The program will begin promptly at 9:00 am (CST-China)

THANK YOU FOR JOINING ISMPP U TODAY!

March 19, 2015

FOR YOUR BEST ISMPP U EXPERIENCE . . .

2

To optimize your webinar experience today, please:• If using VOIP (Voice Over Internet Protocol) vs. your

phone, turn up the volume of your computer speakers• Use a hardwire connection if available• Use the fastest internet connection available to you• If you experience audio problems, switch to an alternative

access method (VOIP phone or phone VOIP)

ISMPP WOULD LIKE TO THANK. . .

. . . the following Titanium and Platinum Corporate Sponsors for their ongoing support of the Society:

Questions…

4

• To ask a question, please type your query into the Q&A box.

• To ensure anonymity, please choose the drop box option "Hosts, Presenters and Panelists." Otherwise, all audience members will be able to see your submitted question.

• Every attempt will be made to respond to all questions.

Moderator: Julliana Newman, ELS, CMPPDirector, Publications Operations and StrategyAstraZeneca Pharmaceuticals LTD

A PRACTICAL GUIDE TO IMPLEMENTING GLOBAL PUBLICATION PLANNING PRACTICES IN ASIA-PACIFIC COUNTRIES AND EMERGING MARKET REGIONS

DISCLOSURES – JULLIANA NEWMAN, ELS, CMPPTM

• I am a full-time employee of AstraZeneca Pharmaceuticals LTD.

• I am a member of ISMPP and an ISMPP Certified Medical Publications Professional (CMPP) .

• I serve as Chair of the ISMPP Asia-Pacific Education Task Force.

• I am a voting member of the ISMPP CMPP Board of Directors.

• I am a Certified Editor of the Life Sciences (ELS) by the Board of Editors in the Life Sciences (BELS).

• The opinions expressed in this presentation are my personal views and do not represent the views of my employer or of ISMPP.

6

SPEAKER

Tim Collinson, BSc (Hons), ISMPP CMPP™

• >19 years’ medical writing and editorial management experience in global medical communications and pharma, in the UK, USA and Canada

• Currently, Business Unit Head, West Coast, Fishawack Communications, San Francisco

• ISMPP Asia-Pacific Education Taskforce member

• ISMPP Communications Committee member

• Certified Medical Publication Professional (CMPP)™

• Honours degree in Physiology/Pharmacology with Health Studies

SPEAKER

Lin Lin, PhD

• Currently, Medical Publication Manager at Shanghai Roche Pharmaceuticals

• ISMPP Asia-Pacific Education Taskforce member

• Medical communications agency experience in China

• Postdoctoral research fellow in endocrinology at University College London, UK

• MSc in Neuro and Molecular Pharmacology, and PhD in Molecular Pharmacology from University of Birmingham, UK

• Bachelor’s degree in Clinical Medicine from Sun Yat-Sen University, Guangzhou, China

OBJECTIVES: AT THE END OF THIS SESSION, YOU SHOULD BE ABLE TO:1. Understand the challenges inherent in managing data

dissemination on a global level across heterogeneous regions 2. Apply tailored strategies for scientific exchange at local levels

by balancing cultural sensitivities and adherence to global ethical standards

3. Appreciate how markets are moving towards a universal understanding of publication planning and a consistent application of best practices

4. Strengthen your awareness of the challenges and highlight the opportunities for publication professionals in developing and implementing publication plans in Asia-Pac

Tim Collinson, ISMPP CMPPTM

Business Unit Head, West Coast, FishawackCommunications, San Francisco, USA

A PRACTICAL GUIDE TO IMPLEMENTING GLOBAL PUBLICATION PLANNING PRACTICES IN ASIA-PACIFIC COUNTRIES AND EMERGING MARKET REGIONS

DISCLOSURES – TIM COLLINSON, ISMPP CMPPTM

• I am a full-time employee of Fishawack Communications

• I am a member of ISMPP and serve on its Communications Committee and its Asia-Pacific Education Task Force

• The opinions expressed in this presentation are the personal views of the speaker and do not represent the views of his employer or of ISMPP

11

OVERVIEW

• Pharma’s increasing move from mature markets to seek growth in developing nations

• Clinical trials in new locations, data originating from different regions

• Reassessment of dissemination and communication of data

• Engagement with different audiences in different regions

• Requirement for different approach to publication planning?

