Northrop Grumman Corporation · NYSE:NOC
Northrop Grumman — SAFE-BioPharma Association — Conference Presentation (May 2007)
37 slides from Northrop Grumman's conference presentation, May 2007
Slide 1: The SAFE Standard: Digital Signatures for Achieving Global, Compliant Requirements for Health Care
The SAFE Standard: Digital Signatures for Achieving Global, Compliant Requirements for Health Care Terry Zagar, Northrop Grumman Health Solutions Core Team Member SAFE-BioPharma Association SAFE-BioPharma Association
Slide 2: Topics
Topics The Business Case for SAFE SAFE Overview Using SAFE SAFE in Operation Leveraging SAFE Membership Questions 2 SAFE-BioPharma Association
Slide 3: The Business Case For SAFE
The Business Case For SAFE 3 SAFE-BioPharma Association
Slide 4: What's Wrong With a Signature on Paper?
What’s Wrong With a Signature on Paper? Signatures & signed content can be fabricated – Possible to recreate a modified copy as good as, or better than, the original Growing expense: – Signed record management, retrieval & storage – Mailing of signed originals Physical signing process can be onerous
Slide 5: Financial Impact in Today's Environment - Pharmaceuticals
Financial Impact in Today’s Environment - Pharmaceuticals Industry spends > $1 billion per year on independent identity credentialing models – Over 200,000 clinical investigators sites – 1,500 CRO’s – 1,000 university medical centers – 1,000 medical labs – Total amounts to ~700,000 individual users
Slide 6: Financial Impact in Today's Environment – Health Care
Financial Impact in Today’s Environment – Health Care New England Journal of Medicine, 2004, et.al. – Paperwork = 31% of all health costs / $500 billion in 2004 • Emergency Department: 1 hr. care / 1 hr. of paperwork • Surgery & Inpatient Acute Care: 1 hr. care / 36 min. paperwork • Skilled Nursing
Slide 7: So What's Hindering Us?
So What’s Hindering Us? Regulatory Concerns – Good clinical, lab, safety, and manufacturing practices; global digital signature requirements; privacy protection Legal Concerns – Global operations; legal liabilities; regional acceptance Trust Concerns – Digital identity; consistency across trading pa
Slide 8: The Global Identity Challenge
The Global Identity Challenge EMEA Ethics Committees Biopharma1 EU MS1 CRO(s) EU MS2 4-5x Biopharma 10x+ user overlap 2 user overlap Research Sites/ EU MS…n Investigators Biopharma 3 MHLW Trade/supply partner(s) FDA If tackled independently Æ recipe for management nightmare 8 SAFE-BioPharma Associat
Slide 9: Enter SAFE ...
Enter SAFE ... SAFE-BioPharma Association Health industry partnership to address regulatory, legal, trust, & infrastructure concerns 9 SAFE-BioPharma Association
Slide 10: SAFE Overview
SAFE Overview 10 SAFE-BioPharma Association
Slide 11: SAFE Mission
SAFE Mission Provide a digital signature standard & associated operating rules – Built on existing standards – minimize reinvention Delivers unique electronic identity credentials – Legally enforceable – Regulatory compliant – Acceptable across the global biopharmaceutical environment Provides share
Slide 12: SAFE & Bio-Pharmaceutical Community Timeline
SAFE & Bio-Pharmaceutical Community Timeline MAY 2003 SAFE Æ strategic PhRMA initiative DEC 2003 Seed investment Æ 12 bio-pharmaceuticals JUN 2003 SAFE Standard v1.0 DEC 2004 SAFE-BioPharma Æ 8 bio-pharmaceutials SEP 2005 SAFE Bridge & SAFE Standard v2.0 12 SAFE-BioPharma Association
Slide 13: SAFE-BioPharma – the Association
SAFE-BioPharma – the Association Not for profit entity: – Created by biopharmaceutical industry – Not about financial return via the SAFE entity; return delivered to members through the use of the system – Ensure open access to all within the broad healthcare industry Provides: – Delivery & maintena
Slide 14: SAFE – a Community Framework
SAFE – a Community Framework SAFE-BioPharma Agreement SAFE Standard Agreement • Business/Legal • Governance Member • Specifications Issuer Full Services Services • For-Profit Entities • SAFE Bridge CA • Certification Authority • Not-For-Profit Entities • Directory • Credentials for Members • Governm
Slide 15: Using SAFE
Using SAFE 15 SAFE-BioPharma Association
Slide 16: SAFE Business Scope
SAFE Business Scope Common digital signature use & acceptance agreement Æ execute once – Continuing accreditation & audit of Members / Issuers – Capped liability limits on SAFE digital signature use – Dispute resolution process & framework for SAFE stakeholders Independent certification of SAFE-enab
Slide 17: SAFE Product Certification Program
SAFE Product Certification Program • Certification Recommendations • SAFE Standard Inputs SAFE-BioPharma Association • Common Test Procedures • Audit Inputs/Responses SAFE Lab • Common Test Tools Accreditation • Global Capability SAFE Product Program Certification Program SAFE-Enabled Product • Test
Slide 18: SAFE Governance
SAFE Governance Board of Directors Policy Approval Authority (PAA) PAA Designated Working Groups Governance & Business Model Operations & Technology Legal & Risk Change Management Accreditation Council Council 18 SAFE-BioPharma Association
Slide 19: SAFE Technical Scope
