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Regulatory scientific advice in drug development: does company size make a difference?
Michelle Putzeist1, Aukje K Mantel-Teeuwisse, Christine C Gispen-De Wied
1Utrecht Institute for Pharmaceutical Sciences, Division of Pharmacoepidemiology & Clinical Pharmacology, Utrecht University, P.O. Box 80 082, Utrecht, 3508 TB, The Netherlands.
European Journal of Clinical Pharmacology
|November 5, 2010
Summary
Company size influences the types of questions asked in Scientific Advice (SA) during drug development. Small companies focus more on quality and nonclinical aspects, while large companies address clinical strategy.
Area of Science:
- Drug development and regulatory affairs.
- Pharmaceutical industry analysis.
Background:
- Scientific Advice (SA) provides regulatory guidance to drug developers.
- Understanding the knowledge and strategic gaps in drug development is crucial.
Purpose of the Study:
- To determine if company size correlates with the content of Scientific Advice (SA) questions.
- To gain insights into the challenges faced by companies of different sizes during drug development.
Main Methods:
- Cross-sectional analysis of SA provided by the Dutch Medicines Evaluation Board (MEB) from 2006-2008.
- Company size categorized by total revenues.
- SA questions scored by predefined domains (quality, nonclinical, clinical, regulatory, product information) and subdomains.
Main Results:
- 201 SA documents and 1,087 questions analyzed.
- Small companies (54.7%) submitted the most SA questions.
- Clinical questions (65.9%) were most frequent, focusing on efficacy and safety.
- Small companies disproportionately asked quality and nonclinical questions, and fewer clinical questions compared to large companies.
- Small companies more frequently inquired about pharmacokinetics and bioequivalence.
Conclusions:
- Company size is significantly associated with the topics of Scientific Advice questions.
- SA content reflects industry's unresolved issues in drug development.
- The Dutch Medicines Evaluation Board's advice supports both innovative and non-innovative drug development pathways.
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