Raptor Pharmaceutical Corp., announced today that it has named Kathlene L. Powell to the newly created position of VP, Quality Operations.
Ms. Powell will be responsible for overseeing Quality Assurance and Quality Control (QA/QC) for Raptor, as well as leading Chemistry and Manufacturing Controls (CMC) related issues and activities, including the preparation of documents for regulatory submission. In addition, Ms. Powell will manage the coordination and control of outsourced manufacturing and the release of drug product for Raptor's clinical programs and planned commercial products. Ms. Powell will report to Ted Daley, President of Raptor Therapeutics, Raptor's clinical development division.
Mr. Daley stated, "We are thrilled that Kathy has agreed to join us full time at Raptor. Kathy has been working with us as our principal quality and manufacturing consultant in our nephropathic cystinosis program from the start, and has been our FDA/EMA liaison for CMC-related issues over the last three years. She has proven herself as a highly-valued member of our development team at Raptor, and her intimate knowledge of our nephropathic cystinosis program will provide seamless continuity as we near completion of our DR Cysteamine Phase 3 clinical trial and look ahead to our planned submission of registration documents later this year to the FDA and EMA. Moreover, Kathy's deep experience overseeing contract manufacturing organizations will be integral to our plans to scale up our CMC operations towards the potential commercial launch of DR Cysteamine for nephropathic cystinosis in 2012."
Prior to joining Raptor full time, Ms. Powell worked for Pacific BioDevelopment, LLC, a San Francisco-based biotechnology consulting group, where she most recently held the position of Vice President, Quality. During her nine years at Pacific BioDevelopment, Ms. Powell executed numerous quality and control initiatives for their client companies, including the development of CMC regulatory strategies and preparation of CMC sections of regulatory submissions; the selection and management of CMOs for the development, manufacture, and testing of drug substances and drug products; and the evaluation of QC test methods, QC data, stability programs, validation protocols and validation reports.
Previous to her tenure at Pacific BioDevelopment, Ms. Powell's over 20-year career in biotechnology was highlighted by quality control and validation experience at such biopharmaceutical companies as Diosynth-RTP (formerly CBSI, Inc.) and Genentech, Inc. (a member of the Roche group, SIX: RO, ROG; OTCQX: RHHBY). While at Diosynth-RTP, Ms.
Powell was involved in establishing and implementing the company's Pre-Approval Inspection (PAI) readiness program and hosted the facility's first FDA PAI in May 2001. Among her duties at Genentech, Ms. Powell managed the Biochemical Manufacturing Validation group and supervised the Quality Control Chromatography group performing chromatography and cleaning validation testing as well as assay development, transfer, and validation.
Ms. Powell holds an M.S. in biochemistry from the University of Missouri and a B.A. in Chemistry, from Doane College, Crete, Nebraska, where she graduated Summa Cum Laude.