Investigator-Initiated Studies: Program Management & Investment

STUDY OVERVIEW
BENCHMARK CLASS
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Non-members: Click here to review a complimentary excerpt from “Benchmarking IIS Strategy: Investigator-Initiated and Collaborative Studies Management”

STUDY OVERVIEW

Investigator-initiated studies (IISs) and collaborative research studies often fill a different niche to conventional clinical trials and can help biopharma organizations assess the cost-effectiveness of similar treatments and advance patient care. With the industry utilizing IIS studies to expand the breadth of clinical programs, it is critical that organizations don't let costs leapfrog results.

Best Practices, LLC engaged Medical Affairs and Clinical Development leaders in this benchmarking research study to develop key metrics for comparing various factors, budget and activity levels related to IISs and collaborative research studies in leading biopharmaceutical organizations. This study is meant to assist biopharma organizations benchmark their IIS capabilities, expand IIS usage, and improve overall approaches and impact.

KEY TOPICS

IIS Program Management and Investment
Collaborative Studies
Lessons Learned for IIS and Collaborative Research Success

KEY METRICS

For which categories of compounds do benchmark organizations consider IIS proposals?
Approximately how many total approved drugs versus pre-approval compounds are there in benchmark organizations’ current portfolio?
Which group(s) within the organization lead each of the listed aspects of IIS programs for approved and pre-approval compounds?
Which group(s) within benchmark organizations contributed to the decision to consider IISs for pre-approval compounds?
Approximately what percentage of overall IIS program resources are allocated to studies for approved compounds vs. studies for pre-approval compounds?
For which of the listed kinds of compounds have benchmark organizations conducted collaborative research with external parties?
How are key responsibilities and activities shared within the collaborative study model?

SAMPLE KEY FINDINGS

IIS Program: 88% of surveyed organizations have an active IIS capability. Of these active companies:

96% use IISs for approved compounds
65% consider IISs for compounds in clinical trials
26% consider IISs for pre-clinical compounds

METHODOLOGY

Best Practices, LLC engaged 27 Medical Affairs and Clinical Development leaders from 26 biopharma companies in this research through a benchmarking survey instrument. Research participants include Managers, Medical Heads, Directors, Sr. Directors, VPs, and CMOs.

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

If you purchase Best Practice Database document(s), you will have 30 days from the date of purchase to apply some or all of the cost of the document(s) toward the cost of a Full Access Individual, Pharma, Group or University Membership. Write us at DatabaseTeam@bestpracticesllc.com or call David Guinn at 919-767-9179 if you have any questions.

Benchmarking IIS Strategy: Investigator-Initiated and Collaborative Studies Management

ID: 5743

Features:

Pages/Slides: 24

Published: 2022

Delivery Format: Online PDF Document

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