Discovery Statistics
The discovery and pre-clinical development of new drug products is a growing challenge for biopharmaceutical industry. Rapid advances in technologies help to better understand the biology of a new drug product. The vast increase in data, however, increases the risk of false discoveries leading to costly mistakes. In PharmaLex our statistical experts use appropriate statistical methods to improve reproducibility and increase the efficiency of discovery and pre-clinical studies.
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At PharmaLex, our experts of statistics are experienced in helping sponsors to improve the probability of success in discovery and pre-clinical studies, which in turn can benefit further clinical development. Besides applying advanced statistical modeling and machine learning to drug target discovery and lead optimization, our statisticians also have expertise in study and experimental designs, improving the reproducibility of conclusions. In addition, we are experienced in supporting sponsors in their animal studies under the Animal Rule to move experimental medical products toward regulatory approval when human efficacy studies are not ethical or feasible.
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The statistics and data science expertise at PharmaLex helps to extract the relevant information using optimized signal processing methods and reduce the rate of false discovery by means of tailored design of experiments and advanced statistical inference. Second, as regularly mentioned in the scientific literature, pre-clinical studies suffer from a lack of reproducibility. Here again our experience in statistics contributes considerably to improve the reproducibility of conclusions with innovative design of experiments and new analytical strategies. Third, given there are several drug products that are potential candidates, PharmaLex experts propose to de-risk the decision-making process using Bayesian statistics to evaluate the predictive probability of success and supporting optimal portfolio management. Indeed, what matters most is to evaluate the chance for a potential drug product to succeed instead of examining if a past study was successful or not.
According to FDA’s website, “medical countermeasures, or MCMs, are FDA-regulated products (biologics, drugs, devices) that may be used in the event of a potential public health emergency stemming from a terrorist attack with a biological, chemical, or radiological/nuclear material, or a naturally occurring emerging disease”. Sponsors need to show evidence that demonstrates effectiveness of a medical product before it can be approved by FDA. When human efficacy studies are not ethical or feasible, the Animal Rule may be considered to use results of well-controlled animal studies in establishing the product is reasonably likely to produce clinical benefit in humans. PharmaLex is experienced in providing statistical advice and analysis in such animal studies.
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