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Products & Services Medical Affairs Medical Science Liaison

Raising Phase IV Performance & Value Through Optimal MSL Involvement

ID: POP-312


Features:

20 Info Graphics

26 Data Graphics

330+ Metrics

10 Narratives


Pages: 56


Published: 2019


Delivery Format: Shipped


 

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919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
The value of Phase IV studies continue to rise as payers and regulatory bodies incorporate more real world evidence in their decision making. With that in mind, ensuring that study design and execution reflect key stakeholder perspectives is even more essential.

This is where medical science liaisons (MSLs) can play a critical role: MSLs are well positioned to be a conduit of HCP, thought leader, and payer insights about the evidence generation targets that matter most.

This study informs medical affairs leaders about how to raise the performance of their Phase IV studies by allocating the right field medical personnel at the right times in the Phase IV development and execution process. This report also examines field team structures, skills, and training programs that help maximize MSL impact on Phase IV.

Industries Profiled:
Pharmaceutical; Biopharmaceutical; Biotech; Manufacturing; Health Care


Companies Profiled:
AbbVie; Alkermes; BeiGene; BioDelivery Sciences International; Inc.; Biogen; BioMarin; BTG plc; Cipla; Eisai; EMD Serono; Impel NeuroPharma; Intas; Ipsen; Janssen; La Jolla Pharmaceutical; Mayne; Melinta Therapeutics; Inc; Merck; Merck KGaA; Milestone Pharmaceuticals; Myriad Genetics; Novartis; Pfizer; Rakuten Medical; Searle; Shire; Sunovion; Taiho Pharma; Takeda Pharmaceuticals; UniQure; Vifor Pharma

Study Snapshot

Best Practices, LLC engaged 43 Medical Affairs leaders from 31 pharmaceutical and biotechnology companies in this research through a benchmarking survey and interviews.

Key topics covered in this report include:

  • Phase IV study productivity and purpose
  • Operational and team structures for Phase IV development and execution
  • MSL involvement in Phase IV studies
  • Key MSL roles in Phase IV studies
  • Measuring the impact of MSL involvement
  • MSL skills and competencies for Phase IV
  • MSL Phase IV training


Key Findings

Select key insights uncovered from this report are noted below. Detailed findings are available in the full report.

  • Initiate Product-Phase IV Strategy & Goal Setting in Late Phase II: Initiation of specific study type goal setting by product is waterfall like – beginning with comparative effectiveness planning in early Phase III, and ending with expanded access study goal setting during the filing period.
  • Phase IV Studies Are Overseen at the Therapeutic Area Level: 50% of companies use dedicated, cross functional, Phase IV study teams operating within a specific therapeutic area.
  • Involve All MSLs in Supporting Phase IV Study Development & Execution: Nearly 90% of companies involve MSLs in Phase IV study development & execution, 2/3 of them utilize all their MSLs in some capacity for Phase IV.
  • Top Performing Organizations Target RWE & Study Design for Expanded Training in the Next Year: RWE trainings will drive MSL contribution to evidence gap mapping, while the objective of study design training is to increase general knowledge.

Table of Contents

Sr. No.
Topic
Slide No.
I.
Overview3
Research Overview
Universe of Learning
Key Recommendations
II.
Phase IV Study Objectives & Productivity7
III.
Team Structure for Phase IV Studies13
IV.
MSL Involvement In Phase IV Study Development & Execution19
V.
MSL Roles In Phase IV Study Development & Execution25
VI.
Measuring the Impact of MSL Contributions to Phase IV42
VII.
MSL Training & Development for Phase IV45

    List of Charts & Exhibits

    I. Phase IV Study Objectives & Productivity

    • Interview narrative around Phase IV studies
    • Purpose of data collected in Phase IV studies
    • Types of Phase IV studies benchmark companies are involved in
    • Volume of Phase IV study types within benchmark companies
    • Development phase during which Phase IV strategy & study type goal setting begins for a specific product

    II. Team Structure for Phase IV Studies

    • Internal structure of Phase IV study development & execution for a given product
    • Role and title of final decision maker for Phase IV study development and execution for a specific product
    • Business unit leaders overseeing Phase IV – Structural flowchart
    • Functions leading / supporting / informing Phase IV study development and execution within the team structure at benchmark organizations

    III. MSL Involvement in Phase IV Study Development & Execution

    • Formal / informal involvement of MSLs in the development and/or execution of Phase IV studies
    • Span of MSL involvement in Phase IV
    • Average number of Phase IV studies, marketed products, and pipeline products supported by a single MSL at benchmark companies
    • MSLs in a dedicated Phase IV role supporting all products / therapeutic area-specific products
    • Percentage of MSL work time allocated to Phase IV study development and execution relative to their other responsibilities
    • Average ratio of MSLs with Phase IV support responsibilities to MSLs without Phase IV responsibilities
    • Criteria for selecting MSLs to be involved in Phase IV

    IV. MSL Roles in Phase IV Study Development & Execution

    • Interview narratives on MSL alignment with Phase IV trial types
    • Phase IV study activities in which MSLs are involved with at benchmark companies
    • MSL role in stakeholder mapping for Phase IV studies and its importance rating
    • MSL contribution to stakeholder mapping for Phase IV
    • MSL role in targeting stakeholder needs for Phase IV studies and its importance rating
    • MSL contribution to targeting stakeholder needs for Phase IV
    • MSL role in study design, outcome measure selection, protocol development; and importance rating of MSL involvement
    • MSL contribution to study design / outcome measure selection / protocol development - Structural flowchart
    • MSL role in study site staff training & communication, and its importance rating
    • Executive insights on MSL contribution to study site staff training & communication
    • MSL role in investigator management & communication, and its importance rating
    • Executive insights and narratives on MSL contribution to investigator management & communication
    • MSL role in oversight of intervention delivery, data review, reporting & publishing; and importance rating of MSL involvement
    • Interview narrative on MSL contribution to Phase IV study reporting & publishing
    V. Measuring the Impact of MSL Contributions to Phase IV

    • Formal and informal measurement of MSL impact on Phase IV study development & execution
    • Individual and team wide measures to gauge MSL Phase IV performance
    VI. MSL Training & Development for Phase IV

    • Current Phase IV capability rating for MSLs at benchmark companies
    • Steps taken by top performers to further raise performance
    • Important skills for MSLs in regards to Phase IV study involvement
    • Training MSLs on skills needed to support Phase IV studies
    • Phase IV study-related skills most heavily emphasized in MSL training regimens
    • Areas in which top performers will increase MSL training in the coming year
    • Influence of Phase IV study skills on MSL hiring decisions
    • Consideration of Phase IV skills while making MSL hiring decisions
    • Most essential Phase IV study skills for MSL hiring decisions
    • Consideration of MSL competency with stakeholder needs (patients & HCPs) while making hiring decisions