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Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under sterile, tightly...
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An Open Source Technology Platform to Manufacture Hydrogel-Based 3D Culture Models in an Automated and Standardized Fashion
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The productivity crisis in pharmaceutical R&D.

Fabio Pammolli1, Laura Magazzini, Massimo Riccaboni

  • 1Institutions, Markets, Technologies Institute for Advanced Studies Lucca, Piazza S. Ponziano 6, 55100 Lucca, Italy.

Nature Reviews. Drug Discovery
|June 2, 2011
PubMed
Summary

Pharmaceutical research and development (R&D) productivity has declined due to increased investment in high-risk areas targeting unmet medical needs. Despite regional differences in R&D portfolios, no productivity gap was found between US and European companies.

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Area of Science:

  • Pharmaceutical Sciences
  • Drug Discovery and Development
  • Biotechnology

Background:

  • Understanding of disease molecular basis has increased, expanding therapeutic targets.
  • Pharmaceutical research and development (R&D) investment has risen substantially.
  • Despite increased investment, new drug approvals have not proportionally increased, indicating challenges in therapeutic innovation.

Purpose of the Study:

  • To examine the decline in pharmaceutical R&D productivity over the past two decades.
  • To identify the determinants of this decline in R&D productivity.
  • To investigate potential variations in productivity based on company regional location.

Main Methods:

  • Analysis of a large database containing R&D project information for over 28,000 compounds investigated since 1990.
  • Examination of R&D investment trends and their correlation with therapeutic innovation output.
  • Comparative analysis of R&D portfolio composition and productivity across different geographical regions.

Main Results:

  • A decline in pharmaceutical R&D productivity has been observed over the past two decades.
  • This decline is linked to increased R&D investments in high-risk areas, including unmet therapeutic needs and unexploited biological mechanisms.
  • Companies in the United States and Europe exhibit differences in R&D portfolio composition, but no significant productivity gap was identified between these regions.

Conclusions:

  • The pharmaceutical industry faces challenges in R&D productivity, driven by a strategic focus on high-risk, high-reward therapeutic areas.
  • Understanding the determinants of R&D productivity is crucial for future drug development strategies.
  • Regional location does not appear to be a determining factor in pharmaceutical R&D productivity, suggesting common global challenges and opportunities.