Drug Development Lifecycle
Pharmacovigilance & Post-Market
Once a drug is on the market, the monitoring of the drug across the information landscape is paramount for regulatory purposes. Monitoring mentions of company and competitor drugs is also essential for assessing competitive environments, determining the relevance of emerging science, and identifying collaboration opportunities with key opinion leaders. Information is critical at this stage of drug development. Elsevier information solutions extract relevant drug and citation meta-data from the published literature, conferences, and other sources, so that essential information can be quickly passed to decision makers at all stages of the drug development process.
With a major part of Pharma R&D investment concentrated in clinical trials, it is critical to have good information to support decision-making. During this phase of drug development, access to the latest relevant information is a key factor in decisions such as whether to proceed with, adjust or even discontinue clinical trials; who to partner with and how; and how to improve decision-making in transitioning across clinical trial stages.
Despite advancements in earlier stages of discovery, safety and PKPD issues exposed in pre-clinical (or later stages of drug development) remain one of the most significant challenges facing R&D today. The ability to inform this stage of drug development with the most relevant, latest comparative information has the potential to significantly enhance decision making at this inflexion point in drug development. Elsevier solutions draw from the latest academic research, regulatory filings, and post-market reports so pre-clinical researchers can make informed drug development decisions.
Lead Identification and Validation
The design and creation of small and large molecules to ensure site specific binding and favorable alteration of disease progression, while still limiting undesirable toxicological responses, remains at the core of discovery. Critical to success is obtaining the most meaningful information in order to make the best strategic decisions in regards to all aspects of lead validation including insight into structural activity relationships, understanding mechanisms of drug actions, and determining optimal and reproducible routes to creating molecules for screening and testing. Elsevier's range of information solutions help identify existing molecules and their associated bioactivity data, as well as help spur researcher creativity to discover novel molecules of potential therapeutic value.
Target Identification and Validation
Successful commercialization of a drug begins with target validation. Finding, managing, and extracting meaningful data for choosing druggable targets on which to build a platform remains pivotal to future R&D success. Elsevier's innovative range of information solutions serve in identifying and characterizing both well known and novel targets – helping to generate fresh ideas and improve processes to identify, monitor and validate targets of interest.