Conference Q&A: FDA's Regulation of Regenerative Medicine

Conference Q&A: FDA's Regulation of Regenerative Medicine

Stem cells have the power to develop into many different cell types in the body. They serve as a sort of internal repair system, dividing essentially without limit to replenish other cells. This has led to their wide exploration across all of medicine, including high risk diseases. But despite its potential, the FDA has yet to approve stem cell therapies for a wide range of diseases.

Compliance Online are running a two day in-person seminar on the FDA's Regulation of Regenerative Medicine. Taking place on the 14th and 15th of July, it aims to provide an historical context for the use of stem cells in medicine, where the field has been and where it is going.

In preparation for the event, we spoke to Compliance Online about what makes their seminar unique and what attendees can expect from it.

Q.1 What is the focus of this seminar and why is it being offered? What makes this seminar unique compared to others on regenerative medicine?

The focus of the seminar is to provide information concerning FDA regulations in the fields of stem cells, tissue engineering, and gene therapies. We will also cover nanotechnology. It will provide general scientific information as well FDA policies for obtaining approval for these technologies. It is being offered since they are quickly changing fields in which FDA guidelines are quickly changing.

Q.2 Who should attend this seminar and what can they expect from it? What are the benefits of attending? How is the day scheduled?

The day is scheduled as an interactive seminar and attendees should expect an expansion of knowledge in how the FDA treats stem cells, tissue engineering, and regenerative medicine.

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

Q.3 Who is speaking at the seminar and what is their background in the topic? What kind of insights will they provide for attendees? Why were they chosen?

Tom Webster is leading the workshop and is a Professor at Northeastern University who has over 15 years of experience working with the FDA getting approval for these technologies.

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, Outstanding 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).

Q.4 How often is this seminar held? Do you have any highlights from past conferences? What do you hope attendees will take away from this conference?

The workshop is held 3 times a year, the last time in Boston. Past attendees learned a great deal concerning the changing landscape of how the FDA treats these technologies. Attendees should learn a great deal concerning the science behind these growing technologies as well as FDA regulation of these technologies.


This is a hugely exciting field of study. Some of the most serious medical conditions are due to abnormal cell division and differentiation and regenerative medicines could be the key to developing new strategies for therapy.

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FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies: 2-Day In-person Seminar (Irvine, Ca, United States - July 14-15, 2016) - Product Image

FDA's Regulation of Regenerative Medicine including Stem Cell Treatments, Tissue Engineering and Gene Therapies: 2-Day In-person Seminar (Irvine, Ca, United States - July 14-15, 2016)

  • Conference
  • 2 Days
  • Region: Global