thank you for joining ismpp u today · 11/20/2013 · 12 24 21 34 16 . agenda • ......

THANK YOU FOR JOINING

ISMPP U TODAY

The program will begin promptly at 11:00 eastern

November 20, 2013

ISMPP ANNOUNCEMENTS

• Mark your calendars! The 2014 European Meeting of ISMPP is on 21-23 January 2014, ETC Venues, 200 Aldersgate, St Paul's, London; registration

is now open

• Abstracts for the 10th Annual Meeting of ISMPP (April 7 – 9, 2014) are now being accepted ([email protected]); deadline for submission is 5:00 PM

EST, Friday, January 10, 2014

• Applications are now being accepted for the March 2014 ISMPP Certified Medical Publication Professional™ (CMPP) exam

• Spread the word! As part of our membership drive, the December ISMPP U will be open to anyone interested in attending regardless of ISMPP

membership status. See www.ismpp.org for more information

• This program qualifies for 1.0 credits towards recertification

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mailto:[email protected]://www.ismpp.org/

PUBLICATION STEERING COMMITTEES

WHAT SHOULD PUBLICATION

PROFESSONALS CONSIDER?

November 20, 2013

AGENDA

• Introductions

• Survey Demographics to Inform Learning Objectives

• Definitions

• Key Unmet Needs and Recommendations

– PSC Composition and Logistics

– Roadmap to Success

• Summary and Conclusion

• Open Q&A

5

AGENDA

• Introductions


• Definitions





• Open Q&A

6

INTRODUCTIONS

• Faculty: Brian Scheckner is an employee of Shire, as a Director, Scientific Publications, within Global Medical Affairs

• He has worked in the pharmaceutical industry since 1999, serving primarily in publication and medical communication roles at Shire, Interlink

Healthcare Communications, and Wyeth

• Brian attended the University of the Sciences in Philadelphia (PharmD) and Rutgers University (BS, Pharmacy), and has licenses/certifications in

pharmacy, psychiatric pharmacy (BCPP), and publications planning

(CMPPTM)

• Brian is a current member of the ISMPP U Committee, and was a previous member of the ISMPP Standards Committee

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INTRODUCTIONS

• Faculty: Ken Pomerantz serves as Director of the Medical Publications Group at Boehringer Ingelheim Pharmaceuticals Inc.

• Ken has worked in the pharmaceutical industry since 1996. He led domestic and global publication planning for the CVM, Heme/Onc, and

Men’s Health portfolios at Bayer, and led Global SciComms activities in

support of incretin portfolio at GlaxoSmithKline

• Ken attended Georgetown University (PhD in Physiology), pursued post-doctoral research (Columbia University), and served as an Associate

Professor at Cornell University Medical College

• Ken is a current member of the ISMPP U Committee

8

INTRODUCTIONS

• Faculty: Gary Burd is Director of Scientific Services at Caudex Medical with 12 years of medical communications and scientific publishing

experience

• Gary has led communication planning and publication planning activities in several therapy areas, including diabetes, solid tumour oncology,

haematological malignancies, transplantation, multiple sclerosis,

rheumatoid arthritis, and respiratory and lung disease

• Prior to his medical communications work he gained valuable editorial experience in journal publishing with Portland Press

• Gary obtained his PhD from the Kennedy Institute of Rheumatology, London working on a monoclonal antibody therapy for systemic lupus

erythematosus

9

DISCLOSURES

• Information presented reflects the personal knowledge and opinion of the presenters and does not represent the position of

their current or past employers or the position of ISMPP

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TODAY’S OBJECTIVES

• At the conclusion of this educational session, attendees should be able to:

– Understand the rationale for utilization and establishment of publication steering committees (PSCs)

– Review and understand results from the ISMPP U survey on how PSCs are currently being utilized

– Appreciate and understand where gaps can occur in PSC formation and utilization

– Understand practical considerations for forming a PSC

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AGENDA

• Introductions


• Definitions





• Open Q&A

12

FRAMEWORK FOR TODAY’S WEBINAR

ISMPP MEMBERSHIP EXPERIENCE WITH PSC’S

• Survey conducted to gauge membership unmet need and desires for key learnings

• Qualitative survey sent to ISMPP membership (n=1,284)

• October 13 – 23rd survey window

• 146 respondees

• Survey results designed to illustrate key features regarding PSC use and experience to develop recommendations to inform unmet need.

