Microsoft Partners With PPD To Provide FDA Risk Evaluation and Mitigation Strategy Programs Using Amalga and HeatlhVault Technol
Posted Jul 27 2010 9:25am
Biopharmaceutical companies will have a solution to assess risk and track information as submitted from patients, doctors, and pharmacies participating in various research project. The FDA with all submissions requires risk assessment and in short this is a software program to allow for those studies to be compiled while research is in progress and evaluation of what has been submitted to this point.
HealthVault of course is the PHR (personal health record) which would be an avenue for patient participation to enter information and Amalga which aggregates information into intelligence and useable formats is the avenue for physicians and other health care professionals. Many hospitals systems have already implemented Amalga UIS to aggregate and connect emergency departments of hospitals and has created solutions in other hospital HIE scenarios. You can read my interview from last year with Steve Shihadeh from Microsoft to hear more about Amalga/HealthVault solutions.
The Risk Evaluation and Mitigation Strategy programs add information and are required to ensure patient safety with drugs and pharmaceuticals and can lead to safety warnings and other information on a pro-active basis rather than re-active. You can also visit the PPD website and view their presentations relative to biotech and healthcare that are provided to investors. BD
WILMINGTON, N.C. — July 27, 2010 — PPD Inc. (Nasdaq: PPDI) and Microsoft Corp. (Nasdaq: MSFT) today announced they have entered into an agreement to jointly implement an innovative technology solution designed to improve efficiency in managing U.S. Food and Drug Administration-mandated Risk Evaluation and Mitigation Strategy (REMS) programs.
The technology will be based on Microsoft Amalga Unified Intelligence System (UIS), a data aggregation platform that gives healthcare professionals access to the information they need when they need it, and Microsoft HealthVault, a personal health application platform that lets consumers gather, store and share health information online.
When completed, this first-of-its-kind technology solution will provide biopharmaceutical companies with a long-term system for managing operational components of REMS programs while tracking large amounts of information collected from multiple sources, including the patient, healthcare provider and pharmacy.
The robust solution will integrate PPD’s strategic, scientific, operational and regulatory capabilities in designing and implementing comprehensive REMS and risk management programs with Microsoft’s strong global software development expertise.
“Efficient, effective REMS programs require real-time access to information by multiple internal and external stakeholders,” said Mike Wilkinson, executive vice president and chief information officer for PPD. “We are committed to combining operational and scientific excellence with leading REMS-specific technologies for this rapidly evolving sector of our industry and are pleased to collaborate with Microsoft in this effort.”
Lori Eberhardt, vice president of global late stage research for PPD, added, “Our clients rely on our expertise in delivering comprehensive risk management programs, which are critical to ensuring patient safety. Whether we are working with clients to develop and manage REMS programs to ensure safe use or developing a virtual training curriculum, this platform is an efficient solution to connect, manage and track all components of REMS programs.”
The centralized platform based on Microsoft Amalga UIS and HealthVault will provide an easy-to-use interface for physicians, pharmacists and patients involved in REMS. It will also feature intuitive navigation and a high level of customization to provide clients with greater control of their REMS programs.
“We’re excited to collaborate with PPD to deliver a new REMS solution for the biotechnology and pharmaceutical industry,” said Steve Shihadeh, general manager, Microsoft Health Solutions Group. “Using Amalga and HealthVault, we will be able to connect all of the stakeholders involved in REMS programs and make it much easier for them to get the right information at the right time to help improve patient safety. We look forward to seeing the positive impact our solution brings to PPD clients as they manage the prescription drug life cycle.”
REMS programs are required by the FDA for certain marketed drugs to ensure the benefits of a product offered to consumers outweigh the risks. They can include elements to ensure safe use, communications plans and medication guides, which all require assessment.
PPD is a leading global contract research organization, celebrating 25 years of providing drug discovery, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. With offices in 41 countries and more than 10,500 professionals worldwide, PPD applies innovative technologies, therapeutic expertise and a commitment to quality to help clients and partners accelerate the delivery of safe and effective therapeutics and maximize the returns on their R&D investments. For more information, visit www.ppdi.com .
Founded in 1975, Microsoft (Nasdaq “MSFT”) is the worldwide leader in software, services and solutions that help people and businesses realize their full potential.
Except for historical information, all of the statements, expectations and assumptions contained in this news release, including expectations and assumptions about PPD’s agreement with Microsoft to jointly implement an integrated REMS technology platform, the completion of this technology platform and its commercial value and application, are forward-looking statements that involve a number of risks and uncertainties. Although PPD attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. In addition, other important factors that could cause results to differ materially include the following: risks associated with and dependence on collaborative relationships; rapid technological advances that make our products and services less competitive; the ability to attract and retain key personnel; economic conditions and outsourcing trends in the pharmaceutical, biotechnology, medical device, academic and government industry segments; competition within the outsourcing industry; success in sales growth; loss of large contracts; increased cancellation rates; risks associated with acquisitions and investments, such as impairments; and the other risk factors set forth from time to time in the SEC filings for PPD, copies of which are available free of charge upon request from the PPD investor relations department.