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Corgentech Appoints Patricia Oto Vice President for Regulatory Affairs and Quality Assurance
Palo Alto, Calif., April 22, 2003 -- Corgentech Inc., a privately-held biotechnology company, announced today that Patricia A. Oto, R.Ph., has been promoted to vice president for regulatory affairs and quality assurance. Ms. Oto was formerly senior director of regulatory affairs and quality assurance for the company.
In her new role, Ms. Oto will lead the company's interaction and liaison with the U.S. Food and Drug Administration, as well as Canadian and European regulatory authorities. She will be responsible for all regulatory communications and filings, as well as Corgentech's compliance with established good clinical, laboratory and manufacturing practices.
"With nearly two decades of experience and a track record of success, Patti has a superior understanding of the regulatory landscape, including all stages of clinical development from pre-IND to post-approval, and extensive knowledge of compliance requirements," said John P. McLaughlin, Corgentech's president and chief executive officer. "We are pleased to have her in this role, which is vital to Corgentech at this point in the company's history as we move our late-stage products, such as CGT003, an E2F Decoy for the prevention of graft failure following coronary and peripheral bypass procedures, through late-stage clinical trials closer to market."
Prior to Corgentech, Ms. Oto was senior director of regulatory affairs at Corixa (formerly Coulter Pharmaceutical) where she managed the regulatory affairs and technical publishing departments, and served as regulatory department head representative for all internal and external company interactions and communications. She was actively involved with the review and launch activities of a Biologics License Application (BLA) for a therapeutic radiolabeled monoclonal antibody and was a member of the joint development committee between Corixa and its marketing partner, GlaxoSmithKline.
Prior to becoming a senior director, Ms. Oto was director of regulatory affairs and quality assurance with responsibility for quality assurance and regulatory affairs departments, including the management of all quality contract vendor relationships for GMP (Good Medical Practice) and GLP (Good Laboratory Practice) compliance.
Before joining Coulter, she held various positions in the regulatory affairs and quality assurance departments at Genentech from 1990 through 1997, including regulatory manager where she maintained global responsibility for all regulatory activities for two approved marketed products. Prior to joining Genentech, she held various positions at Syntex and Summa Manufacturing Corporation.
Ms. Oto holds a B.S. in Pharmacy from the University of New Mexico College of Pharmacy, Albuquerque, New Mexico. She is a registered pharmacist.
About Corgentech Inc.
Corgentech Inc. is a privately-held biotechnology company that is the leader in the discovery, development and commercialization of an exciting and powerful new class of therapeutics called transcription factor decoys or TF Decoys. The company's proprietary technology platform is capable of delivering multiple new product candidates to treat diseases that affect large patient populations in a relatively short period of time. Corgentech is based in Palo Alto, Calif. For more information, visit www.corgentech.com.
| Contacts: | |
| Richard Powers Corgentech |
Kristin Nash WeissCom Partners |
| 650-624-9600 [email protected] |
415-302-7951 [email protected] |
