2005 – 2010 Biologics & Biotechnology – Cell, Gene, and Tissue Therapies Expert Committee

Tissues and Tissue-Based Products Workshop
Tuesday May 13, 2008

To Discuss the Value of Public Standards for Tissue-Based Products
To Discuss the Methods Included in USP Documentary Standards
To Explore the Type of Chapters to Develop, on Test Methods for Tissue Products
To Discuss Strategies for Developing Candidates Reference Standards Materials for Tissue and Tissue-Based Products



8:00 a.m.	Continental Breakfast
8:30 a.m.	1. Welcome	Dr. Williams
	2. USP Role in Development of Standards for Drugs and Biologics
	a. USP Standards and Value of Public Standards	Dr. Abernethy (1MB)
	b. Biological Products – Vertical vs. Horizontal Standards	Dr. Morris (786KB)
	c. Cell and Tissue Therapies Standards at USP	Mr. Tente (951KB)

10:00 a.m.	Break

	3. Regulatory Challenges for Tissue-products
	a. U.S. Food and Drug Administration Regulation of for Human Cells, Tissues and Tissues-Based Products	Dr. Witten (114KB)
	b. Use of Standards in Tissue–Based Products Regulated as Devices	Dr. Kaplan (348KB)

11:15 a.m.	4. USP requirements for Tissue–products Standards
	a. Monograph Requirements for Tissue-based products	Dr. Atouf (998KB)

12:00 noon	Lunch

1:00 p.m.	5. Roles for Stakeholder Organizations to Facilitate Development of Scientifically Useful Standards for Development of Tissue Monographs
	a. AATB Perspective	Mr. Brubaker (1.3MB)
	b. ASTM Perspective	Dr. Cahn (343KB)
	c. Industry Perspective
	i. Integra	Ms. O'Grady (141KB)
	ii. Wright Medical Technology	Drs. Burgess/Blum
	iii. Cryolife	Mr. Neja (450KB)

2:30 p.m.	6. Ensuring Quality and Development of Standards for Tissue Products
	a. Microbiology and Sterility Assurance	Dr. Sutton (616KB)
	b. Classification and Nomenclature	Dr. Weber (972KB)
	c. Challenges and Opportunities for Standards development for Tissue – Based Products	Dr. Atouf (1.1MB)

4:00 p.m.	6. Discussions and Wrap–up
4:30 p.m.	Adjourn