SAFE Technical Scope Issuance of a unique SAFE identity credential & its binding to a specific individual Provide business-to-business trust across different infrastructure implementations via the SAFE Bridge Digitally sign an electronic record or object Validate one or more digital signatures on an
Slide 20: Issuing SAFE Credentials
Issuing SAFE Credentials Registration of Subscriber Pr o Issuer Trusted Ide of of Issuer Agent nti ty System For Subscriber Digital File Public Certificate d Pa i gne nt Ph ss Key S eme ras re Subscriber e Ag John Jane S. Doe, MD Subscriber Hardware Agreement Token 20 SAFE-BioPharma Association
Slide 21: Binding of Subscriber & Subscriber's Private Key
Binding of Subscriber & Subscriber’s Private Key “KV- generated & Subscriber’s SH5” protects Private Key controls via Hardware generated pass phrase Token Subscriber’s provided Public Key linked via knows to public key Subscriber issues & can revoke Public Digital Certificate Issuer’s Certification
Slide 22: SAFE Bridge
SAFE Bridge Ensures trust across heterogeneous Issuer systems Ensures transactional interoperability among these “bridged” systems Reduces cost & extends flexibility for SAFE Members by promoting availability of competitive external supply sources or ability to utilize internal solutions Reduces app
Slide 23: Signing with a SAFE Credential
Signing with a SAFE Credential Signer: 1. Selects document to sign 2. Acknowledges SAFE signature rules 3. Provides reason for signing (if needed) 4. Inserts hardware token 5. Enters pass phrase to complete signing operation 23 SAFE-BioPharma Association
Slide 24: Validating a SAFE Signature
Validating a SAFE Signature Just Click On it ... ? Reason: Affirm information on Form 1472 Jane Doe DN: CN=Jane Doe, C=US, O=Miracle Cure Pharma, OU=000000000177 Date: 2005.10.19 20:33:07 – 4’00’ Validation: Confirms ? Terry Zagar Reason: Document Review DN: CN=Terry Zagar, C=US, O=SAFE-BioPharma As
Slide 25: SAFE Signature Block – Visual Representations
SAFE Signature Block – Visual Representations Valid Signature √ Jane Doe Reason: Affirm information on Form 1472 DN: CN=Jane Doe, C=US, O=Miracle Cure Pharma, OU=000000000177 Date: 2005.10.19 20:33:07 – 4’00’ Invalid Signature XJane Doe Reason: Affirm information on Form 1472 DN: CN=Jane Doe, C=US,
Slide 26: SAFE in Operation
SAFE in Operation 26 SAFE-BioPharma Association
Slide 27: Strategic Approach to Build Critical Mass for SAFE
Strategic Approach to Build Critical Mass for SAFE Centers of Gravity SAFE is focusing its resources and efforts around a small number of Centers of Gravity (Programs) to ensure early stage successes that are self-sustaining and leverageable by others with or without follow-on support from SAFE SAFE
Slide 28: Clinical Site Example
Clinical Site Example NCI/caBIG Pharma C Pharma B User ID/ Site ID Pharma A Pharma D Password Current Environment SAFE Environment Goal One hardware device per person, which holds the digital identity Simplified user environment Common implementation standard across all biopharmaceutical companies 2
Slide 29: Pfizer & SAFE
Pfizer & SAFE Situation: – Pfizer manages identity credentials for over 200,000 employees and contractors – It spends an estimated $10 million per year for password resets – Every digital signature utilized for regulatory and non-regulatory transactions eliminates the costs of approximately $125 dol
Slide 30: GSK & SAFE
GSK & SAFE Situation: – Over 100,000 world wide employees – Seeking time & cost savings, improved operational proficiency, & increased productivity Approach: – Accelerate secure information exchange during clinical trials by leveraging SAFE standard for clinical investigators to improve process effi
Slide 31: Merck & SAFE
Merck & SAFE Situation: – Approximately 72,000 employees worldwide – Seeking a SAFE trust infrastructure, and a common framework to enable global collaboration, alliances, and partnerships Approach: – Qualitative based on perception that Industry moving to automation of regulatory and non- regulator
Slide 32: Leveraging SAFE Membership
Leveraging SAFE Membership 32 SAFE-BioPharma Association
Slide 33: SAFE Participation & Drivers
SAFE Participation & Drivers Sponsors Business Partners Merck, Johnson & Johnson, Abbott Labs, Labs, Investigators , CROs, Bio-Techs, AstraZeneca, Sanofi-Aventis, Bristol Manufacturing Supply Chain, Sales Myers-Squibb, Covance, Pfizer, GlaxoSmithKline, Procter & Gamble Drivers Drivers Simplified end
Slide 34: Participation Benefits
Participation Benefits SAFE Working Groups Æ opportunity to share solutions & lessons learned Best Practice guides for Members (under development): – SAFE / 21 CFR Part 11 Implementation Guidance Checklist – Credential provisioning and applications support guideline Vendor programs: – Application &
Slide 35: SAFE Directions
SAFE Directions Expanding Membership – Shared service model – more members = lower cost to each member – Enhances ubiquity of digital credential approach – Broaden beyond biopharmaceutical companies to all healthcare/healthcare related entities Expanding new business process opportunities – Move bey
Slide 36: Becoming a SAFE Member
Becoming a SAFE Member Visit: http://www.safe-biopharma.org Contact: 36 SAFE-BioPharma Association
Slide 37: Questions?
Questions? 37 SAFE-BioPharma Association
SAFE-BioPharma Association — Conference Presentation (May 2007) on 6ix