Pharmaceutical Executive Europe - May 2008 - (Page 8)

8 News & Analysis May 2008 Pharmaceutical Executive Europe NICE responded to the judgement by explaining that it will review its findings but was at pains to remind people that the ruling does not necessarily mean that the drugs will become available. Furthermore, Andre Dillon, chief executive of NICE, said that the ruling could result in making the approval process slower and more complicated. Europe and India shake hands on safety European and Indian healthcare organisations have joined forces to improve the quality and safety of medicines. The European Directorate for the Quality of Medicines and HealthCare (EDQM) has announced that is has reinforced its relationship with the Ministry of Health of India and the Indian Pharmacopoeia Commission (IPC). The EDQM and Indian authorities have worked closely together since 2002, but they have now identified several potential areas of collaboration including elaboration of chemical and herbals monographs; development of joint inspections of manufacturing sites under the framework of the European Pharmacopoeia procedure of certification; promotion of common training activities in the pharmacopoeial field; scientific cooperation by inviting pharmaceutical scientists to the EDQM; facilitation of information exchange; and observer status for the European Pharmacopoeia to the Indian Pharmacopoeia Commission. Drugs Controller General of India, Dr Surinder Singh, has said that he looks forward to working with the European agency. “We can exchange our scientific expertise and work together on a variety of activities that will benefit all consumers of medicines in our respective countries.” www.edqm.eu ON THE MOVE Dr Dimitri Goundis has been appointed project director of clinical development at Anavex Life Sciences Corp (Switzerland). Dr Goundis will establish a clinical development team as well as select and manage the contract research organisations that will work with ANAVEX to move its drug candidates through clinical trials in preparation for submission to the FDA and other regulatory agencies. Dr Goundis has more than 20 years’ experience in the management of clinical trials, including leadership positions at Speedel AG, The Medicines Company and Roche. Anavex plans to enter human clinical trials with its lead Alzheimer’s compound within the next 12 months. John Rogers has been appointed director, process solutions, for Octagon Research Solutions Inc (US). Mr Rogers will be responsible for leading Octagon’s Process Consulting team, supporting the development, execution and delivery of premiere consulting services across global engagements. Prior to joining Octagon, Mr Rogers served as director, Regulatory Services as well as director, Enterprise and Strategic Operations Solutions at Stelex. Trisha Dowling has joined Biomatrica (US) as vice president of sales and marketing. Prior to joining Biomatrica, Ms Dowling served in the same role at Continental Lab Products, a division of Pelican Life Sciences where she was responsible for direct sales, global marketing, product commercialisation and business development. Biomatrica’s interim vice president of sales and marketing, Jim Johnson will continue to serve as an advisor on the Business Advisory Board. MacroGenics Inc (US), a private biotechnology company focused on the development of products to treat autoimmune disorders, cancers, and infectious diseases, has announced the appointments of Dr Jean-Christophe Tellier as executive vice president and chief commercial officer and Mr James Karrels as vice president and chief financial officer. Dr Tellier joins MacroGenics after 20 years in commercial development at Novartis. Mr James Karrels has been at Jazz Pharmaceuticals, Inc. since 2005, most recently serving as executive director of finance. Nancy Motola, PhD, has joined Rib-X Pharmaceuticals, Inc (US) as senior vice president of regulatory affairs. 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. WIN WITH DHL HEALTHCARE. Take part in our latest online survey today for your chance to win a stylish iPod Nano! Just visit: Sponsored by: www.dhl-healthcare.com http://www.edqm.eu http://www.dhl-healthcare.com http://www.dhl-healthcare.com

Table of Contents for the Digital Edition of Pharmaceutical Executive Europe - May 2008

Pharmaceutical Executive Europe - May 2008
Contents
From the Editor
News and Analysis
Calendar
Rising in the East
Use Your Strategic Discretion
A Blueprint for Success
Market Access and the Patient
Activating Effective Product Differentiation
What Doctors Want
IC Success in Four Steps

Pharmaceutical Executive Europe - May 2008