12

EMERGING MARKETS

• “BRIC nations” — Brazil, Russia, India, China• Argentina, Venezuela, Mexico and Turkey among the most rapidly-

growing “pharmemerging” markets

Emergingmarkets’ drive to improve access to 

health care

Upscaling of research activities in emerging regions

Corresponding significant 

escalation in data

Growing need for publications

Rated Top 10 Emerging Markets 2012‐2017

Source: Global Intelligence Alliance, Business Perspectives on Emerging Markets 2012‐2017 Survey.Question: Which are the top 5 Emerging Markets for your industry over the next 5 years? N=38

IMS Health 2012 report. http://www.globalintelligence.com/insights/all/pharma‐and‐healthcare‐companies‐find‐local‐emerging‐market‐conditions‐and‐prices‐challenging [accessed February 2015]

13

PHARMA UNDER SCRUTINY – MOVE TOWARDS ETHICAL COMPLIANCE IN EMERGING MARKETS

• Bribery scandals, e.g. illegal payments by GSK to doctors in China− China healthcare spend forecast to triple 2013–2020− Low base salaries among hospital physicians

• String of investigations by authorities at China-based global pharma companies− Industry responding by tightening compliance policies− Triggering of anti-corruption drive across many emerging markets

• Increasing need for publication planning activities to stand up to scrutiny

14

PUBLICATION PLANNING IN ASIA-PACIFIC

Common wish to publish in transparent, compliant, 

ethical manner

Cultures Languages Socioeconomic status Healthcare delivery

Common goal to increase patient access to healthcare

15

Are emerging markets driving a need for a new approach to

publication planning?

16

…THE PRINCIPLES OF PUBLICATION PLANNING REMAIN THE SAME

Publishing globally, data originating 

from emerging markets

Core publication planning principles remain the 

same

Disseminating global data within local emerging markets 

Regional unmet needs for education on publication 

planning

Scientific engagement with diverse audiences 

within culturally diverse regions 

Evolution of publication planning to meet market 

needs

17

BALANCING COMPLIANCE AND CULTURE

Publication planning governance – the “rock”Approaches, whether global or local, in markets mature or emerging,

should remain the same

Differing local needs, clinical practices and cultural protocolmay require different contextualization of data

18

PUBLICATION PLANNING: APPROPRIATE, CREDIBLE, UNBIASED DISSEMINATION OF ALL DATA TO MEET THE INFORMATION NEEDS OF HEALTH-CARE AUDIENCES

Effectiveness of publications in informing clinical practice relies on cultural understanding and country‐

specific nuances

Variation in global and regionaldata sources — e.g., increasing relevance of real‐world data

Evolution and diversity in publication media and formats

Relative importance of audiences, e.g., payors (HE data) in publication planning

Informational needs of health‐care audiences

GPP Transparency ComplianceEthics

Scientific exchange

GPP, Good publication practice; HE, health economics

19

ASIA-PACIFIC REPRESENTS A DIFFERENT PUBLICATIONS LANDSCAPE

• Access to the literature differs across regions− Affordability of subscriptions a barrier

• Access to medical education generally lower• Hierarchy remains a significant authorship issue• Acceptance of “Western” medicine• Paper versus online access

− Adoption of online access to medical information differs among countries and between practitioners and researchers

• Reprints and republications− Translation is common but not always authorized

20

PUBLISHING SCIENTIFIC LITERATURE IN ASIA-PACIFIC

• Unique challenges for regional, local and international journal publishers

• Relative to other world regions, journal editors may need to handle high numbers of submissions from non-native English-speaking countries

