This webinar will review FDA's regulatory oversight of stem cell-based products when used in humans and analyze its potential impact on the industry in the future. Learn FDA's criteria for marketing and promotion of stem cell-based products for therapeutic application.
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 Seminar:
- 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
Instructor Profile:
Karl M. Nobert, is an accomplished attorney with expertise in the U.S. Food and Drug Administration’s 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 FDA’s 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”.
