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Quality vs. quantity of data in drug discovery

Source:Ringier Medical Release Date:2015-02-13 1145
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Pharma companies should focus more on the quality of data than on the amount of data from a single source
clinical test with photo creditIN PRECLINICAL development, the key is to focus on strengths as a company and to complete it with the expertise of your partners, according to Ari Tolonen, chief executive officer & chief scientific officer of Admescope Ltd, a contract research organization. 
 
Admescope provides the pharmaceutical, biotechnology and veterinary industry with tailor-made services to drug discovery & development in the area of ADME-Tox. The service offering ranges from highly tailored and optimized studies to High Throughput Screening (HTS). The CRO company’s unique expertise lies in in vitro & in vivo drug metabolism, including metabolite profiling and identification, drug-drug interactions and quantitative bioanalysis.
 
Ahead of attending the marcus evans Discovery Summit 2015, the premium forum bringing elite buyers and sellers together in Lisbon, Portugal on March 16 and 17, Dr. Tolonen gives his insights exploiting current and emerging technologies, boosting pipeline productivity, and recognizing the corporate culture aspects of innovation to tackle pharma's productivity crisis.
 
How could pharma companies improve their ADME studies? What would boost preclinical success?
In preclinical development, the key is to focus on your own strengths, and choose partners with strengths that complete the know-how needed for the best possible outcome. Meaning that all the data required for decision-making does not have to be from a single source; it should rather be from a high-quality source. This ensures that every decision made is based on the highest quality data.
 
What is unique with Admescope’s approach to in vitro and in vivo drug metabolism? Do pharma companies overlook any important areas?
The largest pharma and biotech companies are on all the major decision-making boards within the field, and are fully up-to-date with the important topics concerning drug discovery and development. Nevertheless, there seems to be quite a difference between companies in the way and when they run their preclinical metabolism studies.
 
Some companies could pay greater attention to more thorough estimation of metabolism from the early PK studies; the metabolite profiling, which nowadays comes easily from the same experiments, provides better information on how to evaluate and compare results from different species. If there are mechanistic differences between species they will be pointed out clearly.
 
What would bridge the gap between preclinical and clinical studies?
Everyone is looking for the answer to that question. At the moment, development of in vitro assays parallel with ADME proteomics, and translational modelling and simulation might have a key role. This would enable improvements in in vivo extrapolation and PBPK modelling.
 
In vitro to in vivo extrapolation of cytochrome P450 mediated hepatic metabolism is well established, whereas bridging pre-clinical data on non-CYP mediated metabolism, extrahepatic metabolism and transporters is more challenging. Also, the recent developments in analytical techniques (LC/MS/MS) already enable the use of microdosing with non-labeled compounds, meaning studies in the preclinical stage i.e. in a much earlier stage than microdosing is most often considered.
 
What are the upcoming scientific areas or technologies worth following? What should pharma companies prepare for?
Improved PBPK modelling and simulation systems, and lots of research related to those, as well as research bringing input parameters for these predictive systems. One of these is 3D cell models that could better mimic in vivo systems than traditional in vitro assays. This has been a hot topic in the field for a few years and I do expect further improvements.
 
Analytics could also make yet a further leap forward. In the future, throughput could be much higher, as well as the amount of data received from a single analysis. We may be able to not just track each candidate and if it is metabolized, but at the same time do profiling of what really happens on the biomarker side in the same sample.
 
The Pharma Network - marcus evans Summits group delivers peer-to-peer information on strategic matters, professional trends and breakthrough innovations. Through the two-track Global Discovery Summit, they offer an intimate environment for a focused discussion between early drug discovery and preclinical R&D professionals and specialist solution providers.
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