The MATES Working Group, established in January 2000, is under the broad umbrella of the Office of Science and Technology Policy (OSTP) of the U.S. Federal Government's Executive Branch. Its goals are to: 1) facilitate communication across departments/agencies by information exchanges and a common web site; 2) enhance cooperation through cosponsorship of scientific conferences and facilitation of standards development; and 3) monitor technology by undertaking cooperative assessments of tissue engineering science. MATES members include the Departments of Commerce, Defense, Energy, and Health and Human Services, National Aeronautics and Space Administration, and National Science Foundation, all having divergent missions but frequently overlapping interests in tissue engineering. While much of the experimental work in the field is applied, significant basic science issues are being investigated across applications. Since the Federal investment in tissue engineering is increasing and to assure that agencies' portfolios do not overlap significantly, efficient communication and cooperation regarding overall federal efforts in the field are essential. MATES is targeted towards that end and to maintaining U.S. preeminence in the field. To more effectively meet its goals and to acquaint members with the overall federal effort, MATES meetings are being convened at different member agencies during the course of the year. Program overviews at NIST and NASA were presented in January and March and FDA is hosting the June meeting. Since the medical products developed through tissue engineering are currently under the regulatory purview of the FDA's Center for Biologics Evaluation and Research and Center for Devices and Radiological Health, research and review staff from these centers will provide updates of their activities at the June 15 meeting. The agenda reflects the multi-faceted approach taken by FDA, its centers and cross-cutting working groups, in developing the appropriate regulatory oversight for tissue engineered medical products. Starting with a discussion of the FDA research-review partnership and a survey of initiatives in tissue engineering, the staff will discuss: 1) education and standards efforts; 2) bioeffects studies and test method development in analysis of tissue engineering applications; 3) FDA's regulatory approaches and studies of approved products; and 4) evolving technologies and their impact on tissue engineering.

Table of Contents

• Welcome and Introductory Remarks
  David W. Feigal, Jr., M.D.
  Director, Center for Devices and Radiological Health (CDRH), FDA
• "Tissue Engineering: Introduction to MATES and Survey of FDA Tissue Engineering Initiatives"
  Kiki B. Hellman, Ph.D.
  Office of Science and Technology, CDRH, FDA
• "Role of Education/Training and Standards for Tissue Engineering Applications"
  Grace Lee Picciolo, Ph.D.
  and
  David Kaplan, Ph.D.
  Office of Science and Technology, CDRH, FDA

Tissue Engineering Applications: Bioeffects Studies and Test Methods Development

• "Inappropriate Complement Activation by Medical Device Materials"
  Daniel B. Lyle, Ph.D.
  Office of Science and Technology, CDRH, FDA
• "The Cellular Component in Musculoskeletal Tissue Engineering Applications"
  Malcolm Moos, M.D.
  Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research (CBER), FDA
• "Vascular Grafts"
  John Karanian, M.D.
  Office of Device Evaluation, CDRH, FDA

FDA Regulatory Approaches for Tissue Engineered Medical Products

• "Proposed Approach to Regulation of Cell and Tissue-Based Products: A Framework"
  Marty Wells, MPH
  Human Tissue Program
  Office of Blood Research and Review, CBER, FDA
• "Tissue Reference Group"
  Celia Witten, M.D., Ph.D.
  Director, Division of General and Restorative Devices, Office of Device Evaluation, CDRH, FDA

From Bench to Product

• "Artificial Skin Constructs"
  Charles Durfor, Ph.D.
  Office of Device Evaluation, CDRH, FDA
• "Cartilage Reconstruction"
  Eda Bloom, Ph.D.
  Office of Therapeutics Research and Review, CBER, FDA
• "Metabolic Substitutes: Liver Assist Devices and Artificial Pancreas"
  Miriam Provost, Ph.D.
  Office of Device Evaluation, CDRH, FDA

Evolving Technologies and Tissue Engineering

• Stem Cells
  Liana Harvath, Ph.D.
  Office of Therapeutic Research and Review, CBER, FDA
• Transgenics
  Steve Bauer, Ph.D.
  Office of Therapeutics Research and Review, CBER, FDA
• Gene Therapy
  Carolyn Wilson, Ph.D.
  Office of Therapeutics Research and Review, CBER, FDA