Drug development is full of choices- many of them are easy to make, but difficult to get right. Many’s the team that’s acted in haste and repented at leisure when designing a first-in-man clinical trial. Here’s a primer on how to spot and avoid common causes for program failure on the path to clinical success. (Yeah, you guessed right, it’s an article about mathematical modeling!) ?#drugdevelopment #clinicaltrials #modelingandsimulation #pharma #biotech
Dean Bottino
2 年
This is great! Another thing is what I call the lucky rabbit’s foot syndrome: “We saw a partial response at 30mg/kg in a 72-year-old woman with endometrial cancer…. < 37 meetings and many months later> our recommended phase 2 dose is 30mg, our target indication is endometrial cancer, and our precision patient population is 72-year-old women…”
Dennis Miller
2 年
Quick read, but spot on!
I liked the part about it being premature to optimize marketability via dosing route before knowing whether you have a drug