FDA’s Regulation of Regenerative Medicine including Stem Cell Treatments and Tissue Engineering: 2-Day In-Person Seminar

By:
Theodore Sand,
Vice President, Greyledge Technologies LLC
Randall Thoma,
Principal, VeeSquared Consulting Services
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Course Description:

This Seminar 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 few examples of FDA approved use of stem cells in medicine and what is needed for the field to progress. Learn the fundamentals of stem cells and FDA’s regulatory approach for its use in medicine.

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. Attend this seminar to learn and apply the definitive ways to needed for the field to progress.

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

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
  • Patent lawyers
  • Graduate students
  • Academic faculty and professors
  • Clinicians
  • Entrepreneurs

Course Outline

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

  • 08.30 AM - 09.00 AM: Registration
  • 09.00 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

Meet Your Instructors

Theodore Sand
Theodore Sand,
Vice President, Greyledge Technologies LLC

Theodore T. Sand, Ph.D. (Vice President Research & Regulatory Affairs) joined Greyledge Technologies, LLC in September 2016. He is responsible for expanding the network of in-clinic processing laboratories operated by Greyledge. Dr. Sand also handles implementation of Greyledge’s Quality Management System, manages its clinical studies and the company’s research program. He previously was VP of Cellular Therapies & Regulatory Affairs at Celling Biosciences (Austin, Texas). Dr. Sand started working in translational cell therapy and regenerative medicine in 2002 when he created, optimized and validated the autologous fat tissue-derived stem cell therapy service offered by Vet-Stem, Inc. (Poway, CA).

Dr. Sand received both his B.S. (Microbiology, 1975) and Ph.D. (Biochemistry, 1982) degrees from the University of Minnesota (Minneapolis, MN) and was a Postdoctoral Fellow in the Department of Immunology at Scripps Clinic and Research Foundation (La Jolla, CA) from 1982 to 1983.

Dr. Sand has been the inventor or co-inventor on 15 patents, has coauthored 14 scientific publications and writes posts covering scientific, clinical and regulatory aspects of translational cell therapy for a blog on the Greyledge Technologies website. Two book chapters on the regulatory aspects of the point-of-care regenerative medicine field are pending publication.


Randall Thoma
Randall Thoma,
Principal, VeeSquared Consulting Services

Randy is currently the Principal at VeeSquared (V2) Consulting Services. "VeeSquared" is Verification and Validation. His consulting practice includes development and remediation of Quality Systems (medical device, over-the-counter drug, and blood processing) and process (especially cleaning validation) and test method qualification and validation and education.

He has also been an inspector for the American Association of Tissue Banks (AATB) since 2016.

Prior to entering consulting, he was the Associate Director of Quality Assurance for Zimmer Biologics. In this role he was responsible for Quality at the product development facility and for teaching the scientists how do develop and commercialize products, including human tissue products, targeting orthopedic early intervention.

He served on the AATB Accreditation Committee and is a past-Chair of the committee.

He is also the author and technical contact for the ASTM "Guide for Validating Cleaning Processes used during the Manufacture of Medical Devices".

He is a past President and CEO for a bereavement camp for children and is currently a volunteer driver for the local blood center.

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Testimonials

Presenters were encased & open to discussions.
- Compliance Director, Regenerative Medicine Solutions

It was very helpful high level view of historical changes and the new provisions created to support new science.
- Manager, Bluebird Bio

I really enjoyed this conference as I am new to the regenerative medical space & found this was a great source to get up to speed on how FDA is currently reviewing this space.
- Associate Product Manager, Zimmer Biomet

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