Course Description:

Regenerative medicine focuses on harnessing the power of one’s own stem cells and regenerative capabilities to restore function to damaged cells, tissues and organs. In April 2006, the U.S. Food and Drug Administration’s (“FDA”) implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products (“HCT/Ps”) in humans including bone, ligament, skin, dura mater, stem cells, cartilage cells, and various other cellular and tissue-based products. Currently, there is an ongoing debate in the industry on how such therapies should be regulated – by FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.

This 2-day interactive seminar on FDA regulations of regenerative medicine will cover:

  • How FDA is currently regulating regenerative therapies and products intended for both human and veterinary use.
  • The distinction being made between human regenerative products and their regulation as drugs, biologics, devices, and combination products.
  • The New Drug Application (“NDA”) and the Biologic License Application (“BLA”) review and approval processes including a discussion of available options, application components, relevant meetings, timing, costs and approval requirements.
  • The option for obtaining designation and approval as Orphan Drug Product.
  • Designing and conducting appropriate clinical trials to support the approval of regenerative therapies.
  • FDA’s regulation of some regenerative medicine products and accessories as Medical Devices.
  • The Current Good Manufacturing Practices (cGMPs) and Good Laboratory Practices (GLPs) being applied by FDA to human regenerative products.
  • The labeling and marketing of regenerative products and therapies.
  • The potential for enforcement action and recommendations for mitigating that risk.
  • The current regulation of veterinary cellular treatments including autologous, allogeneic and xenogeneic cellular products in the United States.

Learning Objectives:

Participants who attend this course on FDA regulation of regenerative medicines will leave with a comprehensive understanding of:

  • How FDA regulates regenerative treatments and therapies?
  • The HCT/P Criteria and “Minimal Manipulation Standard”.
  • The Drug and Biological Approval Process.
  • Regenerative Products as Medical Devices.
  • How to Design Appropriate Clinical Trials?
  • Applicable cGMPs and cGLPs.
  • Marketing Exclusivity and Patent Restoration.
  • Product Labeling, Marketing and Advertising.
  • FDA and other Federal Agency Enforcement Action.
  • The Regulation of Veterinary Regenerative Medicine.
  • The New Animal Drug Application (“NADA”) Process.
  • Veterinary User Fees and Waivers.

Who will benefit:

This course is designed for professionals in stem cell, biotech, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:

  • Senior quality managers
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Production supervisors
  • Manufacturing engineers
  • Production engineers
  • Design engineers
  • Labelers and Private Labelers
  • Contract Manufacturers
  • Importers and Custom Agents
  • U.S. Agents of Foreign Corporations
  • Process owners
  • Quality engineers
  • Quality auditors
  • Document control specialists
  • Record retention specialists
  • Medical affairs
  • Legal Professionals
  • Financial Advisors and Institutional Investors
  • Consultants, Inspectors and cGMP Experts

Topic Background:

Regenerative medicine encompasses a broad category of advanced therapies that allow the body to repair, replace, restore and regenerate damaged cells, tissues, genes and organs. Regenerative medicine supports research in a variety of new biotech sectors including biomarker and growth factor identification, tissue and biomaterial engineering, and transplantation science.

The use and awareness of regenerative therapies is growing exponentially in the United States. It is no longer limited to test tubes, pilot studies and political debate … regenerative medicine has become reality and is increasingly becoming the future of medicine. This is demonstrated by reported use of stem cell therapies by Peyton Manning the quarterback for the Denver Broncos for a neck injury in November 2011, Governor Rick Perry of Texas in conjunction with spinal fusion surgery in early July 2011 and Well Armed, the American thoroughbred who won the 2009 Dubai World Cup which is the richest race horse racing.

Day One (8:30 AM – 4:30 PM) Day Two (8:30 AM – 4:30 PM)

