OpenQ webinar 8/27/12 SafeGuard SAFE social

Safeguarding Life Sciences Companies Against Social

Media Compliance Exposure

August 27, 2012

Copyright © 2012 OpenQ, Inc.

Today’s Discussion

Social Media Landscape - 15 min

– Benefits

– Risks

SafeGuard Demo – 10 min

Q&A – 20 min

Goal: Convince you it’s safe to go social so you can convince your legal and compliance teams.

Housekeeping

Call will be on mute during presentation and demo

Please use the chat capability if you have any issues with the audio or visual presentation

If I am not able to get to your question during Q&A, please email me directly: [email protected]

About OpenQ

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 research into solutions

Copyright © 2011 OpenQ,

Inc. 4

Global Customers – From Providers, Advocacy, Pharma, to Biotech

http://www.millennium.com/Default.aspx

http://www.hl-isy.com/

http://www.themmrf.org/

OpenQ provides solutions for Healthcare & Life Science organizations to enable compliant social intelligence

and collaboration


Life Science Social Networks

Healthcare Social Networks

Internal network

Internal network

External Social Benefits

Patient Benefits

• Clinical trial recruiting

• Help navigate paperwork

• Ensure access to factual messaging

• Embed fair-balance into forwards and posts based on product name

• Monitor for AEs and abuse potential

• Help understand, and overcome, disease stigma

• Improve adherence and compliance

Lower Costs

• Reduce marketing costs

• Provide instant access to FAQs, reduce call-center burden

• Reduce company-sponsored PAP costs

• Provide access to vouchers

• Communicate new information and risks instantly

• Create medication reminders for “high risk” patients

Other Advantages

• Conduct research for PROs

• Improve company image

• Manage restrictive REMS communications programs

• Identify new product uses

• Educate patients about risks of buying counterfeit products from overseas


Internal Social Benefits

Increase Growth

• Facilitate global collaboration and share innovative best-practices

• Improve innovation through collaboration

• Identify high performing employees and social media use for replication

• Better collaboration across geographies

Lower Costs

• Reduce time to market

• Reduce cost of compliance monitoring

• Improve employee productivity

• Reduce costs to recruit experts

• Reduce human resource, legal costs and protect employees

• Reduce cost to support an investigation

• Improve sourcing capabilities

• Reduce communication costs

Other Advantages

• Unified platform to manage customer and employee communities

• Facilitate information sharing – data rich and information poor organization. Convert data to information.

• Remove duplication of IT effort across different business units

• Prioritize feasible high-impact initiatives

• Protect intellectual property

• Enable controlled access to content based on group privileges


Building Social Intelligence

Listen/Monitor Research Engage

• Identify unmet needs for new products and indications

• Understand treatment trends

• Monitor drug usage • Predict future Rx

Volume • Identify unknown Side-

Effects • Look for and remediate

off-label usage • Identify critical issues,

such as abuse

• Post questions to a specialist community

• Conduct surveys • Establish panels based

on pre-selected criteria • Monitor disease state

discussions • Track competitive

products

• Participation by scientific liaison staff in community discussions

• Support specialty communities

• Post information and services germane to discussions

Each Engagement Channel Targets a Set of Business Needs

Internal Private External

• Identify habits of high performers

• Knowledge archiving & sharing (don’t recreate the wheel)

• Save email for “critical” communications

• Break down global barriers

• Spur innovation through collaboration

• Collaborate with researchers, thought leaders, advisers

• Share key learning and findings

• Conduct research • Manage vendors • Collaborate with

patients • Online registries

• Share information in two-way dialog

• Conduct research • Patient recruitment • Improve pharma image • Increase patient access,

adherence & compliance

• Identify Patient Reported Outcomes for PIII to optimize P&R and labeling at launch

Currently, socially savvy companies are using internal platforms for…

10

Source: Gartner (Feb, 2012) N=175

Companies are primarily using social platforms for internal collaboration

Example: Social Media in Oncology

Oncologists gather product information online >75% of time (Manhattan Research Strategic Insight, ePharma Physician v9.0 #4, 2009)

25,000 visitors per month on doctors.uk.net oncology area (Feb. 2010)

Sermo MedScape Physician Connect Student Doctor Network Healtheva Relaxdoc SocialMD Sosido Clinical Village iMedExchange Tiromed Ozmosis Medical Plexus Rad Rounds MyPacs MedTrust MedicSpeak Peerclip Syndicom Spineconnect QuatiaMD MDsConnect

The Risks

The Evolution of Risk

Risk – Old Version: execution was about operations,

Risk – New Version: lives outside of the organization now because the power/activity is in the network

Need new skill sets

– Managing big data

– Engagement

– New policies & procedures

Industry in Fear

• Fines

• Litigation costs

• Discovery

•Development

•Enforcement

•Resources

•Lack of clear guidance

•CIAs

•Expertise

•Resources to monitor volume

•Pay agencies to monitor

Cost Regulation

Legal Policy

“…42% of companies admitted

that no one in their

organization monitors

compliance with social media

policies”

Cost to comply with an

investigation: a company spends

between $1.5MM to $2MM in

addition to resource time even

before the fine.

