BearingPoint Announces Launch of Quality by Design (QbD) Practice
25/04/2007
In concert with Conformia, the market leader in life sciences’ enterprise software, BearingPoint will provide end-to-end solutions enabling the life sciences industry to better implement QbD

McLean, Va., April 17, 2007 – BearingPoint, Inc. (NYSE: BE), one of the world’s largest management and technology consulting firms, today announced the launch of its new Quality by Design practice, in concert with Conformia.

The practice will provide broad business transformation capabilities, regulatory/compliance insight and thought leadership in an effort to meet the growing needs of life science companies from strategy to execution of the QbD paradigm.

"BearingPoint's relationship and experience with Conformia uniquely positions us to be the preeminent end-to-end solution provider of QbD-focused business processes and systems implementation for the life sciences industry," said Ellen Reilly, a managing director in BearingPoint’s life sciences practice. "BearingPoint's knowledge of the industry's business and its needs, coupled with our unparalleled customer service, will allow us to bring Conformia's product to our clients. We will be able to aid them in reaping the full benefits of implementing core Quality by Design concepts in the development of new products across the entire product/process lifecycle. Our clients will be able to achieve new efficiencies through process science opportunities for existing product lines."

BearingPoint’s QbD practice specialists are already on the job at a Top 10 pharmaceutical company, where the team is implementing Conformia’s Development Operations Platform and Scale Up Management System to enable better, faster and more comprehensive product/process lifecycle data capture, prior knowledge recall and more efficient technology transfer from development to commercial manufacturing.

"BearingPoint’s expertise and successful track record in deploying SAP® applications for commercial manufacturing across multiple process-manufacturing vertical markets makes them an ideal management and technology consulting provider for Conformia’s new enterprise solutions focused on pharmaceutical development operations spanning lab to plant" said Conformia’s chief marketing officer and co-founder, Anjali Kataria. "BearingPoint’s and Conformia’s new practice will enable comprehensive and cost-effective implementation of core Quality by Design business processes and solutions across the product/process development lifecycle in both pharmaceutical and biotech companies."

BearingPoint’s QbD practice has been designed to assist companies in making the transition from regulatory policy and philosophy to core business operations and strategy. BearingPoint’s collaborative management consulting model, buoyed by experienced industry professionals spanning the entire spectrum of the life sciences industry--from lab to medicine--will enable companies to roll out Quality by Design-focused processes and systems across all products in a company with greater effectiveness. BearingPoint’s practice will provide the following services:

* Benchmark analysis across development operations:

o Product and process development

o Clinical trial supply management

o Compliance procedures, organization and methodology

o Comprehensive development recipe management and electronic batch records to support creation of submission-ready components

* Readiness assessment and technology assessment for implementing QbD across development and commercial manufacturing, including:

o Materials management

o Process and recipe definition, authoring and library management

o Product data management and life cycle management

* Development of business transformation and technology roadmaps

* Full implementation services, which include deployment, change management, validation and data migration

* Full systems integration support to create an integrated data environment for analysis and reporting across the product and process lifecycle including:

o Development of design space

o Application of prior knowledge from submission to submission

o Building a bridge from development to manufacturing

BearingPoint is leveraging the configurability and integration capabilities of the Conformia platform by developing a graphical user interface with the same process design "scheme" as process development scientists use and operate on a daily basis, in compliance with ANSI ISA S88 standards. The system is highly flexible, enabling scientists to more rapidly author and execute experiments, run batches and campaigns, while keeping track of mission critical information across the product and process lifecycle; as well as analysis within and across projects.

BearingPoint will be demonstrating Conformia’s new recipe-authoring application throughout SAP’s annual event, SAPPHIRE®, April 22-25 in Atlanta at BearingPoint’s booth. For more information, stop by Booth #1205 and ask for Don Parriott, a subject matter expert in BearingPoint’s life sciences practice.

For more about BearingPoint and its commitment to assisting companies with QbD, as well as more information about QbD, please visit our information page at www.bearingpoint.com/qbd .

About BearingPoint, Inc.

BearingPoint, Inc. (NYSE: BE) is one of the world's largest providers of management and technology consulting services to Global 2000 companies and government organizations in 60 countries worldwide. Based in McLean, Va., the firm has over 17,000 employees and major practice areas focusing on the Public Services, Financial Services and Commercial Services markets. For nearly 100 years, BearingPoint professionals have built a reputation for knowing what it takes to help clients achieve their goals, and working closely with them to get the job done. For more information, visit the Company's website at www.bearingpoint.com.