It is the business of the future to be dangerous; and it is among the merits of science that it equips the future for its duties.  Alfred North Whitehead

Welcome to the beginning of 2013. Most of us, I bet, had a challenging 2012, certainly it was stressful, but there is so much to be grateful for and, if one is optimistic, there are many opportunities that are full of promise for the New Year.

Personally, I have much to be grateful for, not the least of which are the relationships we have with one another here at Cognigen and also with our clients. These relationships stem from our shared sense of purpose in helping to bring new and important medicines to patients. I have been thinking a lot about these relationships, and I want to share a few thoughts about what I have learned in working on projects this year and provide a few ideas for advancing Pharma of the Future in 2013.

Frustrations about the challenges of bringing new drugs to the marketplace sometimes seem greater than the rewards. Science is a fickle friend; it reveals our genius and our ignorance with equal ease. Further, the economic realities of our collective failures at drug development make the future of the pharmaceutical industry sometimes seem in doubt.
Keep in mind, though, that we as scientists are, in fact, merchants of hope. Each time we uncover a new insight, we open up possibilities to see issues in new ways that can be the inspiration for solutions and innovations for addressing important problems. The possibility of fostering innovation is the motivation that we need to remember whenever the challenges of drug development seem overwhelming.

Over the past 20 years, Cognigen has made great strides in advancing the science and engineering the systems for model-based drug development. The systems we have built and the science we employ enable us to perform remarkably complicated model-based analyses efficiently. Personally, I derive the greatest sense of accomplishment from working with very smart and inquisitive development teams who seek to understand the causes and implications of unexpected findings as the pharmacometric analyses unfold.

In 2012, Cognigen performed model-based analyses for 28 new medicines in 12 different therapeutic areas. These analyses were the basis for 14 Clinical Pharmacology syntheses of the determinants of drug safety and efficacy that were included in New Drug Applications submitted to regulatory agencies. Our work has a direct impact on the product labels and instructions-for-use to patients and healthcare providers world-wide.

We are quite proud of our accomplishments, and we are looking forward to the next steps in building upon what we have already achieved to create the Cognigen of the future. The question we have to answer, though, is what comes next?

This question can’t be answered by any one person because we will be creating the future together with our clients based upon our past experiences, the knowledge and expertise we have gained from these experiences, and the evolving scientific and technical environment around us.

While we have a free hand in envisioning the Cognigen of the future, we do have three requirements that must be satisfied. First, Cognigen must focus on our clients’ needs for analyses that provide insight and inspiration. Second, our pursuit of excellence must balance the strategic, operational and technical aspects of each problem. Third, anything that we call an “innovation” must reflect the goals and needs of the larger R&D ecosystem we seek to influence.

I look forward to talking with you, our existing and future clients, to continue the development of new capabilities and new innovations that will improve the productivity and effectiveness of Pharma R&D.

Are you hooked? Check out the previous Pharma of the Future? blog entry, The Worst Job in Pharma. Or visit the Pharma of the Future archive (link to another blog site) to catch up with the future of pharmacometrics.