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Components of a Strategic &Tactical Publication Plan
Gary McQuarrie, PharmD, MBAPresident and CEO, Thomson Scientific Connexions
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Presentation Agenda
Based on ISMPP Publication Planning Workshop101/102 presented in April 2006
• Top-line overview on content
Expectations for publication plans
Typical components of a strategic & tacticalpublication plan
• Description & purpose• Samples
Questions & discussion
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Introduction
Can vary by pharma company and product• International vs US market• Focused on specific clinical indication(s)• Focused on specific physician or other healthcare
practitioner audiences• Focused on pharmacoeconomics, outcomes, payor
audiences
Plan document needs to be “Good PublicationPractice” compliant
• Plan is basis for appropriate dissemination ofscientific & clinical data, education/awareness,not a marketing communications plan
Expectations for publication plansExpectations for publication plans
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Introduction (continued)
Larger pharma companies with dedicated publicationstaff
• Often develop strategy, some componentsinternally
• May desire only selected, specific componentsfrom agency
• May desire only agency review and input toexisting plan based on expertise/experience
Small to medium pharma companies• May not have publication-dedicated staff• May desire full strategy and/or tactical plan
development
Expectations for publication plansExpectations for publication plans
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Components of aPublication Plan
Executive summary
Situation analysis and/or SWOT
Target audience identification
Key scientific & clinical communication points
Analyses of key journals/medical meetings
Competitor publication & gap analyses
Publication strategy
Depending on need, may include:Depending on need, may include:
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Components of aPublication Plan (cont’d)
Abstract & publication tactical recommendations
Timing of abstracts/posters/publications• Gantt charts, other visual presentations
Key meetings information
Key journals information
May include other communication/meeting activityrecommendations
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Executive Summary
Narrative synopsis to communicate the critical elements of thepublication plan strategy in an abbreviated format
• Summary of product clinical development status/plan• Competitive landscape, clinical issues, challenges,
opportunities– May appear in more detail in association with SWOT
analysis• Publication strategy & objectives• Key target audiences• Key scientific & clinical communication points• Critical tactics & timing
Description & purposeDescription & purpose
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SWOT Analysis
Thorough analysis of product strengths, weaknesses,opportunities, and threats that provides a basis fordeveloping publication strategyBased on multiple sources:
• Available product preclinical & clinical data• Available market research data on product and
competitors (existing & future)• Competitor publications analysis, medical or
marketing communications• Key opinion leader interviews or advisory board
feedback
Description & purposeDescription & purpose
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SWOT Analysis (continued)
New New cytotoxiccytotoxic agent for relapsed ovarian cancer agent for relapsed ovarian cancer
STRENGTHSNovel multicomponent MOAFavorable safety profile, hematol toxicityLack of cross resistanceIn vitro synergy with other agentsGood single-agent activity inplatinum-sensitive patients
WEAKNESSESMinimal single-agent activity in platinum-resistant patients
Optimal dosing TBD
Limited published clinical data
Only 1 active clinical trial, but key for ultimatepositioning
No QOL data
OPPORTUNITIESUnmet need for relapsed ovarian cancer; noSOCPotential in refractory disease due to novelMOAPotential in combination therapy (eg,platinums, liposomal doxorubicin)?Suitable for long-term therapy?
