Moderna and Gilead Teach the “Value for Speed” in Pharma
[Thursday, May 21, 2020] About a month ago, it was being predicted that a treatment for COVID-19 may take several months and a vaccine may not be available for 12-18 months. These predictions got kicked with the emergency approval of Gilead’s remdesivir, and positive results from Moderna’s vaccine trial run by NIH, and this is not by chance. Both these companies have one of the top development teams in the industry that submitted good quality regulatory applications and implemented clinical trials at break-neck speeds. And other developers in this space can learn some strategic lessons from it. Moderna started working with NIH for its COVID-19 vaccine trial as early as in Dec-Jan when early news of the pandemic were spilling out of China. The clinical trial application was filed in February and by May, it had preliminary results of the first vaccine trial. The Gilead team, at the same time, started its clinical trial in China with remdesivir in Feb-March, got results of the first controlled trial in April and got emergency approval a few days after that. There are a few lessons for everyone here, particularly from Moderna. The best lesson to learn from these two cases is to commit resources quickly to a new opportunity. Several companies with potential products waited till late March-April to start and are now lagging. Initiating a new clinical development program requires suspending some ongoing projects. There needs to be reasonable scientific basis for supporting the change in course, but more than that the team needs to adapt rapidly. There are almost 100 vaccine trials currently ongoing for COVID-19, 15 of them in the US, but only one with preliminary results. It is hard to second-guess why one team’s program moved faster than others but starting late certainly contributed. Yes, Moderna’s trial was supported by NIH with unlimited resources and political muscle to move things faster but it can hardly be the only reason for the speed. Another nuance of Moderna’s case is that they quickly capitalized on their collaborations or connections at NIH. Moderna was smart to work with NIH rather than going at it on its own. That way, Moderna was able to execute a clinical trial faster with probably much less capital investment of its own, while getting the full financial benefit of the results. Other governments have similarly helped locally based companies with executing trials quickly. The most important strategic lesson is that it does not always take more than 10 years and costs more than a billion dollars to develop a new drug. Good ideas and good teams can move mountains. It is too early to say how long this success story will last but a lesser known Moderna is on the map thanks to some quick thinking. We can all use some of that. |
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