• Submissions reflecting wide-ranging cultures and health-care practices

• Wide-ranging educational needs among journal readership

21

LANGUAGE

• Not everyone understands English!• However, publishing in English is highly valued• Academics are motivated to read English to

further their own publication accomplishments• Clinicians and their staff commonly require

translated materials• Digital components of publications

(e.g. author videos) useful in enhancing communication

22

UNIQUE CHALLENGES AND CULTURAL PERSPECTIVES

Widely practiced gift authorship

Stipend for volume and placement of publications in top-tier journals

Resistance to change

Language Communication preferences (face-to-face)

Authorship and traditional beliefs: respect for elders, teachers, senior colleagues

Trial registration

Product life-cycle management (emerging markets usually launch months, even years, after the initial launch)

Differing treatment guidelines/standards

Copyright issues

Encore abstracts

23

Role of medical writers

THINK GLOBALLY; ACT LOCALLY

• Publishing in Asia-Pacific regions requires a tailored approach using local publication options

− Chinese Academy of Sciences rivals National Institutes of Health for volume of publications

• Regional differences in perception of some diseases and treatment

• Navigation of traditions around authorship• Poor publication practice at local level can now have

rapid global impact • Locally- or regionally-based publications committees

can facilitate alignment of global/“Western” publication plans to local needs, cultures and languages

24

PUBLICATION STEERING COMMITTEES: KEY ROLE, BUT STILL A YOUNG CONCEPT IN ASIA-PACIFIC

• Establishing publication steering committees offers key guidance within rapidly advancing regions, such as Asia-Pacific− Guidance on authorship and journal selection− Ensuring a commitment to ethical practices is integral to planning− Adherence not only to local industry codes, but also international legislation and

compliance directives− Appropriately addressing sensitivities around local cultures/practices

• Unmet need for education at regional level on the formation, role and value of publication steering committees

25

ISMPP DRIVING EDUCATION AND ADVOCACY FOR GOOD PUBLICATION PRACTICE IN ASIA-PACIFIC

APET, Asia‐Pacific Education Task Force

26

SUMMARY

• Emerging markets are hugely diverse — health-care systems, clinical practice, cultures and attitudes to therapy

• Challenges are inherent in managing the communication of data on a global level across heterogeneous regions such as Asia-Pacific

• Tailored strategies for scientific exchange at local levels must be carefully balanced with cultural sensitivities and an unfaltering adherence to global ethical standards

• Asia-Pacific is moving toward a universal understanding of publication planning and a consistent application of best practices in its execution

http://bestfreew

allpapers.info

Like climbing the Great Wall . . .. . . a long, winding, but worthwhile journey!

27

RESOURCES

• GPP2 guidelines available at: http://www.ismpp.org/gpp2

• ICMJE recommendations available at: http://www.icmje.org/recommendations/

• ISMPP: http://www.ismpp.org/asia-pacific-platform− Asia-Pacific Advisory Committee

− Asia-Pacific Education Task Force Guidelines in Chinese and Japanese are available on

the ISMPP websitehttp://www.ismpp.org/

28

Lin Lin, PhDMEDICAL PUBLICATION MANAGER, SHANGHAI ROCHE PHARMACEUTICALS LTD.

