How Tech Helps Pharma Compliance

How Technology Helps Compliance

For EBG Life Sciences group, September 2011
By Maureen Shaffer
President/CEO Mingletoe LLC
maureen.shaffer@gmail.com

1

Agenda

 Why Technology for Sales and Marketing
Compliance?
 Key Technologies
–Content Management
–Social Collaboration
–Social Media Listening and Engagement
–AE reporting
–Mobile Device Security and Control

 Integration and Conclusion

2 © Mingletoe LLC. All rights reserved.

What We Are Not Covering
 Agg Spend
–www.porziopharma.com/View-Products---Services/Porzio-
AggregateSpendID.aspx
 Content development and approval
–www.slideshare.net/goodpromotionalpractices/navigatingfinalv2-
091015135154phpapp01
 CMS, ECM, DAM reference
–www.realstorygroup.com/
 Copyright compliance for journals and reference text
– www.reprintsdesk.com

 Grants
–www.egrantsolutions.com/
 Training
–www.simbionix.com
–www.brainshark.com
 Verilogue (CareCoach/Recorded MD-rep interactions)
–www.verilogue.com

Compliance: Yield w/o Disruption


Paper Doesn’t Work


Widespread Exposure >250k


Why Technology?

Makes it easy to do the right thing by
enforcing policies and procedures in the
daily habits of employees
1. Reproducible programming=On label, or
appropriate scientific or educational
dissemination
2. Speed=Global changes in ~30 minutes
3. Built-in protections=Off-label information
4. Dashboards=Timely monitoring and auditing
5. Archiving=Quick production of discovery
request

The Time is Now

RT @ChristianeTrue
@sairthebear: Don't think
digital is that relevant to
pharma? Check out these
amazing stats!
http://www.youtube.com/watc
h?v=bidBKtN2mMg


iPad Only Tablet that Matters


Compliance Technology Criteria
Sales and Marketing Focus

 Easy
 Efficient
 Compliant
–Approval workflows
–Permission-based roles
–Solid real-time monitoring/auditing Easy = Sales
Adoption
–Archiving
–Recognized by Gartner

Efficient = Compliant
Save $ = Less Risk


Content Management for Approved Materials

Prolifiq Software
Maureen Shaffer
maureen.shaffer@prolifiq.com
415-341-6863 mobile

11

@GPPnews tweets on #digdevice

 "gone are the days of the 4-page glossy
brochure" per Medtronic at #digdevice
#meddevice #medtech
 @MedtronicANZ @1StevePeck: MDT saved
"Hundreds of thousands of dollars" on paper
print material by moving to the iPad. #digdevice
 80% at #digdevice have released a #mobile
app; most to internal sales force #meddevice
#hcmktg
 4 Reasons Why iPads are Sales BFF
http://ow.ly/5XL4Z #pharma #meddevice
#epharma

Why Content Management?
“The Life Sciences rep of the
future – the ‘information
concierge’ – is remote,
mobile, social, and
commands multimedia. They
live where controlled,
“Approved materials that are compliant content meets
altered, abbreviated or in
any other way modified
Speed for social media.”
(including highlighting) are Sales Dale Hagemeyer
considered unapproved Managing Vice President, Gartner, Inc.
materials.”

235%
Increase

Compliance
for Savings for
Regulatory Marketing
and Legal


Content Management is Needed


Med Device Sales
Select, Send and Follow Up


HCP Receives
Personalized or Branded message
prescribed delivery
message

On message and
Selected product
tracked links
content with
image

Persistent
content

Auto-embeds
Auto-embeds
your contact
labeling and
information
disclaimers
Click Here for Instructions For Use (2ml Product).
Click Here for Instructions For Use (5ml Product).


Pharma
Sales Creates

Text is:
•Benign
•Prescribed
•Pre-Approved
•Compliant

GRP Request


Sales and Marketing Dashboards
Top Messages
Top Messages # Opens
# Sent

Top Messages
Message # Clicks Generated
Drill Down

Click to View
Message


Regulatory Real-time Monitoring

Powerful Filters:
User, Time,
Message,
Recipient


Content Library
Upload in a Tags drive
few clicks organization and
business rules

Quick Sync Status Full version control
immediately updates drives and archiving
content for Sales availability
users


Prolifiq Compliance Controls

Rules operate transparently behind the scenes
Marketing By Message Globally
 Brand  AutoAttach By message rules, plus

 Cadence/  Data capture  Black and white
Campaign lists, authorized
 Disclaimers senders
 Content dip
 Message approval  Content approval
 Formatting
 Segment by user  Danger words
 Mapping or group
 WW propagation of
 Persistent  Workflow new and revised, or
content obsolescence in 30
minutes


Prolifiq Customers/Partners

 Tech and media  Medical device and
clients pharma clients and
partners


Prolifiq’s Native iPad App
Coming Soon!


