Social Media Presentation 12Jul2012

Social Media at Millennium:
A Case for Entering the Conversation
WCI PV Legal Forum
Boston, MA │ July 12, 2012
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Pat Connelly Veronique Kugener, MD, MBA, MSc
Associate Director, Digital Strategy & Communications Vice President, Pharmacovigilance & Risk Management

Christopher Sanders
Manager, Pharmacovigilance & Risk Management 2012/12/29

Legal Disclaimer

The content of this presentation is based on publicly
available information and does not necessarily represent
positions held by any of the presenters or Millennium: The
Takeda Oncology Company or any of its affiliates.

1 ｜ 12 Jul 2012 Millennium: The Takeda Oncology Company

Overview

• Company Background

• Defining Social Media
- What is it and Who uses it?
- Biopharma and Social Media

• Millennium: A Case Study

• AE/PC Reporting Considerations
- Current and Future Regulation

• 5 Steps to Implementation


Millennium: The Takeda Oncology Company

• Fully Integrated Biopharmaceutical Company

• Global Focus in Oncology
– Integration of discovery, development and
commercial insight

• Founded in 1993
– Headquartered in Cambridge, MA
– Approximately 1,500 employees
– Wholly owned subsidiary of Takeda
Pharmaceutical Company Limited


Millennium: The Takeda Oncology Company

A Bold Vision and Mission

• Our Vision
– We aspire to cure cancer

• Our Mission
– To deliver extraordinary medicines for people
with cancer worldwide through our
science, innovation and passion


A Great Place to Work

FORTUNE magazine ranked Millennium 35 on its list of the
‘2012 100 Best Companies to Work For’


Defining Social Media


Directional Change in Communication

Web 1.0 Web 2.0

http://bit.ly/KwCQqz http://bit.ly/KVCaQ3


Controlling the Conversation?

• The Groundswell –
Social phenomena enabling
a power shift to the consumer

• Threat or Opportunity?

• Using social technologies to
shape consumer perceptions


The Big Three

900MM+ Active Users 200MM+ Active Users 800MM+ Users
• 1 in 8 people globally • 107MM in US alone • 4 billion views / day
• 1 in 5 page views • 175MM Tweets / Day • 1 hr uploaded / sec
• 510k comments / min • 51% of Active Users • More in 30 days than
Source: Ansonalex.com follow Company/Brand US TV networks
Source: Edison Research created in 60 years
Source: Time Magazine


Social Media Mavens?

YES
a
NO
a

+23,000,0000

+454,000,0000

+56,000,0000


Social Media and Biopharma:
The Unfortunate Reality


Understanding the Reality…
Social Media and Biopharma

• We may change lives… but, we’re not cool
• Good reasons social hasn’t swept biopharma
– Difficult to assess risk
– Lack of established processes
– Apprehensiveness around AE/PCs
– Social is a sentencing
– Highly regulated environment
• Social won’t drive a transaction
• Time and alignment to implement
– AE/PC reporting
– Resource allocation

12

The Heart of the Matter


80% of Internet Users Search Online
for Health Information
18% are Searching for Others with Similar Health Concerns.
Source: Pew Internet Research, Mar 2012


Social Media’s Corporate Impact

• Driving Patient Care
• Syndicate Additional Resources
• Circulating News Information / Global Communications
• Real-time Updates (micro-blogging)
• Understand our customers better
• HR / Recruitment
• Clinical Trial Recruitment
• Crisis Management
• Enhancing Corporate Image
• Branded Marketing (coming soon?)


Millennium: A Case Study


Millennium’s Use of Social Media…

2010
2011


Deciding to Enter the Conversation

“Owning” our Handles

Digital Guidelines & Policies for the Creation of Standards

Online AE/PC Reporting

Social Media Policy

Interactive Training for Employees

Corporate and Brand Listening Survey


Listening Survey Results

• Final AE/PC count in-
line with expectations
<3% of total posts
• Majority of conversation
was neutral
• Shared the results of
the survey to educate
http://bit.ly/Jausyf
on social media and to
set benchmarks


Fit Within the Existing Organization

Vision > Mission > Strategy > Tactics


1000 Cranes of Hope


1000 Cranes of Hope

• Visual representation of
our company vision and
commitment to patients
• Engages our community
by allowing them to post
wishes online
• User content screened
before posted


Entering the Conversation


Regulatory Considerations:
AEs, PCs and Off-Label Use


Dispelling Social Media’s AE Myth

• Intent of Online Conversations
• 2011 Visible Technologies Study
– 30 day study, 224 major pharma brands (Rx/OTC mix)
– 3.3% of social medial mentions for pharma brands
contained an AE


Definitions

• Company-Sponsored – content that is owned, paid for
or controlled (authority over content) by the company.
– Website owned by the company
– Sponsoring a “page” on a
website/platform the company
doesn’t own

• Non-Company Sponsored – company doesn’t have any
influence or control over the content.


