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.
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 directly:firstname.lastname@example.org
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
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
Currently, socially savvy companies are using internal platforms for… Source: Gartner (Feb, 2012) N=175Companies are primarily using social platforms for internal collaboration10
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 doctors.uk.net MyPacs oncology area (Feb. MedTrust MedicSpeak 2010) Peerclip Syndicom Spineconnect QuatiaMD MDsConnect
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
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
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
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
Risk is an Enterprise Challenge Researchers Product Payers Teams Social Collaboration for Improved Patient Lives Caregivers HCPs Patients
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
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.