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OpenQ webinar 8/27/12 SafeGuard SAFE social
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OpenQ webinar 8/27/12 SafeGuard SAFE social


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Presentation slides from OpenQ hosted webinar on 8/27/2012 - Convince your legal and compliance teams that now it's safe to go social

Presentation slides from OpenQ hosted webinar on 8/27/2012 - Convince your legal and compliance teams that now it's safe to go social

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  • 1. Safeguarding Life Sciences Companies Against Social Media Compliance Exposure August 27, 2012Copyright © 2012 OpenQ, Inc.
  • 2. Today’s DiscussionSocial Media Landscape - 15 min– Benefits– RisksSafeGuard Demo – 10 minQ&A – 20 minGoal: Convince you it’s safe to go social soyou can convince your legal andcompliance teams.
  • 3. HousekeepingCall will be on mute during presentationand demoPlease use the chat capability if you haveany issues with the audio or visualpresentationIf I am not able to get to your questionduring Q&A, please email me
  • 4. About OpenQGlobal Customers – From Providers, Advocacy, Pharma, to Biotech Commitment to compliance – 8 years, 100s of audits, dozens of CIA’s Frequent participant in social compliance dialogue – Presentations, articles, posting Active partner network – Salesforce, Yammer, Facebook, Jive, Oracle Integrating technology and Copyright © 2011 OpenQ, 4 Inc. research into solutions
  • 5. OpenQ provides solutions for Healthcare & Life Scienceorganizations to enable compliant social intelligence and collaboration Life Science Healthcare Social Networks Social Networks Internal Internal network network Copyright © 2012 OpenQ, Inc.
  • 6. External Social Benefits Patient Benefits Lower Costs Other Advantages • Clinical trial recruiting • Reduce marketing costs • Conduct research for PROs • Help navigate paperwork • Provide instant access to • Improve company image • Ensure access to factual FAQs, reduce call-center • Manage restrictive REMS messaging burden communications • Embed fair-balance into • Reduce company- programs forwards and posts sponsored PAP costs • Identify new product based on product name • Provide access to uses • Monitor for AEs and vouchers • Educate patients about abuse potential • Communicate new risks of buying • Help understand, and information and risks counterfeit products overcome, disease instantly from overseas stigma • Create medication • Improve adherence and reminders for “high risk” compliance patientsCopyright © 2012 OpenQ, Inc.
  • 7. Internal Social Benefits Increase Growth Lower Costs Other Advantages • Facilitate global • Reduce time to market • Unified platform to manage collaboration and share customer and employee • Reduce cost of innovative best-practices communities compliance monitoring • Improve innovation • Facilitate information sharing – • Improve employee through collaboration data rich and information poor productivity • Identify high performing organization. Convert data to • Reduce costs to recruit information. employees and social experts media use for replication • Remove duplication of IT effort • Reduce human resource, across different business units • Better collaboration legal costs and protect across geographies employees • Prioritize feasible high-impact initiatives • Reduce cost to support an investigation • Protect intellectual property • Improve sourcing • Enable controlled access to capabilities content based on group privileges • Reduce communication costsCopyright © 2012 OpenQ, Inc.