Registration Process: 8:30 AM – 9:00 AM

Session Start Time: 9:00 AM

Introduction Human Regenerative Medicine: Science and the Law

  • FDA’s approval process for regenerative medicine products
  • FDA’s Regulation of Human Cells, Tissues or Cellular or Tissue-based Products (“HCT/P”)
    • The application of the FFDC Act and the PHS Act
    • The criteria for determining how a product will be regulated
    • The “Minimal Manipulation” Standard
  • Approval of Human Regenerative Treatments
    • FDA’s regulatory approval pathway for HCT/Ps
    • The new drug and biologic approval pathways
    • The various existing regulatory drug approval pathways (the “full” NDA v. the 505(b)(2) application) and the biologic approval pathways (BLA v. biosimilars) will be discussed.
    • The NDA and BLA review and approval processes including a discussion of available options, application components, relevant meetings, timing, costs and approval requirements.
  • Obtaining designation and approval as an Orphan Drug Product
    • Survey of the types of HCT/Ps and those indications receiving designation and approval as Orphan Drugs
    • The process for obtaining orphan drug designation and approval
    • The incentives accompanying orphan drug designation and approval
    • Available Marketing Exclusivity
  • Regulating Some Regenerative Treatments as Medical Devices
    • Products and accessories being regulated as medical devices
    • Identifying such products for regulatory purposes
    • Overview of FDA’s medical device clearance and approval pathways
    • Strategies for marketing and selling such products
  • The cGMPs and cGLPs Applied to Regenerative Treatments and Therapies
    • How to implement appropriate cGMPs and cGLPs applicable to the manufacturing, production, control, packaging and distribution of HCT/Ps
    • Some of the topics to be covered: material sourcing, characterization, manufacturing, sterility and quality controls
    • Standard Operating Procedures or SOPs

Bringing Regenerative Medicine Products to Market: Four Key Components

  • Conducting Clinical Trials to Support Product Approvals
    • Factors to consider when designing study protocols, engaging Clinical Research Organizations and investigators, and conducting clinical studies.
  • Labeling, Marketing and Advertising
    • Definitions and Regulation
    • Applicable Statutory and Regulatory Requirements
    • Federal Agency Shared Jurisdiction
    • Examples of Non-Compliance Labeling and Marketing
  • FDA Enforcement Action and Effective Strategies for Mitigating Such Risk
    • Types of enforcement action
    • A survey of recent FDA enforcement activities
    • Recommendations for mitigating the risk of FDA and FTC enforcement action
    • Strategies for preventing products from being deemed “adulterated” or “misbranded”
  • Intellectual Property Considerations
    • U.S. patent rules applicable to stem cells and other regenerative products
    • Relevant Patent Laws and Cases
    • A survey of past important legal cases A
    • Applicability of patent protection to drug marketing and commercialization, and the concept of Patent Restoration.

Introduction Veterinary Regenerative Medicine

  • The Center for Veterinary Medicine’s (“CVM”)
    • Regulatory Jurisdiction: FDA v. USDA
    • CVM’s Organization
    • USDA’s Organization
  • Statutory and Regulatory Overview
    • The Federal, Food, Drug and Cosmetic Act
    • The Virus, Serum and Toxin Act of 1913
    • Relevant Regulations
    • Guidance Documents and Policy Statements
  • The Regulation of Veterinary Cellular Products and Therapies
    • Regulatory Status
    • Definitions: Drug v. Biologic
  • The Veterinary Drug Approval Process
    • Approval Process
    • NADA Approval Process
    • User Fees and Waiver Request
    • Sections of an NADA
      • Product Characterization, CMC, Safety, Efficacy, etc
  • Managing Veterinary Clinical Trials
    • 7 Major Phases:
      • Planning
      • Study Initiation
      • In-life Activities
      • Site close-out
      • Data management
      • Biostatistical analysis
      • Report writing
  • Labeling, Marketing and Advertising
    • Definitions and Examples
    • Labeling
      • Immediate Container, Outer Packaging, Package Insert, Client Information Sheet, Shipping Label
    • Marketing Materials
      • Brochures, Leaflets, Press Releases, Flyers, Audio and Visual Pieces
  • Advertising
    • Written Media, Broadcast Media, Internet Media, Social Media
  • Standards to Avoid Misbranding
    • Truthful, Substantiated, and Not Misleading
    • Effective Communication, Risk Communications, Risks and Benefits
  • Timing of Review: NADA/ANADA Filing, Initial Publication/Broadcast, Disseminations Following Changes, Drug Experience Reports
  • Post Approval Surveillance: Traditional Media Surveillance, Internet and Social Media Surveillance, Industry and Professional Events, Internal Company Materials
  • Extra-Label Drug Use: Animal Medicinal Drug Use Clarification Act of 1994
  • Veterinary Drug User Fees and Fee Reductions and Waivers
    • Animal Drug User Fee Act (ADUFA) – Applies to Innovators Only
    • Animal Generic Drug User Fee Act (ADGUF) – Applies to Generic Manufacturers
    • Types of User Fees
    • Types of Fee Waivers and Reductions
    • Procedures, Timing and FDA Evaluation of Waivers or Reductions

Meet Your Instructor

Karl M. Nobert
Food and Drug Regulatory Attorney, The Nobert Group LLC

Karl M. Nobert is a food and drug regulatory attorney with the Nobert Group LLC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.

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