When I was a youngster, my father used to ask us kids in the family a question: Why did the dinosaurs go extinct? It was an interesting question to us as we all loved dinosaurs and knew a lot about them. Not long after the question was posed, possible answers started flying around -- an asteroid collision, more volcanic activity, disease, ice age (climate change), movement of tectonic plates, etc. My father's response no matter the proffered answer was No, no, no, no and no.
The RIGHT answer was -- Dinosaurs became extinct because they couldn't adapt to changing conditions.
I thought of that when I saw this post this morning. It deals with the need of pharma and biotech companies to be able to adapt to the changing healthcare climate in order to survive. The post points out that increasingly, it is not enough to get a drug approved by regulators. To thrive, you need to get the drug accepted by payers.
As such, companies need to be attuned to Changing Conditions. What is the competitive standard of care out there at any moment in time? If it changes, can you adapt your clinical trials in progress to examine relevant endpoints to the new standard? Can you add a drug to a study in oncology, for example, if a new therapy is demonstrated using two or more drugs?
Bascially, you need to think about how to differentiate yourself from competitors. Can you show enhanced safety, fewer side effects, greater efficacy, lower toxicity, or identify a patient niche where your drug outpeforms? You need to be able to adapt on the run.
If you can, you will be set up to thrive under the new conditions. If not, you (or your therapy) may be the one who next goes extinct.
Posted by Bruce Lehr May 14th 2013.