He has authored 30 peer-reviewed publications and has delivered more than 80 public presentations globally at scientific symposiums.

Job Titles:

• Global Director of Method Development & Validation, LC - MS Bioanalytical Services
• Global Director of Method Development and Validation for LC

Dr. Eric Thomas is the global director of method development and validation for LC-MS-based bioanalysis for Labcorp Bioanalytical Services. He joined Labcorp more than 10 years ago and has served as the lead for bioanalysis in Indianapolis for the past 8 years. Eric is a graduate of Rose-Hulman Institute of Technology (BS in chemistry) and the University of Michigan (PhD in medicinal chemistry). He performed postdoctoral work with Neil Kelleher at the University of Illinois, focusing on proteomic analysis of histone modifications in cell culture and tissue samples. He then served as a staff scientist at the Moffitt Cancer Center, supporting protein biomarker analysis via mass spectrometry. Eric continues to have a strong interest in biomarkers-he was involved in the proposal that led to the creation of the Labcorp Biomarker Solution Center, and he is engaged in establishing the strategy for future biomarker support within bioanalysis. He is also focused on expanding capabilities for analysis of large molecules via LC-MS through evaluation of new platforms and workflows. He has delivered more than 20 publications and presentations and remains active in forums such as AAPS, WRIB, GCC and EBF.

Job Titles:

• Study Director & Scientist, Molecular Bioanalysis

Dr. James Tunaley has more than a decade of academic research and industrial lab experience in multiple fields, including genomics, genetic engineering, analytical chemistry, molecular biology, cell-based assays and protein expression and purification. He has expertise in supporting clients' cell and gene therapy molecules through the preclinical and clinical stages of development with projects spanning GLP, GCP and GMP regulations. At Labcorp Biopharmaceutical CMC Services, he is responsible for the scientific oversight of method development and validation using a variety of techniques across the field of molecular biology and beyond. He earned his PhD in structural biology and master's in chemistry from the University of York, U.K.

Job Titles:

• Consultant
• Principal Investigator for Biodistribution and Viral Shedding for GLP / GCP
• Scientist, Molecular Bioanalysis

Dr. Jennifer Courtney started her career as a consultant in Washington, D.C., performing analyses of chronic, subchronic, oncogenic and neurotoxic studies of several pesticides and toxic chemicals. She served as principal reviewer for 12 neurotoxic studies and contributed to the completion of approximately 30 Data Evaluation Reports for the EPA's Office of Pesticide Programs. In her current role at Labcorp Biopharmaceutical CMC Services, Jennifer serves as principal investigator for biodistribution and viral shedding for GLP/GCP cell and gene therapy studies. In this role, she designs QPCR and RT-QPCR development, method validation, and sample analysis assays for neurodegenerative diseases, rare pediatric genetic conditions and CAR T cancer therapies for a variety of sponsors. She excels in science communication as a liaison between Labcorp and sponsors. Jennifer earned her PhD in molecular and developmental biology from the University of Cincinnati and her BS in genetics and developmental biology from Pennsylvania State University.

Job Titles:

• Head of Research and Development, Scientific Affairs

Dr. Stephanie Cape heads the Research and Development team within Scientific Affairs at Labcorp Drug Development. The Scientific Affairs team is focused on ensuring that Labcorp Drug Development is positioned with the right technologies and expertise to effectively support the rapidly evolving needs of the pharmaceutical testing industry. In this role, Stephanie focuses on advancing laboratory technologies to enable new capabilities spanning characterization, clinical chemistry and bioanalysis. Over the past 10 years with Labcorp Drug Development, Stephanie has served in a variety of scientific leadership roles, been actively engaged in a number of industry groups and grown a particular interest in enabling new technologies. She is currently serving as the co-chair of the American Association of Pharmaceutical Scientists (AAPS) Bioanalytical Community, the chair for the Land O' Lakes Bioanalytical Conference, the chair for the AAPS Mass Spectrometry Focus Group, a subject matter expert for the Bioanalysis Zone and member of the Bioanalysis journal editorial board. Stephanie is also highly engaged in the global Patient Centric Sampling Interest Group and AAPS Microsampling and Patient Centric Sampling team. Stephanie has authored more than 30 peer-reviewed publications, including four book chapters, and has contributed to many posters and presentations. She received her BS in chemistry from the University of Illinois Urbana-Champaign in 2003 and her PhD in analytical chemistry from the University of Wisconsin-Madison in 2007.

Job Titles:

• Global Director, Method Development & Validation Immunochemistry

Graeme Evans joined Labcorp Bioanalytical Services in 1994 and has more than 25 years of experience in bioanalytical services and analytical research including bioanalytical chemistry, immunochemistry and ligand-binding assay platforms. Currently, Graeme leads Global Immunochemistry for Bioanalytical Services focusing on method development and validation. Graeme has published articles in Bioanalysis Journal as well as works on LC-MS/MS strategies for therapeutic antibodies. He graduated from Prince Henry's Grammar School in Otley, U.K.

Job Titles:

• Lead Scientist
• Lead Scientist, Molecular Bioanalysis

Hazel Staton has a BSc from The University of Sheffield in biochemistry and graduated in 2007. Upon graduation, Hazel joined Labcorp Biopharmaceutical CMC Services as a QC analyst in the molecular biology department and progressed to become a QC scientist. Hazel is currently a lead scientist and provides scientific and regulatory leadership on cell and gene therapy projects, focusing on the molecular biology support for molecules in the preclinical and clinical stages of development as well as wider CMC analytical strategies. Hazel liaises with both internal and external industry experts to maximize Labcorp's analytical capabilities and is part of an integrated team delivering innovative analytical solutions for clients' cell and gene therapy programs.

Job Titles:

• Senior Manager
• Senior Manager, Lead Scientist Team, Immunochemistry

Heather Watson has 22 years of experience in the pharmaceutical and biotech industry, 14 of those in the CRO environment. Her areas of expertise include method development, validation and sample analysis of PK, PD and ADA (inclusive of NAb) methods, supporting both preclinical and clinical programs. She has experience with a variety of drug molecules including but not limited to ADCs, bi- or tri-specific Abs, biosimilars and gene therapies. Heather currently serves as a senior manager of the lead scientist team within the immunochemistry department at Labcorp Bioanalytical Services. She received her BS from James Madison University and received her MS and MBA from Johns Hopkins University.

Job Titles:

• Associate Director of Global Operations, Immunochemistry

Mark O'Dell has more than 18 years of experience working at bioanalytical CROs in a scientific role. He has experience in immunoassays, development and validation, and regulatory and study support. At Labcorp Bioanalytical Services, Mark serves as the global lead for the iChem lead scientists. He is responsible for the harmonization of processes and best practices for the iChem lead scientists and global execution of initiatives and consults with our clients on scientific and regulatory questions related to ligand-binding assays. Additionally, Mark participates in AAPS, WRIB and GCC and establishes and maintains strategic client relationships. Mark received his MA in biology/biotechnology from Washington University and his BA in microbiology from South Illinois University. Mark has several publications in prominent journals, including the Journal of Neuroscience.

Job Titles:

• Scientist, Molecular Bioanalysis

Natalie Oldham joined Labcorp Biopharmaceutical CMC Services in 2012 and is presently a QC scientist focusing on cell and gene therapy testing, providing scientific and regulatory advice in support of molecules in the preclinical and clinical stages of development. Natalie studied human biology and infectious disease at the University of Salford and is a key subject matter expert in the development and validation of DNA- and RNA-targeting assays using various nucleotide extraction and qPCR‑based methods within GLP, GCP and GMP regulations.