  • 8. Building Social IntelligenceListen/Monitor Research Engage• Identify unmet needs • Post questions to a • Participation by for new products and specialist community scientific liaison staff in indications • Conduct surveys community discussions• Understand treatment • Establish panels based • Support specialty trends on pre-selected criteria communities• Monitor drug usage • Monitor disease state • Post information and• Predict future Rx discussions services germane to Volume • Track competitive discussions• Identify unknown Side- products Effects• Look for and remediate off-label usage• Identify critical issues, such as abuse
  • 9. Each Engagement Channel Targets a Set of Business NeedsInternal Private External• Identify habits of high • Collaborate with • Share information in performers researchers, thought two-way dialog• Knowledge archiving & leaders, advisers • Conduct research sharing (don’t recreate • Share key learning and • Patient recruitment the wheel) findings • Improve pharma image• Save email for “critical” • Conduct research • Increase patient access, communications • Manage vendors adherence &• Break down global • Collaborate with compliance barriers patients • Identify Patient• Spur innovation through • Online registries Reported Outcomes for collaboration PIII to optimize P&R and labeling at launch
  • 10. Currently, socially savvy companies are using internal platforms for… Source: Gartner (Feb, 2012) N=175Companies are primarily using social platforms for internal collaboration10
  • 11. Example: Social Media in Oncology Sermo MedScape Physician Connect Oncologists gather Student Doctor Network product information Healtheva online >75% of time Relaxdoc SocialMD (Manhattan Research Sosido Strategic Insight, Clinical Village iMedExchange ePharma Physician v9.0 Tiromed #4, 2009) Ozmosis Medical Plexus 25,000 visitors per Rad Rounds month on MyPacs oncology area (Feb. MedTrust MedicSpeak 2010) Peerclip Syndicom Spineconnect QuatiaMD MDsConnect
  • 12. The Risks
  • 13. The Evolution of RiskRisk – Old Version: execution was aboutoperations,Risk – New Version: lives outside of theorganization now because thepower/activity is in the networkNeed new skill sets– Managing big data– Engagement– New policies & procedures
  • 14. Industry in Fear •Resources to monitor •Lack of clear guidance volume •CIAs •Pay agencies to monitor •Expertise Cost Regulation“…42% of companies admitted Cost to comply with an that no one in their investigation: a company spends organization monitors between $1.5MM to $2MM in compliance with social media addition to resource time even policies” before the fine. Policy Legal •Development • Fines •Enforcement •Resources • Litigation costs • Discovery
  • 15. The Cost of Non-Compliance Loss of first mover advantage – Inefficiencies from lack of access to community feedback Investigations – To support an investigation $1.5MM to $2MM + resource time – 57 Life Sciences companies with Corporate Integrity Agreements with the Office of the Inspector General, 223 ongoing investigations – For every $1 the justice department spends on investigations, they receive $7 in fines. Investigations will increase. Corporate Reserves for fines – Amgen has reserved for $780M – Abbott paid $1.5B – GSK $3B announcedSource - The Economist: Apr 28th 2012
  • 16. Social Networking Listening & Engaging Monitoring Can I engage and remainWhat if I find an AE or compliant without off-label comment? significant resources? Follow current Yes – with a social regulation for enterprise solution submission
  • 17. Risk is an Enterprise Challenge Researchers Product Payers Teams Social Collaboration for Improved Patient Lives Caregivers HCPs Patients
  • 18. Making the Case for Social
  • 19. Making the Case for SocialWhile there is still uncertainty for socialpractices:– The general guidance regarding communication are clear– Industry players are starting to wade inCompliance is embedded from the beginning– Part of the initial proposal– Envisioned as a piece of an enterprise approachGiven that some social is beyond companycontrol, the processes must be in place now
  • 20. Decide which Social “Channels” will be Covered? Internal Sponsor Internal Sponsor / Internal / External Community Community External Sponsor External Sponsor / Internal / External Community Community20Copyright © 2012 OpenQ, Inc.
  • 21. Priorities - Manage Policies in a Hierarchy Geography (Language), Function, Universal Policy Company Policy Engagement “Channel” Privacy Confidentiality Appropriate Branding language Anti- Reputation Corruption21
  • 22. Lever a Multi-tiered ACCESS Plan for Social Engagement Global Patient Community Disease Community Engagement Capabilities Can Vary KOL by Community Community Company Community22
  • 23. Enterprise Capabilities Proactive Risk AnalysisEnterprise Social Data SafeGuard™ evaluateConsolidate internal and activity from socialexternal feeds from social platforms, and othermedia and other enterprise interactions, tocollaboration tools to proactively identify anddeliver accurate and classify risk, going beyondcomplete archiving. Collect social & Analyze data & attachments technologies currently business feeds available.Compliance Controls Integrated Follow ThroughClassification of risk level An intuitive interfaceaccording to industry enables the efficientdriven and company- management and tracking ofdefined priorities. compliance cases.-Regulation-Functional or group Classify levels Investigate-Role of risk violations23 Copyright © 2012 OpenQ, Inc.