US Regulations

• Guiding Principles of FDA are Channel Agnostic
– “New Tools, Old Rules” – Same Rules apply to Digital

• No Clear Guidance on Social Media
– Guidance Responding to Req for Off-Label Information
– Dropped Social Media from its Guidance Agenda


European Regulations

• Current: Companies responsible for monitoring their own
digital properties for safety issues.
• Proposed: Recommendation to “actively monitor” digital
media, such as those of patients’ disease-specific
support groups, in order to monitor for significant safety
issues which may necessitate reporting.


Past EMA Regulation

• Volume 9A, Part 1, Sec 4.3.3:


New GVP Module, Effective July 2012

• GVP Mod VI, Sec B.1.1.4:

Source: EMA Good Pharmacovigilance Practices 25Jun2012 Millennium: The Takeda Oncology Company

General Takeaways

• No Single, Definitive Source to Spell Out Regulations
– Local & National Legislation
– National Codes of Practice produced by Industry Associations
UK’s PMCPA & ABPI, Sweden’s LIF, Turkey’s AIFD

• Global Campaigns – One Size Does Not Fit All
– Regional Variability in Regs and Interpretations in
Local Markets


EMA Publishes EV Data www.adrreports.eu

• Site launched in May 2012 (now 22 languages)
• Data directly from Eudravigilance Database
– ~650 Centrally Approved Medicines
– Nationally Approved expected in coming year
• Effort for transparency; additional challenges for MAHs


FDA AERS Data www.adverseevents.com/


5 Steps to Implementation


Five Steps to Getting Started

http://www.flickr.com/photos/oranguchang/3530584234/


#1 – Define the Problem

Where are the obstacles?

Who needs what information?

http://www.flickr.com/photos/7363465@N08/3925513417/


#2 – Listen to Your Users

What are they talking about?

Where are they talking?

Who are the influencers?
http://www.flickr.com/photos/gideon/429590768/


#3 – Choose the Right Tools

Understand the social platforms

Understand their social context

Know how to configure them
http://www.flickr.com/photos/usefulguy/226362739/


#4 – Define Your Protocols

Pre-define your protocols

Leverage existing procedures

http://www.flickr.com/photos/liberato/2292651755/


#5 – Deploy and Learn

Integrate data points throughout

Have defined success criteria

Experiment & iterate
http://www.flickr.com/photos/natronics/6133831304/sizes/l/in/photostream/


45 ｜ 12 Jul 2012 2012/12/29

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Additional Resources

• PWC Health Research Institute “Social Media “likes” Healthcare from
Marketing to Social Business” Apr 2012
• PMGroup “Digital Handbook: Guide to Using Digital and How to Make the
Most of It” Apr 2012
• Visible Intelligence White Paper “AE Reporting in Social Media” Oct 2011
• ABPI Pharmacovigilance Expert Network “Guidance Notes on the Monitoring
of AEs and PCs from Pharmaceutical Company Websites” 13Jun2011
• Drug Safety Alliance “Social Media and Postmarketing Drug Safety” Apr 2011
• Synthesio “Leveraging Social Media for Pharmaceutical Companies” Dec
2010


2011 Pharma Social Media Highlights

Source: Drug Safety Alliance “Social Media and Postmarketing Drug Safety” Apr 2011


Understanding the Landscape

Monitored

Less Pharma User-Generated User-Generated User-Generated More
Risk Published Pre-screened Post-screened Un-screened Risk

Real-time


Deciding Where to Play

Your Web Site Social Platforms

Host Your Own Social Platforms
 Custom social  Leverage platforms that
functionality people are already on
 Provide unique content  Efficient distribution
and interactivity
 More control


The Conversation Prism

Social conversations
include
community, crisis, suppo
rt, product, sales, market
ing, and PR.

The 28 types of channels can
be divided into 4 categories
including ongoing feedback
and insight, participation, real
world and online connections.


Social Media Presentation 12Jul2012

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