In 1997, the FDA proposed a comprehensive regulatory program for Human Cells, Tissues and Cellular- and Tissue-Based Products (HCT/Ps) outlining the registration and listing procedures for HCT/Ps. This program also differentiates between HCT/Ps that will be regulated via the traditional pathway and those that will undergo approval as new drugs, biologics or devices.
In this seminar, we'll discuss the historical context for the use of HCT/Ps in medicine as well as how the HCT/P market is evolving. You will be shown examples of the FDA-approved use of HCT/Ps and what is required for successful product development. This course will also provide an overview of the health authority regulating HCT/Ps, discuss the regulations that govern HCT/Ps, discuss potential product development strategies and provide an overview of product development in the United States.
Learning Objectives:
Upon completing this course, participants will better understand:
- The FDA’s regulatory approval process for HCT/Ps
- Keys to successful product development of HCT/Ps
- Application of “Minimal Manipulation,” “Homologous Use” and “Chemical Action”
- Currently approved use of HCT/Ps in medicine
- The drug and biologic approval process
- Nonclinical requirements to support product development
- Challenges of product characterization and specifications with respect to HCT/Ps
- Requirements for compliance with good tissue practice, good manufacturing practice and good laboratory practice
- FDA enforcement actions
- The global regenerative medicine market
- The One Health Initiative and its impact
- HCT/Ps and translational medicine
- Future approaches for regulatory approval of HCT/Ps in regenerative medicine
Who will Benefit:
This course is designed for professionals in biotechnology, regenerative medicine, HCT/P, pharmaceutical and animal drug companies, veterinary hospitals and clinics. The following personnel will find this session valuable:
- Graduate students
- Academic faculty and professors
- Clinicians
- Entrepreneurs
- Regulatory professionals
- Compliance professionals
- Manufacturing professionals
- Quality Control professionals
- Contract manufacturers
- Foreign corporations in the regenerative medicine field
- Financial advisors and institutional investors
- 08.30 AM - 09.00 AM: Registration
- 09.00 AM: Session Start
- FDA regulatory oversight of HCT/Ps
- Historical Perspective
- Laws and Regulations
- Definitions
- Jurisdiction
- Tissue Reference Group
- Office of Combination Products
- Request for Designation
- FDA regulatory approval process
- HCT/Ps as drugs/biologics
- HCT/Ps as medical devices
- Compliance
- Good tissue practice
- Good manufacturing practice
- Quality system regulations
- Good laboratory practice
- FDA enforcement actions
- Adverse event reporting
- FDA regulatory guidance regarding HCT/Ps
- Minimal manipulation
- Homologous use
- Same surgical procedure
- Adipose tissue
- Overview of FDA Public Workshop on Scientific Evidence in the Development of Human Cells, Tissues, and Cellular and Tissue-Based Products Subject to Premarket Approval
- Product development
- FDA viewpoint
- Views from professional societies
- Patient experiences
- Overview of FDA Part 15 Hearing on Draft Guidance Relating to the Regulation of HCT/Ps
- Industry perspective
- Professional society perspective
- Patient perspective
- HCT/Ps and translation medicine
- One Health Initiative
- Approaches for regulatory approval of HCT/Ps in regenerative medicine
- FDA expedited review programs
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
Gwen Wise-Blackman
Principal Consultant, Gwen Wise-Blackman Consulting, LLC
Gwen Wise-Blackman, Ph.D., has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals. She is currently Principal Consultant at Gwen Wise-Blackman Consulting. Her career focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.
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