NeoStem Announces the Addition of Jonathan Sackner-Bernstein, MD, Past FDA Official, as Vice President, Clinical Development and Regulatory Affairs (NBS)

NeoStem, Inc. (AMEX: NBS; Stock Twits: $NBS) is engaged in the development and manufacturing of cell-based therapies in the U.S.  Its January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") is central to the Company's strategic mission of capturing the paradigm shift to cell therapy.

 The Company announced the addition of Jonathan Sackner-Bernstein, MD, FACC to Neostem as the Vice President of Clinical Development and Regulatory Affairs.

He brings to the Company over 20 years of experience as a clinical cardiologist and medical researcher with leadership in healthcare management. Dr. Sackner-Bernstein will join the team to advance Amorcyte's PreSERVE AMI Phase 2 trial in addition to providing regulatory support for NeoStem's product pipeline.

 

NeoStem's Chief Medical Officer Dr. Andrew Pecora commented, 

"Jonathan's experience at the FDA and with Clinilabs, coupled with his experience as a cardiologist, make him a perfect choice to develop Amorcyte's AMR-001, in part by leveraging his relationships with clinical investigators and leaders in the cardiology community. In terms of our Amorcyte product under development, a CD34+ cell for the preservation of heart muscle function after a large AMI, we continue to see data in the competitive landscape that supports our notion that this is the right strategy for success. As we are accruing our Phase 2 trial we are noting the incidence of low ejection fraction after a ST segment elevation myocardial infarction. Even with advances in the standard of care that have reduced the adverse events associated with an AMI, a meaningful percentage of patients are being found to have a left ventricular ejection fraction of less than 45 percent several days after an AMI. This is the group at risk for adverse events that AMR-001 is being tested on to determine if it will preserve heart muscle function to prevent adverse events."

Dr. Sackner-Bernstein's past experience includes servings as the Associate Center Director for Technology and Innovation at U.S. Food and Drug Administration's Center for Devices and Radiological Health from 2008 to 2011, and serving as Chief Medical Officer at the clinical research organization, Clinilabs, where he established a Phase 1 research unit from 2006 to 2008. From 1993 to 2003, he was an assistant professor of medicine at the Columbia University College of Physicians and Surgeons.

His academic accomplishments include "contributions to medical therapy of heart failure and patients following heart attack as well as leadership in changing the paradigms of drug development in heart failure. Dr. Sackner-Bernstein also founded ExVivos, LLC, a privately-held company focusing on engineering tissues and organs from human cells for the development of drugs, vaccines and biological products. Dr. Sackner-Bernstein earned his B.S.E. from the Moore School of Electrical Engineering at the University of Pennsylvania and his M.D. from Jefferson Medical College. He completed training in Internal Medicine and Cardiology at Mount Sinai Hospital in New York. In addition, he holds Secret Clearance from the U.S. government."

Dr. Robin L. Smith, Chairman and CEO of NeoStem, stated,

"Jonathan's clinical experience as a cardiologist, and work at the FDA and Clinilabs, make him a perfect addition to the NeoStem senior management as we focus our resources to execute on our operational business plan which includes developing our most mature asset, AMR-001, enrolling patients in the Amorcyte Phase 2 trial and building our contract manufacturing business, Progenitor Cell Therapy (PCT). NeoStem has successfully repositioned the company through the acquisitions of both PCT and Amorcyte, effectively transforming our company to one that is focused on the development of novel cell based therapeutics and, as such, management is focused on execution to build investor confidence and bring value to our shareholders."

 Read more at Neostem.com. 

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