Maximize Investigator-Initiated and Collaborative Study Capabilities

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 Summary	Pg. 3-10
II.	IIS Program Management and Investment	Pg. 11-17
III.	IIS for Pre-Approval Compounds	Pg. 18-25
IV.	Insights from Non-Adopters	Pg. 26-29
V.	Collaborative Studies	Pg. 30-32
VI.	Lessons Learned for IIS and Collaborative Research Success	Pg. 33-35
VII.	Appendix	Pg. 36-37
VIII.	About Best Practices, LLC	Pg. 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

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

ID: POP-355

Features:

Pages: 38

Published: 2023

Delivery Format: Shipped

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