Patheon, Inc. has made several executive management changes with the following appointments: Eric W. Evans as chief financial officer, Paul M. Garofolo as senior vice president and chief information officer, Warren A. Horton as vice president Global Quality Operations, and Doaa A. Fathallah as senior vice president, general counsel Europe and Global Pharmaceutical Development Services.
           
Wes Wheeler, Patheon's chief executive officer and president said, "Eric Evans will be responsible for managing the company's financial function, and will work with me and our executive team as we create strategic and operational improvements in the business."
   
Mr. Evans has more than 24 years of experience in various financial leadership roles in the pharmaceutical industry following a significant career in the steel industry. He joins the company from Novartis AG. He has experience in all aspects of finance as well as extensive operating, analytical, leadership, and business development experience.
   
"Paul Garofolo is a proven leader with a track record of developing and stewarding long-term global Information Technology strategies and implementing new applications and processes. I am confident he will lead Patheon to cost effective global IT platforms. Paul will have responsibility for Information Technology globally including the development and implementation of a five year global IT Master Plan for Patheon. In addition he will assume responsibility for 'The Patheon Advantage', Patheon's lean six sigma excellence program," said Mr. Wheeler.
   
Mr. Garofolo has 14 years of experience in IT and management consulting most recently with Valeant Pharmaceuticals where he served as chief information officer. He has led all aspects of global IT organizations including development and implementation of long-term IT strategies as well as implementation of new applications and processes.
   
"Doaa Fathallah will be responsible for all legal matters for Europe and Global Pharmaceutical Development Services," Mr. Wheeler continued. Ms. Fathallah joins the company from Valeant Pharmaceuticals International where she was general counsel Europe, Middle East and Africa (EMEA) and was responsible for all legal matters in the EMEA region. She also has extensive experience in all aspects of corporate and business law from her private practice where she represented privately held and publicly traded companies.
   
"Warren Horton will be responsible for establishing a new Quality System to be consistently applied at all Patheon sites. He will also ensure that the company meets all regulatory requirements for quality and compliance," Mr. Wheeler said. Mr. Horton has more than 10 years of experience in the pharmaceutical industry. He joins the company from DSM Pharmaceuticals, Inc. where he was responsible for quality assurance and regulatory affairs. In addition he has experience dealing with a large variety of dosage forms, efficient production and quality control and assurance in a variety of liquid and semi- solid topical products.
   
"I am delighted to welcome these executives to the Patheon leadership team. One of my near-term priorities has been to strengthen and rebuild the executive team for Patheon. These individuals bring proven track records, expertise and strong leadership," Mr. Wheeler concluded.

AstraZeneca received approval from the FDA for Seroquel for the maintenance treatment of patients with bipolar I disorder, as adjunct therapy to lithium or divalproex. Seroquel is approved by the FDA for the treatment of schizophrenia, and both depressive episodes in bipolar disorder and acute manic episodes associated with bipolar I disorder.
   
The FDA approval was based on two multicenter, randomized, double-blind, placebo-controlled trials that evaluated Seroquel when used as an adjunct therapy to lithium or divalproex in the maintenance treatment of adult patients with bipolar I disorder. The study design included a 12 to 36 week stabilization phase, which was followed by a longer-term, randomized, double-blind treatment phase that had a mean duration of exposure of 213.2 days for Seroquel and 152.4 days for placebo.
   
The primary endpoint, which was time to recurrence of a depressive, manic, or mixed mood event, was significant for Seroquel compared with placebo in both studies. Study results indicated that patients treated with Seroquel plus lithium-or-divalproex had a risk reduction of 70% relative to those treated with placebo plus lithium-or-divalproex for time to recurrence of a mood event. This reduction in risk was significant for both recurrence of manic episodes and depressive episodes. The proportion of patients who relapsed when treated with Seroquel was 19% versus 50% of patients on placebo.

West Analytical Services LLC has introduced a testing platform to help mitigate the risks associated with testing pulmonary and nasal drug products and their delivery devices. The company’s analytical services for pulmonary and nasal drug products include early-stage development, clinical development and post-product launch stages for pharma, biopharma and medical device clients. West provides testing for: Metered Dose Inhalers (MDIs), Dry Powder Inhalers (DPIs), nasal and oral sprays, and nebulizers at its FDA-registered, cGMP lab in Lionville, PA.
   
“Moving pulmonary and nasal drug products from early-stage development to the market is challenging for pharmaceutical, biopharmaceutical and medical device companies,” said Fran DeGrazio, vice president, marketing and strategic business development. “The challenges include testing the drug product and delivery device. Companies may not have a proven device selection process in place and may not have validated laboratory methods or instruments required to test the drug product and the device. Any misstep along the way runs the risk of costly project delays.”