  • 24. Monitoring Scope Aggregate social media discussions from multiple channels Private Private Sponsored Internal External Community Community Such as Such as Chatter KOL/HCP Portals Safeguard Public Company Social Enterprise Social Application Data and Compliance Suite Content For example using Radian 6 to listen Such as free text in CRM24 system Copyright © 2012 OpenQ, Inc. Confidential
  • 25. SafeGuard ArchitectureInternal Social Engagement External Social Engagement Platforms & Social CRM Platforms (Twitter, Blogs) (Chatter, SFDC CRM) Social Monitoring (Radian6) OpenQ SafeGuard Connector SafeGuard Archive OpenQ SafeGuard AnalyzerSocial Platform Management GRC or Investigation Solution (Buddy Media) (Service Cloud) Copyright © 2012 OpenQ, Inc.
  • 26. Analyze data & Classify levels of risk Monitor For and Classify Riskattachments • Industry specific analysis • Competitor brand claims • False claims • Adverse event potential Context mentions • Anti-kickback language Engine • Personal identification violation • Global or geographically based risk analysis Policy • Company Confidentiality • Stress terms or phrases Engine • Anti-privacy disclosures • Offensive terms or phrases • Sentiment Regulatory • Message Properties Engine • Message quality • Message contributor • Message follower Copyright © 2012 OpenQ, Inc. Confidential
  • 27. Support Inline InvestigationInvestigate violations Easy to View Violations – Visualize captured messages – View new messages requiring attention – View “Up-to-date” metrics Drill-down into risks – Complete message content – Important message attributes (creation user, creation date, risk level, etc. – Link to Parent messages/objects Remediation capabilities – Actions taken to resolve any compliance risks or policy violations – Integration with SFDC Cases – Third-party integrations with Risk Management systems Copyright © 2012 OpenQ, Inc. Confidential
  • 28. Appendix
  • 29. Staffing Models Internal Compliance, Regulatory, Medical• Manage internally: additional resource personnel may be necessary in individual departments depending on scope of monitoring by SafeGuard.• Option to outsource initial case review: develop SOPs for review and flagging high risk cases only to internal teams for management. OpenQ Service support• Manager with regulatory and compliance experience manages review staff and audits performance.• Examples: Can send AE reporting to FDA or internal safety review team. Can file MIRFs or send to internal review team.Agency or CRO Service support• Your existing agency or CRO can develop a support staffing model based on need and how SafeGuard is used; additional seats are purchased on behalf of your agency for implementation.
  • 30. OpenQ Solutions Software Products (Available Integrated Data Services Offerings Natively and on MobileQ AnalyzeReal-Time Native Interface for Validation and Ranking, FMVIdentification & Mobile DevicesStorefront Identify Navigate Analytical Identification, PeerEmpower Investigator Nomination, and Rising StarCompliant Community Discoverycontent Engagementdistribution Profile Orchestrate Complete, Current, and CorrectEngage Speaker Community expert profilesCompliant & EngagementEffective Field ScreenPrograms SafeGuard Review Professional Backgrounds Compliant Social for Infractions Engagement Copyright © 2012 OpenQ, Inc.
  • 31. Who “Owns” Social Media Enterprise Compliance? Clinical Development Compliance Commercial Policy & Regulation Human Information Resources Technology Regulatory Affairs
  • 32. The reality is that governance are key Classifylevels of risk elements in a social media strategy How do I enforce policies? In "Social Media and Its Associated Risks," a report issued by global audit, tax, and advisory firm Grant Thornton and the Financial Executives Research Foundation, a staggering 42 percent of the 141 public and private company executives surveyed admitted that no one in their organization monitors compliance with social media policies.– Destination CRM Copyright © 2012 OpenQ, Inc. Confidential