• Results to be further analyzed for potential abstract submission, and workshop at the 2014 Annual Meeting of ISMPP

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PSC SURVEY:

DEMOGRAPHICS

11.0%

17.9% 20.0%

51.0%

0%

10%

20%

30%

40%

50%

60%

0-3 4-6 7-9 ≥10

How many years have you been in the

Medical Publications Profession?

Years

16 26 29 74

Please characterize your experience in

Medical Publications

Prior/ present

Agency

experience

43.8%

(n=63)

Prior/present

Agency &

Pharma

experience,

30.6%

(n=44)

Prior/present

Pharma

experience

25.7%

(n=37)

Answered/Skipped = 145/1 Answered/Skipped = 144/2

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PSC SURVEY:

EXPERIENCE WITH PSCs

C. Both A&B

33.3% (n=48)

D. Attended PSC in

supportive role, 27.8%

(n=40)

E. No PSC experience

24.3% (n=35)

Have you assisted in or led the

development/execution of PSCs?

A.Lead PSC

development

7.6%

(n=11)

B. Led

execution

(ran) PSC,

6.9%

(n=10)

56.6%

27.7%

8.4% 7.2%

0-3 4-6 7-9 ≥10

0%

10%

20%

30%

40%

50%

60%

How many PSC’s have you been involved

with?


If no, go

to end

47 23 7 6

15

PSC SURVEY:

TYPES OF PSCs?

What type of PSCs have you been involved in? (check all that apply)

41.5%

25.6%

29.3%

14.6%

20.7%

34.1%

63.4%

0% 20% 40% 60% 80%

Other (Phase 4 etc.)

Independent

Outcome study

Individual Phase 2 study

Phase 2 clinical program

Individual phase 3 study

Phase 3 clinical program

Answered/Skipped = 82/64

52

28

17

12

24

21

34

16

AGENDA

• Introductions


• Definitions





• Open Q&A

17

DEFINITION:

WHAT IS A PUBLICATION PSC?

• PSCs typically consist of company scientists and external investigators who may have contributed to clinical protocol design or trial development,

and serve a leadership role in the conception, development, and

execution of a publication plan

Type Multi-Study Clinical

Program

Single Study Independent

Advisory Committee

PSC members

relationship to study

Study Steering Committee

Study Steering Committee

Potential to serve

as authors

Publication Plan

Execution

Role of Sponsor Collaborative Collaborative or

Independent

Collaborative

18

WHY HAVE A PSC?

• Increased Transparency and Sharing of Data

• Shared, collaborative exercise by Pharma sponsor and External Experts.

– Increased engagement from key investigators/authors on the PSC

• Consistent with Data Disclosure and Sharing Initiatives – Data being managed by those who were responsible for protocol

development study design, data collection and analysis.

• GPP2

19

WHAT DOES A PSC DO?

Remit

Commit to publishing the primary and key secondary results of the trial in

an objective and timely manner

Provide input into the initial publication plan for each individual study (e.g., congress presentations and manuscript planning)

Provide input into authorship decisions

Identify, based on robust medical hypotheses, and provide input for publication planning of sub-analyses or exploratory endpoints that would be of interest to the scientific/medical community

Provide input into discussions of educational needs in the therapeutic

area

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AGENDA

• Introductions


• Definitions





• Open Q&A

21

KEY QUESTIONS:

PSC COMPOSITION / LOGISTICS

• When to initiate a PSC?

• Who should lead the PSC?

• Who should the company members be?

• Who should the external members be?

• How to choose the external PSC members?

• How to optimize meeting logistics?

22

KEY UNMET NEEDS:

WHEN TO INITIATE AND CONDUCT A PSC

Start of study

enrollment

End of study

enrollment

After data

availability

A priori

commitment to

publish

Yes Yes No

Time delay Yes- Potentially long

delay between initial

meeting and follow-

up meetings

Minimal -Closer

time to availability of

results

No time delay

Site Enrollment Not complete-

Addition of

sites/countries that

may have been

considered for the

steering committee

Complete Complete

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PSC SURVEY AND DISCUSSION

PSC LEADERSHIP?

