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THANK YOU FOR JOINING ISMPP U
TODAY!
The program will begin promptly at 9:00 am (CSTChina)
March 19, 2015
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2
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4
A PRACTICAL GUIDE TO IMPLEMENTING
GLOBAL PUBLICATION PLANNING
PRACTICES IN ASIA-PACIFIC COUNTRIES
AND EMERGING MARKET REGIONS
Moderator: Julliana Newman, ELS, CMPP
Director, Publications Operations and Strategy
AstraZeneca Pharmaceuticals LTD
DISCLOSURES – JULLIANA NEWMAN, ELS, CMPPTM
•
•
I am a full-time employee of AstraZeneca Pharmaceuticals LTD.
•
•
•
I serve as Chair of the ISMPP Asia-Pacific Education Task Force.
•
The opinions expressed in this presentation are my personal views and
do not represent the views of my employer or of ISMPP.
I am a member of ISMPP and an ISMPP Certified Medical Publications
Professional (CMPP) .
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).
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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
A PRACTICAL GUIDE TO IMPLEMENTING
GLOBAL PUBLICATION PLANNING
PRACTICES IN ASIA-PACIFIC COUNTRIES
AND EMERGING MARKET REGIONS
Tim Collinson, ISMPP CMPPTM
Business Unit Head, West Coast, Fishawack
Communications, San Francisco, USA
DISCLOSURES – TIM COLLINSON, ISMPP CMPPTM
•
•
I am a full-time employee of Fishawack Communications
•
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
I am a member of ISMPP and serve on its Communications
Committee and its Asia-Pacific Education Task Force
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?
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EMERGING MARKETS
•
•
“BRIC nations” — Brazil, Russia, India, China
Argentina, Venezuela, Mexico and Turkey among the most rapidlygrowing “pharmemerging” markets
Emerging
markets’ drive to improve access to health care
Rated Top 10 Emerging Markets 2012‐2017
Upscaling of research activities in emerging regions
Corresponding significant escalation in data
Growing need for publications
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
−
−
•
Low base salaries among hospital physicians
String of investigations by authorities at China-based global
pharma companies
−
−
•
China healthcare spend forecast to triple 2013–2020
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 goal to increase patient access to healthcare
Cultures
Languages
Common wish to publish in transparent, compliant, ethical manner
Socioeconomic status Healthcare delivery
15
Are emerging markets driving
a need for a new approach to
publication planning?
16
…THE PRINCIPLES OF PUBLICATION
PLANNING REMAIN THE SAME
Disseminating global data within local emerging markets Publishing globally, data originating from emerging markets
Core publication planning principles remain the same
Scientific engagement with diverse audiences within culturally diverse regions Regional unmet needs for education on publication planning
Evolution of publication planning to meet market needs
17
BALANCING COMPLIANCE AND CULTURE
Differing local needs, clinical practices and cultural protocol
may require different contextualization of data
Publication planning governance – the “rock”
Approaches, whether global or local, in markets mature or emerging,
should remain the same
18
PUBLICATION PLANNING: APPROPRIATE, CREDIBLE,
UNBIASED DISSEMINATION OF ALL DATA TO MEET THE
INFORMATION NEEDS OF HEALTH-CARE AUDIENCES
GPP
Ethics
Transparency
Compliance
Scientific exchange
Effectiveness of publications in informing clinical practice relies on cultural understanding and country‐
specific nuances
Variation in global and regional
data sources — e.g., increasing relevance of real‐world data
Informational needs of health‐care audiences
Evolution and diversity in publication media and formats
Relative importance of audiences, e.g., payors (HE data) in publication planning
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 Englishspeaking countries
•
Submissions reflecting wide-ranging cultures
and health-care practices
•
Wide-ranging educational needs among
journal readership
21
LANGUAGE
•
•
•
Not everyone understands English!
•
Clinicians and their staff commonly require
translated materials
•
Digital components of publications
(e.g. author videos) useful in enhancing
communication
However, publishing in English is highly valued
Academics are motivated to read English to
further their own publication accomplishments
22
UNIQUE CHALLENGES AND CULTURAL
PERSPECTIVES
Resistance
to change
Authorship and traditional
Differing treatment
beliefs: respect for elders,
guidelines/standards
teachers, senior
Widely
colleagues
practiced gift
Product life-cycle management (emerging
authorship
markets usually launch months, even
years, after the initial launch)
Stipend for volume and
placement of publications in
Trial
Encore abstracts
top-tier journals
registration
Role of medical
Communication
writers
Language
Copyright
preferences
issues
(face-to-face)
23
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
. . . a long, winding, but worthwhile journey!
http://bestfreewallpapers.info
Like climbing the Great Wall . . .
27
RESOURCES
•
•
GPP2 guidelines available at: http://www.ismpp.org/gpp2
•
ISMPP: http://www.ismpp.org/asia-pacific-platform
ICMJE recommendations available at:
http://www.icmje.org/recommendations/
− Asia-Pacific Advisory Committee
− Asia-Pacific Education Task Force
Guidelines in Chinese and
Japanese are available on
the ISMPP website
http://www.ismpp.org/
28
THE CHALLENGE AND OPPORTUNITY
FOR PUBLICATION PLANNING IN ASIAPACIFIC: LOCAL EXAMPLES AND
EXPERIENCE FROM CHINA
Lin Lin, PhD
MEDICAL PUBLICATION MANAGER, SHANGHAI ROCHE
PHARMACEUTICALS LTD.
