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
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
- 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
- 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
Marina Malikova
Executive Director at Boston University School of Medicine
Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.
Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.
In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.
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Bahnhofstrasse
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Zurich Zoo
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Limmat River
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Zurich Old Town
Zurich Old Town (Altstadt ) is a cultural, social and historical melting pot. The highest concentration of clubs in Switzerland, one of the most famous shopping miles, and a plethora of cultural offerings
Schweizerisches Landesmuseum
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