Healthcare Industry News: eculizumab
News Release - May 6, 2008
Rib-X Pharmaceuticals, Inc. Appoints Nancy Motola as Senior Vice President of Regulatory AffairsNEW HAVEN, Conn., May 6 (HSMN NewsFeed) -- Rib-X Pharmaceuticals, Inc. ("Rib-X" or the "Company"), a development-stage company focused on the discovery and development of novel antibiotics for the treatment of antibiotic-resistant infections, today announced that Nancy Motola, PhD, has joined the company as Senior Vice President of Regulatory Affairs.
Dr. Motola will be responsible for ensuring that Rib-X's product development and business strategies are well aligned with global regulatory requirements. Her pro-active approach will keep Rib-X on the leading edge of managing the challenging problems posed by today's regulatory environment.
Dr. Motola brings to Rib-X more than 20 years of years of experience in Regulatory Affairs and Quality, 25 years total in the pharmaceutical and biotechnology industry and has been Regulatory Affairs Certified (RAC) by the Regulatory Affairs Professionals Society (RAPS) since 2002. Most recently, Dr. Motola held the positions of Vice- and Senior Vice President, Regulatory Affairs and Quality at Alexion Pharmaceuticals Inc. While at Alexion she built and managed the Company's Regulatory organization and Quality unit while serving in a leadership role in the development, approval, launch and lifecycle management of Soliris® (eculizumab), a novel fully-humanized monoclonal antibody for a rare hematological disease.
Prior to her time at Alexion, Dr. Motola spent seven years in Regulatory Affairs at Bayer Corporation's Pharmaceutical Division, where she led all U.S. regulatory and registration activities encompassing early development, FDA approval and lifecycle management of several investigational and marketed products including Baycol® (cerivastatin sodium) and Adalat® CC (nifedipine). Before joining Bayer, Dr. Motola served as Regulatory Product Manager at Abbott Laboratories, where she was responsible for all U.S. regulatory and registration activities for the Depakote® (divalproex sodium) product line, as well as all other Abbott CNS marketed and investigational products. Dr. Motola received her PhD in Medicinal Chemistry (Pharmaceutical Sciences), and her M.S. in Medicinal Chemistry from the University of Rhode Island, College of Pharmacy.
"Nancy's extensive regulatory experience with Alexion, Bayer and Abbott will be a tremendous asset to Rib-X as our antibiotic programs make their way through U.S. and International regulatory agencies to commercialization," said Dr. Susan Froshauer, President and CEO of Rib-X. "With RX-3341 poised to enter Phase 3, and with multiple programs in Phase 2 clinical trials, enhancing our management team with a person with Nancy's regulatory knowledge was essential to our corporate growth. Nancy's oversight will ensure we are doing everything possible to advance our programs in the most efficient and prudent way."
About Rib-X Pharmaceuticals, Inc.
Rib-X Pharmaceuticals, Inc. is a product-driven small molecule drug discovery and development company focused on the structure-based design of new classes of antibiotics. The Company's underlying drug discovery engine capitalizes on its proprietary high-resolution crystal structure of the ribosome, which performs an essential role in the fundamental process of protein synthesis. Many known, commercially valuable antibiotics bind to the ribosome, including those used to treat both community-acquired and hospital-acquired pathogens. The Company's integrated research strategy, which combines state of the art, proprietary computational analysis, X-ray crystallography, medicinal chemistry, microbiology and biochemistry, allows it to rapidly synthesize new agents designed to avoid typical antibiotic resistance mechanisms. Rib-X's iterative intelligent engine has yielded several distinctive new antibiotic classes. The Company currently has two programs in human clinical trials, the RX-1741 designer oxazolidinone program as an oral/IV agent to treat serious hospital Gram-positive infections and the RX-3341 program, a next generation fluoroquinolone, active against a broad spectrum of bacteria, including methicillin-resistant Staphylococcus aureus. Additionally, the Company has multiple drug discovery programs. The first of these programs is focused on design and development of an orally active macrolide for community use for treatment of skin infections, including those caused by MRSA. The second discovery program is directed towards identifying a new chemical class of antibiotics active against multi-drug resistant Gram negative bacteria.
For more information on the ribosome and the Rib-X mission, please visit the Company website at www.rib-x.com.
Source: Rib-X Pharmaceuticals
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