10 SMART Questions for Commercial Development

Have you ever played “Truth or Dare?” The first player asks “truth or dare.” If the second player says “truth,” the first player asks a question, usually risky. If they reply “dare,” the questioner asks them to do something, also usually risky. In drug development, biotech and pharmaceutical companies alike play this game internally every day. Do we move this product into Phase III? How much is this market segment really worth? Will physicians use this product and, if so, how? Are the clinical endpoints meaningful enough for physicians to use the product vs. another standard of care? Will it be reimbursed? And no senior manager wants to take the risk of not having answers to these questions in front of the FDA, the Pharmacy and Therapeutics Committee (P&T), a payer or even senior management.

All these questions need to be answered in a world of limited resources. No pharma company, no matter what its size, has an infinite amount of money and resources to stream all its assets through its pipeline. For individual compounds under development, the challenge is to identify early assets that will fail so resources can be reallocated as quickly as possible. For an entire portfolio, whether it is for a specific therapeutic area or an entire company, managers need to understand how their decisions to invest in one product versus another affect risk and value.

The challenge is to answer all the necessary questions to gain the human and financial resources that keep a project moving forward as well as answer all the necessary constituencies. No one gets a perfect SAT score here. No one has the time and the staff to even list them all, let alone, answer them all.

To assist with these kinds of analyses that help understand the Opportunity, the Market and the Value, Manu Bammi and I have developed 10 Smart Questions that must be asked in order to truly understand opportunities from a 360 degree perspective.

Would you be interested in an article like this? If so, please write me at mrovner@smartanalyst.com