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Making better drug development decisions with extracted preclinical and clinical data

Posted on June 12th, 2019 by in Pharma R&D

Challenge

4P-Pharma cannot select every promising drug candidate they review for co-development. To make prompt, well-informed decisions on which drugs to license, 4P first needs to thoroughly understand the drug and drug development environment for the particular indication. With this information, the company can assess a candidate’s true potential to progress forward through the drug development pipeline. 4P-Pharma needs to quickly determine the suitability of drugs they are considering for licensing, so staff can focus their time and energy on the candidates with the most promise.

Solution

4P-Pharma uses the Elsevier R&D Solution PharmaPendium to efficiently review information about a drug molecule’s characteristics and pharmacokinetics and evaluate its upstream potential. This platform is particularly valuable for 4P-Pharma because of the company’s focus on repurposing drugs for new indications. Company staff could search the U.S. Food and Drug Administration and European Medicines Agency websites to acquire this information, but doing so takes days, and pertinent information could get missed. 

With PharmaPendium, 4P can extract and organize all the preclinical and clinical data instantaneously. 4P-Pharma Project Manager Luigi Formicola emphasizes that “what is most valuable is the integration of all the data, and the way they are presented. It’s fast, it’s clear. The table is easily searchable … and it saves us a lot of time.”

4P-Pharma also utilizes this platform to determine the key experiments necessary to perform with the drugs they choose to co-develop. The research team uses PharmaPendium almost daily to review previously performed experiments by other drug developers and decide on the parameters of their own experiments. 

“It saves us resources. We won’t lose time performing experiments with dosage or route of administration that have been tested before and were shown to be toxic… PharmaPendium provides us with a quality assurance for our results, as we know that we have performed our experiments within the expected standards set [for] approved drugs,” Luigi says. Withthis ready access to information through PharmaPendium, “we were able to confirm the efficacy and safety of our [stimulant] abuse deterrent” that 4P is bringing forward into early-stage clinical trials.

Impact

“With the thoroughness of the drug development plan we conduct,” crafted with the help of PharmaPendium, we have “enforce[d] our credibility as a small biotech with the capability of going forward with preclinical development of a drug candidate.” Luigi also indicated that because of its extensive value, “PharmaPendium is now part of our process for decision-making.”

The time the company would have spent searching for information is time 4P-Pharma staff can spend designing experiments and analyzing results. “We are very happy with PharmaPendium. All the time savings, and the confidence in the data that we got from PharmaPendium, helps us to go faster through our preclinical program. People say ‘you cannot buy time’, however, PharmaPendium is doing exactly that: It is buying us time and that is great for us.”

Author

Marnix Wieffer  
Drug Safety Information Specialist 

As drug safety information specialist, I support pharmaceutical companies in identifying potential drug toxicity concerns and adverse effects. During my first 3 years at Elsevier, I have been working with both academic and corporate customers in northern Europe. As senior marketing manager, I am currently responsible for Elsevier’s drug safety messaging, internal training and market engagement.

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Marnix Wieffer


Drug Safety Information Specialist