10 SMART Commercial Pharma Questions

Have you ever played “Truth or Dare?” The first player asks “truth or dare.” If the responder says “truth,” the first player asks a question, usually embarrassing. If they reply “dare,” the questioner asks them to do something, also usually embarrassing.

In the cycle of drug development, biotech and pharmaceutical companies alike play this game internally every day. Do we move this product into Phase 3? 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? And, critically, will it be reimbursed.

Then, of course, we work in a world of limited resources. No pharma company, no matter what its size, has an infinite amount of money and resources to water through its pipeline. For individual compounds under development, they challenge is to fail early and fail fast so resources can be reallocated as quickly as possible. In addition, for an entire portfolio, whether it is for a specific therapeutic area or an entire company, management needs to understand how its decision to invest in one product vs. another affects its risk and its value.

Time and again, we have seen both big and small companies ask these questions internally. And frequently the answers are inadequate and, when confronted by the CEO, embarrassing.

It is not that the players want to be embarrassed. For them, the game is real. There are patients waiting, stockholders looking for investment returns, fellow employees rooting for a success and payrolls to be met. Most importantly, these players are smart. They have developed a drug that has real potential.

The challenge is being able to answer all the necessary questions to gain the human and financial resources to keep the project moving forward. No one owns a perfect 2400 SAT score for answering all the questions here. No one has the time and the staff to even list them all, let alone, answer them all.

When topics range from epidemiology to disease characteristics to treatment algorithms to perceptions by physicians and payers, the ability to assemble, synthesize and develop critical observations and insights can challenge the skills of any Merit Scholar.

In order to assist companies with these kinds of analyses, toward understanding 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 and win the game.

THE OPPORTUNITY
In the beginning, there is an opportunity. The challenge is figuring out how big that pie is and then how big a slice can be cut out.
I. What are the recognized and unrecognized medical needs?
II. How Can We Best Address The Unmet Need?
III. Is the Science To Address the Unmet Needs Differentiated in a Clinically Relevant Way?
IV. Who Is The Target Patient Pool?


THE MARKET
After defining the pie, a company needs to ask itself if who is going to serve the pie and who are they going to have to fight with to get their fair share of that pie.
V. Who Are The Prescribers And What Do They Think?
VI. What Is The Competitive intensity?
VII. What Is The Optimal Clinical Development Path and Associated Regulatory Hurdles?
VIII. How Do Payers, Market Access, Pricing and Reimbursement Affect The Opportunity?

THE VALUE
There are two elements to Value in the SMART questions that you must ask: What are the revenues and how do you mitigate risk and preserve and realize the maximum value.
IX. What Are The Potential Revenues Associated With This Opportunity?
X. How Can Risk Be Managed, Value Preserved and Resources Allocated In An Optimal Way?

THE END-GAME
To paraphrase Dr. Seuss, oh the places you will go and the things you will see by seeking to answer these ten questions. By understanding the Opportunity, the Market and the Value in this kind of a rigorous and diligent way, companies can adapt the best industry practices that have proven to be successful. From the simple questions to the mature play of truth or dare, answering these questions are a game that major pharmaceutical and biotech companies cannot afford to lose.