Healthcare Industry News: AVI BioPharma
News Release - July 10, 2008
Poniard Pharmaceuticals Appoints Janet R. Rea to Vice President, Regulatory Affairs and QualitySOUTH SAN FRANCISCO, Calif., July 10 (HSMN NewsFeed) -- Poniard Pharmaceuticals, Inc. (Nasdaq: PARD ), a biopharmaceutical company focused on oncology, today announced that it has appointed Janet R. (nee Christensen) Rea, MSPH, RAC, as vice president, regulatory affairs and quality.
Prior to joining Poniard, Ms. Rea served as vice president, regulatory affairs and quality at AVI BioPharma. She previously held positions at Targeted Genetics, MDS BioPharma, Immunex (now Amgen) and American Hospital Supply (now Baxter), and also ran her own consulting practice. She has nearly 30 years of ethical drug and biologics industry experience in regulatory affairs, quality assurance, quality control, product development and commercialization.
"Ms. Rea has substantial experience leading to the successful execution of regulatory and quality activities with the FDA and other regulatory authorities," said Ronald Martell, president and chief operating officer of Poniard. "We expect that she will play an important role in preparing our submissions to the FDA to support our targeted commercial launch of picoplatin in 2010."
"I am pleased to join Poniard, which has a well-defined regulatory pathway along which to advance this promising product to market for the treatment of small cell lung cancer," said Ms. Rea. "The product platform potential of picoplatin for multiple formulations and use as a combination product in the treatment of many human cancers is an exciting opportunity."
About Poniard Pharmaceuticals
Poniard Pharmaceuticals, Inc. is a biopharmaceutical company focused on the development and commercialization of innovative oncology products to impact the lives of people with cancer. Picoplatin, the Company's lead platform product candidate, is a new generation platinum therapy with an improved safety profile relative to existing platinum-based cancer therapies. Picoplatin is designed to overcome platinum resistance associated with chemotherapy in solid tumors, and is being studied in multiple cancer indications, combinations and formulations. Clinical trials of intravenous picoplatin include a Phase 3 trial in small cell lung cancer and Phase 2 trials in metastatic colorectal and hormone-refractory prostate cancers, as well as a clinical trial of oral picoplatin in solid tumors. Picoplatin has not been approved by any regulatory authority for use in humans. For additional information please visit http://www.poniard.com.
This release contains forward-looking statements, including statements regarding the Company's business objectives and strategic goals, drug development plans, results of clinical trials and the potential safety and efficacy of its products in development. The Company's actual results may differ materially from those indicated in these forward-looking statements based on a number of factors, including risks and uncertainties associated with the Company's research and development activities; the results of pre- clinical and clinical testing; the receipt and timing of required regulatory approvals; the market's acceptance of the Company's proposed products; the Company's anticipated operating losses, need for future capital and ability to obtain future funding; competition from third parties; the Company's ability to preserve and protect intellectual property rights; the Company's dependence on third-party manufacturers and suppliers; the Company's lack of sales and marketing experience; the Company's ability to attract and retain key personnel; changes in technology, government regulation and general market conditions; and the risks and uncertainties described in the Company's current and periodic reports filed with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 10-K for the year ended December 31, 2007 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2008. Readers are cautioned not to place undue reliance on these forward- looking statements, which speak only as of the date of this release. The Company undertakes no obligation to update any forward-looking statement to reflect new information, events or circumstances after the date of this release or to reflect the occurrence of unanticipated events.
© 2008 Poniard Pharmaceuticals, Inc. All Rights Reserved.
Poniard and Poniard Pharmaceuticals are trademarks of Poniard Pharmaceuticals, Inc.
Source: Poniard Pharmaceuticals
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