BioPoint’s core focus is to enable companies to reduce time to market, ensure regulatory compliance, and optimize resource utilizationBioPoint Solutions, Inc. (www.biopointsolutions.com), recently announced its official company launch. Headquartered in Danvers, Massachusetts, BioPoint was established to fill a void within the biotech and pharmaceutical industry for completely integrated technology solutions and professional services designed to ensure the confidentiality, authenticity, integrity, and availability of all data generated during the pre-clinical drug discovery process. The company’s sole mission is to empower BioPharma companies to reduce time to market for new drugs, ensure regulatory compliance as mandated by Food and Drug Administration (FDA) predicate rules such as 21 CFR Part 11, and to optimize human, financial, and physical resource utilization. BioPoint offers a full range of technology applications and services including drug discovery, toxicity animal testing data management, and workflow enforcement through its flagship solution, DiscoverTrac.
BioPoint Solutions CEO, Elery LeBlanc, said, “Rapid advances in science and technology are revolutionizing the way BioPharma companies manage the pre-clinical drug discovery process. To thrive in today’s competitive marketplace, companies must have a robust information technology platform and an integrated data management infrastructure in place to confidently manage this process.” LeBlanc continued, “BioPoint Solutions’ DiscoverTrac is unique in that it offers the BioPharma industry a vertically focused solution specifically designed to reduce the reliance on paper-based record keeping by automating and electronically recording all data generated during the drug discovery process.” DiscoverTrac addresses the critical infrastructure needs of validation management, integrated data acquisition, change control/audit trail, colony management, laboratory workflow, and report generation. Built on a scaleable architecture that expands as a company’s data management needs increase, DiscoverTrac is secure and easy to use. Data is maintained with strict controls imbedded in the system to prevent data tampering and ensure security in either a closed or open system as defined by the FDA. Information entered is stored in a central Oracle data warehouse, with archival of all raw data, allowing for individual backups that can be submitted with regulatory filings. Authorized users have access to all information inside the database and are also connected to additional drug discovery sources enabling trouble-free, comprehensive access to information. This “one stop data management” approach pioneered by BioPoint is designed to enable users to quickly validate, track, and report on critical laboratory management activity – all within the regulatory framework established by the FDA.
Christopher Hill, chief operating officer, BioPoint Solutions, said, “We are pleased to offer BioPharma companies a smarter, more efficient way to manage the pre-clinical drug discovery process. With DiscoverTrac, BioPoint has distinguished itself from other providers by integrating all aspects of the discovery and validation process with a robust system that also includes toxicity animal testing data management, and workflow enforcement.” Hill continued, “The end result is that companies will be able to focus more time on research and less time on record keeping, with complete peace of mind that all critical lab data is secure and readily accessible to only the people who need it.”
John Blanchard, principal analyst, ARC Advisory Group, noted, “BioPoint Solutions has identified a critical BioPharma industry need for a fully integrated solution designed to facilitate data management and workflow enforcement during the pre-clinical drug discovery process. BioPoint Solutions’ DiscoverTrac provides much needed functionality such as data integration and security, task based financial information, electronic submittal, and reporting. Achieving and maintaining validation is simplified by compliance enabling functionality, documentation, and engineering services. BioPoint Solutions’ DiscoverTrac is an attractive new entrant, with the potential to be an industry leader in the pre-clinical market segment.”
The market opportunity for DiscoverTrac is significant considering there are more than 8,000 biotechnology, pharmaceutical, and drug discovery companies in the United States alone. Factoring in worldwide biotech IT spending which is expected to top $30.6 billion in 2006, according to IDC forecasts, and the average time and cost to bring a drug to market, it is clear that companies offering proven technology solutions that shorten the discovery process, improve productivity, and accelerate the federal compliance process will benefit.