The changing landscape of drug development

Much has been written over the last ten years about the ever-increasing costs of drug development and the decreasing R&D productivity of the industry as measured by new drug approvals. For many companies the efforts to improve R&D productivity is now focused squarely on improving attrition rates. Finding failures earlier will have the benefits of saving hundreds of millions of dollars in late stage trials and enabling the reallocation of that saved money to advance the next generation of more promising drug candidates.

What’s required to improve attrition rates?

• First and foremost, a different approach to development. Drug development can no longer be about sequentially moving a candidate forward, but about simultaneously and proactively looking for the potential causes of failure
• Informed project teams must de-risk their candidate earlier in the process. Project teams need better tools to evaluate the risks and benefits of continuing with a candidate or promoting a different candidate molecule instead
• Improve the therapeutic areas understanding of disease biology. This can be done through the analysis of data from previous studies, by combining data from multiple studies, and by identifying, validating and incorporating biomarkers into their clinical research strategy

As the industry is confronted with this need to change, data analysis and review processes will evolve in many different ways:

• An emphasis on trial subject safety has created a need for earlier access to study data – some companies are developing ‘real time’ safety surveillance systems
• An enhanced need for cross-study analysis capabilities – what did we learn in Phase II that we should have learned in Phase I? Did we miss something? What can we learn about disease biology from such a broad perspective?
• Broad access to trials data within the project team, to allow many people to ask questions and generate hypotheses; and facilitate team meetings where data and hypotheses can be viewed and analyzed collaboratively
• Translational medicine – using genomic data into the clinic, and clinical data back to the researchers to improve disease understanding and enable better business decisions about drug development strategies

As with many information businesses, the next decade of drug development will be about the enablement of scientists to make more informed decisions both individually and as team with unprecedented speed. The companies that are leading the way by embracing these new paradigms are enabling their people to explore more possibilities. In parallel they are automating routine workflows in order to free up cycles to explore the unexpected. Organon is one such company.

“Spotfire’s analytic capabilities introduce a new way for our researchers to exchange and analyze complex data across the R&D organization. The software provides an interactive, analytical environment that supports a new approach to integrated drug design and discovery – optimizing early drug candidates and leading to a reduction in late-stage failures,” said Jacob de Vlieg, CIO Research and Development at Organon.

For the last 11 years Spotfire has been at the forefront of enabling the pharmaceutical industry to gain insight from information from early stage research to sales and marketing. Looking forward, it is clear that the unique Spotfire user experience and information insight will continue to enable pharmaceutical companies to adapt to and compete in an ever changing environment.

“The software provides an interactive, analytical environment that supports a new approach to integrated drug design and discovery” – Jacob de Vlieg

Analysis of biomarker and clinical safety data, overlaying expression of C-Reactive Protein and LDL levels for patients in the active and placebo group and with detailed vital sign data for individual patients.