Conformia Announces Design Suite for Pharmaceutical Product/Process Operations

Market Wire, July, 2008

Conformia, the market leader of product and process lifecycle management (PPLM) solutions for life sciences, today introduced the Conformia Design Suite, a Web-based software solution that automates the design of new drugs during the lab scale environment. The Design Suite completes Conformia's Product and Process lifecycle management offering for Pharma by providing full capabilities from Lab to Launch. Companies will be able to reduce cycle time, cost, and risk across the multi-year and multi-site global development lifecycle. For the first time, using the Conformia Design Suite, chemical, pharmaceutical and biologics teams of scientists can leverage a centralized knowledge repository to view, share and store information, as well as automate experiment test runs. As a result, companies gain greater control and design of experiments, and can begin implementing the ICH Quality Vision.

"With the introduction of the Conformia Design Suite, companies can achieve new levels of collaboration and efficiency," said Joe Prang, CEO of Conformia. "Conformia continues to set standards in automated, Web-based solutions that simplify the design, development and transfer of knowledge in pharmaceutical design."

The Conformia Design Suite offers a breadth of features around the early design of drug experiments, enabling teams from various divisions of the enterprise to collaborate, increase knowledge regarding why certain processes were followed and assess decisions made in the overall process. The Design Suite also maintains a critical history of the process and products created, including the quality aspects essential for implementing Quality by Design approaches. Furthermore, the Design Suite offers seamless connectivity to the supply chain capabilities in Conformia's Develop and Transfer suites such that supporting information such as qualification of suppliers and process analytical technology (PAT) results about the new drug are maintained on a single information platform across the lifecycle.

The Conformia Design Suite is built on the Conformia's Service-Oriented Architecture (SOA)-based PPLM platform, which provides alerts, workflows and audit trails to improve visibility and scientific outcomes during product development. By extending these PPLM capabilities into the R/D design space, the Design Suite provides users a clear structure from the outset of a project through bringing the product to market. Conformia Design Suite users can carry out planning and risk analysis across projects, including a scale to qualify potential risks. By automating design experiments, Design Suite users also remove time-consuming, manual re-test processes.

Conformia created the Design Suite solution in response to the success of its industry "Ace Case Study," a document designed to help pharmaceutical organizations implement quality standard guidelines from the International Conference on Harmonization (ICH) Quality Vision. Conformia established a Cooperative Research and Development Agreement (CRADA) with the U.S. Food & Drug Administration and through repeat success with their initial CRADA work; the CRADA was expanded in 2007 to include development of case studies and formed the CMC-IM working group. This working group was a collaborative effort between Conformia, GSK, Abbott, AstraZeneca, and Eli Lilly to create a mock example of a drug molecule Acetriptan spanning the product/process lifecycle under the new ICH Guidelines. The example was a big hit across industry and has served as an example of how a company might interpret the application of the ICH Quality vision to the Pharmaceutical Development Program.

Research Director Hussain Mooraj of AMR points out that a recent AMR Survey found that 75 percent of companies either have or will have in the next six months a strategy to support Quality by Design implementation (ICH Quality Vision) and that managing design space and risk analysis in an organized manner to promote knowledge and efficiency is a major driver for most large pharmaceutical companies.

"One component of this paradigm is the knowledge management across the lifecycle and Conformia's Design Suite is the first software system to embody key elements of the Quality by Design paradigm and will help companies achieve the benefits of the ICH Quality Vision," said Anjali Kataria, founder and CMO of Conformia. "While it isn't going to bring the entire paradigm to life, it certainly will assist companies in more rapidly adopting the paradigm by filling critical information and knowledge management gaps across the product and process lifecycle, and will help bring other technologies forward such as PAT, platform based development, Design-Automation and analysis tools."

About Conformia

Conformia Software is the leading provider of product/process lifecycle management (PPLM) software solutions to regulated process industries including life sciences. Conformia solutions enable faster time to market, reduced costs, and decreased risk. 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 for public use at no charge go to: www.conformia.com .