The ONLY industry event devoted specifically to uniting cross-team expertise into effective review committees, setting criteria for a successful and compliant review process, and engaging with the social media forums that patients now prefer

The Creators of Present…

PROMOTIONAL REVIEW COMMITTEE COMPLIANCE & BEST PRACTICES

STATE-OF-THE-SCIENCE UPDATES ON:

Establishing the most rigorous quality oversight of PRC performance

Evaluating multiple different meeting styles and formats that deliver the best results

Building cross-team and cross-company teamwork, understanding, and reliability

Structuring compliant promotional materials for social networks

Guaranteeing your sales reps and enduring promotional materials are all in compliance

EISAI Sets PRC Standards that Meet the Needs of your Commercial TeamZafar ToorDirector, Commercial Regulatory Affairs

PFIZER Guides Co-Promotions across Multiple Drug Companies and CommitteesLynn CarmichaelDirector, U.S. Advertising and Promotion Group, Worldwide Regulatory Strategy

ELI LILLY Pre-Validates Promotion Concepts to Avoid Rewrites and DelaysDavid ClemowSenior Clinical Research Scientist

ALLERGAN Selects and Strengthens the Most Essential Skill Sets of PRC CoordinatorsAchsah Bradley Promotion Solutions Manager

AMGEN Benchmarks PRC Training Methods that Will Survive Staff TurnoverFrank PompilioDirector, Medical Communications

Because YOU demanded it: Exclusive case studies devoted specifically to PRC rosters, operations, and compliance – now in a location moreconvenient for you!

June 2-3, 2014// Hilton San Diego Resort and Spa // San Diego, CA

WEST

CO-LOCATED EVENT: 2nd annual Drug Formulation & Bioavailability – West

SPONSOR:

DEAR COLLEAGUE,By assembling a well prepared and cooperative promotional review committee, you can reliably generate compelling promotional materials while avoiding costly regulatory intervention. It is the responsibility of your review committee to make sure that all product claims are accurate and complete, that any depicted outcomes match the average effects on disease indications, and that health and safety information is just as prominent as your advertised benefits.

But before your committee members can help you steer through these complex and subjective regulations, they must learn to work together.

ExL Pharma’s Promotional Review Committee Compliance & Best Practices events are the only conferences on the market devoted specifically to optimizing the roster, teamwork, efficiency, and output quality of your PRC. Now expanding our faculty of industry leaders to a venue convenient for West Coast audiences, this program offers exclusive case studies empowering you to:

» Remain in compliance with guidelines for promotional materials on social networks

» Evaluate and select the PRC interaction, coordination, and documentation methods that work best for your company

» Ensure that your websites, print and tv materials, sales representatives, and reprints and enduring materials are all safely in compliance

» Escalate the review of contentious or high-risk promotional materials to higher-level committees

» Introduce more rigorous quality oversight of PRC performance and outputs

We invite you to join us this summer in San Diego in order to achieve top-notch compliant performance from your PRC!

Sincerely,Matt GreenbaumSenior Conference Producer ExL Pharma

» Promotional Review» Regulatory Promotion &

Advertising» Marketing / New Channel» Regulatory Affairs» Medical Affairs

» Medical Communication / Information

» Labeling» Legal Affairs» Compliance» IP

WHO SHOULD ATTEND

This program is also of interest to:

» CRM / data management software vendors» Regulatory consultants » Medical writing firms

SPONSORSHIP & EXHIBITING OPPORTUNITIES

Do you want to spread the word about your organization’s solutions and services to potential clients who will be attending this event?

Take advantage of the opportunity to exhibit, underwrite an educational session, host a networking event, or distribute promotional items to attendees. ExL Pharma will work closely with you to customize a package that will suit all of your needs.

To learn more about these opportunities, please contact:Andrew FergusonBusiness Development Manager

“The agenda looks phenomenal—a fantastic

opportunity to discuss all the major topics and skills

needed for those who play a role in review committees.

It should prove to be a valuable and interesting venue

to learn from what others in this field are doing.”

—Jackie Fiame, Associate Director, Regulatory Affairs, Advertising and Promotion, ACTELION PHARMACEUTICALS

CO-LOCATED EVENTYour registration at this conference will also allow you to network with the industry leaders at the 2nd annual Drug Formulation & Bioavailability – West

VENUE

Hilton San Diego Resort and Spa1775 E Mission Bay Dr. San Diego, CA 92109

If you require overnight accommodations, please contact the Hilton San Diego Resort & Spa at 877-313-6645 to book your room. ExL has reserved a block of rooms at a discounted rate for conference participants. Please mention

“ExL’s June Meetings” to take advantage of this discount. You must book your room by May 12, 2014 to be eligible for the discounted rate. Please book your room early, as the rooms available at this rate are limited.

