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Conformia Announces Availability of Innovative Pharmaceutical Development Case Study

Collaboration Between Abbott, AstraZeneca, Conformia, Eli Lilly, GlaxoSmithKline and IBM Delivers a Case Study to Support Compan

SUNNYVALE, CA -- (MARKET WIRE) -- 05/13/08 -- Conformia, the market leader of enterprise solutions for product and process lifecycle management (PPLM) for life sciences, today announced the availability of an innovative case study based on a mock drug molecule Acetriptan ("Ace"), designed to help pharmaceutical organizations following the International Conference on Harmonization (ICH) Quality Vision. Scientific, regulatory, quality and information management executives from Abbott, AstraZeneca, Eli Lilly and GlaxoSmithKline co-authored the case study to exemplify how the core principles contained in ICH's Quality Vision guidelines (ICH Q8/Q9/Q10) might be applied to pharmaceutical development programs.

"This case study was designed to enable the pharmaceutical industry's cross-functional senior leadership, including representatives from development, quality, regulatory, IT and commercial operations, to actively engage in discussions with internal and external stakeholders about how to effectively meet quality guidelines," said Lindsay Wylie, Director of Design for Manufacture Program, GlaxoSmithKline. "It is not intended to be prescriptive; instead it should be used as a catalyst for further discussion between industry and agencies now and in the future."

The ICH guidelines Q8/Q9/Q10 cover pharmaceutical development, quality risk management, and quality systems (knowledge management). They offer innovative, high-level approaches to enhancing pharmaceutical quality over the lifecycle of the product. To date, there have been limited published examples of how companies might effectively implement the guidelines. This led to the establishment of a Cooperative Research and Development Agreement (CRADA) between Conformia and the U.S. Food & Drug Administration (FDA) and the launch of the CMC-IM working group, a not-for-profit industry consortium focused on creating examples of implementation of ICH Q8/Q9/Q10. The Ace Case Study, is the first deliverable from the CMC-IM working group. Other case studies focusing on ICH Q10 and a biotech example are underway.

Mike Hannay, Product Development Director from AstraZeneca, points out that, "Together, leaders from the top pharmaceutical companies debated and shared views on the core principles in ICH's quality guidelines and created a truly valuable example for any pharmaceutical development team to reference as they implement ICH guidelines." The discussions that led to the case study took place from July 2007 to February 2008 and culminated with input from regulators and industry teams comprised of cross functional representatives at a recent Summit held in Washington, DC.

John Berridge, one of the working group's key facilitators, explained the approach the working group took, "We reviewed the chemistry, manufacturing and control aspects for developing a drug alongside how best to implement knowledge management for the future. Then, using a fictitious drug 'Acetriptan' or ACE, we described a science and risk-based approach to drug development and manufacture exemplifying the concepts of ICH Q8/Q9/Q10. Ultimately, the case study illustrates the scientific thinking required to enable the paradigm shift that will encourage more facile implementation of ICH guidelines across companies."

"The goal of the CMC-IM working group is to make this case study the first of many deliverables that will help create a more collaborative industry and regulatory environment as organizations enter a new state of pharmaceutical quality in the 21st century," said Anjali Kataria, Founder and CMO of Conformia and leader of the consortium. "The case study itself, the organizations who contributed to it, as well as the individuals who read it, will continue the working group's mission which is to accelerate understanding of global regulatory perspectives on the ICH vision. As we continue to climb forward in this new era of pharmaceutical development, risk management and knowledge management these kinds of dialogs and documents will be essential to our success."

The case study is publicly available for download at www.conformia.com.

About Conformia

Conformia Software provides product/process lifecycle management (PPLM) software solutions to regulated process industries including life sciences and beverage alcohol. Conformia's web-based enterprise software can provide significant savings to companies as well as major product quality improvements, reduction in development program timelines, better preparation of knowledge rich submission, more effective management of outsourcing partners and improved technology transfer. As a company, Conformia remains a thought leader in addressing the most pressing issues facing pharmaceutical development teams across the globe such as implementation of ICH Quality vision.

For more information or to download the ACE Case Study go to: www.conformia.com.

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