LEXINGTON, Ky., Jan. 19 /PRNewswire/ -- Intranasal Therapeutics, Inc. (ITI) announced today that Timothy I. Mitchell has been appointed Vice President of Quality and Regulatory Affairs. He will be responsible for all aspects of quality and compliance management related to the manufacturing of ITI’s nasal drug products, from clinical supplies to full-scale commercial production.
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Mr. Mitchell has 25 years of experience in the pharmaceutical, biotechnology and medical device industries. He has in-depth knowledge of design, construction, start-up and process validation for aseptic manufacturing facilities, as well as the management of quality and compliance support from the preclinical to the commercial launch stage. Fifteen of the 18 new manufacturing operations he supported or supervised were sterile/aseptic facilities.
“Tim Mitchell brings to ITI a wealth of relevant experience across a broad range of technical areas, that will greatly benefit the continued development of our capability to produce sterile nasal drug products,” said John C. Carlisle, ITI’s President and Chief Executive Officer. “We look forward to gaining the benefit of Tim’s substantial expertise as we continue to finalize the validation of our plant, move our pipeline forward and prepare our products for late-stage clinical trials and commercial production.”
ITI’s nasal spray manufacturing facility is dedicated to the formulation, filling and assembly, and packaging of aseptically filled, sterile nasal spray drug products for clinical studies, initial registration with the Food and Drug Administration (FDA), and commercialization. Substantially completed and scheduled for further expansion in 2006, the Lexington, Kentucky-based facility is designed to fully comply with the FDA’s current Good Manufacturing Practices (cGMP) and equivalent European Union standards. ITI believes the plant is the only commercial-scale aseptic nasal filling facility of its kind in the United States.
Mr. Mitchell comes to ITI from Lifenet, Inc. in Virginia, where as Vice President, Quality Assurance & Regulatory Affairs he oversaw the operations and related regulatory issues supporting human tissue and tissue-based medical device products. Previously, he worked as Senior Director, Pharmaceutical Regulatory Compliance at Fluor Corporation, where he advised companies such as Bristol-Myers Squibb, Abbott Laboratories and Amgen on the design, construction, operations and compliance management involving new facilities in the United States and Puerto Rico.
Between 1998 and 2001, Mr. Mitchell was Divisional Director, Quality & Regulatory Affairs for pharmaceuticals at Eastman Chemical Company. Previously he served as Director of Quality for Alpha Therapeutic Corporation, where he restructured four validation departments supporting the manufacturing of plasma-derived biological products. Prior to that, Mr. Mitchell was Senior Manager, Manufacturing Technical Operations for Nabi Biopharmaceuticals and Manager, Quality Assurance & Validation for Systemix, Inc., where he managed U.S. and European validations of aseptic manufacturing plants. A graduate of Purdue University in genetic biology, Mr. Mitchell also worked for 11 years at Eli Lilly and Company in various manufacturing and quality assurance positions.
About ITI
Intranasal Therapeutics, Inc. (ITI) is a specialty pharmaceutical company focused on developing innovative nasally delivered pharmaceutical products, with a particular focus on drugs to treat pain and central nervous system disorders for which there is proven, unsatisfied consumer need. The Company currently has four products in its clinical development pipeline, with several others in formulation or preclinical development. ITI’s goal is to become a leader in the field of intranasal pharmaceuticals by applying formulation expertise across a broad range of therapeutic areas to create new and differentiated products that improve safety, efficacy and convenience for patients, caregivers and health care professionals.
Contact John C. Carlisle President and CEO Intranasal Therapeutics, Inc. Tel.: 859-252-5080 Ext. 226 Fax: 859-252-7280 jcarlisle@intranasal.com
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CONTACT: John C. Carlisle, President and CEO of Intranasal Therapeutics,Inc., +1-859-252-5080, ext. 226, or fax, +1-859-252-7280, orjcarlisle@intranasal.com
Web site: http://www.intranasal.com/
