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Products & Services Medical Affairs Clinical Trials

Benchmarking IIS Strategy: Maximizing Investigator-Initiated and Collaborative Study Capabilities

ID: POP-355


Features:

10 Info Graphics

17 Data Graphics

340+ Metrics

5 Narratives


Pages: 38


Published: 2023


Delivery Format: Shipped


 

License Options:


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919-403-0251

  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • STUDY SNAPSHOT
  • KEY FINDINGS
  • VIEW TOC AND LIST OF EXHIBITS
Investigator-initiated studies (IISs) and collaborative research studies often fill gaps where a conventional clinical trial has left unanswered questions and are an important means for biopharma companies to improve patient care. As biopharma organizations accelerate their use of IIS programs, it is important that they carefully review and respond to IIS proposals and manage resources effectively to ensure costs do not outrun results.

Best Practices, LLC conducted benchmarking research to examine the strategies, resources and activities surrounding IISs and collaborative studies which are needed to help Medical Affairs and Clinical Development groups gain support for IIS programs and maximize the potential of their drug portfolios. This report is meant to assist biopharma organizations benchmark their IIS capabilities, expand IIS usage, mitigate risks, and improve overall approaches and impact.

Video Brief:


Industries Profiled:
Biopharmaceutical; Pharmaceutical; Manufacturing; Biotech; Consumer Products; Diagnostic; Medical Device; Health Care; Science


Companies Profiled:
Alkermes; Arcutis Biotherapeutics; ASC Therapeutics; Astellas; Bayer; Bigfoot Biomedical; Boehringer Ingelheim; Braeburn; Covis Pharma; Emergent BioSolutions; GRAIL; Ipsen; LEO Pharma; Lundbeck; MicroVention; Inc.; Novartis; Prescient Therapeutics; Regeneron; Roche; Santen; Sobi; Stemline Therapeutics; Thermo Fisher Scientific; UCB Pharma; Wright Medical Group N. V.; Zydus Cadila

Study Snapshot

This study distills insights from 27 Medical Affairs and Clinical Development leaders at 26 biopharma organizations through a benchmarking survey instrument. Research partners include Managers, Medical Heads, Directors, Sr. Directors, VPs, and CMOs.

Key topics covered in this report include:

  • IIS Program Capability
  • IIS Program Management and Resources
  • IIS Proposal Consideration and Selection for Approved vs. Pre-approval Compounds
  • Sponsorship of Pre-approval IIS: Study Types and Frequency
  • Risk Mitigation Strategies
  • Reasons Pre-approval Compounds are NOT Considered for IIS Proposals
  • Collaborative Research Studies

Key Findings

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

  • Pre-approval Studies Considered:
    • 100% consider Epidemiology and Disease State studies
    • 93% consider New Patient Population/Subgroup, PRO, and Observational studies
    • 87% consider Retrospective studies
    • 80% consider Intervention and Alternative Indication studies
    • 73% consider Pre-clinical/Translational and New Dosing studies
    • 60% consider Safety studies

  • IIS Risk Mitigation for Pre-approval Compounds:
    • Most important tactic: Use explicit contracting terms around IP and safety reporting (73% total benchmark class)
    • Very important tactic: Confining proposal review to tight area of interest (53% total benchmark class)
Table of Contents

Sr. No.
Topic
Slide No.
I.
Executive SummaryPg. 3-10
II.
IIS Program Management and InvestmentPg. 11-17
III.
IIS for Pre-Approval CompoundsPg. 18-25
IV.
Insights from Non-AdoptersPg. 26-29
V.
Collaborative StudiesPg. 30-32
VI.
Lessons Learned for IIS and Collaborative Research SuccessPg. 33-35
VII.
AppendixPg. 36-37
VIII.
About Best Practices, LLCPg. 38

    List of Charts & Exhibits

    I. IIS Program Management and Investment

    • IIS proposal consideration for different categories of compounds
    • Approved vs. pre-approval compounds in benchmark organizations’ portfolio
    • IIS program leadership for approved compounds
    • IIS program leadership for pre-approval compounds
    • Decision makers for supporting or rejecting IIS consideration of pre-approval compounds
    • IIS budget allocation to studies for approved compounds vs. studies for pre-approval compounds

    II. IIS for Pre-Approval Compounds

    • Types of IISs considered for pre-approval compounds
    • IIS phases and study types
    • Frequency of proposal selection for each study type for pre-approval compounds
    • Importance of strategic factors in benchmark organizations’ decision to support IISs for pre-approval compounds
    • Risk mitigation strategies for pre-approval compounds

    III. Insights from Non-Adopters

    • Important factors for not considering IIS proposals for pre-approval compounds
    • Groups influencing the organizational decision to not consider IIS proposals for pre-approval compounds
    • Voices from the field: Rationale for not considering or supporting IISs for pre-approval compounds

    IV. Collaborative Studies

    • Collaborative research with external parties for different kinds of compounds
    • Collaborative study management process

    V. Lessons Learned for IIS and Collaborative Research Success

    • Specific therapeutic areas, drug candidates or clinical phases favored by benchmark organizations
    • Top three lessons learned from conducting collaborative research studies with external partners