Pfizers SAFE Use Case Michael Lavoie CISSP PMP

Pfizer’s SAFE Use Case Michael Lavoie, CISSP, PMP Member, SAFE Board of Directors 24 -FEB-2016

Disclaimer: This presentation outlines a general technology direction. Pfizer Inc. has no obligation to pursue any approaches outlined in this presentation or to develop or use any functionality mentioned in this presentation. The technology strategy and possible future developments are subject to change and may be changed at any time for any reason without notice. The views and opinions expressed in this presentation and any related discussion(s) are solely those of the individual presenter(s) and may not express the views of and opinions of Pfizer Inc. 2

Background The problem: • Vast quantities of paperwork requiring signatures slows down the drug discovery process • Geographically dispersed global workforce • Online challenges with trust and user identities The solution: Digital identity credentials • Initiative Started in 2005 by Biopharmaceutical Industry to: – Create a trusted identity authentication and digital signature standard – More easily navigate the unique legal and regulatory environment in the complex, partnered biopharmaceutical sector – Transform the Bio-pharma and healthcare communities to fully electronic 3

Electronic vs. Digital Signatures Electronic Signatures Digital Signatures • Tight binding to the individual through face to face or other strong identity verification No Yes • Supports strong non-repudiation No Yes • Detect document tampering No Yes • Tight binding to the document/data signed, i. e. , prevent “forgery” No Yes • Maintains persistence, can be verified after certificate expires No Yes • Legal equivalent of hand written signature Yes • Scalable Yes Feature 4

Pfizer use Cases R&D e-lab notebooks – 2, 200 colleagues • Chemical e-lab notebook • Bio. Book • Experiments are signed by implementer and witness using SAFE Regulatory submissions – 250 colleagues • Regulatory Strategists, GCMC Strategists, Hub Submission Managers, and Publishing Managers • Primarily sign FDA forms: 1571, 356 h, 3674, 2252, and 2253 5

Additional Info • Pfizer colleagues sign >10, 000 documents per month and apply almost twice as many SAFE signatures • ~1 M documents signed using SAFE credentials • > 2 M signatures applied • Pfizer is using similar technologies for internal digital signing which doubles the number of documents and signatures applied 6

Thank You! 7