Biomarker Solution Center
Scientific thought leadership and guidance across our extensive global laboratory testing capabilities. Delivering customized, end-to-end biomarker solutions throughout the drug development life cycle.
PhD-level leaders that can extend your team and / or help you develop a comprehensive biomarker strategy
Industry-relevant insights and specialized therapeutic area biomarker expertise
Customized consultation for biomarker strategy solutions
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.
- Which is the most appropriate biomarker for my intended target?
- What is the best biomarker to interrogate the mechanism of action?
- Where should the biomarker be measured?
- Which regulatory environment and technology best support my intended use?
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 Covance/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 Covance and LabCorp makes it easy to find the right support for your program.
Suso J. Platero, PhD
Head, Biomarker Solution Center
Global Leader, Precision Medicine, Covance
Dr. Suso Platero leads the Biomarker Solution Center, providing clients with biomarker consultation and strategy that leverages both Covance and LabCorp laboratories resources to aid in the development of biomarker delivery. He draws on 20+ years of experience with contract research organizations, diagnostic and pharmaceutical industries and academia, as well as with federal agencies and key opinion leaders in oncology and immuno-oncology.
Dr. Platero has contributed to the discovery of biomarkers and their application in clinical trials as well as the development of biomarkers to support companion diagnostics (CDx) and recently helped develop a companion diagnostic for a drug that was approved by the FDA in 2019. He served as the editor of the book, Molecular Pathology in Drug Discovery and Development, has authored numerous articles and holds four U.S. patents.
Akanksha Gupta, PhD
Head of Immunology, Biomarker Solution Center
Dr. Akanksha Gupta leads the immunology therapeutic team for the Biomarker Solution Center, a team that delivers biomarker solutions and strategy to clients, leveraging the laboratory resources of both Covance and LabCorp. Her strategic leadership provides scientific direction on biomarker strategies integrating innovative technologies, emerging scientific knowledge, clinical feasibility and regulatory requirements for a precision medicine approach across multiple therapy areas including immuno-inflammation, immuno-oncology, respiratory, dermatology and other auto-immune disorders.
Dr. Gupta draws more than 15 years of pharmaceutical industry experience in drug development, translational research and supporting development strategies for early to late stage assets. She shared her experience as author or co-author of multiple research publications, abstracts and patent submissions.
Katherine T. Landschulz, PhD
Head of Cardiovascular / Metabolic Disease, Biomarker Solution Center
Dr. Katherine Landschulz joined Covance in 2010 after 13 years of experience with three major pharmaceutical companies where she supported programs spanning discovery through Phase III. At Covance, 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 15 years of experience in drug development where she directed research for the identification of new clinical biomarkers in oncology as well as designed, developed and characterized antibodies against specific biomarker targets to be used as therapeutic agents and for development of CDx assays. She is the holder of multiple U.S. patents and has authored and co-authored numerous journal articles.