Who leads the PSC?

0%

13%

16%

31%

40%

0% 10% 20% 30% 40% 50%

Neither

External Expert Lead

Company Lead- MedicalAffairs/Clinical Development

Company Lead – Publications

Combined/co-leadership of companyand external

32

25

13

10


24

PSC SURVEY:

COMPANY POLICIES ON PSC CONSTRUCTION

Does your company have a policy regarding construction of the PSC (number of internal and

external participants on PSCs)?

17.9%

65.7%

16.4%

Company has policy regardingnumber of participants allowed

Participation by role with nonumber restriction

Participation by role withrestriction

12 11

44


25

PSC SURVEY:

INTERNAL/COMPANY PSC MEMBER NUMBER?

How many internal/company PSC members are typically on your PSC?

13.0%

61.0%

22.1%

3.9%

0%

10%

20%

30%

40%

50%

60%

70%

0-2 3-5 6-8 >8

47 17

3

10


26

PSC SURVEY AND DISCUSSION

PHARMA REPRESENTATION ON A PSC

Who typically sits on PSC from the pharmaceutical company? (check all that apply)

14.3%

4.8%

32.1%

28.6%

66.7%

76.2%

20.2%

63.1%

84.5%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

Other (please specify)

Legal

Health economics and outcomes

R&D/medical strategy staff

Statistician

Medical affairs physician

Clinical operations

Clinical development physician lead

Publication lead (lead/co-lead)

64

12


71

53

17

56

24

27

4

27

PSC SURVEY:

EXTERNAL PSC MEMBER NUMBER?

19.2%

39.7%

29.5%

11.5%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

0-2 3-5 6-8 >8

31 23 9

How many external PSC members are typically on your PSCs?

15


28

PSC SURVEY:

PSC MEMBER SELECTION PROCESS?

What is the selection process for PSC members for clinical development programs? (check

all that apply)

49.3%

13.3%

41.3%

40.0%

45.3%

13.3%

16.0%

29.3%

60.0%

76.0%

68.0%

0% 10% 20% 30% 40% 50% 60% 70% 80%

Specialty/subspecialty to indication/product

External statistician

Geographical considerations/ diversity

History with company (experience)

Publication history

Use of external expert analytics

Inquiry to investigators

Reliance on consultation with primary investigator

Internal discussions

Investigator lists (process of selection)

Signatory on Protocol/ CSR – primary investigator


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SUGGESTIONS:

EXTERNAL PSC COMPOSITION

• How do you choose who to include in the committee? – Coordinating study Principal Investigator

– Investigators who participated in the study design

– Highly published in the therapeutic area

– Country coordinating investigators

– Are non-investigators allowed on the committee?

• Involvement of external co-chair/primary investigator in decision-making process

30

SUGGESTIONS:

EXTERNAL PSC COMPOSITION (CONTINUED)

• Other practical considerations for external steering committees: – KOLs/academics vs clinicians

– Working styles of potential members/willingness to collaborate

• Assessment through company resources – your own experience, agency experience, MSLs, medical/clinical staff

– Geographic (country) balance on committee

• May vary based on both expertise of investigators and registration program for the product

• Cultural considerations

31

PSC PRESENTATION –

LASTLY, KNOW THE PERSONALITIES…

32

LOGISTICS:

FACE TO FACE MEETINGS

Pros Cons

Conductive to

extensive discussions

and good for lengthier

meetings

Company

medical/legal/regulatory

reviews for live meetings

Free of distractions

from regular work day

Coordinating busy schedules

Payment/compensation and

budget (and separating from

payment for authorship

considerations); possible

PSC member concerns

related to Sunshine Act

Reporting

33

LOGISTICS:

TELECONFERENCES

Pros Cons

Easier to schedule Missing live interactions

and discussions

May not require same

rigor of company

medical/legal/regulatory

review

Not conducive to long

discussions (>2 hrs)

No payment

May supplement with

virtual technology (e.g.,

WebEx, Microsoft Live

Meeting)

34

PSC SURVEY:

TACTICAL PLAN DEVELOPMENT

How is the tactical publication plan developed and discussed by the PSC?

