December 6-7, 2007
The National Transportation Safety Board Conference Center (Washington, DC.)
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. The Food and Drug Administration (FDA) and the National Institute of Standards and Technology (NIST) share an interest in facilitating this critical step in the development of bioengineered medical products. With this interest in mind, FDA and NIST are co-sponsoring this Workshop on "In Vitro Analyses of Cell/Scaffold Products."
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 will explore recent scientific advances that may improve our understanding of cells/scaffold constructs within the framework of a product under consideration for clinical evaluation.
The two main objectives of this Workshop are to investigate:
- What questions should be asked (and addressed when evaluating cell/scaffold products in preparation for the first human studies; and
- 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.
How to Quantify Engineered Tissue Structure and Mechanical Behavior(PDF - 6.3MB) [ARCHIVED] Michael Sacks, PhD FDA Perspective/Review of Cell Scaffold Products(PDF - 271KB) [ARCHIVED] Celia M. Witten, PhD, MD Introduction(PDF - 210KB) [ARCHIVED] Charles Durfor, PhD In vitro Characterization of Hard Tissue Constructs with Structural Role(PDF - 1.9MB) [ARCHIVED] David Kaplan, PhD Overview of Biomaterials Characterization(PDF - 5.4MB) [ARCHIVED] Buddy D. Ratner, PhD In Vitro Characterization of Skin Constructs with a Structural Role(PDF - 277KB) [ARCHIVED] Nancy L. Parenteau, PhD In Vitro Characterization of Cardiovascular Constructs: Vascular Grafts as a Model System(PDF - 2.3MB) [ARCHIVED] Keith Gooch, PhD In Vitro Analysis of Scaffold/Cell Products - Tengion Autologous Neo-bladder Construct(PDF - 276KB) [ARCHIVED] Tim Bertram, DVM, PhD In Vitro Characterization of an Ex Vivo Liver Construct(PDF - 1.8MB) [ARCHIVED] Scott L. Nyberg, MD, PhD Characterization of Cell/Scaffold Products(PDF - 68KB) [ARCHIVED] Kimberly Benton, PhD Advancing Tissue Science and Engineering: A Foundation for the Future(PDF - 137KB) [ARCHIVED] Fred Heineken, PhD Trends in Tools and Strategies for Quantifying Biological Response(PDF - 1.2MB) [ARCHIVED] Anne Plant, PhD Cellular Systems Biology Profiling in Drug Discovery and Development(PDF - 965KB) [ARCHIVED] Kenneth A. Giuliano, PhD Mass Spectrometry Based Proteomic Applications in Cell/Scaffold Products(PDF - 901KB) [ARCHIVED] Daniel Martin, PhD Analysis & Manipulation of Adhesion Receptors & ECM Ligands(PDF - 1.2MB) [ARCHIVED] Andres Garcia, PhD Considerations for Quality Control of In Vitro Cell Cultures(PDF - 1MB) [ARCHIVED] John Elliott, PhD