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The 4BF

The 4BF. The Four Bridges Forum. The SAFE-BioPharma Digital Identity and Signature Standard Mollie Shields Uehling CEO SAFE-BioPharma Association. Moving into the Digital Age: BioPharma and Its Partners. Revolution in life sciences and medical research

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The 4BF

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  1. The 4BF The Four Bridges Forum The SAFE-BioPharma Digital Identity and Signature Standard Mollie Shields Uehling CEO SAFE-BioPharma Association

  2. Moving into the Digital Age: BioPharma and Its Partners • Revolution in life sciences and medical research • Cost and complexity has created crisis in R&D productivity • Need for rapid, close collaboration between pharma, healthcare providers, government agencies and research institutions • FDA and EMEA moving to fully electronic submission, review and response • Healthcare mandate for eMRs for every American by 2014 presents wealth of opportunity for information for research and clinical decision-making • Fundamental to interoperability in sensitive electronic exchanges of information are trusted identities and legal signatures.

  3. SAFE-BioPharma Association • Strategic initiative started by biopharmaceutical industry • Member-governed non-profit collaboration incorporated May 2005 • Trusted identity and non-repudiable digital signature • Single interoperable digital identity across industry • Technology and vendor neutral • Interoperable with Federal agencies • Based on leading government technical and identity proofing standards • Wrapped in a legal, governance and risk mitigation model • Recognized by world’s leading regulatory authorities • To facilitate the transformation of the industry to fully electronic business and regulatory processes

  4. SAFE-BioPharma 2005-2010 • Regulatory engagement and recognition – US, European Union, Japan • Improving usability • Pilots, early adopters • Resulted in expansion of the standard • Improvements in identity proofing process and digital signing options • Building the interoperable network: • Issuers, digital signing, and business applications • Cross-certification with FBCA • EU qualified certificates; Safe Harbor certification • Supporting use • First, ELNs (basic laboratory research) • Then digitally signed regulatory submissions • Now workflow between several/many partners for auth & signing in federated approach SAFE-BioPharma Association

  5. The SAFE-BioPharma Framework Legal, governance, risk mitigation – contract based • Existing Technical and Identity Standards – • NIST,OMB, Federal PKI • Identity verification • Manage identity life cycle • Comply with referenced standards • Security, audit & control requirements • Certification • Accept digitally signed transactions • Agree to limited liability caps • Agree to dispute resolution • Agree to identity assurance • Agree to self-audit & meet SAFE requirements SAFE-BioPharma Association

  6. A Non-Profit, Member-Driven Standards Association Board of Directors & PAA Gary Secrest, J&J, Chair SAFE-BioPharma Member Consortium CEO Mollie Shields-Uehling Working Groups SAFE-BioPharma European Union Advisory Group, Isabelle Davias, Sanofi-Aventis Hans van Leeuwen, Merck • STAFF • Cindy Cullen, CTO • Jon Schoonmaker, Chief, Ops • Gary Wilson, Prog Mgr • Rich Furr, Head, Reg Afrs • Tanya Newton, Mgr, Reg Afrs • Kevin Chisholm, Exec Asst • John Weisberg, PR & Comm • Kay Bross, Member & Vendor Progs • Legal, Financial, Admin Technology WG Justin Bovee, J&J Keith Respass, Merck • Federation TF, Merck/Pfizer • User Group, GSK/Lilly Global Business & Reg Betsy Fallen, Merck Jennifer Shivers, Lilly

  7. SAFE-BioPharma Association – Non-Profit Standards Collaboration Incubating Innovation

  8. Options for Flexible Use • Two levels of trust: • Basic Assurance for authentication • Medium Assurance for trusted identity uniquely linked to digital signature and EU-qualified • Three digital signing technologies: • Software • Hardware (zero footprint now undergoing FIPS certification) • Roaming • Three identity-proofing options • Antecedent – enterprise and on-line • Trusted agent • Notary – including office/home notary services

  9. Member Public Key Infrastructure Options • Internal infrastructure • Cross certified with SAFE-BioPharma Bridge • BMS, J&J • Outsourced infrastructure • Cross-certified with SAFE-BioPharma Bridge: • Chosen Security • Citibank • Entrust • IdenTrust • TransSped • SAFE-BioPharma tiered services infrastructure: • External partners • Regulatory uses • Healthcare providers • Members

  10. EU EU EU EU EU EU EU EU 3rd-Party Antecedent currently available in USA Assurance and Identity Proofing Services* SAFE-BioPharma Association *Provided through outsourced services supplier.

  11. On-Line Antecedent Process • ID Vetting Successful: • Applicant Passes 3rd Party Antecedent identity proofing • Moved to RA queue for processing and Certificate Issuance steps. • It’s a matter of minutes end-to-end. • ID Vetting Not Successful: • Unable to verify identity via 3rd Party Antecedent • Process reverts to Notary Process with two service options: • User locates notary • RAS/NNA will have a local notary contact the Applicant directly

  12. SAFE-BioPharma and Regulators • European Medicines Agency (EMA) and FDA are on paths to requiring fully electronic submissions within the next few years • FDA and EMA helped write SAFE-BioPharma standard; engaged since inception • FDA has received 10,000s of SAFE-BioPharma submissions since 9/06 • EMA eCTD pilot successfully completed; EMA ESG to go live this year • Japan pilot underway – exchanging business, regulatory and clinical documents between pharmas, hospitals, and regulatory agencies

  13. Examples of How SAFE-BioPharma Is Being Used

  14. Pfizer eLabNotebooks Company Profile: • Largest research-based pharmaceutical • Global research organizations • Using paper laboratory notebooks requiring scientists signatures on each experiment! • Replaced with electronic notebooks and digital signatures

