obtaining the highest level of evidence possible to support their investment
M ai n c o n f e r e n c e
Day One — Tuesday, June 22, 2010
7:30 Conference Registration and Continental Breakfast
8:30 Co-Chairs’ Welcome and Opening Remarks
Heather Reilly Powell, Director, Compliance Training and Reporting,
Daiichi Sankyo, Inc.
Ms. Reilly Powell is an attorney who has worked in and with the pharmaceutical
and medical device industries for the past ten years in both legal/regulatory
and compliance capacities. She possesses extensive experience and expertise
in small to medium-sized pharmaceutical and medical device companies in
compliant commercialization of products. She is skilled in compliance program
creation and administration, Corporate Integrity Agreement requirements
and implementation, promotional material creation and review, investigation,
auditing and monitoring of commercial and medical initiatives, state law/
aggregate spend data collection and tracking system design and implementation
and integration of compliance into commercial sales and marketing
organizations. She is currently Director, Compliance Training and Reporting
for Daiichi Sankyo, Inc. in Parsippany, NJ and has previously operated her own
successful consulting business, Compliance Clarity LLC and has held various
legal and compliance positions at Cephalon, Inc. and Sankyo Pharma Inc.
She also has particular interest in social media and in Web 2.0 as they relate to
FDA-regulated industries.
Dennis Urbaniak, Vice President, Innovation and New Customer
Channels (INCC), sanofi-aventis
Under Mr. Urbaniak’s leadership, INCC is responsible for exploring, testing
and developing new business approaches and technologies to more effectively
reach and understand its customers and deliver value. The group works
cross-functionally with the Business Units, Marketing and a range of other
departments to implement commercial innovations that reflect the evolving
needs of its customer base.
Op e n i n g A d d r e ss
8:45 Understand the Impact of Social Media —
Why This All Matters
The internet and social media have opened the door for two-
way direct communication to millions of consumers. At the
same time, these consumers — our patients — are seeking out
more information about medicines and their health through
this channel than ever before. Online health advice comes
from fellow patients, from trained healthcare professionals, as
well as from not-so-trustworthy sources — but too often, the
conversation is lacking a credentialed voice. As a credible,
reliable source of information about diseases, medicines and
treatments, the bio/pharmaceutical industry must be involved in
this space. In this opening address, learn about patients’ online
behaviors and conversations taking place on the internet to gain
a better understanding of how the industry can serve the patient
and recognize the benefits of an online presence, proving that it
is worth overcoming the regulatory and compliance challenges
we currently face in determining what the bio/pharmaceutical
industry’s role should be in this space.
• Examine the drivers of online behavior
• Learn the types of healthcare and medical information
being sought out by consumers/patients online
• Hear data as to where conversations are taking place
— Blogs, discussion boards, Twitter, social networks
• Compare patients’ disease-category searching versus
disease-category talking
• Understand the differences in online conversations
by disease category
Melissa Davies, Social Media and Research Practice Lead,
Return on Focus, LLC
Ms. Davies heads the Social Media Practice at Return on Focus, a marketing
effectiveness firm dedicated to assisting biopharmaceutical companies in
decisions. As Social Media Practice Lead, Ms. Davies strategically analyzes
online conversations to help clients better understand what motivates patient/
caregiver decisions and how they can apply the valuable insights gained to
improve the effectiveness of their brand’s marketing efforts. She is passionate
about the transformative power of social media and believes that it is compelling
a more proactive, evidence-based approach to customer engagement.
Ms. Davies has been a guest lecturer at the Wharton Business School and has
appeared as a conference presenter for the Consumer Healthcare Products
Association (CHPA), the Market Research Association (MRA), Association
of American Medical Colleges (AAMC) and Association of Medical Media
(AMM). In 2009, she testified on behalf of the Word of Mouth Marketing
Association (WOMMA) at the FDA Public Hearing on Promotion of FDA-
Regulated Medical Products Using the Internet and Social Media Tools.
