Mind to Market

Thursday, May 22, 2008

The Progressive Blockbuster

Retiring CEO of GlaxoSmithKline Jean-Pierre Garnier has published his thoughts on the shifting pharmaceutical business model in this month's Harvard Business Review. True to his roots, Garnier advocates returning the management of R&D to the scientists.

But Garnier doesn't stop at restoring R&D management to scientists; he also has some strategies for reorganizing the drug development process. The first is to separate the processes of creating first-in-class from best-in-class drugs. Although discovering a first-in-class may be more satisfying scientifically, pharmas incur less risk and equal, or greater, rewards from best-in-class.

These two R&D processes are currently intertwined in most pharmas which, according to Garnier, leads to reduced productivity in both processes. Of course many of the functions of the processes are shared; complete separation would be impossible, but improved performance could be achieved with a concerted effort.

Garnier's next idea is what he calls "progressive blockbuster." Blockbuster status is the goal that every pharma is seeking yet is becoming more elusive as we enter the smaller patient populations of the personalized medicine era. Enter the progressive blockbuster. This is a drug that has been tested on a carefully selected sub-group of patients which have been shown to benefit and have low side-effects from the drug. The FDA would approve the drug only for patients in this specific sub-group. Once the drug has been approved and marketed to this sub-group, additional sub-groups can be added one by one as they show good results and safety. Eventually you will be marketing to enough sub-groups to make it a blockbuster. Voilà: the progressive blockbuster.

It does sound a bit more palatable to the general population than the current situation; where you begin with a blockbuster population and wait for adverse events to occur. But correlating patient response to genetic profile or phenotype will remain a tough nut to crack.

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2 Comments:

  • Interesting read, but do you think progressive blockbuster will eventually be a feasible and profitable to Big Pharma because the date for generic launch will be decided based on the basic patent filing, in case of progressive blockbuster, innovator company will hardly get any time to cover their investment.

    By Blogger Rajat, At 6:04 AM  

  • If safety and efficacy can be proven on a patient sub-group more quickly than it can be on the general population, the pharma can get to market faster and thus begin to recoup their investment. That is a big "if"; although drug benefit may be higher in certain patient sub-groups, that is no guarantee of safety nor will the FDA necessarily accept it. There are certainly advantages to controlling the number of variables in the patient population however.

    By Blogger Steve Connolly, At 9:27 AM  

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