THREATSOlder agents with more clinical data and/orphysician experience (eg, platinumcompounds, taxanes, liposomal doxorubicin,topotecan)Newer targeted agents, effective againstplatinum-resistant disease
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SWOT Analysis (continued)
May also include a literature gap analysis onpublication plan product
• What’s missing in the literature?–Type of data, journal coverage, communication
points, unaddressed issues or challenges
May be part of “Situation Analysis” section thatincludes:
• Product profile summary• Competitive landscape• Clinical development plan• Issues & challenges
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Target Audience Identification
Identify healthcare professionals & other parties whowill use or influence use of the product and itsreimbursement
Target audiences have data & product profileawareness needs to allow appropriate assessment ofproduct and its clinical role
Identification allows:• Proper planning in terms of where, when, and how
the information is published to reach the specificaudiences of interest
• Resource priority decisions
Description & purposeDescription & purpose
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Target Audience Identification(continued)
Typical audiences• Physician specialists• Primary care physicians• Pharmacists
Other audiences may include:• Physician assistants/nurse practitioners• Nurses• Manage care, payors, case managers• Health economists, outcomes experts• Employers
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Key Communication Points
Primary scientific & clinical communication pointsabout a product’s preclinical & clinical profile inpublications that will underscore a reader’s basicunderstanding of the product
• Based on data and evidence from the product’s preclinical &clinical development program
• Can take competitor profiles and clinical use intoconsideration
• Can evolve as new findings emerge: may be contingent ondata developments
• May change over lifecycle of product• May vary by geography/country
(US vs non-US)
Description & purposeDescription & purpose
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Key Communication Points(continued)
Novel targeted immunotherapeutic for use in patients withcancer
Differs from other therapies; not a traditional ‘vaccine’
New and effective second-line therapeutic option for patientswith advanced pancreatic cancer who have receivedgemcitabine-containing chemotherapy
Subcutaneous ‘prime-boost’ regimen in combination withGM-CSF
Efficacy (increased survival) demonstrated in clinical trials inpatients with advanced pancreatic cancer
Improved safety profile for patients
ImmunomodulatingImmunomodulating agent for pancreatic cancer agent for pancreatic cancer
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Analyses of KeyMeetings/Journals
Top-line assessment of key journals &scientific/medical meetings that are critical tocommunicating product data
• Focuses the publication strategy• Provides guidance on where clinicians seek and
obtain data• Helps prioritize resources
Details on key journals and scientific/medicalmeetings are often provided as appendices to thepublication plan
Description & purposeDescription & purpose
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Analysis of Key Meetings/Journals(continued)
Interscience Conference on Antimicrobial Agentsand Chemotherapy (ICAAC)
Infectious Diseases Society of America (IDSA)American Thoracic Society InternationalConference (ATS)
Annual Meeting of the American College of ChestPhysicians (ACCP)
Society of Critical Care Medicine (SCCM)
New antimicrobial agent for hospitalized New antimicrobial agent for hospitalizedpneumonia for US audiencepneumonia for US audience
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Analysis of Key Meetings/Journals(continued)
Journal (Country)/Ranking Number of Publications1) Neurology (USA) 672) Journal of Neuroimmunology (The Netherlands) 323) Multiple Sclerosis (UK) 324) Annals of Neurology (USA) 315) Archives of Neurology (USA) 206) Journal of Neurology Neurosurgery and Psychiatry (UK) 177) Lancet (UK) 148) European Journal of Neurology (UK) 129) Biodrugs (UK) 1110) European Neurology (Switzerland) 1010) Journal of Interferon and Cytokine Research (USA) 1012) Journal of Neurology (Germany) 913) Journal of Neuroscience Nursing (USA) 9
New multiple sclerosis agent for global audience: New multiple sclerosis agent for global audience:where do trials appear?where do trials appear?
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Competitor Publication Analysis
Narrative, interpretive evaluation of published literature(describe search strategy, sources) on one or more keycompetitors or future competitors to assess the following:
• Numbers of publications• Types and focus of publications (eg, preclinical vs clinical,
reviews, letters)• Timing of publications and publication types (vs lifecycle)• Journals (target audiences)• Geography (US vs non-US, specific countries)• Authors/investigators/research centers & study sites• Key scientific & clinical communication points• Strength of clinical data/evidence
Metrics often presented graphically
Description & purposeDescription & purpose
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Competitor Publication Analysis(continued)
Number & type of publications per year for newNumber & type of publications per year for newproductproduct
0
5
10
15
20
25
30
1997 1998 1999 2000 2001 2002 2003 2004 2005
Clinical EfficacyClinical PharmacologyReview*
Case ReportLetter to the EditorQuality of Life
*Includes only Product X-specific reviews
Time of launch
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Competitor Publication Analysis(continued)
Total number of publications for new product & competitorsTotal number of publications for new product & competitorsat time of launchat time of launch
0
10
20
30
40
50
60
NewProduct
Product A Product B Product C Product D
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Competitor Publication Analysis(continued)
Journal supplements for new oncology agentJournal supplements for new oncology agent
Br J Cancer
