Shazeeye's Blog Thoughts on User Experience, Technology and Business

26Feb/120

How do drugs get their labels?

On March 1st I went for a talk on Target Product Profiles at UCSF. Patrick Scannon, Xoma's Founder and CSO spoke on how drug discoveries can be made into commercial realities with the help of a Target Product Profile (TPP).  A TPP is the first step towards creating a drug label. A TPP is defined as a communication tool to help people in academics (discoverers of drugs in labs) to communicate the value of a drug to investors (people with $ but not convinced). This takes the drug from discovery through development to approval/market entry. It also helps keep various departments/functions such as regulatory, manufacturing, sales, marketing, etc. on the same page.

As drug discovery takes many years to commercialize (about 12 yrs) it is important to have clear goals (TPP) and to start with the end (FDA approval) in mind and work backwards. The TPP defines who the drug is for, what disease it cures, how large is the market, how is it administered and more details as seen in the image. Defining the unknowns upfront helps communicate the goals better to the FDA (governing body that ultimately approves if a drug can be commercialized). The TPP helps in thinking of launch strategies too. For example, some drug companies first launch in an orphan market (diseases affecting fewer than 200,000 people) and then larger markets as its faster to get approval in orphan markets and grants are available to support you in this process. Some companies also choose to launch in international markets before local markets as approval is faster for certain diseases.

Often changes in the IP landscape or manufacturing processes or technical difficulties result in changes to the TPP and CEOs are forced to make a difficult decision  to move ahead with the changes or drop the product. If the CEO agrees to go ahead she/he needs to update the TPP and keep all in the loop. The TPP can be used to increase the value of the company by finding ways to create additional IP, communicating improved benefits and decreased adverse events. CEOs can also use the TPP to forecast different scenarios of the drug. For example, a target scenario, a minimal scenario and an optimistic scenario where the CEO predicts the characteristic of the drug and thus his strategies under these three scenarios.

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