8:00 a.m.
Registration & Continental Breakfast

8:30 a.m.

Chairperson's Welcome & Opening Remarks

Peter J. Pitts, Partner/Director Global Regulatory and Health Policy
PORTER NOVELLI
Former Associate Commissioner
U.S. FOOD AND DRUG ADMINISTRATION

8:40 a.m.

All I Want For Christmas… Is FDA Guidance On Social Media

In November 2009, the U.S. Food and Drug Administration held a two-day public meeting on how regulated industries use social media.  As the year mark approaches since that heralded Part 15 meeting, not only haven’t things become more lucid (from a regulatory perspective) it has (arguably) become more confusing.  Warning letters.  Quixotic podium statements from the Division of Drug Marketing, Advertising and Communications (DDMAC).  What’s a pharma marketer to do?

Social media is here to stay and becoming an increasingly important tool for pharmaceutical and healthcare marketers. What can you expect from the FDA and how will it impact providing accurate information and potent marketing messages in the future?

This session will provide you with practical tips, while addressing many of these pressing issues, including:

• Correction of inaccurate information
• Outreach and interaction with healthcare bloggers
• User-generated content and corporate responsibility
• Sponsored search engine links
• Appropriate disclosure of risk information
• MedWatch and the future of adverse event reporting
• The role of DDMAC in social media oversight and the dangers of "regulatory creep"
• What can we expect from the FDA... and when?

Get the real story on regulating social media from two industry insiders, as they discuss the issue of how social media can help the FDA in its mission to both protect and advance public health. 

(And, be careful what you wish for … you might get it.)

Julie Zawisza, Director, CDER, Office of Training and Communication
Paul Buckman, Director, Online Communications, CDER, Office of Communications
U.S. FOOD AND DRUG ADMINISTRATION

Peter J. Pitts, Partner/Director Global Regulatory and Health Policy
PORTER NOVELLI
Former Associate Commissioner
U.S. FOOD AND DRUG ADMINISTRATION

9:40 a.m.

Break-Out Blitz!
Network And Discuss Social Media Challenges With Your Fellow Conference Attendees

This session will open the conversation by connecting you with other conference participants and gain greater understanding into many similar issues, concerns, and challenges that your peers are also facing. Become acquainted with your fellow conference attendees in this fun and fast-paced forum!

10:30 a.m.

How To Use Twitter To Deliver Measurable
Results For Your Organization

Twitter is often times seen as the ultimate social media tool for quick, concise marketing to an eager group of willing followers. But what happens when the people you want to reach are under the jurisdiction of the most regulated industry possible? You adapt.

Come hear how Novo Nordisk Inc. created the first pharmaceutical branded Twitter page through the combined efforts of its regulatory, legal and marketing teams. The page highlights a partnership with a racecar driver diagnosed with diabetes that sparked a heated debate among marketing professionals about how to best use social media to reach consumers.

Hands-on key takeaways of this session will include how to:

• Determine your value - - Is a Twitter page worth your investment?
  What are you really getting out of this?
• Identify the right partner or voice - - Is the marketing team
  the most credible group to lead this project?
• Assess your promotional challenges - - Does the reward outweigh the risk?
• Define success - - Are your goals realistic?
  When do you need to reevaluate your plans?

Learn from the experiences of the Twitter page creator, and a member of the regulatory affairs promotional review team about how to assist your organization in understanding the risk of such an endeavor, while also highlighting why a project like this can be a cost-effective and beneficial Web 2.0 tool to utilize.

Ambre Morley, Associate Director of Product Communications
Alpesh Patel, Director of Regulatory Affairs - Promotional Review
NOVO NORDISK INC.

11:20 a.m.

How To Effectively Incorporate Social Media Tools To Successfully Expand And Enhance Your Online Presence

Founded in 1886, Johnson & Johnson, is one of the most broadly based companies in human health – encompassing consumer products, medical devices and prescription medicines.  Since 2006, the Johnson & Johnson Corporate Communication department has significantly expanded and enhanced its presence online through the steady launch of new and innovative online communications tools and platforms such as: the Kilmer House and JNJBTW blogs, the Johnson & Johnson health channel on YouTube, the Johnson & Johnson Network on Facebook, the @JNJComm feed on Twitter as well as the re-launch of the existing platform, the corporate website, www.JNJ.com.

As a result, the Corporation not only has access to numerous vehicles to deliver messages and interact with a variety of communities, but has also established credible footholds in different online realms including the blogosphere, the Twittersphere, YouTube and on Facebook, where it can engage, interact and form relationships with different stakeholders.

