Stemedica Cell Technologies, Inc., a leader in adult stem cell research and manufacturing, announced today the appointment of Carl Bullen as Director of Manufacturing. Mr. Bullen will be responsible for manufacturing systems and procedures at Stemedica's San Diego-based manufacturing facility that is built to cGMP standards and is currently pending FDB license.
San Diego, CA (PRWEB) March 5, 2009 -- Stemedica Cell Technologies, Inc. ("Stemedica"), a leader in adult stem cell research and manufacturing, announced today the appointment of Carl Bullen as Director of Manufacturing. Mr. Bullen will be responsible for manufacturing systems and procedures at Stemedica's San Diego-based manufacturing facility that is built to cGMP standards and is currently pending FDB license. Mr. Bullen has extensive experience in all aspects of cell culture manufacturing as well as the commercialization of new biomedical technologies for United States and European markets.
"We are very impressed with Mr. Bullen's track record of establishing and managing manufacturing systems in progressive technologies. His managerial experience combined with his knowledge of international regulatory requirements is a significant advantage as we prepare to supply our adult allogeneic stem cell lines to preclinical and clinical research centers around the world," said Dr. Nikolai Tankovich, Stemedica's President and Chief Medical Officer.
Mr. Bullen has been in the pharmaceutical manufacturing business for the past 16 years having started his career as a Biochemical Technician and progressing to Director of Manufacturing for such companies as IDEC Pharmaceuticals, Biogen Idec, Genentech and Pacira Pharmaceuticals. During the course of his extensive career, Mr. Bullen has employed his innovative thinking and manufacturing experience to develop practical solutions that have supported numerous start-up manufacturing scenarios for some of the world's foremost biotech companies.
"What inspires me about my new role at Stemedica is the opportunity to expand and improve manufacturing systems and processes in a cutting edge environment like the one offered at Stemedica. I am eager to bring my detailed knowledge and experience in building new manufacturing capabilities to Stemedica as they transition from research and development into full scale manufacturing. The set-up of first-time manufacturing is complex and it is an exciting prospect to work with the great minds here at Stemedica. Together, we will create the means to extend the benefits of stem-cell research and therapies to an ever widening audience", said Mr. Bullen.
Mr. Bullen will report directly to Dr. Alex Kharazi, Vice President of Medical Research at Stemedica. "The appointment of Carl Bullen is a significant step in our progress towards supporting clinical trials of our products in the United States and other locations around the world. As we complete the final steps in the certification process with California's Food & Drug Board and evolve toward the manufacturing of allogeneic clinical grade product for external clients as well as for our own clinical trials, it is fundamental to have someone of Carl's biomedical manufacturing expertise working for the organization", said Dr. Kharazi.
About Stemedica Cell Technologies, Inc.
Stemedica Cell Technologies Inc. (http://www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacture of best-in-class adult stem cells for use by approved research institutions and hospitals for pre-clinical and clinical studies. Within the United States, the Company is currently developing regulatory pathways for stroke, traumatic brain injury and wound repair. Outside the United States, Stemedica provides its adult stem cells to hospitals and research centers that are conducting studies under protocols approved by the appropriate regulatory agencies. These studies are focused on the treatment of neurodegenerative disease, sight restoration and wound repair. Stemedica is based in San Diego, California.
Media Contact for Stemedica: Dave McGuigan at dmcguigan (at) stemedica.com.
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