DAY 1 // Pre-Conference Workshop // MONDAY, JUNE 2, 20148:00 REGISTRATION & MORNING COFFEE

9:00 WORKSHOP BEGINS

10:30 NETWORKING AND REFRESHMENT BREAK

11:00 WORKSHOP RESUMES

12:00 LUNCHEON FOR WORKSHOP PARTICIPANTS

WORKSHOP: EXPANDING PROMOTIONAL REVIEW TO SOCIAL NETWORKS

The regulatory guidelines for online promotions can be vague, and this combined with the sheer variety of social media outlets has left many drug sponsors reluctant to engage in the marketing space that both patients and physicians overwhelmingly use the most and view with the highest credibility. This workshop emphasizes:

» Accounting for medical information that enters public domain through social media

» Avoiding inappropriate disclosures while retaining credibility in such high-visibility formats

» Succeeding with branded messaging on Facebook, YouTube, Twitter and other venues

» Establishing firm processes for collecting SAEs as reported through social network responses

» Setting distinct communication styles best for each format» Focusing on the aspects of print promotions most vulnerable to increased

regulatory scrutiny when translated to online forums» Keeping all safety information equally prominent and visible in terms of both

physical presentation and display time

Shazia Ali, Manager, Medical Information, EISAI

12:00 REGISTRATION

1:00 INTRODUCTION FROM CONFERENCE CHAIRPERSON Zafar Toor, Director, Commercial Regulatory Affairs, EISAI

PRC OPERATIONAL GOALS & GOVERNANCE

1:15 FINE-TUNING INTERACTIONS BETWEEN MEDICAL AND REGULATORY AFFAIRS TEAM MEMBERS AT PRC MEETINGS

The keys to a productive PRC meeting include well-prepped medical and regula- tory affairs team members who can clearly identify the most pressing issues and recommend viable and affordable solutions. By focusing on the most important

“do-s” and “don’t-s” clarified by current legislation, these cooperative members can form a framework to set and meet deliverables for useful discussions and setting and meeting of deliverables» Amass and learn from precedents in order to drive solutions» Compare and contrast recommended solutions» Stay atop the latest developments in regulatory guidelines

Gregory Sullins, Assistant Director, Medical Promotion Review, Global Medical Affairs, ALCON LABS

Kevin Hollister, Director, Regulatory Affairs, CUBIST PHARMACEUTICALS

2:00 MEDICAL AFFAIRS PRELIMINARY REVIEW OF INITIAL PROMOTION CONCEPTS AND INTEGRATION OF CLAIMS INTO KEY CONTENT

To make the most efficient use of reviewers’ time, bring the expertise of your medical, regulatory, and legal PRC members aboard in the earliest stages, especially when planning promotional campaigns for novel molecules or indications. Your product-team’s PRC can hold one-off consultations and pre-development input meetings to ensure that initial concepts are sound before the campaign is scheduled and developed. Even for mature molecules, consultation, input sessions, and a vetted claims document can save the team a great deal of downstream rework, time delay, and team frustration.

» Hold early one-off consultation to aid in designing medically accurate marketing materials from initial concept.

» Structure formal PRC input sessions prior to tactic creation or subsequent reviews to aid in creation of compliant outputs.

» Guide medical stewardship through integration of claims into claims key content documents.

David Clemow, Senior Clinical Research Scientist, ELI LILLY

2:45 NETWORKING AND REFRESHMENT BREAK

3:15 CONSTRUCT AND MANAGE RELATIONSHIPS WITH AN EXECUTIVE PRC FOR HIGH RISK MATERIALSWhen dealing with promotional materials that are subject to strong internal dissension within the PRC itself, or those that are judged to be of especially high risk (ie something for the earliest stage of a launch, or similar to other items that may have incurred enforcement in the past), your company could strongly benefit from the extra oversight of an Executive Promotional Review Committee. Composed of higher managerial individuals with greater authority, these boards would naturally be convened less frequently and on matters of greater severity.» Identify the precise circumstances that would trigger E-PRC involvement» Conceptualize the proper mix and level of personnel and their direct

simultaneous involvement (or lack thereof) with the standard PRC members» Prioritize the time of higher-level executives by sorting out high risk issues

Lois Jessen, Associate Director, Global Regulatory Affairs, Promotion Compliance, OTSUKA PHARMACEUTICALS

4:00 MANAGE COMMITTEE DYNAMICS DURING MULTI-SPONSOR SHARED PROMOTIONAL CAMPAIGNSThe daily challenges of effective PRC cross-team communication and understanding grow even heavier when several different drug companies share responsibilities for marketing a co-developed product. In a situation where only one partner has filed the NDA but both must create and approve promotional materials, managing the relationships and outputs of the merged cross-company team is especially difficult – and runs the risk of incurring financial and reputational losses for both companies if not done correctly.

