Two colleagues and I were featured in the winter 2010 edition of GLOBAL DEVELOPMENT CONNECTIONS (a Bayer HealthCare internal newsletter) as experts in and advocates of Good Publication Practice.

1. GLOBAL DEVELOPMENT
connections
WINTER 2010 VOL. 3, NO. 4
L I N K I N G T H E G L O B A L C O M M U N I T Y
Xarelto® Wins Country
11th Taking Spotlight:
9 International
Prix Galien 10 Quality to a
new level 17 The Russian
Federation

2. Table of Contents
3 A Message from Kemal Malik
5 Feature Story
A Quick Look Back and Full Speed Ahead
for Bayer HealthCare Pharma’s Oncology Business
8 Event
US FDA Approves the First Contraceptive Pill Fortified with Folate
9 Event
Xarelto® Wins the 11th International Prix Galien
for Best Pharmaceutical Agent
10 GD Organization Spotlight
Taking Quality to a New Level
12 GD Asia Hub Update
Biostats GD Asia overview
13 Leadership
A discussion on Leadership with Joachim Schmidt,
Head Global Operations & Branded Generics
15 Operational Excellence
New Standard Operating Procedure
Raises the Bar for Observational Studies
17 Country Spotlight
The Russian Federation: A Core Part of Bayer’s Emerging Market Strategy
19 Employees Speak Out
What is a recent accomplishment of Global Development Russia
that you are especially proud of ?
20 Customer First
Bayer HealthCare Pharma’s Global Publication Policy
Outlines Our Commitment to Good Publication Practice
22 Key Links
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3. u CUSTOMER FIRST
Bayer HealthCare Pharma’s Global
Publication Policy Outlines Our
Commitment to Good Publication Practice
For the past two years, the Scientific Communications team within Global Medical Affairs has been leading a Best Practices
initiative, which has reached a major landmark of completing a Global Publication Policy for the Pharma division which will
be published soon on www.bayerscheringpharma.de. GD Connections talked to members of the team responsible for the
new policy.
The past couple of years have seen heightened scrutiny and criticism of the GD Connections spoke with Chris James, Scientific Publications and Information
pharmaceutical industry’s publication practices, particularly with regard to “hot Management; Tricia Gooljarsingh, PhD, Publications and Medical
topics” such as the timeliness of scientific publications, criteria for authorship, Communications; and John Zoidis, MD, Publications and Communications ,– as
acknowledgement of editorial and writing support (“ghost authors and ghost well as the sponsor – Richard Nieman, MD, now Head of Medical Affairs Asia – to
writers”), and conflicts of interest. Although learn how and why this initiative was launched.“It wasn’t a question of changing
Bayer HealthCare itself has not been the target how we do things within Bayer – we have been following good publication
of any public criticism, its Scientific practice all along,” said James. “We developed this policy not only to ensure that
Communications teams nonetheless wanted we are doing the right thing, but also to be able to
collectively to ensure the company continues show that we are.” Dr. Gooljarsingh, added that
to adhere to Good Publication Practice (GPP) "our commitment to good publication
standards and that its policy for scientific practices will reinforce in a very public way,
publications remain transparent. our commitment to the healthcare
Hence the rollout of the Global community - to provide valuable
Publication Policy, which is based information from our trials in a
on prevailing GPP guidelines such compliant and ethical manner.”
as the International Committee of
Medical Journal Editors (ICMJE)
Uniform Requirements1 and the
GPP guidelines developed by the
International Society for Medical
Chris James,
Publication Professionals (ISMPP).2
Tricia Gooljarsingh, PhD,
and John Zoidis, MD
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4. u CUSTOMER FIRST
u Collaborative effort the forefront of good publication practice, and will allow the organization to be
To develop the policy, the team of James, Gooljarsingh and Zoidis, and others proactive instead of reactive when it comes to adhering to ever-changing GPP
working on scientific publication management formed a Good Publication Practice standards. We meet regularly to discuss GPP issues, identify any changes in the
working group that began meeting regularly to share best practices and practical GPP landscape, and render any due diligence recommendations we believe are
experiences and to discuss key issues. Over time, the group developed a series of necessary. We want Bayer to lead by example when it comes to GPP adherence.”
recommendations, based on current GPP guidelines and practices, for how Bayer
“It is because the external guidelines, and thus prevailing standards for GPP,
HealthCare Pharma should best handle scientific publications. The cornerstone of
continue to evolve that it is important to ensure everyone working to communicate
these recommendations was the creation and publication of the Global Publication
our clinical trial results is aware of GPP and the potential criticisms we face if we
Policy. Dr. Nieman (who at the time was based in Montville as Head of Global
fail to meet these standards,” added James.
Medical Affairs for Therapeutic Areas) presented these recommendations to Bayer
HealthCare Pharma’s Board of Management, which endorsed them in May. “We have such a great pipeline of products like Xarelto®, Eylea™ and others in
development, which makes publishing information about our clinical trials all the
In the context of the policy, “publication” means all non-promotional, product-
more important,” Dr. Nieman added. “When we have such good information to
related, scientific publications, including abstracts, posters, review articles, peer-
share, it’s key to have a good process in place for doing that.”
reviewed primary and secondary study manuscripts developed for publication in
biomedical journals, and presentations at scientific congresses and other external 1 International Committee of Medical Journal Editors. Uniform requirements for manuscripts submitted
meetings. to biomedical journals: writing and editing for biomedical publication. Updated April 2010. Accessed
December 1, 2010. Available at: http://www.icmje.org/urm_main.html.
“One of the things we recommended was that all publication activities be 2 Graf C, Battisti WP, Bridges D, et al. Good publication practice for communicating company
coordinated by Medical Affairs,” Dr. Nieman said. Medical Affairs has taken the sponsored medical research: the GPP2 guidelines. Br Med J. 2009;339:b4330.
lead, he explained, “because our function is all about communicating the safety,
efficacy and value of our products, so we need our scientific information to be of
the highest quality.” Added Dr. Nieman, “The policy also reiterates Bayer The GPP Working Group
HealthCare’s commitment to disclosing accurate and balanced information about
the design and results of its clinical trials and its adherence to strict ethical Chris James Philipp Lengsfeld / Kimberly Boothe
standards regarding authorship of scientific publications.” GMA NOH Petra Palkowitsch US RMA
GMA Diagnostic
u Evolving landscape John Zoidis Cynthia Guerra
Imaging
Dr. Zoidis noted that GPP is a constantly changing landscape. “This policy GMA Oncology US RMA
demonstrates the Pharma division’s alignment with the current standard for quality Kathrin Stauch
control and due diligence in ensuring that every aspect of our business is up to Tricia Gooljarsingh Elisabeth Operschall
GMA NIS
these standards, and demonstrates in a completely transparent fashion that we’re GSA Hemophilia GSA Avelox
Gerlind Holberg
keeping an eye out on these standards as they continue to evolve,” he said. It will Elvira Baumann
GMA Rivaroxaban
be the task of the GPP Working Group (Table) to monitor changes to GPP (Bettina Althoff)
standards and make recommendations to ensure ongoing adherence. Added Dr. GMA Female Healthcare Ralf Winnen
Zoidis, “The GPP Working Group will continue to ensure that Bayer is always at MA Bayer Vital
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