Social Collaboration

Jive Software
Stephen D’Angelo, Sr. Director Strategic Accounts
steve.dangelo@jivesoftware.com
(201) 404-1146 mobile

25

Why Collaboration Software?

 Internal use: One-stop employee
communication
 Hybrid: Clinical investigator portal
 External: Disease awareness community
 Functionality
–Define user roles, profiles, access
–Ideal environment for training
–Wikis, configurable group, teams and community
areas, blogs, content upload with tags and share
functions


Jive for Social Collaboration


Jive Sales Home


Jive: Content, People, Places


Centralized Content Repository


Jive Content Background


Jive Content Editing Console


Jive for Apple Support Community


Jive’s Compliance Controls

 Latest greatest content
 Expiration dating
 Permission-based content restrictions
 Publishing rights based on login
 Sharing permitted with specific communities
 Customizable archiving, compliance monitoring
tools, and archive search capabilities for HIPAA
and SOX compliance


Jive’s Pharma Customers


Social Media Listening and
Engagement

Radian6
Adam Draper, Business Development Manager
Adam.draper@radian6.com
(902) 452-9931

36

@GPPnews tweets on #sm

 Robin Whalen @KCCorp #meddevice saw 10x
return on monies removed from tradeshow
budget and used for #socialmedia #sm
#digdevice
 For every 1 #heart valve patient, there are 4
caregivers per Adam Pick #digdevice #hcmktg
#meddevice #Medtech


Why Social Media Monitoring?

 Not listening is a PR disaster waiting to happen
–@KCCorp first heard about AEs with patient feeding
tubes on blogs
–Your defense cannot be, ―we had a policy to not listen‖

 Real-time search engines have 1 second lag
scanning social media sites, blogs and web
 Lightning fast action/crisis response plans
–During Domino’s 2 day lag, nearly one million people
viewed the videos on YouTube

 To be credible, lawyers must have SM accounts
(FB, Twitter and LinkedIn), per AMEX general
counsel @djcompliance

Only 5% have Social Media Policy


| WHO USES RADIAN6?

Marketing
and PR Investor
Competitive
Intelligence Relations

Market Product
Research Marketing
Consumer
Affairs
Sales
Customer Recruitment
Service and HR

40

| RADIAN6 PLATFORM PROVIDES
ROI
Insights
know/discover/
understand Summary
Dashboard
share/realize/
inform
Analysis Dashboard
listen/learn/measure
Platform
Coverage/metrics/global

Mobile
API
engage/move/ Engagement Console
Build/integrate
coordinate find/collaborate/
/customize
solve

41

| ENGAGEMENT CONSOLE

42

| API FOR CUSTOM

45

Radian Compliance Controls

 Social rules engine forthcoming late 2011
–Widgets today
–Keyword searches for AEs

 Manual release by task owner
 Manual or auto release by approver
 Super user designation to configuration
 Dashboarding
 Archiving


Low(er) Budget Solutions

 HootSuite Pro
–$5.99/mo
–Account provisioning

 HootSuite Enterprise
–$1499/mo
–Message assignment
–Limited permissions
–Approval workflows

 Sprout Social
–Listening only
–Very intuitive dashboard


Sales Reporting of Possible
AEs

Online AE scanning and reporting covered in
Social Media Listening and Engagement

48

@GPPnews tweets on AEs

 Smart! @KCCorp #meddevice division hired a
nurse to monitor and respond to medical
questions online #digdevice #hcsm #hcmktg
 @wtongen: Only a few! @NucleusMedMedia:
Roche, Boehringer and Pfizer received 1-2 #sm
comments that were adverse events #digdevice


Field Reporting


Field Data Report
Database and/or Email


Mobile Device Security and
Control

MobileIron
Stephan Keller, Director NA VAR Channel
skeller@mobileiron.com
(727) 776-8767

52

@GPPnews tweets on #mobile

 Maquet uses @mobileiron for Mobile Device
Management--transparent pushes of new apps.
No need for sales to download. #meddevice
#digdevice
 38% of physicians have seen #sales reps with
iPads: what they think about it here
http://ow.ly/1vxzIR #meddevice #digdevice


Why MDM?

