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Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches01:23

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
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Related Experiment Video

Updated: May 13, 2026

Rapid In Vivo Assessment of Adjuvant's Cytotoxic T Lymphocytes Generation Capabilities for Vaccine Development
09:03

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Published on: June 19, 2018

Risk in vaccine research and development quantified.

Esther S Pronker1, Tamar C Weenen, Harry Commandeur

  • 1Vacceleron, Utrecht, The Netherlands. e.s.pronker@gmail.com

Plos One
|March 26, 2013
PubMed
Summary

Vaccine development timelines average 10.71 years with a 6% market entry probability. Pandemic influenza vaccines show promise, while acute infectious disease vaccines have lower risk profiles than chronic disease vaccines.

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Area of Science:

  • Pharmaceutical industry
  • Vaccinology
  • Infectious disease research

Background:

  • The pharmaceutical industry faces a productivity gap, with invested resources not matching product turnover.
  • Risk profiles (development timelines, transition rates) are established for new chemical entities (NCE) but not well-documented for vaccines.
  • Understanding vaccine development risks is crucial for addressing infectious diseases.

Purpose of the Study:

  • To calculate risk profiles for human infectious disease vaccines.
  • To analyze development timelines and market entry probabilities for vaccines.
  • To compare vaccine risk profiles across different disease areas and applications.

Main Methods:

  • Compiled a database of vaccine projects from 1998-2009, covering pre-clinical to market registration phases.
  • Analyzed development timelines and market entry probabilities.
  • Stratified data by disease area and vaccine type (prophylactic vs. therapeutic).

Main Results:

  • The average vaccine development timeline is 10.71 years, with a 6% market entry probability.
  • Pandemic influenza vaccine targets are identified as lucrative.
  • Vaccines for acute infectious diseases and prophylactic vaccines exhibit lower risk profiles compared to those for chronic infections or therapeutic applications.

Conclusions:

  • The study provides key statistics for human infectious disease vaccines.
  • Further analysis is needed for vaccines targeting cancer, allergies, and autoimmune diseases.
  • Variables like orphan status, licensing, firm size, and experience require further investigation to fully understand their impact on vaccine risk profiles.