FDA Regulation of Therapeutic Use of Live Cells

Why Should You Attend:

Cellular therapy is a term used in both medicine and cosmetic products. It is a fast developing and extremely promising field (especially stem cell therapy and human organ bio-fabrication), attracting a great deal of attention from physicians, investors and manufacturers alike. Yet most people are not aware that in the US there are some strong federal rules restricting the use of this emerging technology. In February 2009, the FDA issued its document “Compliance Program Guidance Manual” regulating the use of human cell lines and tissues. There were some additions to the document since that time. Also, there are some special regulations approved by certain states.

This webinar will address the issues with regard to the potential of using live cells in medicine and major rules by FDA and other controlling organizations regulating this important field.

Areas Covered in the Webinar:

• How human cells are used in medicine and industry now and what are the anticipated changes for the future.
• Rules for handling such objects in cellular and gene therapy; major differences between the rules in the USA and other countries.
• FDA guidance documents for cellular and gene therapy (from 1997 to 2014).
• Human cells and cell lines regulated by CDRH and by CBER. What is the difference?
• PHS Act section 361 and section 351 products.
• FDA and regulatory issues surrounding personalized medicine.
• Can stem cells be regulated as drugs? - Court appeals decision on 4 February 2014.
• Flat and 3D cellular models – pro and contra; 3D live cell printing for human organs.
• Robotic systems available for handling human cells and cell lines for cellular therapy and new drug screening assays.
• Business forecast for the future.
• Ethical and regulatory debates around bio-printing.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel in new and emerging companies operating in the field of live cell therapy and bioprinting. The following titles will benefit:

• Regulatory professionals
• Compliance professionals
• Production supervisors
• Manufacturing engineers
• Production engineers
• Design engineers
• Labelers and Private Labelers
• Contract manufacturers
• Quality engineers
• Quality auditors
• Investors looking for a winning company in the field
• Healthcare providers interested to learn about perspectives of patient-oriented methods of live-cells handling and organ bioprinting

Instructor Profile:

Dr. Igor Zlatkin, gained his PhD in biochemistry. He is a co-inventor on three patents on the use of novel anti-cancer drugs and author of more than 30 scientific publications in internationally reviewed journals in such areas as Microbiology, Cellular Biology and Anti-Cancer Drug development. He recently was involved in R&D and QC/QA of an HTS device for bioprinting of a large variety of live cells, including human stem cells.

Topic Background:

In 1931, a Swiss doctor Paul Niehans – who has been called the inventor of cell therapy– attempted to cure a patient by injecting material from calf embryos as anti-cancer treatment. Cellular Therapy is now defined as the transplantation of human cells to replace or repair damaged tissue and/or cells. With new technologies, innovative products, and limitless imagination, many different types of cells may be used as part of a therapy or treatment for a variety of diseases and conditions, including, aging, cancers, autoimmune disease, urinary problems, infectious disease. Cellular therapy could also help in rebuilding damaged cartilage in joints, repairing spinal cord injuries, improving a weakened immune system, and helping patients with neurological disorders. Some of the cells that may be used for such treatments include hematopoietic (blood-forming) stem cells (HSC), skeletal muscle stem cells, mesenchymal stem cells, lymphocytes, dendritic cells, and pancreatic islet cells. Research into human embryonic stem cells is one of the most promising and controversial. Regulation of the use of human embryonic cells varies from country to country, with some countries banning it outright. Nevertheless, these cells are being investigated as the basis for a number of therapeutic applications, including possible treatments for diabetes and Parkinson's disease. Hematopoietic stem cell transplantation (also called bone marrow transplant) is currently the most frequently used cell therapy and is used to treat a variety of blood cancers and hematologic conditions. Over the past five years, there has been a jump in the number of cell therapy products commercially distributed by companies in the US, with 8 cell therapy products receiving approval since 2009. Once such therapies are approved for the market, however, biopharmaceutical companies face new challenges to manufacture larger quantities of cell products while maintaining high standards of QC.

Another area, where live human cells will be used soon is bioprinting, or the process of creating human tissues with 3D printers. This is a highly contested area of technological innovation. From a technological perspective, the rise and development of 3D printing and its capabilities will play an undeniable part in our future lives. Although, currently printed tissues are generally used for medical research, the printing of whole organs, if approved, could be a reality within the next decade. Ethically and morally, concerns have been raised over ensuring the quality of the organs, and who controls the right to produce them. Others claim 3D printing human components further blurs the line between man and machine, giving us the right to 'play God' on an unprecedented scale. But there is no denying that bioprinting has the potential to revolutionize medicine and healthcare beyond what seemed possible even 20 years ago.

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