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

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.

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

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

Dr. Thomas J. Webster’s degrees are 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). He is currently the Department Chair and Professor of Chemical Engineering at Northeastern University in Boston. His research explores the use of nanotechnology in numerous applications. Specifically, his research addresses the design, synthesis, and evaluation of nanophase materials (that is, materials with fundamental length scales less than 100 nm) as more effective biomedical devices. He has completed extensive studies on the use of nanophase materials to regenerate tissues and 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, at least 567 conference presentations, and 32 provisional or full patents. His H index is 47. Some of these patents led to the formation of 9 companies. His research on nanomedicine has received attention in recent media publications including MSNBC (October 10, 2005), NBC Nightly News (May 14, 2007), PBS DragonFly TV (covered across the US during the winter, 2008), and ABC Nightly News via the Ivanhoe Medical Breakthrough Segment (covered across the US during the winters of 2008 and separate research segments in 2010 and 2011). 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 (the first international journal in nanomedicine which in five years has achieved an impact factor of 4.97), serves on the editorial board of 15 additional journals, has helped to organize 22 conferences emphasizing nanotechnology in medicine, and has organized over 53 symposia at numerous conferences emphasizing biological interactions with nanomaterials. He also recently chaired the 2011 Annual Biomedical Engineering Society (BMES) Conference and has organized numerous symposia for AIChE, IEEE, MRS and ASME Annual Meetings. He has received numerous honors including, but not limited to: 2002, Biomedical Engineering Society Rita Schaffer Young Investigator Award; 2003, Outstanding Young Investigator Award Purdue University College of Engineering; 2005, American Association of Nanomedicine Young Investigator Award Finalist; 2005, Coulter Foundation Young Investigator Award; 2006, Fellow, American Association of Nanomedicine; 2010, Distinguished Lecturer in Nanomedicine, University of South Florida; 2011, Oustanding Leadership Award for the Biomedical Engineering Society (BMES); and Fellow, American Institute for Medical and Biological Engineering (AIMBE, representing the top 2% of all medical and biological engineers).

For Registration - http://www.complianceonline.com/fda-regulation-regenerative-medicine-stem-cell-tissue-engineering-gene-therapies-seminar-training-80340SEM-prdsm?channel=speedycourse          

Note: Use coupon code  NB5SQH8N  and get 10% off on registration.