Drug Development Paradigms

Our approach at CuraGen has been to practice an updated drug development paradigm that specifically uses large-scale systems biology innovations to drive and... 

Drug Development Paradigms for Molecularly Targeted Agents... 

To conclude, the future drug development paradigm that is built on human biology-based in vitro models, in silico tools, and accurate prediction of human ADME and exposure is expected to provide a decrease in late-stage development failures and withdrawals of marketed drugs, faster timelines from discovery to market, and reduced development costs and larger number of patient-centric, safer therapies (Fig. 7.1). 

Gore, E.R., Immune function tests for hazard identification a paradigm shift in drug development, Basic Clin. Pharmacol. Toxicol., 98, 331, 2006. 

It is not clear how the immense base of knowledge generated under the various rubrics of genomics will ultimately be utilized to improve drug safety and the drug development process. What is clear, however, is that it will be some years before such studies displace the current paradigm of testing. 

The paradigm shift from critical activities from later drug development to earlier discovery phases some years ago has effectively led to a change in lead optimization and added a new dimension of complexity, while it is envisioned that from a multidimensional, data-driven process more suitable candidates in accord with the therapeutic target product profiles may emerge for the treatment of currently unmet medical needs. 

Altered startle reactivity and attenuation of the inhibition of the startle reflex by an acoustic prepulse has been observed in psychiatric patients, e.g. in schizophrenia (Braff et al. 1978). Disrupted prepulse inhibition in rats can be normalized by antipsychotics and this paradigm is being used as an animal model for drug development. Interestingly, a2c-KO mice had enhanced startle responses, diminished prepulse inhibition, and shortened attack... 

Breimer DD, Danhof M. Relevance of the application of pharmacokinetic-pharmacodynamic modelling concepts in drug development. The wooden shoe paradigm. Clin Pharmacokinet 1997 32 259-67. 

New Drug Development Regulatory Paradigms for Clinical Pharmacology and Biopharmaceutics, edited by Chandrahas G. Sahajwalla... 

But botanicals do not fit easily into this development paradigm. As a drug class, botanicals have no rival for their structural complexicity or diversity of effects. Defined by their heterogeneity, botanicals have multiple... 

---