1. PHARMACEUTICAL PUBLICATION
PLANNING & MANAGEMENT
JULY 30-31, 2015 | PHILADELPHIA, PA
Elevating the Value of Pharmaceutical Publications through Defining Success &
Measuring Results, Establishing Effective Global Partnerships and Publication
Management as well as Preparing for the Next Generation of Digital Publications,
All While Meeting Increasingly Demanding Deadlines
INDUSTRY THOUGHT LEADERS:
JOURNAL PUBLICATION PRESENTERS:
Brian Scheckner
Senior Director, Head of Scientific
Publications - US, Global Medical Affairs
SHIRE
Kim Pepitone, CMPP
Scientific Director
CACTUS COMMUNICATIONS
Vice Chair
ISMPP SUNSHINE ACT TASK FORCE
Manon Boisclair
Global Lead, Publications
Operations
CELGENE
Alan Hempel, PharmD
Lead of Market Publications for
Specialty Brands
BRISTOL-MYERS SQUIBB
Louise Wyhopen, BSN, RN, CMPP
Director Scientific Communications
NOVARTIS PHARMACEUTICAL
CORPORATION
Svetlana Pidasheva
Associate Director Global Medical
Publications, Biosurgery
SANOFI
Lisa Underhill
Director, Scientific Publications and
Communications
GENZYME
Angela Sykes
Director, Publication Specialist
PFIZER
S. Bala Dass
Director of Publications,
Medical Affairs
REGENERON
Kanaka Sridharan
Director, Global Head Scientific
Communications, Cell &
Gene Therapies Unit
NOVARTIS
Jonathan Druhan
Director, Medical Affairs Publications
ASTRAZENECA
Gina D’Angelo
Director, Global Scientific Publications
SHIRE
Kelly Reith
Sr. Director Publications & Scientific
Communications
INCYTE
Kenneth Pomerantz, PhD.
Director of Medical Publications
BOEHRINGER INGELHEIM
Ann L. Davis, MPH, CMPP
Global Publication Advisor
BRISTOL-MYERS SQUIBB
Patricia Zimmer
Associate Director, Publications
BAYER HEALTHCARE
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
Dr. Rebecca E. Cooney, Ph.D.
North American Editor
THE LANCET
Joshua M. Liao, MD
Associate Editor, Healthcare
THE JOURNAL OF DELIVERY SCIENCE
AND INNOVATION
Leslie Citrome, MD, MPH
Editor-in-Chief, International
Journal of Clinical Practice
WILEY-BLACKWELL
CONFERENCE SPONSORS:
ISMPP CREDITS:
Neil Adams
Publishing Manager
NATURE PUBLISHING
This program has been approved
by ISMPP for 5.75 CMPP credits
LOGO: LARGE FORMAT
An ICON plc Company
An ICON plc Company

2. PHARMACEUTICAL PUBLICATION PLANNING & MANAGEMENT
DAY ONE | THURSDAY, JULY 30
7:30 REGISTRATION AND MORNING COFFEE
8:20 CHAIRPERSON’S OPENING REMARKS
Mike Smith, Managing Director, ALPHABIOCOM
8:30 INCREASING THE PROFILE OF PUBLICATION TEAMS ACROSS THE
GLOBAL ENTERPRISE
In order to fully optimize the publication function within a pharmaceutical cor-
poration, teams must have the robust support of an executive management
team that values and supports publication strategies, as well as the immediate
and long-term impact that publications have on commercial viability. Through
elevating the importance of publication strategies, executives will ensure stron-
ger project management and deadline consistency while ensuring cross-collab-
oration on joint authorship projects across the organization. Illustrating the piv-
otal role of publication teams will ensure greater support and ensure success.
• Evaluating & exhibiting value of publication teams
• Garnering support from internal champions
• Delivering on long-term value of publications to commercial success
Patricia Zimmer, Associate Director, Publications
BAYER HEALTHCARE
9:15 SUCCESSFULLY MANAGING OBJECTIVES & TIMELINES:
REDUCING TIME TO SUBMIT FOR PUBLICATION
With limited time to focus on overall strategy and innovation, publica-
tion teams are continually plagued with more tactical and compliance
driven tasks. Managing varying responsibilities while enforcing deadlines inter-
nally and externally can lead to development of particular responsibilities and
underdevelopment of others. Bringing clarity to the multiple strengths required
by a publications team will create a balance between efficiently managing com-
pliance requirements and continually evolving strategy and growth.
