FEB 22, 2017 12:00 PM PST

Measurement Assurance for Tissue Engineering & Regenerative Medicine

Speaker
  • Biologist, Biosystems & Biomaterials Division
    Biography
      Dr. Simon is a biologist in the Biomaterials Group at the National Institute of Standards and Technology. We aim to develop reliable tools and standards for measuring the properties of cells, biomaterials, scaffolds and tissue-engineered constructs. As regenerative medicine moves from a research endeavor to a viable industry that benefits patients and U.S. commerce, reliable methods for assessing product consistency and quality are required. In one of our projects, we are working with Kapil Bharti (NIH) to establish simple, robust methods for characterizing tissue-engineered retinal pigment epithelium for use in a clinical trial to treat age-related macular degeneration. In another project, we are working with Pamela Robey (NIH) to improve sampling in measurements of osteogenesis induced by stem cell/scaffold formulations in an ectopic bone mouse model. We also work with computer scientists to develop image analysis and bioinformatics methods for assessing the physical properties of 3D tissue scaffolds and how they influence cell function. Dr. Simon is Chair of ASTM Committee F04.43 "Cells and Tissue-Engineered Constructs" where documentary standards are being developed to support the development of tissue-engineered medical products. He earned a B.S. in Biology from Bucknell University and a Ph.D. in Biochemistry from University of Virginia where his thesis focused on signal transduction during human platelet aggregation. He trained as a post-doctoral fellow in NIST Polymers Division and became a staff scientist at NIST in 2003. Dr. Simon is active in the Society for Biomaterials, ISO, TERMIS and Phacilitate, and is on the editorial board for "Biomaterials" and "Journal of Biomedical Materials Research Part B - Applied Biomaterials".

    Abstract

    Challenges in achieving comparability, reproducibility and accuracy in biological assays has driven a demand for improved confidence in measurements that support development of regenerative medicine therapies.  There have been extensive discussions about the inability to reproduce biological research findings and two surveys of industry stakeholders have found that product consistency and lack of standards may be the single greatest challenge facing the field of regenerative medicine [1,2].  There are many strategies for achieving measurement assurance, such as reference materials, inter-laboratory testing and standard test methods.  However, there are challenges in applying these strategies to complex biological measurements which will require critical thinking to unravel.  

     

    Learning Objective 1: Understand the concept of measurement assurance.

    Learning Objective 2: Learn key measurement definitions: measurand, uncertainty, reference material, inter-laboratory comparability study.

    Learning Objective 3: Learn strategies to achieve measurement assurance.


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