GLOBAL DEVELOPMENT WINTER 2010 VOL. 3, NO. 4

Xarelto® Wins11thInternationalPrix Galien

TakingQuality to anew level9 10

CountrySpotlight: The RussianFederation17

connectionsL I N K I N G T H E G L O B A L C O M M U N I T Y

3 A Message from Kemal Malik

5 Feature StoryA Quick Look Back and Full Speed Ahead for Bayer HealthCare Pharma’s Oncology Business

8 EventUS FDA Approves the First Contraceptive Pill Fortified with Folate

9 EventXarelto® Wins the 11th International Prix Galien for Best Pharmaceutical Agent

10 GD Organization SpotlightTaking Quality to a New Level

12 GD Asia Hub UpdateBiostats GD Asia overview

13 LeadershipA discussion on Leadership with Joachim Schmidt, Head Global Operations & Branded Generics

15 Operational ExcellenceNew Standard Operating Procedure Raises the Bar for Observational Studies

17 Country SpotlightThe Russian Federation: A Core Part of Bayer’s Emerging Market Strategy

19 Employees Speak OutWhat is a recent accomplishment of Global Development Russia that you are especially proud of ?

20 Customer FirstBayer HealthCare Pharma’s Global Publication Policy Outlines Our Commitment to Good Publication Practice

22 Key Links

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Table of Contents

The past couple of years have seen heightened scrutiny and criticism of thepharmaceutical industry’s publication practices, particularly with regard to “hottopics” such as the timeliness of scientific publications, criteria for authorship,acknowledgement of editorial and writing support (“ghost authors and ghostwriters”), and conflicts of interest. AlthoughBayer HealthCare itself has not been the targetof any public criticism, its ScientificCommunications teams nonetheless wantedcollectively to ensure the company continuesto adhere to Good Publication Practice (GPP)standards and that its policy for scientificpublications remain transparent.Hence the rollout of the GlobalPublication Policy, which is basedon prevailing GPP guidelines suchas the International Committee ofMedical Journal Editors (ICMJE)Uniform Requirements1 and theGPP guidelines developed by theInternational Society for MedicalPublication Professionals (ISMPP).2

GD Connections spoke with Chris James, Scientific Publications and InformationManagement; Tricia Gooljarsingh, PhD, Publications and MedicalCommunications; and John Zoidis, MD, Publications and Communications ,– aswell as the sponsor – Richard Nieman, MD, now Head of Medical Affairs Asia – tolearn how and why this initiative was launched.“It wasn’t a question of changinghow we do things within Bayer – we have been following good publicationpractice all along,” said James. “We developed this policy not only to ensure that

we are doing the right thing, but also to be able toshow that we are.” Dr. Gooljarsingh, added that

"our commitment to good publicationpractices will reinforce in a very public way,our commitment to the healthcare

community - to provide valuableinformation from our trials in a

compliant and ethical manner.”

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For the past two years, the Scientific Communications team within Global Medical Affairs has been leading a Best Practicesinitiative, which has reached a major landmark of completing a Global Publication Policy for the Pharma division which willbe published soon on www.bayerscheringpharma.de. GD Connections talked to members of the team responsible for thenew policy.

Bayer HealthCare Pharma’s GlobalPublication Policy Outlines OurCommitment to Good Publication Practice

Chris James, Tricia Gooljarsingh, PhD, and John Zoidis, MD

u Collaborative effort To develop the policy, the team of James, Gooljarsingh and Zoidis, and othersworking on scientific publication management formed a Good Publication Practiceworking group that began meeting regularly to share best practices and practicalexperiences and to discuss key issues. Over time, the group developed a series ofrecommendations, based on current GPP guidelines and practices, for how BayerHealthCare Pharma should best handle scientific publications. The cornerstone ofthese recommendations was the creation and publication of the Global PublicationPolicy. Dr. Nieman (who at the time was based in Montville as Head of GlobalMedical Affairs for Therapeutic Areas) presented these recommendations to BayerHealthCare Pharma’s Board of Management, which endorsed them in May.

In the context of the policy, “publication” means all non-promotional, product-related, scientific publications, including abstracts, posters, review articles, peer-reviewed primary and secondary study manuscripts developed for publication inbiomedical journals, and presentations at scientific congresses and other externalmeetings.

“One of the things we recommended was that all publication activities becoordinated by Medical Affairs,” Dr. Nieman said. Medical Affairs has taken thelead, 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 ofthe highest quality.” Added Dr. Nieman, “The policy also reiterates BayerHealthCare’s commitment to disclosing accurate and balanced information aboutthe design and results of its clinical trials and its adherence to strict ethicalstandards regarding authorship of scientific publications.”

u Evolving landscape Dr. Zoidis noted that GPP is a constantly changing landscape. “This policydemonstrates the Pharma division’s alignment with the current standard for qualitycontrol and due diligence in ensuring that every aspect of our business is up tothese standards, and demonstrates in a completely transparent fashion that we’rekeeping an eye out on these standards as they continue to evolve,” he said. It willbe the task of the GPP Working Group (Table) to monitor changes to GPPstandards and make recommendations to ensure ongoing adherence. Added Dr.Zoidis, “The GPP Working Group will continue to ensure that Bayer is always at

the forefront of good publication practice, and will allow the organization to beproactive instead of reactive when it comes to adhering to ever-changing GPPstandards. We meet regularly to discuss GPP issues, identify any changes in theGPP landscape, and render any due diligence recommendations we believe arenecessary. We want Bayer to lead by example when it comes to GPP adherence.”

“It is because the external guidelines, and thus prevailing standards for GPP,continue to evolve that it is important to ensure everyone working to communicateour clinical trial results is aware of GPP and the potential criticisms we face if wefail to meet these standards,” added James.

“We have such a great pipeline of products like Xarelto®, Eylea™ and others indevelopment, which makes publishing information about our clinical trials all themore important,” Dr. Nieman added. “When we have such good information toshare, it’s key to have a good process in place for doing that.”

1 International Committee of Medical Journal Editors. Uniform requirements for manuscripts submittedto biomedical journals: writing and editing for biomedical publication. Updated April 2010. AccessedDecember 1, 2010. Available at: http://www.icmje.org/urm_main.html.

2 Graf C, Battisti WP, Bridges D, et al. Good publication practice for communicating companysponsored medical research: the GPP2 guidelines. Br Med J. 2009;339:b4330.

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Chris JamesGMA NOH

John ZoidisGMA Oncology

Tricia GooljarsinghGSA Hemophilia

Elvira Baumann(Bettina Althoff)GMA Female Healthcare

Philipp Lengsfeld / Petra PalkowitschGMA DiagnosticImaging

Kathrin StauchGMA NIS

Gerlind HolbergGMA Rivaroxaban

Ralf WinnenMA Bayer Vital

Kimberly BootheUS RMA

Cynthia GuerraUS RMA

Elisabeth OperschallGSA Avelox

The GPP Working Group