Monrovia, CA -- (SBWire) -- 02/27/2012 --Tiina Palomäki, Safety Working Party & Cell Products Working Party, European Medicines Agency & Finnish Medicines Agency to give a Featured Presentation on “Regulatory Requirements for Stem Cell-based Medicinal Products in the EU” at the 8th Stem Cell Summit (April 19-20, 2012 in Boston, MA)
Regulatory Requirements for Stem Cell-based Medicinal Products in the EU
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.
The 8th Stem Cell Summit includes two concurrent tracks including a couple joint sessions. This summit provides cutting-edge information on developments in all areas of stem cell research including the biology, medicine, applications, regulations, and the business of Stem Cells.
Recent developments in pre-clinical and clinical trials of stem cell therapy, regenerative medicine and tissue engineering, cancer stem cells, stem cell reprogramming, and regulatory policies regarding stem cell research will be addressed.
In addition, focuses on the business opportunities, challenges and potential strategies for overcoming these challenges will be addressed. What categories of companies are currently commercially viable? How are they being funded? What kind of strategic relationships are available within the industry?
Session Topics for each track are shown below:
Track 1: Stem Cell Research & Regenerative Medicine:
-Funding Opportunities (Joint Session)
-Regulatory Guidance & Updates (Joint Session)
-Novel Advances in Stem Cell Research
-Advances in Regenerative Medicine and Tissue Engineering
-Overcoming Challenges in Clinical Development
-Bringing Research to Drug Discovery
Track 2: Stem Cell Commercialization & Partnering:
-Funding Opportunities (Joint Session)
-Regulatory Guidance & Updates (Joint Session)
-Novel Technologies in Stem Cell Research
-Partnerships & Acquisitions
-Panel Discussion: Partnerships & Acquisitions
-Commercialization: Bringing Drug to Market
-Panel Discussion: Commercialization: Bringing Drug to Market
Keynote & Featured Speakers Include:
Glen Prestwich, Presidential Professor, Department of Medicinal Chemistry, University of Utah
Douglas Losordo, Vice President, Medical Director, New Therapies, Baxter
Leanna Caron, Vice President, Cell Therapy & Regenerative Medicine, Genzyme
Devyn Smith, Chief Operating Officer, Neusentis Research Unit, Pfizer
Sridaran Natesan, Scientific Site Head & Head, External Innovation & Partnering, Sanofi-Aventis
Brock Reeve, Executive Director, Stem Cell & Cancer Research Institute, Harvard Stem Cell Institute
Tiina Palomäki, SWP and CPWP, EMA, & Finnish Medicines Agency
Gregory Bonfiglio, Managing Partner, Proteus Venture Partners
The Stem Cell Summit will also be running concurrently with GTC’s 2nd Diabetes Summit.
For more information, please visit http://www.gtcbio.com
Tiina Palomäki to present at 8th Stem Cell Summit – April 19-20, 2012 in Boston