Sunday, September 20, 2009

Pharma Opportunites Lie In the Eyes of the Marketer

UNDERSTANDING THE OPPORTUNITY FOR NEW DRUG COMPOUNDS

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. Providing more more thoughts on key Pharma questions that must be asked when you want to understand how big the opportunity:

I. What are the recognized and unrecognized medical needs?
In any given therapeutic area, there are a host of needs that are both known and unknown. An unmet recognized need could be associated with inadequacies associated with the current Standard of Care, offering an opportunity that could be addressed through improvements based on specific clinical endpoints. Unrecognized, unmet needs can be gleaned through conversations with stakeholders (patients, doctors, payers) and can lead to a paradigm shift in the treatment of the disease that is different from the current Standard of Care.

II. How Can We Best Address The Unmet Need?
Identifying the medical need is one thing; the ability to address that need is another. Opportunities can be on many different sides of the care equation, for example, improved efficacy in terms of ameliorating symptoms or being curative, better safety and tolerability or more convenient forms of dose administration. All of these elements factor into better initiation, compliance and adherence. Just because there is a need does not mean there is an opportunity. It is critical for companies to clearly define where and how they want to play.

III. Is the Science To Address the Unmet Needs Differentiated in a Clinically Relevant Way?
Following the characterization of the need is the science. Does the company’s science support the improved efficacy, safety or dosing truly differentiated. Over the last decade, the pharma industry has been criticized for developing me-too follow-on compounds designed to stand on the shoulders of patent expiries of blockbuster compounds and offering little in the way of true differentiation. The most powerful advantage in any business, pharmaceutical or otherwise, is the advantage of innovation. For pharma companies, innovation lies in the differentiation of the science.
There has been and will continue to be a tectonic shift from small molecules to large molecules as the science and the solution for disease cure and management becomes increasingly less productive in small molecule development. Targeting and scientific developments no longer keep pace with the commercial pressures required for success and growth in the marketplace. As a result, companies need to carefully assess how their science stacks up in the marketplace vs. existing and emerging competition.


IV. Who Is The Target Patient Pool?

Of course, there is the patient, who is waiting for the relief or the cure. Who are they? How many are there? In assessing target patient populations, both product and commercial developers many times identify a patient population that is too large, leading to over-optimistic commercial objectives and possible misappropriation of resources. The key here is to truly match the medical need with the appropriate patient pool by identifying the underlying symptoms or disease manifestations to as precise a level as possible. This accurate definition and identification of patient populations is critical to many other aspects of commercial development, e.g. clinical trials and physician targeting and messaging. When a company understands the real sub-population for a given indication and need, it is better able to accurately define the commercial opportunity.

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