1<!DOCTYPE html>
2
3Anonymous
4/bestp
5/bestp/domrep.nsf
62C1D608C3506DA82002589210036CD53
8
9
10
11
12
13
140
15
16
17/bestp/domrep.nsf/products/db-benchmarking-iis-strategy-investigator-initiated-studies-for-pre-approval-compounds?opendocument
18
19opendocument
2044.201.72.250
21
22
23www.best-in-class.com
24/bestp/domrep.nsf
25DB




Products & Services Medical Affairs Clinical Trials

Benchmarking IIS Strategy: Investigator-Initiated Studies for Pre-Approval Compounds

ID: 5744


Features:

6 Info Graphics

9 Data Graphics

220+ Metrics

4 Narratives


Pages/Slides: 23


Published: 2022


Delivery Format: Online PDF Document


 

License Options:


Buy Now

 


  • STUDY OVERVIEW
  • BENCHMARK CLASS
  • SPECIAL OFFER
Non-members: Click here to review a complimentary excerpt from “Benchmarking IIS Strategy: Investigator-Initiated Studies for Pre-Approval Compounds”

STUDY OVERVIEW

Biopharma organizations can significantly advance patient care through support of innovative investigator-initiated studies (IISs) aimed at the advancement of disease knowledge. The number of IIS submissions has risen in recent years, marking them as a critical operational area for most biopharma companies.

Best Practices, LLC undertook this benchmarking research to develop key metrics for comparing various factors related to IISs for pre-approval compounds in leading biopharmaceutical organizations. Medical Affairs and Clinical Development leaders can refer to this study to benchmark their IIS capabilities, expand IIS usage, mitigate risks, and improve overall approaches and impact.

KEY TOPICS

  • IIS for Pre-Approval Compounds
  • Insights from Non-Adopters

KEY METRICS

  • Which types of IISs are considered for pre-approval compounds - and in which phases of compound’s clinical development?
  • How frequently do benchmark organizations select proposals for each study type for pre-approval compounds?
  • How important are each of the listed strategic factors in benchmark organizations’ decision to support IISs for pre-approval compounds?
  • How effective are each of the listed strategies for mitigating common risks associated with IISs for pre-approval compounds?
  • Why have certain benchmark organizations decided not to consider IIS proposals for pre-approval compounds?
  • Which group(s) in benchmark organizations contributed to the decision to not support IISs for pre-approval compounds?

SAMPLE KEY FINDINGS

  • 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)

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.