3-hr Virtual Seminar - Regenerative Medicine: An Introduction to FDA's Regulation of Cell Therapies and HCT/Ps Generally

Why Should You Attend:

This 3-hr virtual seminar will provide an introduction to the U.S. Food and Drug Administration’s regulation of cell therapies and other HCT/Ps for human use. It will cover several topics including who is responsible for the regulation of cell and gene therapies in the U.S., how such therapies are regulated, and explore the various regulatory criteria against which these therapies are distinguished.

The presenter will also discuss product labeling, FDA inspections and the potential enforcement risks associated with the marketing and sale of such therapies in the U.S. today. Attendees will also be provided with an overview of FDA’s current enforcement activities in the areas of cell and gene therapies, and HCT/Ps generally.

Learning Objectives:

By participating in this webinar, an attendee will gain an understanding of

• Who regulates cell therapies and other HCT/Ps in the U.S. today?
• The statutory and regulatory authority granted to the FDA to govern such products.
• How cell therapies and HCT/Ps generally are regulated in the U.S. today and the regulatory criteria against which a firm's product is judged for regulatory purposes.
• FDA labeling and promotional rules.
• Various strategies for commercializing a stem cell-based product for intended human use.
• How to prepare for an FDA establishment inspection?
• The potential regulatory risks associated with the marketing and sale of a cell therapy or HCT/P, and
• FDA's potential regulation of veterinary cell therapies for horses, dogs and cats.

Areas Covered in the Seminar:

• Who regulates cell therapies such as stem cells in the U.S.
• FDA's statutory and regulatory authority over cell-based therapies.
• How FDA currently regulates cell therapies and other HCT/Ps generally.
• The criteria FDA uses for determining a product's regulatory status.
• Options for commercializing HCT/Ps including stem cell-based products.
• Labeling and promotional considerations.
• Recommendations for preparing for an FDA facility inspection.
• Recent enforcement against firms marketing and promoting cell therapies for human use, and strategies for mitigating such risks.
• An introduction to veterinary stem cell therapy.

Who will Benefit:

• Individuals who work in the Regulatory Affairs departments of pharmaceutical, biotech & biologics, and device companies who are researching, developing or simply interested in regenerative medicine therapies and products
• Quality Assurance team members
• In-house counsel, lawyers who work for or represent pharmaceutical and biotech companies and other legal staffers interested in the development and commercialization of cell therapies and HCT/Ps for human use
• Financial analysts, investment bankers, venture capitalists and brokers focusing on or watching the pharmaceutical, life sciences and biotech industries.
• Foreign-based cellular firms interested in entering the U.S. market
• Policy makers responsible for creating laws governing the use of stem cells

Instructor Profile:

Karl M. Nobert, is an accomplished attorney with knowledge of and experience with the U.S. Food and Drug Administration’s regulation of regenerative medicine including cell therapies and HCT/Ps, 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 therapies and products including the FDA’s regulation of such products, the commercialization of cell therapies, the marketing and sale of stem cell-based products intended for human use; and the introduction of veterinary cell therapies to the market. He frequently presents and publishes on the subject, and currently services as Legal Advisor to an international consortium of stem cell researchers and firms.

Topic Background:

Stem cells intended for therapeutic purposes in humans are regulated by the U.S. Food and Drug Administration’s Center for Biologics Evaluation and Research (“CBER”) under the Agency’s regulations governing the use of human cells, tissues, and cellular and tissue-based products (“HCT/Ps”). 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.”

FDA’s 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.

FDA’s regulatory approach to cell therapies and other HCT/Ps is based on an established drug / non-drug comparison that is made on the basis of an established “minimal manipulation” standard. Depending on the level of manipulation involved in the production process and a product’s ultimate intended use, such a product could be regulated as simply an HCT/P or something entirely more complex such as a licensed biologic, an approved drug product or a medical device.

From a regulatory perspective, there are also various labeling and promotional considerations that a firm must be aware of when marketing a cell therapy in the U.S. Over the past few years, a lack of awareness of such rules by some companies has resulted in FDA enforcement action.

This presentation will provide participants with an overview of who regulated cell therapies and other HCT/Ps in the U.S. today. It will also provide an introduction to the regulatory criteria that FDA applies when governing such products. The presentation will examine current FDA labeling rules, will provide recommendations for preparing for an Agency inspection and will offer strategies for mitigating potential enforcement risks.

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