  15. Pfizer ELN Results – Over 1 million digital signatures Results: • Less time on paperwork, more in the lab • > 3300 researchers in 280 departments in 20 countries; • > 550,000 documents signed • >1,000,000 digital signatures! • 3.3 million pages not printed! • >16 tons of paper saved • Better patent defense • Signed, time-stamped in timely manner • Better compliance with internal regulations • Easier access to research • Electronic search of records • Faster research cycles • More time in lab, less on paperwork; No more delays to collect witness signatures

  16. SNAP Diagnostics Company Profile: • Leader in diagnostic technology for detection of sleep apnea and analysis of snoring problems • Provides physicians in the U.S., EU, and Latin America with proprietary diagnostic equipment used in home settings Scope: • Records of at-home tests analyzed by company physicians who advise referring physicians re therapeutic approach • SNAP physicians digitally sign diagnoses and send to personal physician Results: • Eliminated paper in day-to-day reviews of diagnostic information • Eliminated costs associated with handling, signing, shipping, storing and accessing paper

  17. Premier Purchasing • Company profile • Largest Group Purchasing Organization (GPO) in U.S. • Owned by non-profit hospitals • Serves 2,000 U.S. hospitals and 53,000-plus other healthcare sites • Buys from ~700 suppliers • http://www.premierinc.com/ • Scope: • Eliminate overnight shipping, fax and related workflows for contract origination and amendments • Provide SAFE-BioPharma credentials to Premier Sourcing/Procurement employees and their supplier colleagues for signing new and amended supplier contracts • eContracting process ~700 companies and thousands of contracts and/or amendments • Future: • Digitally sign and submit required reports to CMS

  18. National Cancer Institute-Bristol-Myers Squibb: The Business Issue • NCI – pre-imminent cancer research institution • Collaborates with pharma, biotechs, many research institutions and individual researchers • Lots of contracts, clinical documents, amendments, signatures • Bristol-Myers Squibb (BMS) conducts collaborative research with NCI’s Clinical Trials Evaluation Program (CTEP) and its many collaborative research partners (cooperating groups) • Clinical trial agreements • Clinical trial documents • Clinical materials orders and supply • Leverage PIV (Federal credentials) , BMS cross-certified SAFE-compliant credentials and SAFE-BioPharma credentials for authentication and digital signing SAFE-BioPharma Association

  19. The NCI-BMS Project • Credentials – Medium Assurance • BMS • BMS SAFE-BioPharma Cross Certified credentials • SAFE-BioPharma Credentials • NCI • PIV cards • Cooperative Groups – research organizations – academic, CROs, etc. • SAFE-BioPharma Credentials • Signature Work Flow • SAFE-BioPharma Digital Signing Service Pilot – MySignatureBook/MyOneLog-on • A “cloud” service SAFE-BioPharma Association

  20. Digital Signature Service Cooperative Group

  21. Digital Signature Service Cooperative Group

  22. Leveraging the Value of the 4BF • Very challenging economic environment • Investment flowing to areas that will improve productivity and lower FTE • Opportunity to leverage network of interoperable credentials and • To create network of trusted partners • Move government-business and B2B processes into the cloud • Bring value to government program managers and private sector business process owners by improving business process efficiencies SAFE-BioPharma Association

  23. Value of SAFE-BioPharma Digital Identity and Signature in the Partnered Digital World Established, tested standard meeting needs of governments, regulators, industry Ability to identity proof and issue certificate in ~15 minutes (including medical license) Contract-based system tailored to pharma/healthcare needs (HIPAA compliance; risk mitigation) Secure Legal enforceability Regulatory recognition and acceptance (US, EU, Japan) Global standard and set of services Links Federal agencies to pharma and healthcare providers Provides interoperability Interoperable standard that facilitates transition to fully electronic business and regulatory processes

  24. Please visit the SAFE-BioPharma website: http://safe-biopharma.org/ • Please visit the 4BF website: http://www.the4bf.com/ • Pfizer’s Implementation of SAFE-BioPharma Digital Signatures in ELNs: http://www.safe-biopharma.org/images/stories/pfizer%20white%20paper_v1.pdf • AstraZeneca’s Implementation of SAFE-BioPharma for FDA Submissions: http://www.safe-biopharma.org/images/stories/az_safe_final.pdf • Learn more about the SAFE-BioPharma Implementation Toolkit: http://safe-biopharma.org/index.php?option=com_content&task=view&id=254&Itemid=422 • Watch the SAFE-BioPharma introductory video: http://www.phillipsvideopost.com/safe • Contact us for more information: Jon Schoonmaker Chief of Operations & Technical Program (301) 610-6060 jon.schoonmaker@safe-biopharma.org Kay Bross, Director Member/Vendor Progs kbross@safe-biopharma.org (513) 489-3840 (o) (513) 673-2344 (c) • Mollie Shields Uehling • CEO • mollie@safe-biopharma.org • (201) 292-1861 • (201) 925-2173 (cell) Cindy Cullen CTO cindy.cullen@bms.com (609) 818 4152 Gary Wilson Prog. Mgr (781) 962-3172 Gwilson@safe- biopharma.org Tanya Newton Manager, Reg Afrs (908) 213-1069 tanya.newton@safe-biopharma.org Kevin Chisholm, Admin. Kevin.Chisholm@SAFE-BioPHarma.org (201) 292-1860 Rich Furr Head, Reg. Afrs. RFurr@SAFE-BioPharma.org (610) 252-5922

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