THE CHALLENGE AND OPPORTUNITY FOR PUBLICATION PLANNING IN ASIA-PACIFIC: LOCAL EXAMPLES AND EXPERIENCE FROM CHINA

• I am a full-time employee of Shanghai Roche Pharmaceuticals Ltd, focusing on publication strategy and medical education in China

• I am a member of ISMPP’s Asia-Pacific Education Task Force

• The opinions expressed in this presentation are the personal views of the speaker and do not represent the views of her employer or of ISMPP

DISCLOSURES – LIN LIN

30

Adapted by permission from Macmillan Publishers Ltd: Nature 492, 324-327 copyright (2012)

INCREASING PUBLICATION VOLUMES IN APAC REGION

31

OVERVIEW

− Products life-cycle management− Differing treatment guidelines/standards− Language

− Publish in transparent, compliant and ethical manner− Timeline management

Generation of Publication Plan

Implementation of Publication Plan

32

OVERVIEW

− Products life-cycle management− Differing treatment guidelines/standards− Language

− Publish in transparent, compliant and ethical manner− Timeline management

Generation of Publication Plan

Implementation of Publication Plan

33

• Emerging markets usually launch months, even years, after the initial launch in the West

• Under the new policy from China FDA (CFDA), registration of new drug in China may delay further 2-3 years from 2015

• Most of obvious publication gaps have been filled

Figure 1.6  The life cycle,  An introduction to nutrition  v.1.0

CHALLENGES: PRODUCTS LIFE-CYCLE MANAGEMENT

34

• Generic drug and biosimilar• High-tier journal lost interest to publish papers of a drug that

has lost patentCFDA: Principles and guidelines on development and evaluation of biosimilar -- released on 25th Feb 2015

CHALLENGES: PRODUCTS LIFE-CYCLE MANAGEMENT

35

• Phase IV studies with good quality - standing on the shoulders of giants

• Publication of local data from a multi-centered global study

• Unique population/disease characteristics in local region

www. mrseah.com

OPPORTUNITIES: PRODUCTS LIFE-CYCLE MANAGEMENT

36

• Not able to follow global guidelines e.g., different drug access between global and local market

• Lack of local treatment guidelines• Difficult to target global high-tier journals and congresses

Global Local

Vs.

CHALLENGES: DIFFERENT TREATMENT GUIDELINES/STANDARDS

37

• Choose target journals and congresses carefully e.g., target journals or congresses in APAC region who can understand the local situation more

• Improve the updating of local treatment guidelines• Improve the awareness and follow-up of global treatment

guidelines

38

OPPORTUNITIES: DIFFERENT TREATMENT GUIDELINES/STANDARDS

InternationalCongresses

International

National

Regional

City/Local

English Journals

Local CongressesChinese JournalsEncore Abstracts

12

3

4

5

• Distribution of 1st to 5th tier cities in China

• Different levels of doctors in China

LANGUAGE: DIVERSIFIED READERS IN CHINA

39

While international journals and congresses play a more important role, local Chinese media is a significant source of information.

*Survey conducted in 2013Q2. Totally 240 responders including Pathologists, Hematologists, Oncologists (LC, BC, GC, CRC).

LANGUAGE: DIVERSIFIED READERS IN CHINA

40

More than 50% of Chinese doctors don’t know English well and have limited resource to attend international congress

• Local congresses and journals are also important for communication purpose

• Translation of papers published in English journals are helpful• Copyright for encore abstract and translated manuscript are

very important

CHALLENGES AND OPPORTUNITIES: LANGUAGE

41

− Products life-cycle management− Differing treatment guidelines/standards− Language

− Publish in transparent, compliant and ethical manner− Timeline management

Generation of Publication Plan

Implementation of Publication Plan

OVERVIEW

42

− Products life-cycle management− Differing treatment guidelines/standards− Language

− Publish in transparent, compliant and ethical manner− Timeline management

Generation of Publication Plan

Implementation of Publication Plan

OVERVIEW

43

• Authorship: e.g., gift authorship and traditional beliefs: respect for elders, teachers, senior colleagues

• Acknowledgement and disclosure of conflict of interest, e.g. role of pharmaceutical company and medical writers

• Trial registration• Stipend for volume and placement of publications in

top-tier journals• Copyright issues

CHALLENGES: PUBLISH IN TRANSPARENT, COMPLIANT AND ETHICAL MANNER

44

SOURCE: The outflow of academic papers from China: why is it happening and can it be stemmed? Learned Publishing 24(2):95—97, 2011

