Clinical Development of Stem Cell Therapies: Scientific, Regulatory and Ethical Considerations

Date(s) And Time(s):
Apr 12 2010 8:00AM - Apr 13 2010 5:00PM

Bethesda North Marriott Hotel and Conference Center
5701 Marinelli Road
North Bethesda, MD 20852

Interest Area(s):
CMC, Clinical Safety/Pharmacovigilance, Clinical Research, Nonclinical, Research & Development


Strategies for Enabling the Clinical Development of Stem Cell Products.

Join representatives from academia, industry and regulatory agencies, to analyze the transitional process from discovery and regulatory approval to the therapeutic use of stem cell products. Experts will present specific examples of, and solutions for, issues related to the preclinical, CMC, and clinical stages of development for stem cell products

Learning Objectives:
At the conclusion of this conference, participants should be able to:
• Discuss US and EU regulatory requirements for stem cell products
• Outline strategies for clinical development of stem cell products
• Describe the ethical challenges surrounding stem cell research
• Compare successful product development strategies from industry case studies
• Explain CMC challenges of reagents, devices and potency

Target Audience:
Professionals involved in the development and regulation of stem cells for therapeutic use, including those involved in:
• Biotechnology
• Clinical research and development
• Clinical safety/Pharmacoepidemiology/Pharmacovigilance
• Chemistry, Manufacturing and Controls (CMC)
• • Devices
• • Nonclinical safety and efficacy/Toxicology
• • Quality control/assurance
• • Regulatory affairs/Policy/Drug or device approval/GRP
• • Research and development/Strategic issues
• • Preclinical studies
• • Clinical trials

Contact Information:
Contact Marjorie Davis, Program Developer, Phone +1.215.442.6176
Fax +1.215.442.6199, email