Software supports drug development lifecycle.
May 9, 2007 -
Offering integrated data environment spanning product/process development lifecycle, Development Operations Platform serves as foundation for application modules, including Recipe, Batch Record, Material, Equipment, and Environmental Management. Platform enables companies to achieve integrated process knowledge data for regulatory submissions, optimize technology transfer to commercial manufacturing, and minimize time between development and clinical application.
Original Press release
Conformia Software Inc.
150 Mathilda Place
Sunnyvale, CA, 94086
Conformia Platform and Applications Bridge Drug Development Lifecycle
Development Operations Platform and Integrated Applications Provide Breakthrough Capabilities for Chemical and Biological Drug Development
SUNNYVALE, Calif., April 17 / -- Conformia Software, the market leader in enterprise solutions for drug development, today announced the general availability of the second release of its Development Operations Platform, an integrated data environment spanning the product/process development lifecycle. The Development Operations Platform serves as the foundation for Conformia's full line of integrated application modules for recipe, batch record, material, equipment, and environmental management. Offered in preconfigured application suites designed to manage drug substance (chemical and biological) as well as drug product development, Conformia's platform and applications enable companies to achieve integrated process knowledge data for regulatory submissions, improve technology transfer to commercial manufacturing, and reduce the time between drug development and clinical application.
"Pharma companies are plagued with slow and costly new product development-an average of 8 to 11 years from investigational new drug (IND) to launch-and are under pressure to reduce costs, derive greater value from their existing portfolios, and launch drugs more successfully," according to AMR analysts Hussain Mooraj, Michael Burkett, Alison Smith and Colin Masson in their report, PLM: The Antidote for Pharma's NPDI Blues. "Product lifecycle management strategies can help pharmaceutical companies streamline the collaborative processes inherent in new product development and launch, significantly reducing the time and expense associated with getting a new product approved and into the market."
Traditionally, Product Lifecycle Management has focused more on discrete manufacturing, and the Drug development information systems have been very fragmented, with process, equipment, materials, environmental, and standards information scattered across geographies and isolated into islands of expertise, culture, and function," said Joe Prang, CEO of Conformia Software. "Conformia's Development Operations Platform and applications provide the only solution that manages development activities across the product/process lifecycle ranging from lab to pilot plant and through clinical scale up, culminating with manufacturing science and transfer to commercial manufacturing."
The Conformia Development Operations platform and application modules enable a new level of visibility across the product/process development lifecycle, from early development stage through late clinical stage, from drug substance through drug product, and from product development to commercial manufacturing. By breaking down the individual information silos that currently exist within most organizations and aggregating and centralizing information, the Conformia solution encourages cross-discipline, cross-product and cross-company collaboration.
The Conformia platform provides a consistent user interface, operational dashboards, workflows, review and approval mechanisms, and other features to enable ease of use, and consistent and harmonized business processes. The integrated application modules -- Recipe, Batch Record, Material, Equipment, and Environmental Management -- provide information that is rich in context and easily correlated. For example, when a pharmaceutical company is planning to produce a batch of a new compound, material availability, equipment qualification, process safety, and process control strategy can all be verified simultaneously using the Conformia platform and applications. Reports, summaries, genealogies, and traces can include data from all application modules.
The Conformia Development Operations Platform also enables companies to build a foundation for support of the FDA's forward paradigm of pharmaceutical quality. Companies that seek to achieve a systematic approach to enabling quality by design and risk management can centralize key knowledge needed to support the rationale of development in the submission and develop robust models for product/process characterization across the lifecycle. Furthermore, the overall Conformia system enables companies to achieve a sound quality management system by reducing experiment and campaign planning overhead, monitoring business processes, reducing batch processing errors, and variability. With Conformia, scientists and engineers can spend more time characterizing and refining the target process and developing deeper product/ process understanding. The Conformia platform automatically organizes data into process knowledge that can be included in Chemistry, Manufacturing and Controls (CMC) submissions to the FDA or be mined later for future projects or fed into complex models, statistical equations, data analysis tools.
CRADA collaboration to drug development, leading to IND, BLA, ND "Conformia's pharmaceutical development solutions can have a profound impact on companies who seek to improve both the scientific innovation and product quality/ risk management of new drug development through real product/process lifecycle management including: better material specification, process development, characterization and validation all at higher levels of data integrity. For most companies, these are critical sources of multiple delays and high expenses and have in the past contributed to significant compliance issues and inventory shortfalls," said Anjali Kataria, Conformia Co-Founder and CMO.
Development Operations Platform supports healthy IT environment
The Conformia Development Operations Platform is highly configurable to a wide variety of development environments without additional programming. Universal Platform Services manage business process workflows, users/roles/sites, traceability/audit trails, security/ permissions, and a web services-based integration framework. To create an integrated view of the development lifecycle data, the platform serves as an integration hub for other enterprise applications, including enterprise document management systems (EDMS), library information management systems (LIMS), enterprise resource planning systems (ERP), and others. The platform manages the data from internal and external applications modules and integrates it to create a structured database, called an electronic Development Record (eDR), that represents the full development lifecycle. The knowledge repository for development, the eDR is searchable and its data can be analyzed and output in variety of formats.
The Conformia Development Operations Platform was developed using a service-oriented architecture and supports technology components by leading application and database server vendors, including SAP NetWeaver, Oracle, BEA, IBM, and Microsoft.
All of Conformia's products have been developed in the company's Software Engineering Institute (SEI) Capability Maturity Model (CMM) Level 3-certified development center using a fully traceable development methodology, which ensures linkage between software requirements, product functionality, quality testing, and documentation; and have been validated in customer environments.
Conformia Software provides product conformance management (PCM) software solutions to two regulated process industries: life sciences and beverage alcohol. These solutions enable companies in these highly regulated industries to save significant time and money through major improvements in product development operations. Conformia's web-based enterprise software helps improve product quality and integrity, reduce development lifecycles, enhance operational visibility and traceability, and decrease the costs and ramifications associated with non-compliance with global regulatory agencies. The market leader and innovator in providing enterprise software solutions for development operations in the pharmaceutical industry, Conformia is SAP's endorsed business solution for pharmaceutical development operations; together SAP and Conformia are building a bridge to support the product/process lifecycle from development to manufacturing. For more information, go to www.conformia.com.
NOTE: Conformia is a trademark of Conformia Software Inc. All other brands, products, or service names are or may be trademarks or service marks of their respective owners.