Adjust Font Size:

Press Releases

Edmund Mickunas Named Vice President of Regulatory for Advanced Cell Technologies

WORCESTER, Mass.-- (BUSINESS WIRE)--Advanced Cell Technology, Inc. (OTCBB:ACTC.PK-News), announced today that it has hired Edmund Mickunas as Vice President Regulatory. Mr. Mickunas will be in charge of spearheading the company's effort to translate its cutting edge research into FDA approved therapies ready for clinical trials. Specifically, Mr. Mickunas will work with Dr. Robert Lanza and ACT's Development Team to finalize and submit an IND for the RPE program to the FDA for approval to commence a Phase I Clinical Trial. Mr. Mickunas has over 28 years of experience across a breadth of disciplines including the biotechnology, medical device and pharmaceutical fields. During his career he has worked in preclinical program development, clinical affairs, regulatory affairs/compliance and quality assurance, and has worked closely with all disciplines involved in product development. Prior to joining Advanced Cell, Mr. Mickunas was Executive Director, Regulatory Affairs and Quality Assurance for Applied Genetic Technologies Corporation, a privately held gene therapy and genomics-focused biotech company.

Before joining Applied Genetic Technologies, he was Vice President, Regulatory, Quality and Clinical Affairs for Oragenics, a company engaged in the development of vaccines, biologics and pharmaceuticals. Mr. Mickunas was previously Senior Director of Regulatory Affairs and Compliance for Control Delivery Systems, Inc., where he managed the submissions of IND filings, among other responsibilities. He also held senior regulatory positions at Bioheart, Inc., Cytomed and Del Laboratories. He received his B.S. and pursued graduate studies in human biochemistry at Fairleigh Dickinson University, as well as a Masters Degree from Fairfield University.

"We are pleased that Ed has elected to join us as his extensive regulatory expertise and experience in filing IND's will be invaluable as we prepare to file our first IND with the FDA in the second half of this year,” said William M. Caldwell IV, Chairman & CEO of Advanced Cell. "Ed's most recent assignment focused on retinal programs. He has strong relations with the Ophthalmology Departments of our clinical advisors as well as recent first hand experience with processing retinal IND applications through the FDA. We look forward to his input and to his role in helping to move our stem cell therapeutic programs into and through the clinical process.”

Before joining Applied Genetic Technologies, he was Vice President, Regulatory, Quality and Clinical Affairs for Oragenics, a company engaged in the development of vaccines, biologics and pharmaceuticals. Mr. Mickunas was previously Senior Director of Regulatory Affairs and Compliance for Control Delivery Systems, Inc., where he managed the submissions of IND filings, among other responsibilities. He also held senior regulatory positions at Bioheart, Inc., Cytomed and Del Laboratories. He received his B.S. and pursued graduate studies in human biochemistry at Fairleigh Dickinson University, as well as a Masters Degree from Fairfield University.

"I look forward to joining ACT at such an exciting time in the Company's development,” said Mr. Mickunas. "I am impressed that despite a challenging economic and political environment, the Company has been able to acquire and develop such a promising regenerative medicine platform and to advance it to an industry leading stage of clinical development. I feel very privileged to be working with Dr. Lanza, a well respected leader in the field of regenerative medicine and Mr. Caldwell, whose financial experience is setting the Company on sound footing to make the clinical development of these very significant biotechnology platforms possible.”

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc. is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words "will,” "believes,” "plans,” "anticipates,” "expects,” "estimates,” and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the company's periodic reports, including the report on Form 10-QSB for the quarter ended September 30, 2007. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the company's management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change.

Press Contact


Michael Wachs
(212 )732-4300

Download PDF


08.10.09.pdf

To view PDF Files, you must have Acrobat Reader.

Download Adobe Acrobat