23.5%

61.7%

7.4%

7.4%

From scratch

From a company-developedinitial draft

By authorship subteams

Other (please specify)

6 6


19

50

35

PSC SURVEY:

PSC DURATION FRAMEWORK?

Do you have parameters for your PSC and publication outputs that are? (check all that apply)

16.7%

79.5%

23.1%

26.9%

0% 10% 20% 30% 40% 50% 60% 70% 80% 90%

None of the above

Dictated by the needs of the strategic andtactical publication plan

Financial based (budget of $$ for the year or lifeof PSC)

Time based PSC (i.e., will exist for xx months)

62

13


21

18

36

AGENDA

• Introductions


• Definitions





• Open Q&A

37

KEY UNMET NEEDS

ROADMAP TO SUCCESS

• What are the factors critical for success?

• What are the guiding principles PSCs should follow?

• What hurdles to successful PSCs have been identified?

38

PSC SURVEY: CRITICAL ATTRIBUTES

OF A SUCCESSFUL PSC

• Engagement/Communication/Commitment – Involvement and participation – Clear, timely communication – Establishing the group as a team – Transparency – Senior Medical Affairs Buy-In

• Roles and Responsibilities – Well-defined aim and outcomes of

PSC activities and objectives

– Accountability – Identify and state (clearly and often)

expectations and best practices

– Allow PSC members the freedom to develop the publication plan

– Proactive rules creation – Adherence to required standards – Willingness of stakeholders to abide

by PSC decisions

– Understanding of and adherence to guidelines and policies

39

PSC SURVEY: CRITICAL ATTRIBUTES

OF A SUCCESSFUL PSC

• Chair / Composition – Committed and well-respected Chair

who can lead and moderate

discussion and adjudicate dispute

– Right internal/external members

• Driving to Consensus – Early consensus on goals and

objectives of plans and publications

– Willingness to consider divergent point of view

– Be realistic about what you want outcomes to be

– Agreement on working processes

• Tactical Publication Plan Development – Appropriate guidance and input into

publication in a timely manner

– Early data access, and completeness of data provided

– Pre-work – Understanding of the clinical program – Working with external investigator

leads for meeting content

– Defined timelines

40

PSC SURVEY: DEVELOPMENT AND

USE OF A CHARTER/AGREEMENT?

Charter 13%

(n=11)

Both 17%

(n=14)

Neither 37%

(n=30)

Does your company use a Charter and/or

Agreement?

Agreement

33%

(n=27)

If you employ a charter, how is the charter

developed?

25.9%

22.2%

51.9%

A completed charter thatdoes not undergo

refinement by committee

An outline template that iscompletely customized forthe purposes of the PSC.

Provide a detailed PSCcharter prior to the meetingthat undergoes refinement

by PSC members at theinitial meeting(s)

0% 20% 40% 60%


14

6

7

41

PUBLICATION CHARTER:

PURPOSE AND GENERATION PROCESS

• Typical Process

– Initial drafts generated by sponsor

– Reviewed and customized by all PSC members

– Review and approval by Sponsor Legal/Compliance

– PSC members sign Charter Agreement

• Purpose:

– Provides a roadmap to develop and execute publication plan

– Defines roles and responsibilities of study

sponsors, chairs and members

– Ensures adherence to Publication Policies

– Externalizes roles to ensure transparency and trust

42

PUBLICATION CHARTER:

CONTENTS

• Goals • Structure and Composition

– PSC Membership, – Membership Criteria

• Roles and Responsibilities – Strategic Publication Planning – Tactical Publication Planning – Agree to conflict resolution

process

– Authorships

• Data Access – Holder of primary database – Levels of data access – Independent statisticians

• Compliance – Publications Principles – CIA directives

• Operational – Third parties – Logistics – Duration of the PSC – Succession planning