• Steps needed to develop a set of social media policies
• Process and structural changes that will support specific social media efforts
• Expectations for communicating on the social web

Marc Monseau, Director, Corporate Communication, Social Media
JOHNSON & JOHNSON

Chris Iafolla, Pharmaceutical Practice Lead
SHIFT COMMUNICATIONS

12:10 p.m.
Lunch On Your Own -- But Not Alone!

Join a group of your colleagues for lunch with an informal discussion facilitated by one of our expert speakers. Take this opportunity to connect with others in a small, interactive group setting to network and brainstorm solutions to your most pressing social media for pharma concerns.

1:40 p.m.

Group Exercise:

You asked for it, you got it! Interact and discuss how to implement the latest technology tools to assist you in overcoming your social media for pharma challenges with your fellow attendees and our experienced speakers. You will leave with new tools and ideas for more successfully applying best practices to your own Web 2.0 pharma initiatives.

2:25 p.m.

How To Overcome The Challenges Of Social Media
In A Regulated Environment

Hear the latest report on how Vertex Pharmaceuticals launched a twitter program in a pre-commercial pharma world. Shwen Gwee, a social media expert in the industry, will share his lessons learned and tips on how to create your own Twitter campaign and expand your social media platform.

Shwen Gwee, Digital Strategy and Social Media Lead
VERTEX PHARMACEUTICALS, INC.

3:30 p.m.

Integrating Social Media Into Your Direct-To-Consumer Campaigns To Better Engage Your Target Audiences While Minimizing Risk

Patients are often overwhelmed with information regarding their medical conditions, and because of this, they often overlook the severity of complications associated with their ailments. 

As the manufacturer of Dermagraft®, a bio-engineered skin substitute indicated for diabetic foot ulcers (DFUs), Advanced BioHealing (ABH) is dedicated to raising awareness and helping the thousands of people across the nation who are at risk of developing the condition understand the need to seek treatment from a wound care specialist.

Recognizing the role social media can play in disease awareness and patient adherence, ABH launched a direct-to-consumer campaign, called Heal2gether, which uses social media as a vehicle to engage in discussions with patients and physicians about the importance of maintaining proper care. In addition, social media efforts promote community health and screening events, share patient stories, and encourage patients to get treated. 

Learning from ABH’s experiences, you will leave this high-impact session with a greater understanding of how you, too, can use social media to achieve a holistic approach
to patient care by:

• Recognizing the importance of social media in reaching and engaging
  with your target audience
• Implementing well thought out strategies to incorporate social media in your direct-to-consumer campaigns—including alignment with company programs and priorities (e.g. Facebook, Twitter, YouTube, program website, etc.)
• Understanding the continued regulatory challenges that all life science companies face in expanding their social media footprint – and steps to take to address risk management

Justin Gardner, Marketing Communications Manager
Lindsey Hart, PR Communications
ADVANCED BIOHEALING, INC.

4:20 p.m.

Proving The Value & Limitations Of Social Media In A Highly Regulated Environment: Practical Implementation Steps To Enter The Conversation

Companies that make or distribute diagnostic equipment or other products that are sold strictly business-to-business may overlook social media because common thinking is that they should only talk directly to their customers. Other pharma companies may discourage social media out of regulatory or other legal concerns. However, social media can be an outstanding way to interact with health care professionals or business leader audiences and to gain early warning of emerging trends among key stakeholders. This can be especially important during scientific conferences, FDA meetings or other public events and should become part of every business’ media monitoring activity to monitor public sentiment and stakeholder interests.

Through specific examples, you will gain a greater understanding of social media monitoring programs and how they can be used for your business intelligence.

• Which social media platforms matter to your company and why?
• How can you track social media when there is so much out there?
• When should your company enter the conversation?
• Who from your company should be allowed to participate in social media?
• What are the key elements of a social media policy for a regulated business?

Doug Levy, Executive Director of Communications and Public Affairs
COLUMBIA UNIVERSITY MEDICAL CENTER
Former (Interim) Director of Communications
NOVARTIS DIAGNOSTICS

5:10 p.m.

End Of Day One

5:15 p.m.

Networking Reception: Please Join Us!

We invite you to join us for a drink as you relax with your peers. All conference attendees and speakers are welcome to join us for this special opportunity to continue networking. Don't miss this chance to benchmark new ideas over complimentary drinks!

Sign up during the day for dinner with a group. Take advantage of New York City's fine dining while you continue to network with your colleagues.