The Industry Standard for Digital Trust

Dear SAFE-BioPharma colleague,FINALLY, FINALLY we’re seeing cloud collaboration become a reality, and with it appreciation of the importance of identity trust.

The entire concept of collaboration derails if your partners can’t authenticate their identities and your organization can’t validate those identities as legitimate

The SAFE-BioPharma® standard solves that problem – and a few other obstacles to seamless cloud collaboration.

The standard provides the ability to apply legally-enforceable and regulatory-compliant signatures to electronic documents.

It also overcomes the interoperability issues created when different authentication and signing approaches are used. All cyber-identities based on the SAFE-BioPharma standard are interoperable with each other, with the US federal government, and with other cross-certified communities. That level of identity trust is helping make cloud collaboration a reality.

Now, your standard has gone mobile.

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News for 2012 from SAFE-BioPharma Association

SAFE-BioPharma Mobile is a driverless, cloud-based credential that allows mobile devices to be used for authentication and/or digital signing -- anywhere there’s an Internet connection.

This is especially relevant given recent announcements of new industry activities to facilitate R&D collaboration.

In the years since the world’s leading biopharmaceutical firms started our non-profit, the SAFE-BioPharma community has continuously improved the standard and related ecosystem to stay ahead of industry’s needs.

SAFE-BioPharma Mobile is one example – the result of many pilots and close examination of the digital identity needs of clinical investigators and healthcare professionals.

I encourage you to stay abreast of our progress and to participate in the SAFE-BioPharma community by way of our working groups, Board of Directors, and Business Advisory Board.

All the very best,

The views expressed in this material represent an individual opinion and do not constitute legal advice. Please consult your own legal counsel for any guidance or questions related to use of the SAFE-BioPharma industry standard or any related technology.

SAFE-BioPharma® is a trademark of SAFE-BioPharma Association. Any use of this trademark requires approval from SAFE-BioPharma Association.

Dear SAFE-BioPharma colleague, con’t.

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SAFE-BioPharma® is the industry standard developed to transition the biopharmaceutical and healthcare communities to paperless environments. The SAFE-BioPharma standard is used to verify and manage digital identities involved in electronic transactions and to apply digital signatures to electronic documents. SAFE-BioPharma was developed by a consortium of biopharmaceutical and related companies with participation from the US FDA and the European Medicines Agency.

SAFE-BioPharma Mobile provides all of the benefits of the SAFE-BioPharma standard with complete, global portability. It is a digital identity credential that is universal (one credential that takes the place of all others) and fully mobile. It lets you authenticate your identity and securely apply digital signatures to electronic documents virtually anywhere on the planet.There are no drivers to install or maintain. The credential is stored in a hardware module in the cloud and securely accessed from any computer including tablets, smart phones and other mobile devices.

No drivers means less cost. SAFE-BioPharma Mobile costs about one-half of token-based credentials and the single credential can be accessed using multiple devices. We developed

SAFE-BioPharma to support industry’s embrace of Internet-based global collaboration. It’s being incorporated into use for clinical study collaboration, adverse event reporting, authentication into portals and applications, eTMFs, regulatory document management systems, and eSampling.In the coming months SAFE-BioPharma Mobile credentials will be deployed to hundreds of thousands of US prescribers to help them meet DEA requirements for ePrescribing controlled substances.

SAFE-BIOPHARMA MOBILE: Authenticate and Sign Anywhere, Anytime

APIs Available to Integrate SAFE-BioPharma Mobile into BioPharmaceutical and Healthcare Apps

The Application Programming Interfaces (APIs) to integrate SAFE-BioPharma Mobile authentication and signing functionality into existing and future biopharmaceutical and healthcare applications are now available by

Plug-in software is available to allow digital signing by those using

SAFE-BioPharma Mobile cloud-based credentials with

Adobe Plug-In Gives Signing Capability for PCs

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contacting iuisapiinfo@verizon.com. Their use will improve access to clinical portals and electronic health records and facilitate signing of electronic prescriptions and regulatory documents using SAFE-BioPharma Mobile.

their PCs. The plug-in can be downloaded from www.pdfcloudsign.com/index.html. Documentation and FAQ’s, also are available at that address.

