Extracting Knowledge from Failed Development Programmes

@article{Wang2012ExtractingKF,
  title={Extracting Knowledge from Failed Development Programmes},
  author={Yaning Wang},
  journal={Pharmaceutical Medicine},
  year={2012},
  volume={26},
  pages={91-96}
}
  • Yaning Wang
  • Published 2012
  • Medicine
  • Pharmaceutical Medicine
Drug development is a challenging business with high risks. Multiple factors can contribute to the failure of a programme. Lack of efficacy and unacceptable safety have been the major reasons for product failure since 2000. Even though the drug molecule and disease target are the most fundamental aspects for successful drug development, rational dose and dosing regimen selection also play an important role in the new drug development era and may determine the fate of a programme. Two case… Expand
Using gene expression signatures to identify novel treatment strategies in gulf war illness
TLDR
Of the associated drugs, immunosuppressants currently used in treating rheumatoid arthritis, and hormone based therapies were identified as the best available candidates for treating GWI symptoms. Expand
Reverse Payments: An EU and US Perspective
In recent years, reverse payment settlements in the pharmaceutical industry have attracted the attention of US and European competition authorities. Originator pharmaceutical companies facing patentExpand
High-throughput screening for intrinsically disordered proteins by using biophysical methods
TLDR
Fluorescence-based methods and nuclear magnetic resonance (NMR)–based methods, which offer a combination of high-medium throughput and comprehensive structural insight, are discussed in detail, with recent examples applied to IDPs. Expand

References

SHOWING 1-10 OF 15 REFERENCES
Trends in Risks Associated With New Drug Development: Success Rates for Investigational Drugs
TLDR
The study examined the development histories of these investigational compounds from the time point at which they first entered clinical testing through June 2009 and estimated clinical approval success rates and phase transition probabilities differed significantly by therapeutic class. Expand
Keynote review: Is declining innovation in the pharmaceutical industry a myth?
TLDR
Data are provided that demonstrate that with regard to innovation rates, the current perception of pharmaceutical R&D is wrong - although there have been, and continue to be, fluctuations in drug launches, there has been a steady increase in the number of new chemical entities launched. Expand
The cost of biopharmaceutical R&D: is biotech different?
The costs of developing the types of new drugs that have been pursued by traditional pharmaceutical firms have been estimated in a number of studies. However, similar analyses have not been publishedExpand
Integrating predictive biomarkers and classifiers into oncology clinical development programmes
TLDR
Methods to adaptively integrate predictive biomarkers into clinical programmes in a data-driven manner are presented, wherein these biomarkers are emphasized in exact proportion to the evidence supporting their clinical predictive value. Expand
Exploration of therapeutic targets for sexual dysfunctions: lessons learned from the failed stories
TLDR
By learning from failures, a drug may not only be kept alive, but also better therapeutic strategies and design of new drugs may be developed. Expand
History of Quantitative Structure–Activity Relationships
This chapter gives an overview of the historical development of the quantitative structure–activity relationship (QSAR) paradigm with a particular emphasis on the past 50 years. Parameters used toExpand
Can the pharmaceutical industry reduce attrition rates?
TLDR
The pharmaceutical industry faces considerable challenges, both politically and fiscally, and the fiscal pressures that face the industry from the perspective of R&D are dealt with. Expand
EGFR Mutations in Lung Cancer: Correlation with Clinical Response to Gefitinib Therapy
TLDR
Results suggest that EGFR mutations may predict sensitivity to gefitinib, and treatment with the EGFR kinase inhibitor gefitsinib causes tumor regression in some patients with NSCLC, more frequently in Japan. Expand
NIH Roadmap . 2003 [ online ]
  • Manag Dec Econ
  • 2007
Challenge and opportunity on the critical path to new medical products Available from URL: http://www. fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative
  • Challenge and opportunity on the critical path to new medical products Available from URL: http://www. fda.gov/ScienceResearch/SpecialTopics/CriticalPathInitiative
  • 2004
...
1
2
...