One of the more challenging things we face with our partners is the extraordinary amount of data which has become available over the past few years. When I say “available,” I’m referring to content that is (a) digitized, (b) can be integrated into a working informatics platform, and(c) able to increase the speed and/or ability to make decisions. Meeting these three criteria isn’t always easy and we spend a considerable time thinking about which data can helpful and which cannot, including allowing the data to speak for itself.
Our challenge as a Strategic Development Partner (SDP) is to screen through this data and provide our partners with a clear and concise method for assimilating and using this data. In this process, we actively manage existing data and leverage it with existing platforms. This mostly a backward- looking process, utilizing systems and informatics that have proven their worth over time.
But this is only the first part of the dilemma. The second part of the problem is understanding what future data will become available and how this might affect future decision making. An example of this is Clinical Trials.gov. Ten years ago it would have been a truly daunting task to identify each and every clinical trial – planned, ongoing, and completed – submitted to the FDA. Yet sitting here at my computer today, I have after ten seconds information scarcely imaginable only a few years ago.
Our challenge as a SDP is to look out over the drug discovery and development landscape and identify where this data might come from in the future, what role it will play in decision making, and how it adds strategic value to our partners. This is already leading us to areas of clinical and non-clinical informatics we hadn’t considered important or relevant. One example is the role that CEDAC, NICE and formulary hurdles might play in critical go/no-go decision making during discovery and development process.1,2 Where will this data come from? Will we need additional depth or breadth for the data? How will we package this data and integrate into a working model which allows for a more risk-weighted approach, one that considers the economic viability as well as scientific merits? How will that information be developed over time, and can it be continuously integrated with the clinical aspects? All of this will play a vital role to our sponsor partners as they make the tough decisions on allocating capital and achieving targeted R&D internal rates of return.
Our value as a SDP is going to be driven by how well we can strategically look ahead as well as design our operations around this new data. In the final analysis, our value will be driven by not only the quality of our human capital, but equally by our strategic use of the growing world of informatics.
- Gilmore P, Mozeson M. A New Key to Access: Solve the Payer’s Problem. Oliver Wyman, 2012.
- Reid TR. The Healing of America: A Global Quest for Better, Cheaper, and Fairer Health Care. London: Penguin Books, 2010.