Prior to joining ROF, Ms. Davies was Healthcare Research Director at Nielsen
BuzzMetrics. In that role, she oversaw integrated online research and analytics
for the healthcare practice in Nielsen’s Online Division. Ms. Davies led hundreds
of research projects to study patient/caregiver perceptions about multiple disease
categories and treatments, as well as key marketplace issues affecting the
healthcare industry.
9:45 Networking and Refreshment Break
E x te n d e d I nte racti v e S e ssi o n
10:15 Top Considerations of a Social Media Task Force
Acknowledging that social media channels are becoming
an increasingly important way to reach and interact with
customers and consumers, many companies are forming
task forces specifically focused on developing a corporate-
wide plan of action to ensure the company is leveraging the
benefits of an online presence while taking into consideration
the many regulatory and legal risk areas that come with
it. In this extended, interactive session, hear about one
company’s social media task force as we examine the top
areas of consideration to evaluate to ensure a compliant and
successful implementation of practices using new online and
social media channels.
• Identify the key stakeholders for the task force
* discuss the optimal size for the task force
* develop a steering committee and working group
* select members from different disciplines within
the organization
> Regulatory, Compliance, Legal, Medical,
Marketing, etc.
• Discuss goals of a social media task force
* identify your company’s starting point —
is this the first venture into the social media space?
* examine what your company’s corporate philosophy
is going to be regarding social media and align that
philosophy with your company’s overall values,
branding and strategies
* discuss what types of policies and procedures
are necessary
> Legal and Compliance policies such as what
gets reviewed
> IT policies such as who has the authority to
buy domain names
• Develop a social media implementation plan
* move into listening mode, unbranded
communications (disease awareness and education)
or branded communications
* evaluate the budget and resources necessary
* establish administrative and monitoring plans
 * communicate to third-party agencies or F DA K e y no t e A ddr e ss
consultants parameters in place with respect to
your company’s tolerance for risk
• Participate in an interactive discussion
* the delegation is encouraged to share experiences —
hear from companies of different sizes on how far
along each is within the process, successes and
lessons learned
Heather Reilly Powell, Director, Compliance Training and Reporting,
Daiichi Sankyo, Inc.
Zoe Dunn, Principal, Zoe Digital Consulting
12:00 Luncheon hosted by:
Analysis of the Nov. 2009 FDA Part 15 Public Hearing
and Insight on FDA Oversight of Social Media
P h R M A A ddr e ss
1:15 PhRMA’s Position on FDA’s Regulation submitted to the docket.
of Social Media
There is an unprecedented demand for reliable health
information on the internet by both patients and HCPs.
Significantly, manufacturers hold the most up-to-date and
comprehensive information about medicines and have
traditionally provided reliable — regulated, truthful and
scientifically accurate — information to patients and HCPs.
This is why the industry trade association, PhRMA, believes
that responsible online communications by manufacturers is
necessary and promotional information should be truthful
and scientifically accurate. As an example, PhRMA
presented a compelling idea during the FDA hearing in
November for the Agency to develop a universal safety
symbol that could be displayed on web or social media
sites designating the content on that site has the regulatory
approval of FDA. In this address, hear more about the
proposed suggestion and other work the association has done
representing the bio/pharmaceutical industry in this area.
Jeff Francer, Assistant General Counsel, PhRMA
Mr. Francer is Assistant General Counsel of the Pharmaceutical Research and
Manufacturers of America (PhRMA), where he provides advice and advocacy
on FDA regulatory and policy matters. Mr. Francer counsels the association
and member companies on a wide range of issues relating to the regulation of
drugs and biological products, including: drug approval and postmarketing
requirements, product labeling and promotion, direct-to-consumer advertising,
clinical trials and current Good Manufacturing Practice (cGMP). Mr.
Francer also advises and participates in the committees that draft PhRMA’s
Code on Interactions with Healthcare Professionals (the PhRMA Code), its
Principles on Conduct of Clinical Trials and Communication of Clinical Trial
Results and its Guiding Principles on DTC Advertising. In addition, Mr.
Francer represents PhRMA in discussions of the International Federation
of Pharmaceutical Manufacturers & Associations (IFPMA) relating to
its Marketing Code and Joint Positions on clinical trial transparency.