43

PUBLICATION CHARTER: ROLES AND

RESPONSIBILITIES OF ALL MEMBERS

• Understand and agree to goals and principles

• Accept and implement the responsibilities of membership

• Adhere to all Sponsor Governance and Related Publication Policies, Protocols, and Compliance Directives

• Attend/participate in PSC meetings

• Commit resources (time commitment) to achieve successful implementation of the Charter

1-Adapted from Bridges and Patel: Steering Committees in Medical Publications: 7th Annual Meeting ISMPP, 2011

44

https://ismpp.memberclicks.net/assets/docs/Education/AnnualMeeting/7thAM/GeneralSession/steering coms and authorship.pdf

ROLES AND RESPONSIBILITIES OF

SPONSOR AND CHAIR

• Sponsor – Chair Selection – Draft charter – Draft Publication plans – Run meetings – Electronic Publication Database – Compliance – Allow data access – Manage Med Pubs Agency support – CIA directives – Corporate Publication Policies – External Publication Policies – Compliance Monitoring

• Chair – Leadership, vision – Communication with members – Assist in meeting planning – Agenda development – Moderator – Recommend membership – Conflict Resolution

45

PSC AGREEMENT

• A PSC agreement may be: – Shorter – Distributed for signature in advance of the initial PSC meeting – Is not typically discussed unless questions arise

• Includes: – Formal invitation to join PSC – Responsibilities of the PSC, including commitment to publishing

primary study results

– Commitment to follow ICMJE criteria for future publications • When to use PSC Charter vs Agreement (or both?)

46

PSC SURVEY

HURDLES/CHALLENGES? (QUANTITATIVE)

8.6%

8.6%

9.9%

11.1%

19.8%

19.8%

24.7%

24.7%

29.6%

34.6%

35.8%

38.3%

50.6%

0% 10% 20% 30% 40% 50% 60%

HCP recruitment

Others (Please list in the space below)

Impact of CIA (if applicable)

HCP identification

Compliance concerns (COI)

Identification, selection of Chair

Use of a charter or PSC agreement

Differences in policies within alliances

Global vs regional responsibility

Selection process for PSC membership

Agreement to Charter principles

Internal policies

Logistical concerns

What have been your most significant hurdles/challenges in developing and executing a PSC

(check all that apply)?

41

31

29

28

24

20

20

16

16

9

8

7

7


47

AGENDA

• Introductions


• Definitions





• Open Q&A

48

SUMMARY

In this session, we:

• Defined different types of PSCs • Provided the rationale and strategy for the utilization of PSCs • Provided real-world user experience of PSCs to provide benchmarks for

– Timing of PSC initiation – PSC member selection – Understanding roadblocks/impediments – Understand elements which lead to success

• Established the value of a PSC Charter and Agreement to codify PSC roles and remit

49

FINAL CONCLUSIONS

• Use of PSCs continue to be under-utilized, but will become increasingly important as transparency and disclosure policies

continue to evolve

• PSCs formulate the basis of collaborative data dissemination planning and execution

– Transparency

– Credibility and reputation of Pharma-sponsored clinical studies

50

AGENDA

• Introductions


• Definitions





• Open Q&A

51

OPEN Q&A

52

QUESTIONS......

To ask a question, please type your query into the

‘Q&A’ chat box at the bottom left of your screen. Every attempt will be made to answer all questions.

PSC WORKSHOP OPPORTUNITY

• Anyone with experience or expertise in PSCs is invited to participate in developing a PSC workshop for the upcoming 10th

Annual Meeting of ISMPP

• Interested? Email [email protected]

• Please include your contact information including email address. An ISMPP staff member will reach out to you

54

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UPCOMING ISMPP U TOPICS

• Invite Your Colleagues! As part of our membership drive, the December ISMPP U will be open to ALL regardless of ISMPP

membership status. Please encourage your colleagues who

want to learn more about ISMPP to attend. See www.ismpp.org

for more information

– Digital Innovations in Medical Communications (case-based): Wednesday, December 11th at 11:00am (ET) / 4:00pm (GMT)

• January 2014 ISMPP U topic: Plagiarism

55

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THANK YOU FOR ATTENDING!

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thank you for joining ismpp u today · 11/20/2013 · 12 24 21 34 16 . agenda • ......

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