• Working with authors to specific deadlines
• Ensuring a timely editing process for papers
• Communicating strategies to meet deadlines
• Developing productive relationships with external authors and stake holders
Louise Wyhopen, BSN, RN, CMPP, Director Scientific Communications
NOVARTIS PHARMACEUTICAL CORPORATION
10:00 COFFEE & NETWORKING BREAK
IMPLEMENTATION OF A UNIFIED PUBLICATION STRATEGY
ACROSS AN ORGANIZATION
Creating an overarching strategy for a publication department requires align­
ment and resources from various internal departments, and can often be dif­
ficult to achieve as well as maintain. Developing a unified corporate-wide ap­
proach to publication planning and execution will enable a transparent vision
of upcoming projects, as well as cohesion with departmental and corporate
objectives.
10:30 DETERMINING TIMING FOR PUBLICATION INVOLVEMENT
• Timelines for involving publication teams in research & development
• Methods for inclusion of publishing in varied phases of differing projects
• Working with executive leadership to secure support for publications
Kelly Reith, Sr. Director, Publications & Scientific Communications
INCYTE
11:00 SUCCESSFUL USE OF A PUBLICATION STEERING
COMMITTEEE
• Ensure appropriate representation on the publication steering committee
• Review the role of the publication steering committee in overall publication
management
• Discuss best practices in setting publication steering committee meetings to
collaborate on projects
Brian Scheckner, Senior Director, Head of Scientific Publications - US, Global
Medical Affairs, SHIRE
11:30 IMPACT OF INTERNAL V. EXTERNAL PUBLICATION SUPPORT
• Best practices when engaging external authorship resources
• Weighing the time & cost benefits in utilizing external resources
• Consistent communication, deadline management & accountability
Lisa Underhill, Director, Scientific Publications and Communications
GENZYME
12:00 LUNCHEON FOR ALL CONFERENCE GUESTS
1:30 EFFECTIVE GLOBAL PUBLICATION STRATEGY
As the pharmaceutical industry continues to dominate global markets,
many publication teams struggle with developing a comprehensive and
cohesive global publication strategy to meet the informational needs of
healthcare providers on a global scale. Local decentralization of publication ef-
forts have increased in complexity as leadership often remains at the corporate
level, but with foreign team members supporting publication efforts abroad.
The development of a global publication strategy which overrides regional and
local goals is essential in ultimately surviving in an increasingly fast-paced mar-
ket where access to information online is immediate.
• Identifying efficiencies in a global strategy
• Challenges with decentralized publication efforts
• Reducing duplication in publication plans
• Increasing speed of publication development
• Compliance considerations in global markets
Gina D’Angelo, Director, Global Scientific Publications
SHIRE
2:15 GLOBAL PUBLICATION MANAGEMENT: PARTNERSHIP FOR
EFFECTIVE STRATEGY AND COMPLIANCE
From both the global and regional perspectives, the primary goal of all
scientific publications is to inform an audience about safe and effective
use of medicines. For regional partners without dedicated publications teams
or significant volume of publications, ensuring adherence to industry standards
may be challenging. HQ publications teams are tasked with helping regional
partners understand and follow appropriate guidelines, as well as monitoring
compliance of regional adherence, thus making partnership between HQ and
regional publication teams essential. However, differences exist across regions
in terms of resources, understanding of publications guidelines, data needs,
and cultural nuances. The HQ team’s understanding of these differences en-
ables better alignment with publication planning and development across dif-
ferent continents and cultures. Partnership for effective strategy and compli-
ance includes:
• Establishing and maintaining productive relationships
• Model of shared accountability across HQ and regional teams
• Identifying and meeting needs of regional teams
• Ensuring regional compliance with global standards
Ann L. Davis, MPH, CMPP, Global Publication Advisor
BRISTOL-MYERS SQUIBB
Alan Hempel, PharmD, Lead of Market Publications for Specialty Brands
BRISTOL-MYERS SQUIBB
3:00 COFFEE & NETWORKING BREAK
3:30 CELGENE CASE STUDY: DEFINING SUCCESS & MEASURING
RESULTS POST PUBLICATION
A consistent challenge among publication departments within pharma-
ceutical companies is determining a measure of success on any given
paper. With so many different ways to assess a publication, including the num-
ber of downloads, citations, time the information was brought to print and the
impact of journal to which it was accepted, measuring success has become
a pseudo-science in a highly scientific arena. A walk-through of examples of
will illustrate how relevant download numbers, citations and peer review are of
value to the industry.
• Establish goals to appropriately measure results
• Aligning publication goals with corporate strategy
• Appropriate length of time to monitor manuscript impact
• Evolution of altmetrics and the effect on publication
Manon Boisclair, Global Lead, Publications Operations
CELGENE
4:15 MEASUREMENTS & BEST PRACTICES IN PEER REVIEW
The effect of peer review within publications has an undeniable im-
portance, however soliciting a meaningful number of quality reviews
to determine the industry perspective on the highlighted topic can be
quite difficult. Traditional methods of double-blind or single-blind reviews can
cause a publication delay of months in order to refute all claims, resulting in
tremendous delays and additional time spent by authors. Understanding the
best practices for re-submissions based on reviews and optimal methods for
determining a meaningful number of reviews will not only smooth the peer re-
view process, but also provide publishing teams with realistic benchmarks for
measuring success.