Semin Oncol
Semin Oncol
Semin Oncol Semin Oncol Semin OncolOncology
Oncology
Lung Cancer
Lung Cancer
Lung Cancer
Clin Lung
Cancer
Clin Lung
Cancer
Clin Lung
Cancer
Exp Rev
Anticancer
Ther
Ann Oncol
0
1
2
3
4
5
6
1998 1999 2000 2001 2002 2003 2004 2005 2006
Year
No
. o
f S
up
ple
men
ts
NSCLC NDAFiling11/03
FDAApproval
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Publication Strategy
Narrative summary that distills the essentials of thepublication plan and execution of the plan into a “planof action”
• Strategic objectives• Key scientific & clinical communication points• Target audiences• Top-line tactics• Critical timing
Typically appears near beginning of plan or followingSWOT/Situation Analysis section
• Includes previously discussed information
Description & purposeDescription & purpose
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Publication Strategy (continued)
Objectives:• Increase awareness level among key target audiences
during prelaunch, launch, & postlaunch periods• Emphasize & reinforce novel features and unique MOA• Present scientific rationale for a fixed-dose treatment
regimen• Communicate clinical trial results highlighting efficacy,
safety, and tolerability to primary target audiences• Extend data to secondary target audiences
New agent to treat multiple sclerosisNew agent to treat multiple sclerosis
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Abstract/Publication TacticalRecommendations
Tactical recommendations for specific abstractsubmissions and publications (eg, clinical trialmanuscripts, reviews, letters) that are based on:
• Strategic considerations• Data considerations for target audiences based on
one or more clinical indications• Meeting and journal considerations for target
audiences• Timing & resource considerations
Creating a “road map” for communications and datadissemination
• Can be organized in variety of formats (eg, bystudy, chronology, key communication points)
Description & purposeDescription & purpose
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Abstract/Publication TacticalRecommendations (continued)
TimingMeeting/JournalPrimary Author
TargetAudienceFocusTitle/Study
Design/ObjectiveStudy
Abstract deadline:November 1, 2004
AAN 2005April 9-16, 2005AU: Doe J, et al.
NeurologistsClinical efficacyand safety data
Product A reducesdisability progression inpatients with relapsing-remitting multiplesclerosis.
C-1702
Abstract deadline:November 1, 2004
AAN 2005April 9-16, 2005AU: Smith A, et al
NeurologistsMRI dataProduct A attenuateslesion number andvolume in patients withrelapsing- remittingmultiple sclerosis(RRMS)
C-1701
Abstract deadline:November 1, 2004
AAN 2005April 9-16, 2005AU: Johnson C, et al.
NeurologistsClinical efficacyand safety data
Product A reducesannualized relapse ratescompared with placeboin patients withrelapsing- remittingmultiple sclerosis
C-1701
AAN 2005
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Abstract/Publication TacticalRecommendations (continued)
Submit: Q4 2005Publish: Q2 2006
Journal: JAMAAU: Roth J, et al.
NeurologistsEfficacy/safetydata
Combination therapyslows the progression ofdisability in patients withrelapsing-remittingmultiple sclerosis
C-1702
Submit: Q2 2005Publish: Q1 2006
Journal: JAMAAU: Doe J, et al.
NeurologistsEfficacy/safetydata
New product slows theprogression of disabilityin patients withrelapsing- remittingmultiple sclerosis
C-1701
Submit: Q2 2005Publish: Q4 2005
Journal: Journal ofImmunologyAU: Smith J, et al.
Neurologists/Immunologists
Immunogenicity ofnatalizumab
Immunogenicity of newproduct
C-1700
Submit: Q1 2005Publish: Q4 2005
Journal: MultipleSclerosisAU: Jones M, et al
NeurologistsSubgroup analysisof relapsing-progressivepatients
Efficacy of Product A inpatients with relapsing-progressive multiplesclerosis
C-260
TimingMeeting/JournalPrimary Author
TargetAudienceFocusTitle/Study
Design/ObjectiveStudy
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Timing of Abstracts, Posters,Publications
Summary of submission, presentation, andpublication timing
• Can be presented in a variety of formats (tabular,graphic) based on:–Meetings, target audiences, study number,
specific data analyses, calendar dates
Provides additional layers of detail for plan tactics,allows for resource planning and other time-relatedconsiderations
Description & purposeDescription & purpose
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Timing of Abstracts, Posters,Publications (continued)
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Key Meetings Information
In a publication plan document, this information provides keydetails on scientific and medical meetings relevant for targetaudiences for reference purposes
• Typical information on:– Sponsor, affiliation & contact/website information– Date & location– Number and breakdown (if available) of attendees– Abstract deadline– Abstract notification date– Presentation opportunities (abstracts, posters, oral
presentations, sponsored satellite symposia)Typically appears as an appendix to the planMay be supplemented by proprietary publication planningsoftware, sponsor internet sites
Description & purpose Description & purpose
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Key Meetings Information(continued)
PostersCommercial symposiaAbstracts (published in Pharmacotherapy)
Abstract deadline:late June 2006Symposiumdeadline: earlyJune 2006
1,500October 26-29, 2006St. Louis, MO
American College ofClinical PharmacyMeeting OrganizerAmerican College ofClinical Pharmacy3101 Broadway, Suite650Kansas City, MO 64111Tel: 816-531-2177Fax: 816-531-4990E-mail: [email protected]:www.accp.com
PostersOral presentationsAbstracts (published in Proceedings of theAACR)Educational sessionsNo commercial symposiaExhibit
Abstract deadline:Nov 14, 2005Late-breaker: Feb1, 2006
Abstract deadline:Mid Nov 2006
Abstract deadline:Mid Nov 2007
13,000–16,000
April 1-5, 2006Washington, DC
April 21-25, 2007Boston, MA
April 12-16, 2008San Diego, CA
American Associationfor Cancer Research(AACR)Tel: 215-440-9300Fax: 215-440-7228E-mail: [email protected]: www.aacr.org
Presentation OpportunitiesAbstract/Symposium DeadlinesNo.