Peter Alterman Named COO, SAFE-BioPharma Association

Peter Alterman, Ph.D., is the association’s new Chief Operating Officer. He

serves as the association’s primary liaison with the U.S. FDA and other global regulatory authorities and represents our interests on global standards and policy bodies. He also is responsible for a variety of association management functions.

Peter is a widely recognized creative leader who held numerous senior information security positions within the U.S. federal government. He played a major role in establishing the Federal PKI Policy Authority. He was Senior Advisor to the

National Program Office of the National Strategy for Trusted Identities in Cyberspace (NSTIC), NIST; Senior Advisor to the NIH CIO for Strategic Initiatives, Assistant CIO for e-authentication at the National Institutes of Health and Chair of the U.S. Federal PKI Policy Authority. He also helped develop the pioneering Research Collaboration in the Cloud project in which industry cancer researchers using SAFE-BioPharma credentials and NCI researchers using Federal PKI credentials have been able to use the cloud to review, amend, sign and exchange trial start-up documents.

His role in Internet technology started in 1989 as a member of the Federal Research Internet Coordinating Committee.

The Association has organized a volunteer advisory board of senior level executives from a variety of international biopharmaceutical companies. The purpose of the group is to serve as a forum to generate informed business advice aimed at making use of the SAFE-BioPharma standard ubiquitous across the life sciences and healthcare. Members participate in periodic meetings. The inaugural meeting was held in New York in May with a

second meeting in mid-November. Participating organizations include Actelion Pharmaceuticals, Bayer HealthCare Pharmaceuticals, Biogen Idec, Celgene, Duke University, Eisai, INC Research, GlaxoSmithKline, Grunenthal, GmbH, ICON Clinical Research, Nigel-Montgomery, LLC, Pearl Therapeutics, Pfizer, Quintiles, Roche, SARcode, Taiho Pharma, USA, and Widler & Schiemann.

Association Launches International Business Advisory Board

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US Government Certifies SAFE-BioPharma as Trust Framework Provider

The US Government has approved SAFE-BioPharma as one of four government-approved Trust Framework Providers (TFP) available to Credential Service Providers and Identity Providers issuing cyber-identity credentials.

Trust Framework Providers develop and maintain policies and practices used by identity credential issuers. Government approval of a TFP means that identity credentials associated with that TFP can be trusted and used at a known level of assurance by US federal entities such as NIH, VA, and FDA.

As an approved Trust Framework Provider, SAFE-BioPharma will help credential issuers expand use of trusted cyber identities for applications ranging from collaborative research

Omnicare and Allscripts are among the newest members of SAFE-BioPharma.

Omnicare, Inc. provides comprehensive pharmaceutical services to patients and providers across North America. It is the market-leader in professional pharmacy, related consulting and data management services for skilled nursing, assisted living and other chronic care institutions. It is a Fortune 400 company and is based in Cincinnati, Ohio.

Omnicare, Allscripts Join SAFE-BioPharma

to patient access to medical records.

With its newly approved TFP status, the association supports issuance of both Public Key Infrastructure (PKI) and non-PKI identity credentials. Previously, it had supported credentials based only on PKI, a technology with stringent identity-proofing requirements.

SAFE-BioPharma identity credentials are available for Levels of Assurance (LOA) 2 and 3. LOA 2 satisfies identity-proofing and credential issuing practices acceptable for access to systems where risk of identity fraud is minimized (e.g. patient access to read-only medical records, and veteran access to read-only military medical records). LOA 3 is required for most transactions in regulated industries such as pharmaceuticals and healthcare.

Levels of Assurance ranging from 1 to 4 were established by the National Institute of Standards and Technology (NIST) to identify acceptable levels of trust for the use of

electronic identity credentials in different settings. Each level of identity trust is determined by the process used to establish the identity of the credential’s user.

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Allscripts provides innovative solutions that empower all stakeholders across the healthcare continuum to deliver world-class outcomes. The company’s clinical, financial, connectivity and information solutions for hospitals, physician practices and post-acute organizations are the essential technologies that enable a Connected Community of Health. Allscripts is listed on NASDAQ and is based in Chicago.