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 announced

Source - The Economist: Apr 28th 2012

Social Networking

Listening & Monitoring

What if I find an AE or off-label comment?

Follow current regulation for

submission

Engaging

Can I engage and remain compliant without

significant resources?

Yes – with a social enterprise solution

Risk is an Enterprise Challenge

Social Collaboration for Improved Patient Lives

Researchers

Product Teams

HCPs

Patients

Caregivers

Payers

Making the Case for Social

Making the Case for Social

While there is still uncertainty for social practices:

– The general guidance regarding communication are clear

– Industry players are starting to wade in

Compliance is embedded from the beginning

– Part of the initial proposal

– Envisioned as a piece of an enterprise approach

Given that some social is beyond company control, the processes must be in place now

Decide which Social “Channels” will be Covered?

Internal Sponsor / Internal

Community

Internal Sponsor / External

Community

External Sponsor / Internal

Community

External Sponsor / External

Community

Copyright © 2012 OpenQ, Inc. 20

Priorities - Manage Policies in a Hierarchy

Geography (Language), Function,

Engagement “Channel”

Company Policy Universal Policy

Appropriate language

Confidentiality

Privacy

Branding

Reputation Anti-

Corruption

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Lever a Multi-tiered ACCESS Plan for Social Engagement

Global Patient Community

Disease Community

KOL Community

Company Community

22

Engagement Capabilities Can Vary

by Community

Copyright © 2012 OpenQ, Inc. 23

Collect social & business feeds

Classify levels of risk

Investigate violations

Analyze data & attachments

Integrated Follow Through An intuitive interface enables the efficient management and tracking of compliance cases.

Proactive Risk Analysis SafeGuard™ evaluate activity from social platforms, and other enterprise interactions, to proactively identify and classify risk, going beyond technologies currently available.

Compliance Controls Classification of risk level according to industry driven and company-defined priorities. -Regulation -Functional or group -Role

Enterprise Social Data Consolidate internal and external feeds from social media and other collaboration tools to deliver accurate and complete archiving.

Enterprise Capabilities

Monitoring Scope Aggregate social media discussions from multiple

channels

24

Safeguard Social Enterprise Compliance Suite

Public Social

Private Sponsored External

Community

Private Internal

Community

Copyright © 2012 OpenQ, Inc. Confidential

Such as Chatter

For example using Radian 6 to listen

Such as KOL/HCP Portals

Company Application Data and Content

Such as free text in CRM system

SafeGuard Architecture


External Social Engagement Platforms (Twitter, Blogs)

Internal Social Engagement Platforms & Social CRM

(Chatter, SFDC CRM)

Social Monitoring (Radian6)

Social Platform Management (Buddy Media)

OpenQ SafeGuard Connector

OpenQ SafeGuard Analyzer

GRC or Investigation Solution (Service Cloud)

SafeGuard Archive

Monitor For and Classify Risk

Regulatory Engine

Policy Engine

Context Engine

• Industry specific analysis • Competitor brand claims • False claims • Adverse event potential

mentions • Anti-kickback language • Personal identification

violation • Global or geographically based

risk analysis • Company Confidentiality • Stress terms or phrases • Anti-privacy disclosures • Offensive terms or phrases • Sentiment

• Message Properties • Message quality • Message contributor • Message follower


Analyze data &

attachments


Support Inline Investigation

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


Investigate violations

Appendix

Staffing Models

Compliance, Regulatory, Medical Internal • 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.

Service support OpenQ • 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.

Service support Agency or CRO • 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.

Software Products (Available Natively and on Force.com)

Integrated Data Services Offerings

OpenQ Solutions


Discover Real-Time Identification & Storefront

Empower Compliant content distribution

Engage Compliant & Effective Field Programs

MobileQ Native Interface for Mobile Devices

Navigate Investigator Community Engagement

Orchestrate Speaker Community Engagement

SafeGuard Compliant Social Engagement

Analyze Validation and Ranking, FMV

Identify Analytical Identification, Peer Nomination, and Rising Star Discovery

Profile Complete, Current, and Correct expert profiles

Screen Review Professional Backgrounds for Infractions

Who “Owns” Social Media Enterprise Compliance?

Policy &

Regulation

Clinical Development

Commercial

Information Technology

Regulatory Affairs

Human Resources

Compliance

The reality is that governance are key elements in a social media strategy


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

How do I enforce policies?


OpenQ webinar 8/27/12 SafeGuard SAFE social

Technology

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