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翻译生物标志物解决方案
Exploratory biomarker insights to guide your decision-making from discovery to the clinic
Flexible, fit-for-purpose biomarker support to propel your drug development.
Accelerate your progress with a translational biomarker strategy
Access collaborative support with fit-for-purpose assay development and validation
识别和访问尖端技术和专业知识
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.
Specialized Support
Immunoassays/LBA
- 超声敏感
- Custom-immunogenicity assays
- Low-sample volume with improved detection
- 多路复用和专业平台测定
- Electrochemiluminescence
- Microfluidics-based ELISA
- Kit-based immune assays
- Immunoassay autoanalyzers
Cellular-based Analysis
- High-parameter immunophenotyping of blood, PBMC and tissues
- 体外药理学
- Immunotoxicology for cytokine release
- Cellular Immunology
- Cell-Based Assays (including ADCCs, CDCs, Proliferation, Apoptosis and viability, etc.)
Flexible and fit-for-purpose biomarker testing solutions
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.
扩展到可访问最佳技术
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.
- 内消旋规模发现(MSD)
- Luminex
- 蛋白质简单的ella.
- 陀螺仪
- ECLIA (Roche e601)
- Octet
- Cytoflex（Beckman Coulter 6色）
- Miltenyi Automacs Pro
- Miltenyi Octo Dissociator
- BD Fortessa X-20 (18-Color)
- CTL ImmunoSpot
非监管环境中生物标志物的质量方法
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.
使用TBS，您可以获得一套可靠和可重建的结果，使得能够向您的下一个里程碑进入所需的监管环境和结构化转型。
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 her16-plus years of experience in生物分析免疫测定的发展，优化和执行。Troksa博士已领导多种平台新型免疫测定的开发与验证。
在2013年3月加入Covance之前，她曾担任EMD Millipore的野外科学家，培训研究科学家在多路复用免疫测定中的适当技术，flow cytometry, protein quantitation and other technical applications.Troksa博士赢得了伊利诺伊大学芝加哥伊利诺伊大学的埃克斯·勒纳奖。她是关于各种议题的几个同行评审日刊文章的作者或共同作者。
保罗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.
Trampont博士于2018年12月获得了董事会卓越奖。他是众多同行评审科学文章和摘要的作者和共同作者，经常邀请在与方法验证有关的主题上发言。
Bhaskarjyoti Sarmah, PhD
Senior Scientist and Manager, Translational Biomarker Solutions
Bhaskarjyoti Sarmah博士带领我们的科学家团队负责开发，验证和实施可溶性生物标志物免疫测定和生物测定。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
员工科学家，铅免疫测定和特种化学，翻译生物标志物解决方案
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.
Stamatkin博士以前曾担任印第安纳大学医学院血液学/肿瘤学院的助理研究教授，以及印第安纳大学西蒙癌症中心的助理验证核心和血管生物古代。Stamatkin将他作为众多同行评审科学期刊文章，摘要和演示的作者和共同作者的经验，并且是行业会议的常见演讲者。
凯瑟琳（凯蒂）A.硕士
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.
她是南部中央临床微生物学联系的成员，是几个出版物和海报演示的共同作者。在加入Covance之前，她为印第安纳州卫生实验室的病毒学主管服务了八年。