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TE Research (Problem (Cost (Adequate funding), Developmental Stage =>…
TE Research
Problem
Developmental Stage => Product Selling
Regulatory Process
Viable Safe Sources of cells
Bioreactor Design
Preservation and Shelf-life of products
Large-Scale Production Techniques
Time
Cost
Adequate funding
Applications
Living Skin Equivalents
Cartilage Replacement
Tissue Subs
Biohybrid Organs
Stem Cell Therapies
Biomaterials
FDA Regulations
Comprehensive /Proposed Approach
Product Review Level ~ Degree of Risk
No change in tissue function/characterisitcs
APPROVED!
"Banked" Human Tissues
Cornea
Skin
Umbilical Cord
Blood Stem Cells
Cartilage
Bone
Medical Products
Clinical Testing
Premarket Applications
Combination Products
more than 1 Component
Biomolecules/Cells/Tissues + Biomaterials
Implementation Rules
List manufacturers & products
Donors to be tested for communicable diseases
Good Tissue Compliance
Donor Eligibility
Classification + Regulatory Concerns
Regulatory Concerns for Human Biologics
Infectious Disease Transmission
Processing & Handling
Autologous Tissue
Tested for infection agents
Appropriate records kept
Patient tissues not mismatched
Allogeneic Tissue
Tested for infection agents
Appropriate records kept
Donor Screened
Manipulation
Ex Vivo Changes on Biologics
Low
Cell Selection/Separation
Cutting
Freezing
High
Cell Expansion
Cell Encapsulation
Clinical Safety
Uses & Advertising
Monitoring & Education
Control Distribution and Sale of Medical Products
Potential risk/harm to users
Classification of Medical Products
Federal Law
Medical Product
Drug
Biologic
"Safe"
Freedom from harmful effect to person
"Pure"
No impurities whether harmful or not in product
"Potent"
Ability to produce expected result under lab /clinical tests
Combination Product
Device
X
Therapeutic / Diagnostic Benefit obtained through metabolization
Allogeneic Skin Products
Organogenesis's Apligraf
Interactive Burn & Wound Dressings
Classes
Class 1
Class 2
Class 3
Implant/Life-Supporting Device
"Safe"
Benefits > Risks
"Effective"
Good clinical results from population
Determines review and approval process
Special
Orphan
Humanitarian
Human Tissues Ownership
Allogeneic Materials
Processes
Combine living cells with biomaterials
Use living cells as therapeutic/diagnostic reagents
Cultivate cells or tissues in vitro for therapeutic implantation
Provide materials or tech for all 3
FDA Products
Apligraf (Organogenesis)
Living Skin Equivalent for diabetic and venous ulcers
Carticel (Genzyme Biosurgery)
Autologous Chondrocytes for cartilage repair
Derma graft (ATS)
Living Skin Equivalent for diabetic and venous ulcers
OrCel (Ortec)
Living Skin Equivalent for burn patients
Solution
Diversification
Private Sector Firms => Revenue Generating Areas
Offset Costs
Funding
Large rich pharma companies
Collaboration
Private & Federal Sectors
Integrate discovery with application
National Initative
Funding
Regulatory Framework
Categories/Sectors
Cellular (RISE)
Stem Cell/Therapeutic Cloning
Encapsulated Cell Therapy
Metabolic
Bioartificial Liver
Bioartificial Pancreas
Bioartificial Kidney
Structural (DECLINED!)
Skin
Cardiovascular Disease
Muscloskeletal
HCT/P
Applications
Cadaveric Ligaments
Dura Mater
Heart Valves
Spermatozoa