Where Niches Fear To Tread

I recently spoke at the Nicholas Hall OTC conference in Venice on the importance of knowing your customer.

At the conference, I cited three successful innovations where marketers took the brands into even more focused niches:

· Listerine mouthwash launched Listerine Pocketpaks for on-the-go oral care,
· Tylenol Extended Relief was renamed Tylenol Arthritis Pain,
· K-Y Jelly launched K-Y Massage Oil.

In all three cases, the key success factors were

· Identifying an unmet consumer need related to the main brand,
· Capitalizing on that specific and focused need,
· Leveraging the emotional connection associated with the parent brand,
· Utilizing a clear product name that identified the line extension’s usage,
· Supporting the launches with strong advertising and promotional support.

The main virtue here was sterling consumer research work that uncovered these insights and translating them into focused executions.

Now just imagine how they all combine into the same usage occasion. Hmmmnn.

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.

Pearls Before Swine Flu

I was recently quoted by Morningstar and Medical News Today on the critical lack of information and communication to the general public on the treatment options for the current H1N1 flu, also known as the misnamed "Swine Flu" outbreak.

The most basic misconception is that, unlike influenza vaccines which are preventative, medications recommended to combat the current flu outbreak, Tamiflu by Roche and Relenza by GSK are used for symptom control. This treatment means that these medications manage the symptoms and offer relief more rapidly than if the virus is left untreated. However, neither of these medications are designed to prevent or cure the illness.

In a public health emergency, people don't take the time to understand the distinctions between treatment and prevention."

In addition, while these medications are designed for symptom relief and control, their effectiveness varies in accordance with the strain of influenza. This "swine flu" is a type of Influenza A, which is an H1N1 virus strain. Therefore, treatment options should be sought out that will most effectively manage this virus.

In December 2008, The Centers for Disease Control (CDC) released a special advisory noting potential resistance to Tamiflu during the initial phase of the 2008/2009 influenza season. This advisory was based on the fact that there are various strains of influenza which could require treatment specific to their composition. 98% of Influenza A virus strains showed resistance to Tamiflu this season (2008/2009) compared to only 11% last year (2007/2008). With each flu season, viruses change and mutate, therefore the effectiveness of each drug treatment varies greatly.

There is never one vaccine that fits all outbreaks. Strains are always changing, and sometimes, when you formulate a vaccine for a seasonal outbreak, it is often easy to miss all the strains. It is like the Heisenberg Principle in vaccine formulation. The attempts to create cures can cause changes themselves over time.

Like that Heisenberg Principle, you got to stay on your toes to make sure you are hitting the right targets.