FDA Guidelines on Usage of Stem Cells in Medicines

Why Should You Attend:

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 webinar will provide a 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 stem cell field to progress.

Learning Objectives:

At the end of this course, attendees will have a better appreciation for:

• Stem cell sources and how to control stem cell differentiation
• What technologies (FDA and non-FDA) exist in stem cell technologies
• What future directions and opportunities exist for stem cell technologies

Areas Covered in the Webinar:

• 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
• Future thoughts on approaches for regulatory approval of stem cell technologies
• Remaining hurdles
• Outlook for new technologies

Who Will Benefit:

• Scientists
• Industry personnel
• Students (all levels)
• Patent lawyers
• Clinicians
• All persons with an interest in stem cell technologies

Instructor Profile:

Thomas J. Webster has degrees in chemical engineering from the University of Pittsburgh (B.S., 1995) and in biomedical engineering from Rensselaer Polytechnic Institute (M.S., 1997; Ph.D., 2000). In his 15 years in academics, Prof. Webster has graduated/supervised over 109 visiting faculty, clinical fellows, post-doctoral students, and thesis completing B.S., M.S., and Ph.D. students. To date, his lab group has generated over 9 textbooks, 48 book chapters, 306 invited presentations, at least 403 peer-reviewed literature articles (222) and/or conference proceedings (181), at least 567 conference presentations, and 32 provisional or full patents. Some of these patents led to the formation of 9 companies.

His research on nanomedicine has received attention in media publications including MSNBC, NBC Nightly News, PBS DragonFly TV, ABC Nightly News via the Ivanhoe Medical Breakthrough Segment, Fox News, and the Weather Channel. His work has been on display at the London and Boston Science Museums. He is the founding editor-in-chief of the International Journal of Nanomedicine, has helped organize 22 conferences emphasizing nanotechnology in medicine, and has organized over 53 symposia at numerous conferences emphasizing biological interactions with nanomaterials. He also chaired the 2011 Annual Biomedical Engineering Society Meeting and has organized numerous symposia for MRS, AIChE, and ASME conferences.

Prof. Webster has received numerous honors including, but not limited to 2013 Fellow, Biomedical Engineering Society and 2014 Fellow, Ernst Strugmann. He currently serves as the director of the Indo-U.S. Center for Biomaterials for Healthcare which serves to catalyze research between the U.S. and India in the area of biomaterial science with over 20 participating universities and industries. He was also recently elected president of the U.S. Society for Biomaterials.

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