MONROVIA, CA, March 20, 2013 /24-7PressRelease/ -- Tiina Palomaki, Senior Researcher at The European Medicines Agency will present on "Regulatory Requirements for Stem Cell-based Medicinal Products in the EU" at GTC's Stem Cell Summit 2013 (Apr 29-30, 2013 in Boston, MA).
Stem cells hold the promise as a source of cells for therapeutic applications in various conditions, including metabolic, degenerative and inflammatory diseases, for the repair and regeneration of damaged or lost tissues and also in the treatment of cancer. The two principal characteristics that define stem cells, i.e. capacity to self-renew and differentiate make stem cells attractive and promising source for cellular replacement therapies. However, the same characteristics can be seen as the primary cause of additional risks of tumourigenicity as well as of unintended differentiation at ectopic locations. Safe therapeutic application of stem cells necessitates understanding the possible risks. Stem cells represent a spectrum of different cell-based products with varying amount of scientific data and clinical experience. Similarly, perceived risks associated with different types of stem cells are not the same.
In the EU, the regulatory framework for development of stem cell-based medicinal products is laid down in the legislation and in the guidelines. Existing EU guidance on cell based medicinal products lays down general outlines that are applicable to all cell based-medicinal products including stem cells. In addition, stem cell-associated additional safety concerns are covered in the recent Reflection paper on stem cell based medicinal products which highlights the potential and theoretical safety concerns based on the current scientific understanding, as well as the technical and methodological challenges related to non-clinical and clinical development of stem cell based products.
Dr. Tiina Palomäki has been working as a senior researcher at the Finnish medicines agency as a responsible person for preclinical aspects of advanced therapy medicinal products and biotechnological products since 2006. She was a member of the former European Medicines Agency (EMA) Cell-based product working party (CPWP) 2008-2012 and an alternate member of the former Gene therapy working party (GTWP) 2008-2010. Currently she is an expert of the Safety working party (SWP). She has been actively involved in development of the EU guidelines for cell-based medicinal products as well as for other biotechnological products.
Stem Cell Summit 2013 includes two parallel tracks. This summit provides cutting-edge information on developments in all areas of stem cell research including the biology, medicine, applications, regulations, and commercialization of stem cells.
Track A: Stem Cell Research & Regenerative Medicine:
Joint Session: Funding Opportunities
Joint Session: Regulatory Guidance & Updates
Session: Advances in iPS & ES Cells
Session: Advances in Adult Stem Cells
Session: New Paradigms for Cell Therapy
Track B: Stem Cell Commercialization & Partnering:
Joint Session: Funding Opportunities
Joint Session: Regulatory Guidance & Update
Session: Novel Technologies in Stem Cell Research
Session: Overcoming Challenges in Clinical Development
Session: Commercialization: Bringing Therapeutics to Market
Session: Partnerships & Acquisitions
Summit Agenda: http://www.gtcbio.com/stemcellsummit/agenda
Summit Speaker List: http://www.gtcbio.com/stemcellsummit/speakers
For more information, please visit http://www.gtcbio.com
GTCbio organizes conferences specifically for the biomedical and biopharmaceutical industries. Our goal is to facilitate the exchange of biopharmaceutical and biomedical intelligence between industry leaders, academic and government organizations, and the financial community.
GTCbio is a subsidiary of Global Technology Community, LLC, a privately held company founded in 2002.
Contact: GTCBIO (626) 256-6405, (626) 256-6460 fax, firstname.lastname@example.org
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