FDA’s Christine Moore, Ph.D. to Keynote Life-Science MES Congress

YARDLEY, PA. and WOBURN, MA., July 15, 2009  — Axendia, Inc., a trusted advisor to Life-Science Executives on Business, Technology and Regulatory strategies, and CBI Research Inc., a provider of live and electronic conferences for senior-level executives in the pharmaceutical and biotech industries, today announced that Christine Moore, Ph.D. Deputy Director,Office of New Drug Quality Assessment, CDER, FDA will provide the Keynote Address at the 4th Annual Manufacturing Execution System Congress.

Dr. Moore’s address will provide an Update on the Agency’s Implementation of Quality by Design including:

  • History of Quality-by-Design (QbD) and update on ICH guidance and major initiatives
  • FDA experience with New Drug Applications (NDAs) including the CMC Pilot program
  • Considerations for QbD submissions and applications
  • Scientific and regulatory gaps in implementing QbD

“FDA initiatives such as Quality by Design (QbD) and Total Product Lifecycle (TPLC) management provide a springboard for Life-Science organizations to speed innovation, improve quality and lower costs while supporting compliance to regulatory requirements,” commented Daniel R. Matlis, returning Congress Chair and President of Axendia.  “Manufacturing Execution and other Operational systems play a foundational role on the road to QbD and TPLC, enabling forward thinking Life-Science Organizations to meet and surpass today’s challenges,” added Matlis.

“We are delighted to have leading industry companies, including Eli Lilly, Pfizer, Wyeth, Merck, Abbott, Bristol-Myers Squibb, Cordis-Johnson&Johnson, and Biotronic sharing experiences and best practices at the congress” commented Sharon Langan, Senior Program Manager for The Center for Business Intelligence. “This is the premier event for lean manufacturing and manufacturing execution systems in the pharmaceutical, biotech and medical device industries,” added Langan.

Constituents at the congress discuss current approaches to maximize MES returns and improve quality, manufacturing efficiency, and control while meeting increasing regulatory requirements
For detailed information about the 4th Annual MES for Life Sciences Congress visit

About CBI Research, Inc.
Founded in 1994 in Massachusetts, CBI Research, Inc. is dedicated to developing market-driven, unbiased conferences in pharmaceuticalsbiotech, medical devices, risk and insurance and managed care markets. CBI Research, Inc. offers conferences and summits that serve senior executives and government officials by providing a unique platform for highly focused content and presentation. As a delegate, speaker or sponsor, you receive timely information on the latest investment opportunities, business strategies, domestic and international regulatory issues, operations and applied technologies. Our events provide you with concrete, real life examples that you can begin to apply at your organization immediately for significant impact on costs and revenue. Plus, there are extensive opportunities for networking and discussion with senior policy and decision makers. Additional information on CBI Research can be found at

About Axendia, Inc.
Axendia is a leading analyst and strategic advisory firm focused on the Life-Sciences and Healthcare markets. We provide trusted advice to Life-Science Executives on Business, Regulatory and Technology issues. Axendia professionals offer a unique combination of deep hands-on industry experience coupled with strategic vision. Axendia serves the complete Life-Science Eco-System including Life-Science Organizations, Technology & Service Providers and the Investment community. Our clients range from startups to Fortune 100. We contribute to our client’s success by providing long-range visibility and helping them navigate the ever-changing landscape in the Life-Sciences and Healthcare markets. For more information, visit
www.axendia.com or contact us at info@axendia.com. To stay informed on Industry trends, read Axendia’s Life-Science Panorama, a Journal for Industry Executives, at http://lsp.axendia.com

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