Mr. Francer served as Associate Chief Counsel of the Food and Drug
Administration from 2003-2005 where he advised agency leaders on a wide
range of issues involving the regulation of drugs and biologics including clinical
investigation and emergency use of medical products, enforcement matters
and legislative matters. Immediately prior to joining PhRMA, Mr. Francer Panel
served as Associate General Counsel, U.S. Compliance Officer and Acting
International Compliance Officer of Biogen Idec, Inc. At Biogen Idec, Mr.
Francer was the primary in-house counsel on FDA issues, fraud and abuse
and patient privacy. Mr. Francer was also responsible for overseeing the U.S.
and international corporate compliance program. Mr. Francer received his
A.B. in Public Policy and Economics from Brown University, his M.P.P. from
Harvard University and his J.D. from the University of Virginia.
2:00 FDA’s Internet and Social Media Public Hearing
and Comments Summary
On November 12-13, 2009, the FDA held a public hearing
on “Promotion of FDA-Regulated Medical Products Using
the Internet and Social Media Tools” for participation and
comments on the promotion of prescription drugs for humans
and animals, prescription biologics and medical devices using
these newer channels. The hearing was intended to help guide
FDA in making policy decisions on the promotion of regulated
products using the internet and social media tools. Following
the hearing, the Agency accepted written or electronic
comments to the docket through February 28, 2010. In this
address, hear a high-level summary directly from the Agency
on the 77 presentations that were made at the hearing and a
brief synopsis of the promotion-related comments that were
• Understand FDA’s process for policy development
and Good Guidance Practices
• Hear a high-level overview of comments received
* examine the demographics of comments —
who did they come from?
Jean-Ah Kang, Pharm.D., Special Assistant to the Director, DDMAC, FDA
Dr. Kang, Special Assistant to the Director in DDMAC, is responsible for
guidance and policy development initiatives and focuses on communication
efforts for these issues. Her areas of interest include the use of Web 2.0
and emerging tools to convey information about prescription drugs and
the application of regulations for the promotion of accelerated approval
products. Dr. Kang previously worked in DDMAC from 1999-2003 as a
professional group leader and oncology reviewer. As a senior regulatory
affairs scientist at Science Applications International Corporation (SAIC)
from 2003-2008, she provided consulting services to the pharmaceutical
industry by advising clients on their advertising and promotional labeling
materials and providing training to various disciplines, including regulatory,
marketing, medical and legal. Earlier in her career, she served an assistant
professor and drug information specialist at Shenandoah University School
of Pharmacy and she also completed a drug information residency at the
University of Pittsburgh Medical Center. She obtained her Pharm.D. at the
University of Maryland School of Pharmacy and her B.A. in Biochemistry
and Music at the University of Virginia.
3:00 Networking and Refreshment Break
3:30 Industry Perspectives on an Optimal FDA Guidance
The industry is hungry for FDA Guidance so that it can have
a better feel for what is deemed appropriate and inappropriate
by those that are governing it. The FDA is currently
addressing the issue. But, there is still the possibility of a
disconnection between what will be helpful for the industry
and what type of guidelines the FDA may develop. In this
panel, hear industry perspectives on the key elements that
could make an FDA Guidance effective and helpful to
manufacturers in ensuring compliance.
• How narrow or broad should guidance be?
• How can it be structured to keep it relevant over time?
 • Should there be inclusion of an FDA review process?
* how might “live comments” be treated?
