Eight global pharmaceutical organizations, including AstraZeneca, Bristol-Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer Inc., Procter & Gamble and Sanofi-Aventis have come together as the founding members to form SAFE–BioPharma, LLC, a not-for-profit limited liability company, to support widespread adoption of the global digital identity standard, Secure Access for Everyone - SAFE. SAFE-BioPharma, LLC will establish and maintain the standards and operating rules for the provisioning and management of digital credentials that will be used in electronic clinical research records between the biopharmaceutical industry and government regulatory agencies globally. As an industry initiative, SAFE-BioPharma, LLC, will continue to encourage other biophar! maceutical companies of all sizes to join the organization and leverage the standard. Amgen Inc. has also agreed to be a member of the newly incorporated company.
The SAFE digital credential standard was developed to simplify business partner interactions across the biopharmaceutical industry through a policy and technology framework for digital signature and authentication. This allows the SAFE community to eliminate the need for multiple identity credentials when interacting with each other and business partners.
The SAFE coalition has been working together for more than a year to develop the policies, procedures and technical specifications that form the SAFE standard. To ensure the standard meets global regulatory requirements, SAFE-BioPharma, LLC has collaborated with the Food & Drug Administration (FDA), the European Agency for the Evaluation of Medicinal Products (EMEA), the European Federation of Pharmaceutical Industries and Associations (EFPIA), and Pharmaceutical Research and Manufacturers of America (PhRMA).
The initial version of the SAFE standard was completed in June 2004. SAFE sponsors are now implementing the digital credential standard across a wide variety of applications to securely authenticate business partners to review, edit and digitally sign business documents.
The not-for-profit limited liability company, SAFE-BioPharma, LLC is expected to be in operation by March 2005. SAFE-BioPharma, LLC will:
* Manage and maintain the SAFE standard
* Provide accreditation and certification programs to ensure that SAFE-enabled applications and identity credentials are commercially available
* Establish best practices to simplify the implementation and use of the SAFE standard by biopharmaceutical companies, regulators and industry business partners
* Operating the SAFE-BioPharma Bridge to provide seamless interoperability of credentials issued by Accredited SAFE Issuers into the SAFE environment
"Over the past year, the SAFE coalition sponsors have provided the resources and leadership to develop the standard needed to solve a common business problem," said Gary Secrest, director of World Wide Information Security at Johnson & Johnson and chairman of the SAFE initiative. "With the establishment of SAFE-BioPharma, LLC, the industry can begin commercial implementations and use of the standard."
"Our members are already implementing the SAFE digital credential standard for authentication and digital signing to help streamline clinical trials processes. As an industry, we can now simplify our business partner interactions and increase our electronic submissions to the regulatory agencies globally. SAFE-BioPharma, LLC provides reduced costs through a shared cost model, and sponsors benefit from the shared experience of developing and implementing the standard," Secrest continued.
"The formation of SAFE-BioPharma, LLC is a powerful demonstration of how the industry and global regulators can work together toward a common set of goals that will benefit the entire process of developing new drugs," said Alan Goldhammer, an associate vice president for Science and Regulatory Affairs at PhRMA. "SAFE has broad applicability that can simplify the life of the doctor in a clinical trial. With the ever-increasing cost of drug development, it is essential that we rally as an industry around standards such as SAFE to ensure electronic health information is reliably protected."
About The SAFE Standard
The SAFE (Secure Access for Everyone) coalition was formed in 2003 to develop SAFE as a biopharmaceutical industry trust standard. The mission of SAFE is to deliver unique electronic identity credentials for legally enforceable and regulatory compliant electronic signatures across the global biopharmaceutical environment. The SAFE standard is intended for business-to-business, and business-to-regulator transactions. SAFE-BioPharma, LLC offers a variety of membership options for organizations seeking to join or leverage the SAFE standard.
For more information, visit www.safe-biopharma.org