Model-Based Drug Development

In the 1990’s and 2000’s, there was an interesting change in role for IT professionals. Once seen as the people who received help desk calls to support forgotten passwords and internet hook-ups, the implementation of an IT strategy elevated their positions to now include corporate strategy and assistance in driving overall efficiency in their companies. Pharmacometricians are on the verge of forging a new role with drug and device companies in much the same fashion.

New to the Harte Group suite of support companies is a modeling and simulation company called Cognigen Corporation. I am impressed with the art of this science – the creation and use of quantifiable data for assessing the likelihood of success for a drug or device. This science helps to eliminate much of the bias and emotion involved with decision-making (go/no go decisions). It can also provide a wealth of support for ongoing studies (such as dose justification, effectiveness on targets, appropriate sample size, etc.) and in post-approval (brand protection for proper assessment of investigator-initiated studies, design of additional studies to support safety and efficacy claims).

This week, is was also comforting to learn that the FDA has implemented this science as part of their drug reviews and evaluations. While the science itself is not novel, it is gaining in popularity for its ability to help design earlier stage trials (phase I/II studies) with more impact. For many drug and device companies looking to maximize their R&D spend, the use of pharmacometrics should be an integral part of the strategy.

I also find an ability for this science to be leveraged by venture capitalists. This group is somewhat naive to the drug development space, but they certainly understand the return on investment when their drug partner receives an agency approval. Many VCs have been resistant to invest in the biotechnology space because of the amount of investments required to get a drug to the point of in-license/out-license opportunity – in some cases, multi-millions. The use of pharmacometrics by venture companies would allow for clinical studies to be properly designed, thereby providing support for the time and cost associated with activity required. Appropriate milestones can also be identified for making go/no go decisions, and providing quantifiable evidence for future investment. Along with thought leaders in the industry who interpret the clinical data, this is the closest means of monitoring the likelihood of success for a drug or device that can provide comfort for investors.

Every building needs a blueprint, and the use of pharmacometrics provides and supports the “blueprint” for drug and device development activity. I am proud to be associated with the Cognigen Corporation, a group which has been providing these services for 15+ years and have received very positive feedback from many FDA reviewers alike. In my due diligence, reports from the agency (FDA) suggest that review of Cognigen’s material provides a high degree of comfort as the data is always well-defined, reports are always well-written, and the presentation of the materials are always “first class”. One reviewer suggested that “Cognigen Corporation has raised the bar in terms of how data should be assembled and submitted”.