Components of a Strategic & Tactical Publication Plan · Components of a Strategic & Tactical...

Components of a Strategic &Tactical Publication Plan

Gary McQuarrie, PharmD, MBAPresident and CEO, Thomson Scientific Connexions

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

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

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

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:

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

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

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


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

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

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


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

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)


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

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


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

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?

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


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


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


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

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


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

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)


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


AAN 2005April 9-16, 2005AU: Smith A, et al

NeurologistsMRI dataProduct A attenuateslesion number andvolume in patients withrelapsing- remittingmultiple sclerosis(RRMS)

C-1701


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

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


Journal: JAMAAU: Doe J, et al.

NeurologistsEfficacy/safetydata

New product slows theprogression of disabilityin patients withrelapsing- remittingmultiple sclerosis

C-1701


Journal: Journal ofImmunologyAU: Smith J, et al.

Neurologists/Immunologists

Immunogenicity ofnatalizumab

Immunogenicity of newproduct

C-1700


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

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


Timing of Abstracts, Posters,Publications (continued)

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

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

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


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

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

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

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

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