SAFE-BioPharma was recognized by the Computerworld Honors

Program recognizing visionary applications of information technology promoting positive social, economic, and educational change. The standard was cited for its role in facilitating

SAFE-BioPharma Named 2012 Computerworld Laureate…

BOARD ELECTS PFIZER’s KAREN BIEN and GENZYME’s SUE DUBMAN

We are fortunate to have Karen Bien and Sue Dubman as members of the SAFE-BioPharma Board of Directors. Their understanding of the use of bioinformatics and technology to advance collaborative communities within biopharmaceuticals will be valuable to the governance of the standard, • Karen Bien is Director,

Business Technology, in Pfizer’s Acquisition, Collaboration, and Divestiture team where she leads a team providing technical services and support required for external alliances. Karen previously held a variety of compliance, continuous improvement, and related roles with Wyeth (now Pfizer) Siemens Medical Systems, and Solvay Pharmaceuticals.

• Sue Dubman is Senior Director, R&D IS, Strategy,

…and Information Security Executive (ISE) Project Finalist

The NCI and Research Partner Study was named a

finalist in the ISE Northeast Project Awards and selected for a case study presentation

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cloud-based collaboration resulting in accelerated initiation of a cancer clinical trial while lowering its costs and reducing paper-reliance. The study is being conducted with National Cancer Institute researchers and their private sector counterparts. We received a medallion during Computerworld’s Laureate Medal Ceremony and Gala in Washington, D.C.

at ISE’s National gathering in November. ISE Project awards recognize innovation, success and teamwork in the security information community. The group’s members comprise the CISOs of the nation’s leading companies and government agencies.

Standards and Architecture, Genzyme (a Sanofi company), where she heads global implementation of data standards required to meet regulatory requirements and streamline operations. Sue is an authority on information technology standards and R&D bioinformatics in both the private and public sectors.Prior to Genzyme, she held executive IT and bioinformatics positions at Theravance and Bristol-Myers Squibb and was senior director of Biomedical Informatics Initiatives for the National Cancer Institute

Board participation is voluntary and focuses on leading SAFE-BioPharma’s global expansion involving biopharmaceutical industry partners in governments, research institutions, and the U.S. healthcare system.

HighQ Collaborate has been certified compliant with the SAFE-BioPharma standard, providing the association’s member companies with a new, cloud-based document approval process, which is efficient, enforceable and regulatory-compliant.

The product provides the life sciences with a unified space for secure document

HighQ Collaborate Compliant with Standard

SAFE-BioPharma at Major Industry Conferences

SAFE-BioPharma receives a lot of podium time at major conferences in the US and Europe.

• In 2012, alone, association personnel will have presented in more than 20 conferences including HIMSS, Molecular Med TriCon, BIO IT World, eClinical Technology Summit, Barnett Clinical Trial Summit: Clinical Project Management Forum, BIO IT World Europe, and the Smart Card Alliance.

• In 2013, look for us at the 2nd Trial Master File Summit (January 24,

DocuSign and SAFE-BioPharma in Strategic Relationship

DocuSign, the global eSignature solution, recently announced deeper support for E.U. Directive n.93/1999 by

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exchange and social collaboration across a global network of employees, researchers, and partners. It allows users to communicate with discovery teams, CROs, investigators and business development partners worldwide. Users are able to securely exchange documents using their SAFE-BioPharma digital identities, ensuring their credentials are available anytime and anywhere.

introducing digital signatures on the DocuSign Global Network. This includes an offering to biopharmaceutical and healthcare companies that are SAFE-Biopharma members.

Arlington, VA.), New Drug Application Under PDUFA V conference (January 25, Arlington, VA.), D4: Data Driven Drug Development (January 28, Philadelphia), SCOPE: “Summit for Clinical Ops Executives (February 5, Miami), eClinical Decision Making (February 26-28, San Francisco, CA), and BIO IT World Boston, MA, April 9). Members of the SAFE-BioPharma community may be eligible for substantial discounts to these and other meetings. The calendar at www.safe-biopharma.org lists all upcoming conferences where we are presenting.

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Members:

den rust ™

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Vendor Partners, Cross-Certified Issuers, Commercial Issuers:

and Dart Neuroscience and Veroha

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SAFE-BioPharma Association • 1 Bridge Plaza, Suite 275 Fort Lee, NJ 07024 • 201-849-4545 • www.safe-biopharma.org