FROM THE EDITOR
Editor's Message Dear Reader,
Welcome to the March/April issue of Pharmaceutical Outsourcing. My colleague, John Essex, has left his post to pursue exciting opportunities, and we wish him all the very best in his endeavors! As a guest editor for this issue, I am revisiting the fast-paced world of pharmaceutical research and development—a world that I admire for its ability to combine scientific innovation with the intricacies of business in a global system of checks and balances.
North American and European pharmaceutical companies are increasingly outsourcing specific stages of their drug development cycles—ingredients processing and injectables top the lists, and overall, clinical research and packaging are in high demand. Biomanufacturing has overcome obstacles to become more globally accessible. Strategic, targeted therapeutic development, production, and licensure are gaining traction—specialized drug targets, mechanisms of actions, and routes of administration are being identified, qualified, and launched on the global stage.
The domain of targeted therapeutics is ramping up the focus on patient-centric quality and results. In this issue, J. Michael Maher, MS, Executive Director of U.S. Regulatory Policy at Pfizer, discusses the importance of patient data regarding disease symptoms and how they translate to aspects of care and function. Jilla Boulas, a regulatory consultant, offers advice for handling clinical manufacturing and control (CMC) changes, and the following statement underlines the principles of targeted therapy development: “Developing a product is a well-planned journey that takes into account the influence of scientific, economic, and human factors.”
We certainly have a busy season upon us! The American Association for Cancer Research (AACR) Annual Meeting will be held in Philadelphia, PA, USA, April 18-22, and is sure to bring exciting news in areas such as cancer immunology and pediatric cancer therapy. At around the same time, April 21-23, the INTERPHEX annual meeting will be held in New York, NY, USA. This year, the Rockwell Automation Center for The Connected Enterprise will be offering educational sessions on remote manufacturing, remote monitoring, data analytics, and more.
These two industry events will provide an incredible wealth of knowledge on drug therapy trends, globalizing manufacturing protocols, streamlined data management, and more. We hope to see you there!
Thank you for allowing Pharmaceutical Outsourcing to be an integral part of your outsourcing knowledge journey. Sincerely,
Emilia Raszkiewicz
Emilia Raszkiewicz is managing editor, American Laboratory
eraszkiewicz@comparenetworks.com
Pharmaceutical Outsourcing | 2 | March/April 2015
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