Adapting to Opportunity

Published on: 
BioPharm International, BioPharm International-04-01-2009, Volume 22, Issue 4

The biopharmaceutical industry must continuously evolve to keep up with changing trends.

Darwin demonstrated that all species evolve over time through the process of natural selection. The most adaptable prosper. The rest become fossilized remains. Darwin might see similarities in our evolving industry.

Mollie Shields-Uehling

Scientific advances have created enormous opportunities and challenges. Global partnering is complex and costly, and requires new ways of managing business relationships. The Pfizer–Wyeth deal signals greater consolidation.

Companies need to adapt to these changes with speed and efficiency, while paying attention to their bottom lines. Speed, efficiency, and cost reduction were the drivers that led several large pharmaceutical players to develop the SAFE-BioPharma digital identity and signature standard. The SAFE-BioPharma standard is facilitating the industry's move to a fully electronic environment.


The SAFE-BioPharma standard provides a secure, enforceable, and regulatory-compliant way to verify identities and apply digital signatures in electronic transactions. Among other things, its use mitigates legal, regulatory, and other business risks associated with electronic transactions. It also facilitates interoperability between disparate information systems. And it greens the pharmaceutical and healthcare industries by dispensing with paper originals and other cumbersome forms of back up.

The companies that use the standard are members of SAFE-BioPharma Association, which comprises virtually every large biopharmaceutical player in the industry. Those members are using the SAFE-BioPharma digital standard in many ways, such as:

  • AstraZeneca, GSK, Pfizer, and others are digitally signing submissions made through the FDA's eSubmissions Gateway

  • Pfizer, Bristol-Myers Squibb, and other companies are digitally signing electronic laboratory notebooks

  • Some companies are using it to sign production records

  • Some are equipping clinical investigators with SAFE-BioPharma digital signatures so they can digitally sign forms that accompany data.

At the same time, we have been actively evolving and improving the standard. Last year, the standard was expanded to provide members with a broader range of digital signature technology options. These include:

  • basic and medium assurance identity proofing

  • basic assurance software certificates

  • an online identity proofing system

  • medium assurance software, hardware, and roaming credentials

  • portable roaming digital ID, which allows healthcare professionals to sign documents electronically without being tethered to a specific computer.

Regulatory agencies also are looking to the SAFE-BioPharma standard as a way to achieve their efficiency goals. FDA officials have been trained to recognize and accept digitally signed documents using it, and SAFE-BioPharma certificates comply with the European electronic signature directive.

Determined to stay ahead of the evolutionary curve, SAFE-BioPharma created an identity trust hub and linked it to a similar infrastructure used by the FDA, the Department of Health and Human Services, the Centers for Disease Control, and a host of other federal agencies. This means that sensitive information can be exchanged securely across the Internet between trusted parties. The potential of this ability has yet to be realized, but is enormous.

SAFE-BioPharma is on an evolutionary growth spurt with improved services and new uses among our member companies. The biopharmaceutical and healthcare communities are responding enthusiastically, as reflected in pilots that address health information technology, the increase in vendor-partners, and the increase in our member companies. They all see the short- and long-term opportunities to adapt and evolve to improve the bottom line.

Mollie Shields-Uehling is president and CEO of SAFE-BioPharma Association, Fort Lee, NJ, 201.292.1861,