Lynn Carmichael, Director, U.S. Advertising and Promotion Group, Worldwide Regulatory Strategy, PFIZER

4:45 VISUALIZING AND REALIZING THE CHARACTERISTICS OF A SUCCESSFUL PRC MEETINGMany factors will determine the success of your meetings, including the amount of time set aside for review, number of pieces reviewed, and length and number of cycles required for approval. But there are less tangible guiding factors at work as well, including corporate philosophy, product philosophy, and the ability to guide collaborative meetings such that all participants have equal input and

“voice.”» Differentiate between a “tick-the-box” process and the ability to engage a

team within the boundaries of the process itself» Build a culture emphasizing preparation and reflecting the team’s greatest

needs in the agenda» Cultivate directed actions in a blame-free environment that encourages

ownership of each team member’s role in the review process

Daniel Zavodnick, Legal Counsel, BAYER

5:30 END OF DAY ONE

DAY 1 // Main Conference Begins

DAY 2 // TUESDAY, JUNE 3, 2014

8:00 CONTINENTAL BREAKFAST

8:45 RECAP OF DAY ONE FROM CONFERENCE CHAIRPERSON Zafar Toor, Director, Commercial Regulatory Affairs, EISAI

9:00 CASE STUDY: ESTABLISHING QUALITY CONTROL FOR PRC PERFORMANCEHow can you best review the work of your own reviewers, and make sure that from the outset they are only looking at the highest-quality materials? Making a targeted decision to install a quality oversight division as part of PRC operations can significantly improve the accuracy of your documentation and metrics. » Map the job-specific roles and procedures that yield best-quality PRC results» Craft optimal change control procedures around PRC operations» Document every deviation from SOP

Sarah Foster, Marketing Integration, Neuroscience, ELI LILLY

9:45 SETTING REVIEW COMMITTEE PERFORMANCE STANDARDS THAT MEET THE NEEDS OF YOUR COMMERCIAL TEAM

The primary responsibility of developing promotional materials is driven by the commercial team. However, the need to be compliant may give the impression that promotional material development is chiefly driven by priorities of regulatory affairs, legal and medical colleagues. Ultimately it is the PRC’s responsibility to provide feedback that ensures all promotional materials are truthful. The process protects and improves upon the messages and campaigns of the commercial team while ensuring compliance with regulations.» Enhance collaboration between the review committee and the commercial

team» Instill an ethic of “improving” commercial message instead of “shredding”

them» Identify key measurable performance metrics to improve accountability and

efficiency

Zafar Toor, Director, Commercial Regulatory Affairs, EISAI

10:30 NETWORKING AND REFRESHMENT BREAK

MAINTAINING COMPLIANCE WITH UNCLEAR REGULATIONS

11:00 REGULATORY REVIEW: KNOWN FACTORS, EFFECTIVE INFLUENCE, AND PRC PREPAREDNESSKeeping up with the promotional grey zones in new (or absent) guidance can be daunting in the face of mounting business pressures. Regulatory’s ability to influence PRC decisions pre- and post-launch is critical to successful product pro- motion—from both the marketing and regulatory authority lens. Thinking fast on your feet can save your reputation and help your company avoid potential false claims activity.

» Avoid the pitfalls and read between the lines of untitled and warning letters» Map the boundaries of the regulatory “grey zone” in order to know what can

be fully learned and what cannot» Earn credibility from marketing and regualtoryo authority stakeholders and

use their motivations to your advantage

Linda Pollitz, Director, Regulatory Affairs, Advertising & Promotion, ALKERMES

11:45 SATISFACTION GUARANTEED? MODERATING THE DEGREE OF RESOLUTION DEPICTED IN PROMOTIONAL ITEMSRegulatory oversight of the depiction of outcomes in promotional material is highly subjective and ad-hoc. Materials involving actors and / or animation

are especially vulnerable to interpretation, with agency reviewers judging that slight visual nuances could oversell the usefulness of the drug. Though this subjectivity is difficult, it is worthwhile to grasp the most likely points of contention.» Guide directors and actors towards accurately depicting product outcomes» Design storyboards that are clear and specific enough to be submitted for

useful FDA advance feedback

» Accurately translate drug success into simulated human performance

Kevin Hollister, Director, Regulatory Affairs, CUBIST PHARMACEUTICALS

12:30 LUNCHEON

1:30 COORDINATING PROCESS AND PERFORMANCE: ESSENTIAL ELEMENTS FOR SMOOTH PRC FUNCTIONSelecting the proper coordinator is essential for the performance of your PRC. Whether from marketing, regulatory, or other departments, this person directs traffic during the review process and helps streamline and document the transmission of information among participants, making sure each has had their say. Their guidance can have tremendous impact on both PRC compliance and timeliness. » Focus on the different interactions needed for each departmental PRC

member» Cultivate adaptability in circumstances where participants want to submit

comments via video or other multimedia format» Safeguard the neutrality of your committee by not privileging marketing

needs

Ynhu Juliano, Director, Advertising & Promotional Compliance, ALLERGAN

Achsah Bradley, Promotion Solutions Manager, ALLERGAN

2:15 DEPTH OF A SALESMAN: MANAGING SALES REPRESENTATIVE TRAINING MATERIAL TO MAXIMIZE PROFITS AND MINIMIZE RISKThe need to make compelling pitches that favorably compare your product tocompetitors must be tempered by risks of divulging off-label information and be- coming non-compliant. In light of the Caronia decision, what is the best balance to strike in your training materials?

