Cautious welcome for FDA pharmacogenomics guidance

@article{Katsnelson2005CautiousWF,
  title={Cautious welcome for FDA pharmacogenomics guidance},
  author={Alla Katsnelson},
  journal={Nature Biotechnology},
  year={2005},
  volume={23},
  pages={510-510}
}
  • A. Katsnelson
  • Published 1 May 2005
  • Biology, Medicine
  • Nature Biotechnology
Strong political signal in favor of personalized medicines. 
Industry strategies on theranostics : Need for structural alignment
Theranostics is said to change the way patients will manage their disease. Such a change assumes that diagnostics and therapeutics become increasingly linked based on genetic information. Companies
1.05 – Personalized Medicine
TLDR
This chapter introduces the concept of personalized medicine and its historical background, outlines a few specific examples related to drug pharmacokinetics and pharmacodynamics, and lists the key barriers and optional solutions for its implementation in the clinic, including some ethical and societal aspects.
Functional genomics identifies ABCC3 as a mediator of taxane resistance in HER2-amplified breast cancer.
TLDR
A functional genomics approach using a well-characterized panel of breast cancer cell lines to identify putative biomarkers of resistance to antimitotic agents such as paclitaxel and monomethyl-auristatin-E (MMAE) shows that amplification of ABCC3 is present in primary breast tumors and that it occurs predominantly in HER2-amplified and luminal tumors.
The Application of Toxicogenomics to the Interpretation of Toxicologic Pathology
TLDR
This chapter illustrates how the toxicologic pathologist can effectively participate in as well as guide and instruct toxicogenomic practices; provides specific examples of momentous Toxicogenomic studies; and predicts future directions of toxicogenomics over the next decades.
Prospective positioning of industrial players: the case of theranostics
TLDR
By studying annual reports, this work gains insight into how industries react strategically towards emerging technological fields and makes a contribution to positioning theory itself.

References

SHOWING 1-2 OF 2 REFERENCES
FDA and EMEA pool scientific advice
Biotech companies could have their say in setting up standards for regulatory approval of cutting edge drugs, as they benefit from parallel scientific advice from Europe and the US.