My 2008 Presentations & Articles Relevant to Regenerative Medicine

2008 was an extremely busy year for me, as I am sure it was for you as well. The net result is that I have been slow to post updates and thoughts regarding translation of regenerative medicine products to the clinic. In the ‘better late than never” category, I thought I would share some of the presentations and relevant articles I have written over the past year.

Links are provided for most of the presentations and articles I have generated over the past year.

If you want copies of the presentations or articles for which public links are not available, let me know in the comments section and I will send them to you.

If some of this information is baffling (regulations frequently are) let me know of any questions you have in the comments and I will do my best to answer them.

Presentations:

• “Unique issues associated with stem cell therapeutics”
  National Academy of Sciences: Translation of Stem Cells into Clinical Stem Cell Therapeutics Public Symposium, Washington, DC, November, 20, 2008
• “Regulatory Expectations for GMP Production of hESC-derived Therapies”
  California Institute for Regenerative Medicine, 2008 Workshop on GMP, San Francisco, CA, November 03, 2008
• “Bench to Bedside: Translation of CT Products into Clinic”
  2008 AABB Annual Meeting and TXPO, Montreal, Canada, October 06, 2008
• “Problems in Product Development for Cell-Based Therapies”
  International Society for Cell Therapy Somatic Cell Therapy Symposium, Bethesda, MD, September 22, 2008
• “Medical Product Development and the FDA Regulatory Process”
  University Washington Tech Transfer, Seattle, WA, July 01, 2008
• “Establishing USP Monograph Names for Tissues and Tissue-Based Products”
  US Pharmacopoeia Tissue Workshop, Rockville, MD, May 12, 2008
• “Regulatory Considerations for Cell Manufacturing and Delivery“
  International Society for Cardiovascular Translational Research, San Diego, CA, February 10, 2008

Articles:

• “Understanding and Implementing Good Tissue Practices” Regulatory Focus, July 2008, Vol. 13(7) 18-28.
• “Regulatory Considerations for Manufacturing and Delivery of Cell-based Therapies for Cardiovascular Indications”
  J. of Cardiovasc. Trans. Res. (2008) 1(3): 196-200
• “The FDAA Act of 2007 and Mandatory Registration of Clinical Trials”
  ISCT Telegraft Newsletter, 15(1) Winter 2008

Enjoy!

-Darin

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