AttendeesVenues/MeetingDates
Society
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Key Journals Information
In a publication plan document, this information provides keydetails on journals relevant for target audiences for referencepurposes
• Typical information on:– Publisher, affiliation & editor/editorial board– Journal focus/content– Frequency/circulation– SCI rankings, Impact Factor– Online indexing– Rejection rates– Publication lead times– Notes on specific requirements
Typically appears as an appendix to the planMay be supplemented by proprietary publication planningsoftware, publisher/journal internet sites
Description & purposeDescription & purpose
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Key Journals Information(continued)
Peer review
Editorials, unsolicitedreviews, book reviews,original research, shortcommunications, casereports, letters
Trial registrationinformation (name,number, URL) to belisted at the end of theabstract
Contribution of eachauthor and of all othersinvolved (eg, editorialassistance) must beprovided
Trial protocol must besubmitted
Regular†4 weeks
‡5 to 6weeks
Fast Track†2 weeks
‡2 weeks
BIOSISPreviewsIDISIPACINAHLMEDLINEEMBASESciSearch/CC
94%2General &InternalMedicine
24.831
48/year
350,437 99% (US) 1% (ROW)
Internists,generalpractitioners,residents,students,physicians
Promotesthescienceand art ofmedicineand thebetterment ofpublichealth
Journal of theAmerican MedicalAssociationAmerican MedicalAssociationPO Box 10946Chicago, IL 60610Tel: 800-262-2350E-mail: [email protected]
Society Affiliation:American MedicalAssociationWebsite:http://jama.ama-assn.org
Editor-in-Chief:Catherine D.DeAngelis, MD,MPH
Editorial Office:address, phonenumber, website
NotesPublicationLead TimeIndexing
RejectionRate
SCI® Rank/ImpactFactor
Frequency/CirculationFocus
Journal/Publisher/Society Affiliation/Editor
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Key Journals Information(continued)
N(except those in theICMJE UniformRequirements)
N(exceptthose inthe ICMJEUniformRequirements)
N(exceptthose inthe ICMJEUniformRequirements)
NYYAnnAllergyAsthmaImmunol
AllergyandImmunology
1. All fundingsources andinstitutional orcorporateaffiliations.
2. Authors mustsubmit a Conflict ofInterest form statingspecifically whetherany commercialassociations exist.
NNNNNAllergyAsthmaProc
AllergyandImmunology
No more than 8authors withoutjustification.
"Any majorsponsorship shouldbe mentioned."
YNostatement
NNForreferencesonly
AllergyAllergyandImmunology
Specialrequirements(written)
Disclosure/Acknowledgmentrequirements
CONSORTrequirement forRCTs?
ClinicalTrialRegistration (&dates)
Otherstyle(specify)
AMAstyle?(Y/N)
ICMJEUniformRequirements? (Y/N)
JournalTherapeuticArea
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Other Communication & MeetingRecommendations
If desired, publication plan may contain othercommunication components & activities, such as:
• Symposia/roundtables (journal supplementproceedings)
• Advisory board meetings• Medical affairs monographs• Slide programs/slide resource program• Formulary kits/AMCP dossiers• Other communication vehicles & concepts
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Questions & Discussion
Publication plans vary in content and scopedepending on what is desired
• May vary in presentation by agency or pharmacompany style
Publication plans need to be “Good PublicationPractice” compliant
Publication plan strategies & tactics are dynamic“road maps” that change as time progresses and newdata, challenges, issues, and competitors arise
Summary Summary