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.
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
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.