• Understanding the impact of digital publications
• Benefits, limitations and opportunities in current review processes
• Methods for refuting and overcoming negative reviews
Neil Adams, Publishing Manager
NATURE PUBLISHING GROUP
5:00 CONCLUSION OF DAY ONE SESSIONS

3. PHARMACEUTICAL PUBLICATION PLANNING & MANAGEMENT
DAY TWO | FRIDAY, JULY 31
8:00 REGISTRATION AND MORNING COFFEE
8:20 OPENING REMARKS
8:30 DEVELOPING PUBLICATION PRACTICES TO ADDRESS
FUTURE BARRIERS
With the availability of data in many industries becoming increasingly immedi-
ate, the publication of information in the pharmaceutical industry continues to
be a lengthy process. The next round of physicians is bringing new tech-savvy
and data hungry attitudes of their generation to the healthcare industry, by
having an expectation to immediate data availability and not accepting barriers
to access that data. Acknowledging and preparing for these demands, by utiliz-
ing digital outlets and striving for broader readership, will position publication
teams to meet and exceed these new-found expectations.
LEVERAGING DIGITAL OUTLETS FOR LARGER IMPACT
• Discuss how physicians use social media to gather information & communicate
• Patient impact of digital health, social media and open-source publications
• Preparing strategy for next generation media
Svetlana Pidasheva, Associate Director, SANOFI
9:15 PANEL: JOURNAL PERSPECTIVES ON STREAMLINED
SUBMISSION & REVIEW PROCESSES
Journal editors play a pivotal role in the publication process, as they work to se-
lect the most relevant and timely articles for publications from the vast number
of submissions received. By understanding the journal review process, publica-
tions professionals can gain an understanding of how to provide all pertinent ma-
terials during the first submission and reduce time spent on resubmission edits.
A frank dialogue with journal editors will allow publication industry executives
unique insights into decision making and the inner-workings of leading journals.
• Defining the hallmarks of a good manuscript
• Value in publishing in open access vs. subscriber journals
• Overcoming issues in research saturation
• Journal editor perspectives on paper selection
MODERATOR:
Kim Pepitone, CMPP, Scientific Director, CACTUS COMMUNICATIONS
Vice Chair, ISMPP SUNSHINE ACT TASK FORCE
PANELISTS:
Leslie Citrome, MD, MPH, Editor-in-Chief, International Journal of Clinical Practice
WILEY-BLACKWELL
Dr. Rebecca E. Cooney, Ph.D., North American Editor, THE LANCET
Joshua M. Liao, MD, Associate Editor, Healthcare
THE JOURNAL OF DELIVERY SCIENCE AND INNOVATION
10:00 COFFEE & NETWORKING BREAK
10:30 ALIGNING PUBLICATIONS WITH COMPLIANCE GUIDELINES:
OPERATING IN A REFOCUSED ENVIRONMENT
The recent surge in compliance regulations, in both the US and globally,
has resulted in many companies entering into Corporate Integrity Agree-
ments, being released from CIAs, or electing to implement operating practices
that would align with CIA guidelines. This surge in compliance activity has had
a direct impact on publication teams as they work to realign strategies and
procedures for working with authors and physicians around the world. Having a
firm grasp on how compliance regulations impact publication teams will ensure
a compliant approach to all interactions with healthcare providers and authors.
• Implications of CIAs on transfer of value reporting
• Aligning on internal best practices for compliance
• Transparency of guidelines with authors and physicians
Jonathan Druhan, Director, Medical Affairs Publications, ASTRAZENECA
11:15 EXCHANGE GROUPS
Program attendees will break into 5-7 smaller groups to further address import-
ant topics impacting pharmaceutical publication planning and execution. All
attendees are encouraged to actively participate, allowing for better exchange
of ideas, peer-to-peer learning and open discussion.
12:00 LUNCHEON FOR ALL CONFERENCE GUESTS
1:15 INDUSTRY ROUNDTABLE: NAVIGATING TOV INTERPRETATIONS AND
APPROACHES
The multiple presentations of what qualifies for reporting as a transfer of value
(TOV) has the potential to cause confusion across the numerous stakeholders af-
fected by The Sunshine Act. Reviewing suggestions and case studies for current
protocol, while continuing to operate with clarity gives publication teams fewer
hurdles to overcome in order to complete a project with integrity. Industry ex-
perts discuss best practices in navigating TOV interpretations and approaches.
