Stemedica President Invited To Lecture At The University Of Oxford

Nikolai Tankovich, MD, Ph.D., President and Chief Medical Officer of Stemedica Cell Technologies, Inc. was invited to lecture at a multi-disciplinary seminar at the Centre for Science and Society at Trinity College, a constituent college of the University of Oxford, England. The seminar, which focused on current research and medical applications for stem cells, was attended by more than 300 professors and staff representing all facets of the University.

Dr Nikolai Tankovich, President and Chief Medical Officer of Stemedica at the Centre for Science and Society at Trinity College, a constituent college of the University of Oxford, England

Dr. Tankovich gave a presentation to medical and business professionals on stem cell research and clinical applications entitled, “From Research Bench to Patient Treatment.” In his lecture, Dr. Tankovich presented detailed ideas and information on:

• Novel pre-clinical and clinical research currently being conducted with stem cells.
• Procedural standards on how stem cells must be properly sourced and manufactured in order to meet evolving legal and regulatory rules.
• The regulatory requirements for cGMP facilities and licensed manufacturers.
• Tests and studies that must be done prior to the implementation in clinical trials.
• Types of governmental authorization required to begin clinical trials.
• Business infrastructure requirements necessary to enter into clinical trials and beyond.

Dr. Tankovich also discussed Stemedica’s multinational collaboration efforts currently underway to bring stem cells from research laboratories to clinical trials on a worldwide basis.

“I was very proud to be invited to lecture at an institution as prominent as Oxford University’s Trinity College,” said Dr. Tankovich. “Significant contributions to stem cell research have been made by Oxford University scientists and clinicians and it was my honor to present the research, pre-clinical and clinical applications currently being advanced by Stemedica through our various development & manufacturing activities.”

Following Dr. Tankovich’s lecture, a number of positive discussions took place between Dr. Tankovich and those present regarding potential research collaborations between Oxford University and Stemedica. Numerous scientists, doctors, and teaching professors, having expressed a strong interest in knowing more about Stemedica’s research, stem cell & stem cell factors product line as well as Stemedica’s Business Model, were invited by Dr. Tankovich to visit Stemedica and its cGMP compliant, FDB (Food & Drug Branch) licensed manufacturing facility in San Diego, California.

Dr. Frank C. Schuller, Director of the Centre for Science and Society at Trinity College said, “Many members of various departments including, Physiology, Biology and the Medical School at John Radcliff Hospital were present and several were quoted as saying that they thought this was one of the premiere seminars on stem cells ever offered at Oxford. Based upon Dr. Tankovich’s presentation and the response that it received, Stemedica can look forward to several collaborative initiatives evolving with Oxford over the coming months. Finally, a number of the participants at the Seminar commented that Dr. Tankovich’s presentation will help them frame their own research in a more efficient and effective way as they proceed from bench top research to controlled clinical application. This is of great benefit to efforts taking place here at Oxford.”

About The Centre for Science and Society
The Centre for Science and Society addresses contemporary issues and problems resulting from emerging technologies that affect society and public policies.

About Stemedica Cell Technologies, Inc.
Stemedica 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@stemedica.com

Stemedica Achieves Major Milestone – Company Receives License to Manufacture Clinical Grade Stem Cells

(Source: September 1, 2009; Stemedica Cell Technologies, Inc.)

Stemedica Cell Technologies, Inc., (“Stemedica”), a leader in adult stem cell research and manufacturing, announced today that it has been granted a license by the State of California’s Food & Drug Branch to manufacture stem cells for human clinical trials. This Drug Manufacturing License recognizes Stemedica as being compliant with California law and the applicable provisions of the Code of Federal Regulations.

From left – Dr. Alex Kharazi, MD, PhD, Vice President Research and Manufacturing for Stemedica is joined by Eugene Helsel (Left), Sr. Director of Quality and Carl Bullen, (Right) Director of Manufacturing in accepting the California cGMP Manufacturing License.
Originally uploaded by Stemedica

“This is an important development for Stemedica,” said Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica. “With this license we become an even stronger worldwide leader within the stem cell industry. Our stem cells and stem cell-derived factors can now be purchased by pharmaceutical and biotech companies, research institutions and medical facilities conducting approved human clinical trials. As more and more organizations get involved with stem cell research and clinical trials, including drug discovery programs, Stemedica’s ability to service their needs becomes a critical asset to the organization and to the industry.”

“This stamp of approval positions Stemedica as one of only a few companies in the world capable of manufacturing and delivering its own unique multiple cell products and factors. The Company also has the ability to custom manufacture for select companies. These dynamic capabilities give us a significant point of advantage in the marketplace.” said Roger Howe, PhD, Executive Chairman for Stemedica.

Stemedica has dedicated significant financial and human resources over the past four years in preparation for securing this license. The government’s rigorous inspection and approval process has included: a comprehensive, in-depth audit of Stemedica’s manufacturing process and procedures; examination of Stemedica’s Quality Systems; interviews with facility management; and an onsite inspection of the facility.

“We’re very proud of the hard work, dedication and professionalism of the team that has made this possible.” stated Maynard Howe, PhD, Stemedica’s Vice Chairman and Chief Executive Officer. “Their experience and expertise has been instrumental in assuring that our facility meets regulatory compliance requirements. With the approval and licensing process behind us we can now focus our efforts on manufacturing the highest quality stem cell products.”

About Stemedica Cell Technologies

Stemedica Cell Technologies, Inc. (www.stemedica.com) is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company has currently filed a pre-IND request with the FDA in preparation of IND submissions for stroke and wound repair. Stemedica is headquartered in San Diego, California.

For more information regarding this Media Release or Stemedica Cell Technologies, contact Dave McGuigan at dmcguigan@stemedica.com.

As released via PRWeb