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Project Overview: Leveraging Biomarker & Translational Research in China
Cambridge Healthtech Associates (CHA) is launching a multi-client, collaborative project to assess the feasibility of leveraging the biological research capabilities of China to conduct clinically-relevant biomarker and translational research in drug safety and efficacy.

The overall objective of this project is to provide a thorough and insightful understanding of the increasingly sophisticated biomarker and translational research capabilities in China, as well as the evolving regulatory environment governing biomarker efforts generally and the import and export of biological samples specifically.

This project will address numerous strategic questions essential to understanding the biomarker and translational research capabilities within China, from a Technology Platform, Clinical Center, and Regulatory perspective:

Technology Platform Issues

  • To what extent are China-based service providers equipped with necessary modern equipment (microarrays, mass spec, NMR, MRI, PET, and even next-generation tools)?
  • What is their demonstrated capacity for generating high-quality output using such equipment?
  • Are they currently—or at least approaching—GLP-like standards in their use of this equipment?
  • Does their management & scientists possess experience working in Western institutions?

Clinical Center Issues

  • What is the specific therapeutic area expertise of specific clinical centers—oncology, cardiovascular disease, immune disorders?
  • Is there expertise in the collection of human tissues, peripheral fluids?
  • Is tissue collection efficient and effective for research purposes?
  • Does the center have experience in exporting collected tissues?

Regulatory Issues

  • What are the requirements and limitations for the export—or import—of human tissues and samples?
  • Is the regulatory framework for tissue collection and export evolving, and how?
  • How are standards for informed consent changing?

This project is designed to be collaborative and thus facilitated peer-to-peer discussion and learning will be at the foundation of the entire process.

CHA is proud to have engaged the cooperation of Applied Biosystems, a driving force in the changing dynamics of the true life science technologies, in accessing and assessing leading biomarker and translational medicine service providers in China, through Applied Biosystems’ China-based division.

Client participation in this project is limited large, fully-integrated biopharmaceutical companies.

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