An Introduction to FDA's Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (''HCT/Ps'') including Stem Cell-Based Drug Products for Human Use

Why Should You Attend:

Stem cells intended for therapeutic purposes in humans are regulated as biologics under FDA’s 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 product’s satisfaction of FDA’s other regulatory criteria, and consideration of a product’s 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 product’s 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 product’s 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 FDA’s regulation of veterinary stem cell therapy.

Areas Covered in the Webinar:

• FDA’s legal authority over HCT/Ps including stem cell-based products.
• FDA’s regulation of HCT/Ps including stem cell-based products.
• The criteria FDA uses for determining an HCT/P’s regulatory status.
• The various options for commercializing HCT/Ps including stem cell-based products.
• FDA’s 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

Karl M. Nobert
President, ReCellerate, Inc.

Karl Nobert, Esq. is an FDA Regulatory Attorney with the law firm of Michael Best in their Washington, DC office.

Karl focuses his practice in FDA Regulatory law, representing U.S. and international clients in the food and drug industries with regard to pharmaceuticals and OTC drugs, biologics, medical devices, food and beverages including dairy products, cosmetics vitamins and dietary supplements; and veterinary products. He has particular experience in the areas of prescription drugs and regenerative medicine, and has counseled numerous clients seeking FDA approval for Rx drugs and cellular-based products to treat both humans and animals.

Karl has significant experience in the areas of understanding FDA product detentions and developing strategic solutions for the removal of companies and products from Import Alerts. He has successfully assisted multiple clients with resolving costly detention issues including a large Canadian food company with multi-national operations, several Japanese drug and ingredient manufacturers, a European beverage maker, an Israel-based pharmaceutical distributor and a start-up pet product company.

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