McGowan Institute faculty member Michael Sacks, PhD, the William Kepler Whiteford Professor, Department of Bioengineering, University of Pittsburgh, was an invited participant in a recent federal workshop, “In Vitro Analyses of Cell/Scaffold Products.” The workshop was co-sponsored by The Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST), two partner agencies affiliated with the Multi-Agency Tissue Engineering Science Interagency Working Group of the National Science and Technology Council. Dr. Sacks was invited to the 2-day Washington, DC, event because of his tissue engineering research efforts. His presentation, “Novel Methods to Quantify Tissue Structure and Multi-Axial Mechanical Testing,” added to the discussion on the current development of mechanical characterization and analyses of cell/scaffold constructs with a focus on structure-function relationships.
The FDA and NIST share an interest in facilitating the critical step in the development of bioengineered medical products. Both of these agencies are aware as scientific theories and research initiatives leave the bench, assembling the data necessary to characterize a medical product in support of a first clinical study can be one of the most scientifically challenging efforts a sponsor faces during product development.
FDA is a science-based, regulatory agency that is committed to staying abreast of the latest scientific innovation at crossroads with our regulatory role in the biomedical device industry. The Agency is continually improving its understanding of new or alternative approaches for the treatment of disease and improvement of human health as well as associated novel approaches to product characterization. Furthermore, as the Agency acquires new understanding of the biomedical sciences, every effort is made to share our perspective of the key scientific and medical issues under consideration during review of pre-market applications (e.g. INDs and IDEs).
NIST is a science-based, non-regulatory agency, with a mission to promote U.S. innovation and industrial competitiveness by advancing measurement science, standards, and technology in ways that enhance economic security and improve our quality of life. NIST is committed to facilitating the incorporation of advances in measurement science into tissue engineering research, development, and manufacturing. This commitment extends to the provision of forums in which investigators of metrology and tissue engineering can identify areas of common interest and work to generate consensus standards for the quantitative analysis of engineered tissue products.
To further these goals of FDA and NIST, this workshop explored recent scientific advances to improve their understanding of cells/scaffold constructs within the framework of a product under consideration for clinical evaluation. The main objectives of this workshop were to investigate:
1. What questions should be asked (and addressed when evaluating cell/scaffold products in preparation for the first human studies);
2. What test methods are available and what analytical procedures should be further researched, developed, and/or standardized to determine the safety, purity, potency, and consistency of cell/scaffold products; and
3. What emerging measurement and analysis technologies are on the horizon that may be important in the future to improve understanding of mechanism and to predict the response of cell/scaffold products in clinical applications.
Illustration: McGowan Institute for Regenerative Medicine.
Advancing Tissue Science and Engineering, A Multi-Agency Strategic Plan, June 2007