Wayne, PA. (April 24, 2007)- CEO & Chairman Jim Walker of Octagon Research Solutions, Inc. , a pioneer and leader in the electronic transformation of clinical R&D in the life sciences industry, today announced the appointment of John Aitken, Ph.D. to managing director, West Coast Operations.
In his new role, John will be responsible for providing regulatory support and developing opportunities on the west coast.
Dr. Aitken brings to Octagon over 14 years in the pharmaceutical industry, with extensive experience and knowledge in the areas of electronic (eCTD) and paper regulatory submissions in the US and Europe, medical writing, and electronic document management. Prior to joining Octagon, Dr. Aitken was senior director, Regulatory Operations at Elan Pharmaceuticals San Diego office where he was directly responsible for compilation of Elan's regulatory submissions in eCTD and paper format for development and marketed products in the US and Europe. Dr. Aitken also led the migration from paper to eCTD for all US submissions and EU MAAs.
This included US INDs to both CDER and CBER and EU centralized MAAs including responses to CHMP questions and post-approval variations. He also led the selection and implementation of Elan's electronic document management, publishing and eCTD compilation systems for production of electronic documents and regulatory submissions in the US and Europe. John Aitken also held positions in Medical Writing and Regulatory Operations at Roche Pharmaceuticals.
Alan Horgan, chief operating officer noted, "John is certainly a welcome addition to our already renowned Regulatory team. His global experience and eCTD knowledge in the U.S. and Europe is what Octagon looks for in recruiting the best talent available in the industry. He has earned a reputation for being a knowledgeable, credible industry leader and he will add a wealth of practical expertise to our west coast presence which will better serve our expanding client list."
John Aitken added, "I am delighted to be affiliated with an organization that has such a strong regulatory reputation. I believe there are significant opportunities to grow Octagon's business on the west coast and I will be focusing my efforts on evangelizing the cross-functional, electronic document and submission process message and developing a leadership position in the regional market."
About Octagon Research Solutions, Inc.
Octagon is a pioneer and leading process-centric solutions provider that offers a suite of regulatory, clinical, process, and IT solutions to the life sciences industry. Octagon synchronizes processes and increases automation to reduce island-to-island inefficiencies within the clinical research and development process. We leverage the power of electronic submissions through cross-functional electronic submission expertise, a holistic process approach, deep domain knowledge, and integrated solutions. Octagon is headquartered in Wayne, PA, with European headquarters in Amersham, UK. For more information please visit www.octagonresearch.com.