• Understanding the varying interpretation of The Sunshine Act
• Defining qualifying TOV activities
• Establishing fair market value payments
• Author clarity on TOV requirements
MODERATOR:
Kim Pepitone, CMPP, Scientific Director, CACTUS COMMUNICATIONS
Vice Chair, ISMPP SUNSHINE ACT TASK FORCE
PANELISTS:
Jonathan Druhan, Director, Medical Affairs Publications, ASTRAZENECA
S. Bala Dass, Director of Publications, Medical Affairs, REGENERON
Kenneth Pommerantz, PhD., Dir Medical Publications, BOEHRINGER INGELHEIM
2:00 ENSURING TIMELY & TRANSPARENT PUBLICATION OF CLINICAL
RESEARCH DATA
New regulations surrounding the transparent disclosure and publication of clin­
ical research data in both the US as well as internationally have resulted in
an increased awareness surrounding the publication of all clinical data with­in
pharmaceutical corporations. Publication teams must be well-versed in the re-
quirements related to clinical trial data publication as well as work closely with
clinical teams in order to ensure the appropriate and accurate information is
published. Proactively working with clinical research teams as well as managing
potentially negative data is essential in remaining transparent and compliant.
• Clinical trial data transparency as it impacts publications
• Working with Journals when publishing negative data
• Ideal collaboration with clinical research teams
Angela Sykes, Director, Publication Specialist
PFIZER
2:45 BEST PRACTICES FOR MANAGING PUBLICATION OF
INVESTIGATOR INITIATED STUDIES
Throughout the life science industry, many journals and publications
have shown a preference for publishing investigator led research, which
has been viewed as less biased or influenced by the pharmaceutical industry.
Much of this research has been funded directly by industry. Investigators have a
responsibility to publish the data of their research and although this process is
independent, industry (sponsors) have a responsibility to ensure that the study
is reported. Publication teams must recognize the differences in working with
investigator authors in order to manage projects effectively, compliantly, and
within contractual specifications.
• Challenges & limitations in publishing investigator initiated research
• Differences in funding and recording transfer of value when working with IIR
• The external perception of IIR papers v. internally developed papers
Kanaka Sridharan, Director, Global Head Scientific Communications, Cell &
Gene Therapies Unit
NOVARTIS
3:30 PROGRAM CONCLUSION
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4. PHARMACEUTICAL PUBLICATION PLANNING & MANAGEMENT
JULY 30-31, 2015 | PHILADELPHIA, PA
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com
UPCOMING EVENTS
6th Semi-Annual
MANAGED MARKETS AND PAYER MARKETING STRATEGIES
CONFERENCE
October 15-16, 2015 | San Diego, CA
2nd Semi-Annual
PHARMACEUTICAL STRATEGIC PRICING CONFERENCE
October 5-6, 2015 | San Diego, CA
Improving Patient and Market Access through the Development of Targeted Value
Propositions, Comprehensive Contract Assessment and Measurement Strategies
through to In-Depth Knowledge Regarding Payer Formulary Coverage Trends
Adapting To Changing Payer Expectations, New Government Regulations and the
Increased Focus on Product Innovation to Develop Optimal Pricing Strategies that Ensure
Greater Patient Access while Maximizing a Pharmaceutical Company’s Profitability
Dan Danielson, Pharmacy Manager, Clinical Services, PREMERA BLUE CROSS
Marc Cohen, Collaborative Quality Initiatives Value Partnerships, BLUE CROSS BLUE SHIELD MICHIGAN
Duane Barnes, Vice President, Specialty Pharmacy & PBM Strategy Global Value, Access & Policy, AMGEN
Sophie Opdyke, VP, Commercial Development, Biosimilars, PFIZER
Pfizer, Janssen, AbbVie and BMS
• Advocating Collaborative and Open Communication with Payers within Pharmaceutical Managed Care
• Evaluating the Current Landscape of Limited Distribution Drugs
• Decoding Payer Coverage Decisions Regarding the Expansion of Biosimilar Therapeutic Treatments
• Trends Regarding Private Exchange Coverage and Impact on Employee Benefit Design
• Revised Pricing Strategies in Line with 340B Omnibus Guidance
• Identifying the Impact Of Generic and Biosimilar Encroachment on Pharmaceutical Pricing
• Payer Perspectives on the Evolving Healthcare Landscape and Effect on Pharmaceutical Pricing
• Risk Sharing, Value Based, and Exclusivity: Trends within Innovative Contracting Types
KEY SPEAKERS INCLUDE:
KEY COMPANIES ON AGENDA
KEY TOPICS INCLUDE:
KEY TOPICS INCLUDE:
500 N. DEARBORN STREET, SUITE 500 CHICAGO, IL 60654 (P) 312.822.8100 (F) 312.602.3834 www.q1productions.com