RMB: Renminbi, Chinese yuan, CNY

1000 RMB ≈ US $15510,000 RMB ≈ US $1,55050,000 RMB  ≈ US $7,750

200,000 RMB ≈ US $31,000300,000 RMB ≈ US $46,500

At Guangzhou Medical University the payment scale is: IF  1, 3,000 RMB IF <2, 15,000 RMB IF < 3, 25,000 RMB IF < 4, 35,000 RMBIF < 5, 45,000 RMBIF < 8,70,000 RMBIF < 10, 90,000 RMBIF < 15, 130,000 RMBIF  15, 300,000 RMB

• Stipend for volume and placement of publications in top-tier journals

CHALLENGES: PUBLISH IN TRANSPARENT, COMPLIANT AND ETHICAL MANNER

45

• International standards or guidelines for medical publications

OPPORTUNITIES: PUBLISH IN TRANSPARENT, COMPLIANT AND ETHICAL MANNER

SOURCE: Graf C., et. al., BMJ. 2009

46

• ICMJE recommendations• Good publication practice

(GPP2)

OPPORTUNITIES: PUBLISH IN TRANSPARENT, COMPLIANT AND ETHICAL MANNER

SOURCE: Graf C., et. al., BMJ. 2009http://www.ismpp.org/gpp2

SOURCE: Graf C., et. al., BMJ. 2009http://www.icmje.org/recommendations/

47

• Delay of study and SAR generation• Delay of manuscript generation and publication

− Journal selection (over expectation)− Repeated revision− Simple outlines− Lack of awareness on the importance in timely

publication

CHALLENGES: TIMELINE MANAGEMENT

48

• Education− Communication and visiting− Publication workshop

• Publication Steering committee• Investigators meeting

SOURCE : Marisa Peacock,  CMSwire,  Dec 17 2013

SOURCE :  www.sitepoint.com

OPPORTUNITIES: IMPLEMENTATION OF PUBLICATION PLAN

49

Publish in transparent, compliant and ethical manner

Local Publication Plan

Local situation•Journal•Congress•Guideline•Drug access•Local needs

Global situation•Journal•Congress•Guideline•Drug access•Studies and publications

• Publication steering committee

• Investigator meetings

• Education

SUMMARY

50

QUESTIONS......

To ask a question, please type your query into the Q&A box.

To ensure anonymity, please choose the drop box option "Hosts, Presenters and Panelists." Otherwise, all audience members will be able to see your submitted question.

Every attempt will be made to respond to all questions.

Workshop on APAC Publications at ISMPP’S 11th Annual Meeting

If you plan to attend the Annual Meeting, why not sign up for the pre-meeting workshop, “Publication Planning in the Asia-Pacific Region”?• Learn to navigate challenges and utilize opportunities to build a

foundation for good publication practice in the increasingly important APAC region

• An interactive session providing practical examples for facilitating the publication of scientifically significant information in a compliant and transparent manner

• Monday, April 27, 8:30AM-1:00 PM• Taught by APET’s Tim Collinson and Julie Newman

52

UPCOMING APET ISMPP U

53

• Waking the Sleeping Tiger: An overview of Scientific Publications in India (June 2015)

• Back to basics: a review of good publication practices for Asia-Pac (September 2015)

• Update on GPP3: Understanding its impact on publications practice in Asia-Pac (November 2015)

2 0 1 5   A S I A   P A C I F I C  M E E T I N G   O F   I S M P P

COLLABORATING FOR. . .ETHICAL & EFFECTIVE MEDICAL PUBLICATIONS

Early September, 2015Beijing, ChinaTokyo, Japan

THANK YOU FOR ATTENDING!

• We hope you enjoyed today's presentation. Please take a few moments to complete the survey that will appear on your screen immediately after the presentation. We depend on your valuable feedback as we develop future educational offerings.

55