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Seminar Summary:

This tutorial will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. (see full course description)

 
 
 

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Training Course Syllabus:


FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies

Course Description:

Stem cells harness the power to differentiate into numerous cells upon stimulation. This has led to their wide exploration across all of medicine, including high risk diseases. Of course, significant scientific breakthroughs in the use of stem cells to prevent, diagnose, and treat numerous diseases has caused numerous start-up companies to form. Despite, such promise, the FDA has yet to approve stem cell therapies for a wide range of diseases, except cord blood-derived hematopoietic progenitor cells for certain indications.

This tutorial will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. It will also provide the few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress. For example, in 2006, the U.S. FDA implemented regulations governing the use of human cells, tissues, and cellular and tissue-based products 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 industry on how such therapies should be regulated, in particular by the FDA or under the practice of medicine, under federal law or state law, and as drugs or simply biologics.

Learning Objectives:

Upon completing this course participants should have an understanding of:

Fundamentals of stem cells
What is all the excitement about
How to control stem cell differentiation
Sources of stem cells
Incorporating stem cells into biomaterials
Avoiding immune system clearance of stem cells
FDA regulatory approvals for the use of stem cells in medicine
Currently approved use of stem cells in medicine
FDA guidance documents for stem cell technologies
Global approval of stem cell technologies
How the FDA regulates regenerative treatments and therapies
The use of human cells, tissues, and cellular and tissue-based product criteria and “Minimal Manipulation Standard”
The drug and biological approval process
Regenerative products as medical devices
How to design appropriate clinical trials
Applicable good manufacturing and good laboratory practices
Product labeling, marketing and advertising
FDA and other federal agency enforcement action
Future thoughts on approaches for regulatory approval of stem cell technologies
Remaining hurdles
Outlook for new technologies

Course Outline:
Day One (8:30 AM - 4:30 PM)

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

9:00 AM: Session Start

Fundamentals of stem cells
Definitions
What is all the excitement about
How to control stem cell differentiation
Sources of stem cells
Incorporating stem cells into biomaterials
Avoiding immune system clearance of stem cells
Research examples pre-clinical approval
Research examples post-clinical approval
FDA regulatory approvals for the use of stem cells in medicine
Currently approved use of stem cells in medicine
FDA guidance documents for stem cell technologies
Global approval of stem cell technologies


Day Two (8:30 AM - 4.30 PM)


FDA regulatory approvals for the use of stem cells in medicine (continued)
How the FDA regulates regenerative treatments and therapies
The use of human cells, tissues, and cellular and tissue-based product criteria and “Minimal Manipulation Standard”
The drug and biological approval process
Regenerative products as medical devices
How to design appropriate clinical trials
Applicable good manufacturing and good laboratory practices
Product labeling, marketing and advertising
FDA and other federal agency enforcement action
Future thoughts on approaches for regulatory approval of stem cell technologies
Remaining hurdles
Outlook for new technologies
Strategies for commercializing stem cell technologies
Questions

Seminar Summary:

This tutorial will provide an historical context for the use of stem cells in medicine, where the field has been and where it is going. (see full course description)

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