An Introduction To Fda's Regulation Of Human Cells, Tissues, And Cellular And Tissue-based Products

Stem cells intended for therapeutic purposes in humans are regulated as biologics under FDAs April 2006 regulations governing the use of human cells, tissues, and cellular and tissue-based products (HCT/Ps) in humans. These regulations define HCT/Ps as articles containing or consisting of human cells or tissues that are intended for implantation, transplantation, infusion, or transfer into a human recipient.

Among other things, the regulations include provisions governing registration and listing requirements for establishments that manufacture and process HCT/Ps; provisions discussing donor eligibility; recommended current good tissue practices covering all stages of production, including harvesting, processing, manufacture, storage, labeling, packaging, and distribution; and other requirements intended to prevent the introduction, transmission, and spread of communicable diseases in humans.

An HCT/P is not automatically treated as a drug product by FDA. Instead, a drug v. non-drug distinction is made between HCT/Ps on the basis of an applied minimal manipulation standard and other identifiable criteria. Thus, depending on the amount of manipulation involved in the production process, a products satisfaction of FDAs other regulatory criteria, and consideration of a products ultimate intended use, HCT/Ps (including stem cell-containing products) can be regulated as simply licensed biologics or products requiring Agency review and approval as new drugs.

This presentation will provide participants with an overview of the HCT/P regulations, an understanding of the criteria that FDA uses to determine a products regulatory status for marketing and sale; and a discussion of some of the risks associated with commercializing an HCT/P such as a stem cell-based product today.

Learning Objectives:

- Understand the criteria that FDA uses to determine a products regulatory status (i.e., a biologic, drug or medical device).
- Become familiar with the various regulatory options for commercializing a stem cell-based product.
- Recognize the potential regulatory risks associated with marketing and - selling an HCT/P such as a stem cell-based product.
- Exposure to FDAs regulation of veterinary stem cell therapy.

Areas Covered in the Seminar:

- FDAs legal authority over HCT/Ps including stem cell-based products.
- FDAs regulation of HCT/Ps including stem cell-based products.
- The criteria FDA uses for determining an HCT/Ps regulatory status.
- The various options for commercializing HCT/Ps including stem cell-based products.
- FDAs recent enforcement action against firms promoting stem cell-based therapies for human use.
- An introduction to veterinary stem cell therapy.

Who Will Benefit:

- Individuals who work in the Regulatory Affairs departments of pharmaceutical, biotech & biologics companies
- Quality Assurance
- In-house counsel, lawyers who work for or represent pharmaceutical and biotech companies and other legal staffers interested in the development and commercialization of HCT/Ps such as stem cell-based products
- Financial analysts specializing in and investors watching the pharmaceutical, life sciences and biotech industries
- Policy makers responsible for creating laws governing the use of stem cells

Instructor Profile:

Karl M. Nobert, is an accomplished attorney with expertise in the U.S. Food and Drug Administrations regulation of prescription and over-the-counter drug products, food, biologics, medical devices and veterinary products. Mr. Nobert possesses a considerable understanding of and experience dealing with the FDAs regulation of human and veterinary regenerative medicine including the marketing and sale of stem cell-based products intended for human use. He frequently presents and has published on the subject, and currently services as Legal Advisor to the International Veterinary Regenerative Medicine Society.