Healthcare Industry News: SUSTIVA
News Release - January 8, 2013
AtheroNova Names New Clinical Affairs OfficerJoan Shaw Named to Clinical Post
IRVINE, Calif., Jan. 8, 2013 -- (Healthcare Sales & Marketing Network) -- AtheroNova Inc. (AHRO), a biotech company focused on the research and development of compounds to safely regress atherosclerotic plaque and improve lipid profiles in humans, today announced that Joan E. Shaw, MT (ASCP), SCC has joined the Company as Senior Director of Clinical Operations.
"We are pleased to announce that Joan Shaw has recently joined AtheroNova's management team, adding another integral part to the staffing necessary to continue to work toward our entry into clinical trials in the coming months," stated Thomas W. Gardner, CEO of AtheroNova. "Joan's extensive experience in the risk management and quality assurance of clinical trials along with her Lean Six Sigma Black Belt will add to the core team that we have assembled at this stage of our development. Our recent additions to the team bring deep experience in cardiovascular clinical trials without adding significantly to our current cash burn rate moving forward."
"Joan's tremendous experience with clinical operations in general and the ASTEROID trial in particular while at AstraZeneca translates to real value as we move forward with AHRO-001 in lipid modulation and potential plaque reversibility," commented Mark Wedel, M.D., Chief Medical Officer of AtheroNova. "We are looking to capitalize on our pre-clinical success in the development of AHRO-001 and we are rapidly moving forward toward entry into Phase 1 clinical trials."
Ms. Shaw brings more than 20 years of drug development experience leading to successful NDA submissions and product launches for leading organizations such as AstraZeneca and DuPont Pharmaceuticals.
Between 2002 and 2012, she served in multiple areas of AstraZeneca ultimately serving as Executive Director of Clinical Operations in the Wilmington, Delaware headquarters. For the last two years, Ms. Shaw was the Executive Director of Continuous Improvement, leading a team of Master Black Belts to define efficiencies in the drug development process. Her group was responsible for identifying, planning and implementing critical continuous improvement projects across R&D to deliver value and improve productivity while introducing and integrating Lean Six Sigma and Kaizen methodologies within AstraZeneca's global R&D division.
As Executive Director of US Study Delivery she provided direct oversight and life cycle management guiding over 1,500 researchers that conducted and supported 100-150 Phase I- Phase IV studies in the Cardiovascular, CNS, Respiratory, Inflammation, Oncology, GI and Pain areas.
She was also the Clinical Project Director for the $3B dollar product Seroquel, and led the development and submission of 4 new indications and a Sustained Release (SR) formulation for that drug. She managed a $190M clinical budget and 250 deployed staff in 4 global locations to deliver an integrated global clinical plan for Seroquel.
From 1982 through 2002, she led the Discovery and Development Project Management Department at DuPont Pharmaceuticals which conducted important research, development and delivery of pharmaceuticals and radiopharmaceuticals that are used in the treatment of HIV, cardiovascular disease, central nervous system disorders, cancer and inflammatory diseases. She was responsible for planning the strategic clinical development of several new drugs including ReVia for alcoholism, Cozaar, and SUSTIVA to fight HIV infection. As Project Management Director for a new indication for ReVia (naltrexone), she had direct responsibility for the approval and launch of the ReVia alcoholism indication in the US and Canada and 8 additional countries, as well as the approval of new formulation and packaging in an additional 13 countries.
Ms. Shaw holds a Master of Science (Clinical Chemistry), Bachelor of Science (Medical Technology) and a Lean Six Sigma Black Belt, and is a licensed Medical Technologist. She is a co-patent holder for the new indications for Seroquel.
AtheroNova Inc., through its wholly-owned subsidiary, AtheroNova Operations, Inc., is a biotechnology company focused on the discovery, research, development and licensing of novel compounds to reduce or regress atherosclerotic plaque deposits and to safely improve lipid profiles in humans. In addition to its lead compound AHRO-001, AtheroNova plans to develop multiple applications for its patents-pending therapies in market sectors that include: Cardiovascular Disease, Stroke, Peripheral Artery Disease, Dementia and Alzheimer's and Erectile Dysfunction, all of which have been linked to atherosclerosis. Atherosclerosis and its related pharmaceutical expenses for these indications cost consumers more than $41 billion annually in the United States alone. For more information, please visit www.AtheroNova.com.
This news release includes "forward-looking statements" within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of AtheroNova's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements.
Risks and uncertainties include but are not limited to, general industry conditions and competition; significant fluctuations in expenses associated with clinical trials, failure to secure additional financing, the inability to complete regulatory filings with the Food and Drug Administration, general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; AtheroNova's ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of AtheroNova's patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions.
AtheroNova undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in AtheroNova's 2011 Annual Report on Form 10-K and the company's other filings with the Securities and Exchange Commission (SEC) available at the SEC's Internet site(www.sec.gov).
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