PPD, Microsoft help manage REMS programs
PPD and Microsoft have entered into an agreement to jointly implement a 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’s 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 from the patient, healthcare provider and pharmacy.
The 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 assure 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.
“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.”
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 assure safe use, communications plans and medication guides.
Meanwhile, PPD also reported net revenue of $369.9 million for the second quarter of 2010, compared with $354.6 million for the second quarter of 2009. Second quarter 2010 operating income was $40.1 million, compared with $58.3 million for the same period in 2009.
Operating income for the second quarter of 2010 was lower than the same period last year due primarily to operating and integration expenses related to PPD’s recent acquisitions and an increase in business development expenses. Second quarter 2010 operating income was also impacted by increased compound partnering research and development expenses prior to the spin-off and general and administrative costs related to the spin-off. These costs will not continue since the spin-off was completed in mid-June. Diluted earnings per share for the second quarter were $0.18, compared with $0.49 for the second quarter of 2009.