Saturday, May 16, 2009

The human element in Nostradmus

This past week I was speaking on how approaches to forecasting pharmaceutical compounds at CBI's Early Commercialization and Forecasting conference, and, before I spoke, I asked the audience what their most concerning issues were in forecasting.

I half-joked that our approach was called Nostradmus and I was half-right about the relational side of accurate forecasting.

The three key issues I was asked about were:
  1. Addressing regulatory matters
  2. Understanding competitive pipelines of drugs in development
  3. Internal alignment.
Issues 1 and 2 require the same kind of effort, namely staying on top of what is going on. In terms of regulatory, it is a matter of paying attention to FDA approvals and comments, understanding how the agency's views and considerations of clinical end points are changing.

The same diligence is necessary in tracking pipelines. However, there it is not just a matter of tracking published results. It is also important to understand the different kinds of MOAs in development, what they are targeting, how are they working, to deeply appreciate what is novel and what is just me-too.

In understanding these kinds of evolving issues, you can better track game-changers and make more accurate risk-adjusted forecasts.

However, for me, the key question was alignment. You can have the absolute best checklist of approach but, if you don't have internal alignment around and support for your assumptions, it does not make a difference what you do.

That is the human element. It is not the science, not the modeling, not the data.

It is that very human relational issue that can spell success or failure in the development of a drug.

The best way to meet this issue head on is to make your assumptions as transparent as possible, and discuss them thoroughly internally so everyone precisely understands and agrees to those assumptions. In that way, you get the best minds providing their best thoughts on the best outcome.

In that way, even if it is a forecast, you will be roughly right, not just in the data but in the agreements to move forward.

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