Moderator:Michael A. Misocky, R.Ph., J.D., President,
Misocky Consulting Group, LLC;
Former Regulatory Review Officer, DDMAC, FDA
Panelists: Preeti Pinto, Executive Director, Promotional Regulatory Affairs,
AstraZeneca
Kim M. Murdock, Pharm.D., MBA, Director, Neuroscience,
U.S. Pharmaceuticals Law and Promotion Compliance,
Bristol-Myers Squibb
Christopher Firriolo, Director, Regulatory Affairs Advertising and
Promotion, Health Care Compliance Pharmaceuticals Group,
Johnson & Johnson Pharmaceutical
Research & Development, L.L.C. (Invited)
Regulatory and Compliance Considerations
Regarding the Use of Social Media
4:15 Social Media Monitoring Tools and Strategies
An anonymous survey was conducted throughout 2010
examining bio/pharmaceutical social media usage and
monitoring. This survey explored the types of social media
outlets (if any) being used, the purpose for these uses and
the review and approval processes, monitoring practices
and training initiatives companies have in place regarding
social media technology. While everyone is in agreement
that the industry cannot be expected to monitor the entire
World Wide Web for mentions of a company or product,
manufacturers may be responsible to monitor certain web
sites and activities for regulatory compliance. In this session,
hear survey results regarding usage and monitoring currently
in the industry, identify the areas of the internet companies
may be expected to monitor and learn about tools and
techniques companies can put in place to achieve that goal.
• Hear results from the recent industry survey and
insights gained following the FDA hearing
• Discuss what you are monitoring for
* AE reports, medical questions, off-label
conversation, people looking for more information
• Identify when monitoring is necessary and how far
monitoring should go
* created, cooperated/supported or compensated
someone to create it
• Learn what tools and techniques are available to you
and how you can use them
* maximize use of available internal resources
• After monitoring, then what?
Mark A. DeWyngaert, Ph.D., Managing Director,
Huron Consulting Group
5:30 Close of Day One
5:30-6:30 Networking,
Wine & Cheese Reception
Join colleagues and friends in a relaxed setting.
Photo by: Photolink / Getty Images
Day Two — Wednesday June 23, 2010
7:30 Continental Breakfast
8:00 Co-Chairs’ Review of Day One
Heather Reilly Powell, Director, Compliance Training and Reporting,
Daiichi Sankyo, Inc.
Dennis Urbaniak, Vice President, Innovation and New Customer
Channels (INCC), sanofi-aventis
8:15 Companies’ Responsibilities Surrounding
Online Information
One of the biggest questions amongst those in industry is the
extent of responsibility to which manufacturers may be held
accountable for information found online about their products,
Panel
including: risk disclosure, off-label information, AE reporting,
disclosure of material connections by bloggers under the
FTC revised guidance on endorsements and testimonials and
correcting misinformation. In this discussion, hear a variety
of perspectives as the panelists share their interpretation of
the level of responsibility by industry to report adverse events,
monitor off-label discussion or correct misinformation through
various scenarios manufacturers have or may face online or
through social media channels.
• Control — What does it mean?
* SideWiki challenges — when the owner of a website
actually lacks the ability to control content that
looks like it’s attached to its website
* YouTube and video format challenges —
addressing risks/concerns with viral videos,
misinformation or off-label discussion in comments
attached to a video
* insight following the FTC revised guidance
affecting testimonial advertisements, bloggers and
celebrity endorsements
• What considerations should be taken into account
for engagement in the context of company versus
third-party communities?
• What are appropriate responses to an unsolicited
off-label question?
• If and how should a company involve itself to correct
misinformation it finds online?
Moderator: Arnie Friede, Principal, Arnold I. Friede and Associates
Panelists: Martin L. Wilson, Senior Director – Legal, Compliance,
Strativa Pharmaceuticals
Paul Weber, M.D., R.Ph., MBA, Head, Medical Affairs,
PTC Therapeutics
Mark Gaydos, Senior Director, U.S. Regulatory Affairs,
Marketed Products, sanofi-aventis U.S.
8:50 Discuss Relevant Regulations, Guidances and
Enforcement Actions Related to Product Promotion
There are a number of regulations and guidances the industry
is currently following that can be related to the online
advertising and promotion of prescription drugs. In this
session, examine the regulations and enforcement actions that
currently exist to guide the industry.
• Reminder ad policies
• Guidance on presenting risk information in
advertising and promotion
• Recent DDMAC enforcement actions —
Warning letters, untitled letters
* YouTube
* Google sponsored links
Mary Sullivan, Director, Advertising and Promotion, Drug Regulatory Affairs,
Boehringer Ingelheim Pharmaceuticals Inc.
