Affymax Announces Executive Management Promotions.PALO ALTO Palo Alto, city, California Palo Alto (păl`ō ăl`tō), city (1990 pop. 55,900), Santa Clara co., W Calif.; inc. 1894. Although primarily residential, Palo Alto has aerospace, electronics, and advanced research industries. , Calif. -- Affymax, Inc. (Nasdaq: AFFY) today announced the promotions of Anne-Marie Duliege, M.D., M.S., to chief medical officer and Christine Conroy, PharmD., to vice president, Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: "The promotions of Anne-Marie and Christine are a reflection of the significant contributions and leadership each has brought to the advancement and development of our product pipeline, specifically to our lead product, Hematide[TM]," said Robert Naso, Ph.D., executive vice president, Research and Development at Affymax. "We are fortunate to have access to their depth of knowledge and years of experience in their respective fields and look forward to their expanded leadership roles as we grow our business and advance Hematide into Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. and beyond." Dr. Duliege joined Affymax in 2004 as vice president, Clinical, Medical and Regulatory Affairs. Under her leadership, Affymax's lead compound, Hematide, completed Phase 1 and Phase 2 clinical trials phase 2 clinical trial Phase 2 study. See Phase study. and is now poised to enter a Phase 3 clinical program. As chief medical officer, Dr. Duliege will continue to lead the Clinical, Medical and Regulatory Affairs departments and will have responsibility for clinical development of Affymax's pipeline of products. She will also lead strategy development for medical affairs activities, including post-marketing medical support and reporting, and she will continue to oversee the integration of our clinical and regulatory strategies. Dr. Conroy, in her new position as vice president, Regulatory Affairs and GCP GCP Good Clinical Practice GCP Ground Control Point GCP Global Carbon Project GCP Gateway Control Protocol GCP Global Consciousness Project GCP Granulocyte Chemotactic Protein GCP Grand Central Parkway (New York) Compliance, will continue to report to Dr. Duliege where she will represent all Affymax programs and projects to the U.S. and international regulatory agencies regulatory agency Independent government commission charged by the legislature with setting and enforcing standards for specific industries in the private sector. The concept was invented by the U.S. . She will take the lead in developing regulatory strategies for Hematide for development in the U.S. and in coordinating implementation of our regulatory strategies for Hematide with Affymax's partner Takeda Pharmaceutical Company Takeda Pharmaceutical Company Limited (武田薬品工業株式会社 Limited. Dr. Conroy will also oversee our compliance with good clinical practices, or GCP, regulations. Dr. Conroy joined Affymax in 2004 as senior director, Regulatory Affairs and was subsequently promoted to executive director, Regulatory Affairs in January 2006. Under her leadership, Affymax received clearance by the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and European regulatory agencies enabling the company to evaluate Hematide in Phase 2 clinical trials. Most recently, Dr. Conroy was instrumental in discussions with the FDA on the design of the Phase 3 program for Hematide in chronic renal failure chronic renal failure Chronic kidney failure Nephrology A slow decline in renal function, which may be 2º to chronic HTN, DM, CHF, SLE, or sickle cell anemia and, if extreme, leads to ESRD, mandating kidney dialysis; an abrupt decline in renal function may be . About Affymax, Inc. Affymax, Inc. is a biopharmaceutical company developing novel drugs to improve the treatment of serious and often life-threatening conditions. Affymax's lead product candidate, Hematide[TM], is currently in Phase 3 clinical trial stage for the treatment of anemia associated with chronic renal failure and in clinical trials for the treatment of anemia in cancer patients. For additional information, please visit www.affymax.com. This release contains forward-looking statements, including statements regarding the timing, design and results of the Company's clinical trials and drug development program. The Company's actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties, including risks relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc the continued safety and efficacy of Hematide in clinical development, regulatory requirements and approvals, research and development efforts, industry and competitive environment, intellectual property rights and disputes and other matters that are described in the Company's Quarterly Report on Form 10-Q Form 10-Q See 10-Q. filed with the Securities and Exchange Commission. Investors 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 in this press release. |
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