 Software Distribution — The ability to
manage and support mobile application
including deploy, install, update, delete or block.
 Policy Management — Development, control
and operations of enterprise mobile policy.
 Inventory Management — Beyond basic
inventory management, this includes
provisioning and support.
 Security Management — The enforcement of
standard device security, authentication and
encryption.


MobileIron used by Med Devices

https://info.mobileiron.com/gartner_mq_2011_ORG.html

Mobile OS Evolution
2007 2010 2013

• Touch wins
• Consumer UX
wins
• Global IT will
have to support
3-5 OS

Mobile apps are catalyzing a new
breed of Shadow IT
The new Shadow IT:

End-user
Solo developers
Desktop
Datacenter Mobile Contractors
(client-server)

Small teams
Highly fragmented
Highly decentralized

“IT bypass” catalyzed by:
Corporate • Strong user demand for mobile apps
• Increasingly technical user base
IT • Easy (initial) app development
• Corporate policies lagging technology


Enterprise Lifecycle Support
2 Configure fully

Support for all iOS
configuration and security
options
Enforce security and
1 See all devices 5 profile updates silently

3 Configure securely
Control international
6 roaming costs

Multi-OS console for
employee- and company-
owned phones Over-the-air, protected Publish approved apps
via SCEP 7 & monitor rogue apps

Wipe (full or selective)
9 when lost or retired Roll out at scale
4

Control access to
By group and policy
8 ActiveSync


Business Needs and IT Meet
End-user needs IT needs

Bridges the gap between what
end users demand and what IT
requires

• Get up and going with • Know who and what’s out
easy self service there
• Gain secure access to • Block unauthorized
enterprise resources devices
• Easily get needed apps • Provision, secure, and
configure at scale, per
• Help make sure services user
are working well
• Update policies over time
• Have an simple, intuitive
enterprise experience • Enforce the enterprise
data boundary for user-
owned iPhones

60
60

Silent Enforcement
Zero-Touch
Security

 Provision & modify
enterprise policies &
certificates
 Enforce restrictions
 Enforce enterprise
data boundary –
selectively
 Alert on device
No User Interaction events such as
Required storage usage or
compromised devices

MobileIron Compliance Controls
Notifications
Cost and quality
Management and security platform Int’l roaming detection

Service quality (user-driven)

Rogue app protection
Application delivery Application lifecycle
Access control Installed app inventory

Enterprise data boundary
Advanced security
Certificate delivery
Device-side
APIs and services Inventory and detection

Zero-touch enforcement
Policy and settings
Profile delivery

Profile creation


MobileIron’s Customers


Tie It All Together

Simplifying Multiple Systems of Record

64

Consider…

 Policies before technology; Revisions later
–Flow charting data, responses, and responsibilities
–Broad team participation in policies
–Easy, intuitive interfaces (―skins‖) or build interfaces
for different roles

 Strong integration partner for large enterprises,
e.g. Accenture (top in LS), Deloitte, IBM
 Built on known platforms, e.g. Sharepoint
 Well-respected integration technology, e.g.
salesforce.com, Oracle, SAP


Why Software?

 Flexible integration to legacy systems via APIs
 Not a core competency to regulated industries
 Smart and sustainable: SaaS/Cloud software
learns rapidly from the community and every
benefits
 Cost efficient Easy = Sales
Adoption
 ~Hardware agnostic

Efficient = Compliant
Save $ = Less Risk


Contact Information

Maureen Shaffer, President/CEO Mingletoe LLC
maureen.shaffer@gmail.com
www.linkedin.com/in/maureenashaffer
www.twitter.com/maureenshaffer


Best eDiscovery Cost Slide Ever


Digital Marketing Cuts Sales Reps

 Some of the drug giants have already begun
slashing their sales forces and experimenting
with digital marketing. Sanofi-Aventis has
www.ipractice.com, AstraZeneca offers
Touchpoints, and Merck has
www.merckservices.com – all of which offer
24×7 information.
http://www.pixelsandpills.com/2011/08/30/poin
tcounterpoint-digital-tools-replace-sales-force

/


How Tech Helps Pharma Compliance

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