9:30 Networking and Refreshment Break
 10:00 Develop New Corporate Policies Surrounding 12:05 Luncheon
Online Communication and Promotion
Using the previous presentation as a jumping off point,
panelists discuss what types of policies and procedures Case Studies of Successful Engagements
companies are considering or have put in place regarding Using Online Media
online presence, product promotions and social media
engagements. Examine how these policies can create
safeguards for companies to mitigate enforcement risk. 1:05 Examining Appropriate Social Media Initiatives
• Are the policies and processes for online pieces the in Industry
same as or different from other promotional reviews?
• How do you address the differentiation because Mayo Clinic has been successful at engaging its customers
Case
of space constraints, real-time communication Study through Twitter, Facebook, YouTube and blogs. Its goal
Panel or sites where you don’t have immediate control
(particularly if you find inaccurate information has been to develop quality medical news resources for
within those sites)? mainstream media and use social media applications to
• Are companies limiting corrective information to create more in-depth, extended relationships with key
sites they do control? How are they managing or
addressing third-party sites? stakeholders. In this case study, hear about the “safe”
• Is there consideration of an appeals process? areas it was able to embark upon to leverage its customer
Moderator: Daniel A. Kracov, Partner, Arnold & Porter LLP engagement through the internet.
Panelists: Marc Monseau, Director, Corporate Communication, Social Media, Lee Aase, Manager, Syndication and Social Media,
Johnson & Johnson
Natalie “Natasha” Nelson-Ling, Executive Director, Ethics and Mayo Clinic
Compliance, Novartis Pharmaceuticals Corporation
Craig M. Audet, Vice President, U.S. Regulatory Affairs, 1:55 Launching a Corporate YouTube Site
Marketed Products, sanofi-aventis U.S.
Hundreds of millions of videos are viewed everyday on
10:40 The Patient Perspective of Industry’s YouTube, with health being amongst the most popular types
Social Media Initiatives
A panel of highly-influential e-patients shares its Case of searches. In August 2008, Johnson & Johnson launched
experiences on how they use the internet and social media Study its health channel on YouTube with a goal of developing
tools to manage their conditions, research new therapies videos to promote a better understanding of health. The
and connect with other patients. Panelists review current
examples of social media initiatives that companies have company also hoped the launch would create additional
Panel launched and share their perspectives on what is working,
touch points with consumers, enhance the company’s
what isn’t and why. The panelists also provide their
recommendations for what companies should be doing reputation as a trusted source of information and help
with social media to meet their needs. develop an online community. However, the company also
Moderator: Fabio Gratton, Co-founder and Chief Innovation Officer, Ignite Health had to overcome a variety of barriers, including cultural,
ePatient Panelists:
business and, especially in the light of the FDA hearings,
Ann Bartlett, a Type 1 Diabetic for 40 years, Owner of Body in Balance
Center, JDRF board member and blogger at Health Central legal and regulatory concerns. In this case study, learn
Alicia C. Staley, a three-time Cancer survivor, Founding Director of the more about the benefits the company has realized from
Staley Foundation, Community Leader at WEGO Health having an online presence, in particular on YouTube, and
Diane Bayer, Living with Multiple Sclerosis and Depression and mother how it overcame hurdles to achieve success.
to a child with Autism, Community leader and writer for Health Central,
contributor to “Embracing Autism” (Jossey-Bass, 2008), Mental health Rob Halper, Director, Video Communication,
activist on Health Central (My Depression Connection) Johnson & Johnson

11:25 What’s Next in Social Media — 2:35 Close of Conference

Beyond Twitter and Facebook
While many companies are just beginning to utilize
Twitter and Facebook, other pioneers are using these
platforms to create new and exciting ways of educating
patients and HCPs. Through case studies, we illustrate
how innovative companies are using these platforms to
create new digital tools and user experiences beyond the
basic network platforms. Learn how firms are using tools
like the Facebook API and the iPhone to create new media
properties and services and what’s coming next in the
digital pharma space.
Mike Myers, President, Palio
DJ Edgerton, CEO, Zemoga