DISCLOSURES – LIN LIN
•
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
30
INCREASING PUBLICATION VOLUMES IN
APAC REGION
Adapted by permission from Macmillan Publishers Ltd: Nature 492, 324-327 copyright (2012)
31
OVERVIEW
 Generation of Publication Plan
−
−
−
Products life-cycle management
Differing treatment guidelines/standards
Language
 Implementation of Publication Plan
−
−
Publish in transparent, compliant and ethical manner
Timeline management
32
OVERVIEW
 Generation of Publication Plan
−
−
−
Products life-cycle management
Differing treatment guidelines/standards
Language
 Implementation of Publication Plan
−
−
Publish in transparent, compliant and ethical manner
Timeline management
33
CHALLENGES: PRODUCTS LIFE-CYCLE
MANAGEMENT
•
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
34
CHALLENGES: PRODUCTS LIFE-CYCLE
MANAGEMENT
•
•
Generic drug and biosimilar
High-tier journal lost interest to publish papers of a drug that
has lost patent
CFDA: Principles and guidelines on development and
evaluation of biosimilar -- released on 25th Feb 2015
35
OPPORTUNITIES: PRODUCTS LIFE-CYCLE
MANAGEMENT
•
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
36
CHALLENGES:
DIFFERENT TREATMENT
GUIDELINES/STANDARDS
• 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.
37
OPPORTUNITIES:
DIFFERENT TREATMENT
GUIDELINES/STANDARDS
• 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
LANGUAGE: DIVERSIFIED READERS IN CHINA
• Distribution of 1st to 5th
tier cities in China
• Different levels of
doctors in China
International
National
1
International
Congresses
5
English Journals
2
3
4
Regional
City/Local
Local Congresses
Chinese Journals
Encore Abstracts
39
LANGUAGE: DIVERSIFIED READERS IN CHINA
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).
40
CHALLENGES AND OPPORTUNITIES:
LANGUAGE
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
41
OVERVIEW
 Generation of Publication Plan
−
−
−
Products life-cycle management
Differing treatment guidelines/standards
Language
 Implementation of Publication Plan
−
−
Publish in transparent, compliant and ethical manner
Timeline management
42
OVERVIEW
 Generation of Publication Plan
−
−
−
Products life-cycle management
Differing treatment guidelines/standards
Language
 Implementation of Publication Plan
−
−
Publish in transparent, compliant and ethical manner
Timeline management
43
CHALLENGES: PUBLISH IN TRANSPARENT,
COMPLIANT AND ETHICAL MANNER
•
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
•
Copyright issues
Stipend for volume and placement of publications in
top-tier journals
44
CHALLENGES: PUBLISH IN TRANSPARENT,
COMPLIANT AND ETHICAL MANNER
• Stipend for volume and placement of publications in top-tier
journals
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 RMB
IF < 5, 45,000 RMB
IF < 8,70,000 RMB
IF < 10, 90,000 RMB
IF < 15, 130,000 RMB
IF 15, 300,000 RMB
RMB: Renminbi, Chinese yuan, CNY
1000 RMB ≈ US $155
10,000 RMB ≈ US $1,550
50,000 RMB ≈ US $7,750
200,000 RMB ≈ US $31,000
300,000 RMB ≈ US $46,500
SOURCE: The outflow of academic papers from China: why is it happening and can it be stemmed? Learned Publishing 24(2):95—97, 2011
45
OPPORTUNITIES: PUBLISH IN TRANSPARENT,
COMPLIANT AND ETHICAL MANNER
• International standards or guidelines for medical publications
SOURCE: Graf C., et. al., BMJ. 2009
46
OPPORTUNITIES: PUBLISH IN TRANSPARENT,
COMPLIANT AND ETHICAL MANNER
•
•
ICMJE recommendations
Good publication practice
(GPP2)
SOURCE: Graf C., et. al., BMJ. 2009
http://www.ismpp.org/gpp2
SOURCE: Graf C., et. al., BMJ. 2009
http://www.icmje.org/recommendations/
47
CHALLENGES: TIMELINE MANAGEMENT
•
•
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
48
OPPORTUNITIES:
IMPLEMENTATION OF PUBLICATION PLAN
•
•
Publication Steering committee
Investigators meeting
SOURCE : Marisa Peacock, CMSwire, Dec 17 2013
•
Education
−
−
Communication and visiting
Publication workshop
SOURCE : www.sitepoint.com
49
SUMMARY
Local Publication Plan
Local
situation
• Journal
• Congress
• Guideline
• Drug access
• Local needs
• Publication
steering
committee
• Investigator
meetings
• Education
Global
situation
• Journal
• Congress
• Guideline
• Drug access
• Studies and
publications
Publish in transparent, compliant and ethical manner
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 premeeting 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
• 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)
53
2 0 1 5 A S I A PAC 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, 2015
Beijing, China
Tokyo, Japan
THANK YOU FOR ATTENDING!
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depend on your valuable feedback as we develop future
educational offerings.
55