Linda Pollitz, Director, Regulatory Affairs, Advertising & Promotion, ALKERMES

3:00 SET ENDURING TRAINING STANDARDS FOR PRC MEMBERS TO ENSURE COMPLIANCEThere is typically no consistent training timeframe or methodology across the multiple different teams involved in promotional review. If some members were hired specifically to work in the PRC and then experienced mostly “on-the-job training,” while other members are expected to put in more of a consulting role on top of their other full-time responsibilities, then both the dedication and skill level can vary significantly within the team.

» Grasp how your staffing level will impact the time, dedication, and performance available for promotional review

» Retain best practice and successful methods during staff turnover, mergers and acquisitions

» Balance expertise levels of specific hires with those promoted from within

Frank Pompilio, Director, Medical Communications, AMGEN

3:45 END OF CONFERENCE

REGISTRATION FEESEARLY BIRD PRICING

Register by Friday, April 18th, 2014

Your Investment:

Conference + Workshop: $2,195

Conference Only: $1,895

STANDARD PRICING

Your Investment:

Conference + Workshop: $2,395

Conference Only: $2,095

ONSITE PRICING

Your Investment:

Conference + Workshop: $2,495

Conference Only: $2,195

MEDIA PARTNERS

REGISTRATION INFORMATION

43

GROUP DISCOUNT PROGRAMSOffers cannot be combined, early bird rates do not apply

Save 25% per person when registering four For every three simultaneous registrations from your company,

you will receive a fourth complimentary registration to the

program (must register 4 at one time).

Save 15% per person when registering three Can only send three? You can still save 15% off of each

registration.

PAYMENT

Make checks payable to ExL Events, Inc. and write code C504 on your check. You may also

use Visa, MasterCard, Discover or American Express. Payments must be received in full by

the conference date. Any discount applied cannot be combined with any other offer‚ and

must be paid in full at the time of order. Parties must be employed by the same organiza-

tion and register simultaneously to realize group discount pricing options.

Please note, there will be an administrative charge of $300 to substitute, exchange and / or

replace attendance badges with a colleague occurring within five business days of any ExL

conference.

CANCELLATION POLICY

If you need to cancel your registration for an upcoming ExL conference, please note the

following policies derived from the Start Date of the event:

Four weeks or more: A full refund (minus a $295 processing fee), or a voucher to another

ExL event valid for 18 months from the voucher issue date.

Four weeks or less: A voucher to another ExL event valid for 18 months from the voucher

issue date. If you cancel at any time after receiving the conference documentation, the

voucher issued will be $395 less.

ExL Pharma reserves the right to cancel any conference it deems necessary and will not

be responsible for airfare‚ hotel or any other costs incurred by registrants. ExL Pharma’s

liability is limited to the conference registration fee in the event of a cancellation and does

not include changes in program date‚ content‚ speakers‚ or venue.

TERMS AND CONDITIONS

By registering for an ExL Events, Inc. (“ExL Pharma”) event, you agree to the following set

of terms and conditions listed below:

Registration Fee: The fee includes the conference‚ all program materials‚ and designated

continental breakfasts‚ lunches and refreshments.

The opinions of this faculty do not necessarily reflect those of the companies they repre-

sent or ExL Events, Inc.

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CONFERENCE CODE: C504PLEASE MENTION PRIORITY CODE

EISAI Sets Review Committee Standards that Meet the Needs of your Commercial TeamZafar ToorDirector, Commercial Regulatory Affairs

PFIZER Successfully Guides Co-Promotions across Multiple Drug Companies and CommitteesLynn CarmichaelDirector, U.S. Advertising and Promotion Group, Worldwide Regulatory Strategy

The ONLY industry event devoted specifically to uniting cross-team expertise into effective review committees, setting criteria for a successful and compliant review process, and engaging with the social media forums that patients now prefer

June 2-3, 2014// Hilton San Diego Resort and Spa // San Diego, CA

The Creators of Present…

PROMOTIONAL REVIEW COMMITTEE COMPLIANCE & BEST PRACTICES

Because YOU demanded it: Exclusive case studies devoted specifically to PRC rosters, operations, and compliance –now in a location moreconvenient for you!

WEST□ Yes! Register me for the conference + workshop!