Exploratory biomarker insights to guide your decision-making from discovery to the clinic
Accelerate your progress with a translational biomarker strategy
Access collaborative support with fit-for-purpose assay development and validation
Identify and access cutting-edge technologies and expertise
Translational biomarkers can play a critical role in helping you quickly assess biomarker feasibility to better understand how it can be utilized in a clinical environment. When it comes to analytical characterization, one size doesn’t fit all. You need a flexible approach that considers your phase of development and desired outcomes to provide the best support for the intended use of your data.
Exploratory biomarkers, while not guided by specific regulations, still utilize robust quality principles, expertise and process to deliver high-quality and reliable data. A trusted partner who has familiarity with CAP/ CLIA and GxP environments can streamline your transition and retain critical insights about your assay and goals.
Since 2009, the Translational Biomarker Solutions (TBS) team has been supporting assay development and validation needs in an exploratory – but, principled – environment. Expertise in cellular analysis and immunoassays can help you develop your strategy from concept to implementation to meet your critical goals for exploratory biomarkers.
- Custom-immunogenicity assays
- Low-sample volume with improved detection
- Multiplexed and specialized platform assays
- Microfluidics-based ELISA
- Kit-based immune assays
- Immunoassay autoanalyzers
- High-parameter immunophenotyping of blood, PBMC and tissues
- In vitro Pharmacology
- Immunotoxicology for cytokine release
- Cellular Immunology
- Cell-Based Assays (including ADCCs, CDCs, Proliferation, Apoptosis and viability, etc.)
From initial feasibility and development to advanced validation, testing and production, we deliver insights to drive your decision making. Our team provides unique solutions for historic (banked) samples, difficult matrix types, or complex assay development in a flexible environment that provides robust exploration to guide new paths forward in biomarker discovery. As your clinical biomarker needs evolve, the TBS team can help you transition seamlessly into a CAP/CLIA or GxP environment for qualification, method validation and implementation.
Comprehensive knowledge of assays spanning ultrasensitive and multiplexed, kit-based and custom-built, low-sample volume and cell-based, gives you an experienced partner with access to a toolbox of diverse platforms. Together, we can support your biomarker analysis and advance your discovery through the use of precision technology, such as:
- Quanterix Simoa
- Meso Scale Discovery (MSD)
- Protein Simple ELLA
- ECLIA (Roche e601)
- Cytoflex (Beckman Coulter 6-color)
- Miltenyi Automacs Pro
- Miltenyi Octo Dissociator
- BD Fortessa X-20 (18-Color)
- CTL ImmunoSpot
In parallel with Covance’s regulated lab work, the TBS team works under a set of standardized quality principles to ensure accuracy and quality for your exploratory objectives of the studies. This system is further verified by both internal and external QA audits, as well as proficiency testing, giving you confidence that the data produced meets the highest standard of quality.
Working with TBS, you get a set of reliable and reconstructable results that enables informed development decisions and a structured transition to the regulatory environment required to progress to your next milestone.
Next, meet the team that will work with you to help solve your translational biomarker challenges.
Erica L. Troksa, PhD
Associate Director, Translational Biomarker Solutions
Dr. Erica L. Troksa drives overall scientific performance and quality delivery of on-time services for the Translational Biomarker Solutions team. She leverages her 16-plus years of experience in development, optimization and execution of bioanalytical immunoassays. Dr. Troksa has led development and validation of novel immunoassays for multiple platforms.
Before joining Covance in March of 2013, she served as Field Scientist for EMD Millipore, training research scientists on proper techniques in multiplexing immunoassays, flow cytometry, protein quantitation and other technical applications. Dr. Troksa won the Klaus R. Unna Award as Outstanding Graduate Student at the University of Illinois at Chicago. She is the author or co-author of several peer-reviewed journal articles on various topics.
Paul C. Trampont, PhD
Principal Scientist and Senior Lab Manager, Translational Biomarker Solutions, Covance
Dr. Paul C. Trampont leads a team of scientists and technical staff responsible for developing cell-based assays to support drug development. He joined Covance in December 2014, bringing with him more than 20 years of professional experience in human immunology and oncology research. Before joining Covance, he served as Assistant Professor in the Department of Medicine, Division of Hematology and Oncology at the University of Virginia.
Dr. Trampont was awarded a Covance Scientific Excellence grant in December 2018. He is the author and co-author of numerous peer-reviewed scientific journal articles and abstracts, and is frequently invited to speak at industry conferences on topics related to method validation.
Bhaskarjyoti Sarmah, PhD
Senior Scientist and Manager, Translational Biomarker Solutions
Dr. Bhaskarjyoti Sarmah leads our team of scientists responsible for developing, validating and implementing soluble biomarker immunoassays and bioassays. He draws on more than 10 years of experience working in biomarker and target discovery research across multiple therapeutic areas, including cardio-metabolic, renal, autoimmune/inflammatory diseases, and immuno-oncology.
Dr. Sarmah is the author or co-author of more than two dozen journal articles, posters and presentations. Before joining Covance in January 2017, he served as a Research Scientist in Biotechnology Discovery Research for Eli Lilly & Co.
Chris W. Stamatkin, PhD
Staff Scientist, Lead-Immunoassay and Special Chemistry, Translational Biomarker Solutions
Dr. Chris W. Stamatkin serves as staff scientist and lead for Immunoassay and Special Chemistry. He leads the team of scientists and technical staff responsible for developing cell-based assays to support drug development. He joined Covance in November 2017, with over 14 years of experience in laboratory research and drug development.
Dr. Stamatkin previously served as an Assistant Research Professor in the Division of Hematology/Oncology at Indiana University School of Medicine as well as Assistant Director, Therapeutic Validation Core and Angio BioCore at Indiana University Simon Cancer Center. Stamatkin shares his experience as author and co-author of numerous peer-reviewed scientific journal articles, abstracts and presentations, and is a frequent speaker at industry conferences.
Katherine (Katie) A. Masterson
Immunoassay Lead, Translational Biomarker Solutions
Ms. Masterson leads the team of scientists responsible for developing biomarker immunoassays and also consults clients on assay platforms and detection modalities. She joined Covance in January 2014, and brings over 15 years of experience in laboratory research and development to the table.
She is a member of the South Central Association of Clinical Microbiology and is co-author of several publications and poster presentations. Before joining Covance, she served for eight years as the Virology Supervisor for the Indiana State Department of Health Laboratories.