Immunology and Immunotoxicology supports large molecule, small molecule, and advanced therapy safety assessment
An integrated program with deep scientific and technical expertise at 7 global sites
High quality studies delivered on time at an affordable price
To leverage the benefits of a biomarker strategy – including 3x greater probability of successful transition from Phase I to regulatory approval1 – early insights and thoughtful strategy design are critical. Continuity with a single partner, who understands and connects the science, can also enable more insightful clinical trial design and better clinical outcomes.
1BIO, Biomedtracker, Amplion 2016.pdf. www.bio.org
Whether you need support in building your biomarker program strategy or seek to extend your team with industry expertise, we can enable bringing your treatment to market more rapidly.
Our Biomarker Solution Center (BSC) experts work with you to develop biomarker strategies and solutions - from discovery through commercialization - to support your drug development needs. We can identify gaps and provide mitigation strategies to build a customized strategy that integrates therapeutic-area biomarkers and best practices across your development plan.
The BSC has specialized expertise for the following areas:
Designed to engage clients early in the drug development process, providing advice from need identification through project completion, the BSC team can help you address all of your biomarker questions to develop a customized approach for your biomarker program.
Should further consultation be needed at any stage of drug development, the BSC team can also be engaged on a fee-for-service or value-in-kind basis.
The Biomarker Solution Center can help guide your program into one of the LabCorp extensive network of laboratories and regulatory environments. We can also work with you to transfer proprietary assays dependent on your needs – all while maintaining the scientific partnership of the BSC.
Leverage our extensive, multidisciplinary knowledge in biomarkers and therapeutic area expertise to help define and design a comprehensive biomarker strategy tailored specifically to your development needs. Whether you are searching for a specific biomarker or would like to explore available options, our database of 4,500 available assays and markers across LabCorp makes it easy to find the right support for your program.
Katherine T. Landschulz, PhD
Sr. Director, Therapeutic Area Lead
Cardiovascular and Metabolic Disease, Neurodegeneration
Dr. Katherine Landschulz joined Labcorp in 2010 after 13 years of experience with three major pharmaceutical companies where she supported programs spanning discovery through Phase III. At Labcorp, she supports both biotech and large pharmaceutical companies with biomarker selection and strategy development, laboratory placement for method development and qualification/validation, feasibility study design and advises on the use of translational and exploratory biomarker data in drug development.
Dr. Landschulz has a wide range of experience in drug discovery and development, genomic and proteomic biomarker assay development, translational biomarkers, clinical pharmacogenomics and biomarker strategies for Diabetes/CV. She is the holder of two U.S. patents and has co-authored dozens of publications on across a wide range of therapeutic areas.
Maria J. Prendes, PhD, MS
Head of Oncology, Biomarker Solution Center
Dr. Maria Prendes leads the Biomarker Solution Center oncology therapeutic team and works with clients to guide the selection, characterization and development of biomarkers for their clinical trials. Her responsibilities also include supporting companion diagnostics (CDx) development efforts.
Specializing in the fields of immuno-oncology, cancer genetics, cancer biology and molecular oncology, Dr. Prendes has more than 25 years of experience in drug development where she directed industry-based research for the identification of new clinical biomarkers in oncology. She has 48 patents addressing mechanisms to identify and characterize biomarkers. Since 2018, the Biomarker Solution Center has participated in more than 1,200 clinical programs in oncology providing scientific biomarker support. Dr. Prendes received extensive training at Memorial Sloan Kettering, Columbia University and Mount Sinai Cancer Center. Dr. Prendes provides Executive oversight on Biomarkers, working closely with the Labcorp Bioanalytical and Clinical Lab groups to further define the biomarker strategy in clinical programs.
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Robert Martone
Associate Director, Neurology Biomarkers
Robert Martone is a research scientist with deep expertise in neurodegeneration, neuro-oncology, biomarkers and drug discovery. He investigated hereditary neuropathies and the molecular biology of the blood brain barrier at Columbia University, and subsequently managed a portfolio of drug discovery programs at Wyeth Neuroscience targeting Alzheimer's and Parkinson's disease. He was the Neuroscience Therapeutic Area Lead for the Covance Biomarker Center of Excellence, and later established a protein biomarker laboratory at St. Jude Children's Research Hospital. More recently, he was Director of Pre-Clinical Research at Cognition Therapeutics, later supported late stage biomarker and diagnostics efforts at Biogen. He is currently Associate Director supporting Neurology Biomarkers at the Labcorp Biomarker Solutions Center.
