Category: Drug Development

What We Get Wrong About Drug Development

Looking back at history of drug development, and the direction it has gone in the last twenty years or so, I think there are perhaps some assumptions about biology of drugs that we might want to challenge or question. Below are some of my thoughts about drug development productivity I’ve collected over the last couple of years.

Absolute levels of drugs and molecules tell only part of the story. Continue reading “What We Get Wrong About Drug Development”

Improving Productivity

Is There Hope for Improving Drug Development Productivity?

I was recently reading yet another paper bemoaning the dropping productivity in drug development. The authors were discussing the most likely explanations for the decline, which were

  • tighter regulation
  • illusory decline (no actual decline)
  • depletion of low-hanging fruit
  • increasing risk aversion by the drug companies
  • rising hurdles on safety

I mention this only because the paper was written in 1978 Continue reading “Improving Productivity”

Surrogate Endpoints

Note: this is a short primer on surrogate endpoints. I plan to flesh out this post at a later date.

Surrogate endpoint is the most important, and the most dangerous, tool in the clinical trialist’s arsenal.

Surrogate endpoints are endpoints that are not clinically meaningful in itself but correlate with Continue reading “Surrogate Endpoints”

Why Clinical Trials Fail

Why do clinical trials fail?  That is to say, what do you need to know when you design a clinical trial so you can minimize the likelihood of failure?

Generally speaking, there are three root causes of clinical trial failures: molecule issues, logistic issues, and study design issues.  I will focus on the third, but will cover the other two briefly. Continue reading “Why Clinical Trials Fail”

CRO Management 101

I have a couple of friends who run small startup biotechs. They’re seriously considering doing their work in India, primarily because of lower costs, and asked me for some advice. I have accumulated quite a bit of expertise in doing trials in India, but since both of them are clinical trial novices, I put together some general CRO 101 advice for them. Here it is: Continue reading “CRO Management 101”

Reducing Sample Size

How to Reduce Sample Size for Clinical Trials

One of the questions you will often be asked if you’re a clinical trialist is: “Can’t we make the study smaller?” Reducing sample size without losing power can be accomplished by one of three ways. The first is to improve the signal-to-noise ratio. To do this, you can either reduce the noise, strengthen the signal, or reduce variability Continue reading “Reducing Sample Size”

What’s in a Name?

“A rose by any other name would smell as sweet”

When I tell people that it’s becoming more and more clear, based on recent research, that fructose is bad for health, they almost always have one of two reactions. Some people, who have heard of the recent data, just nod. Others pause, raise their eyebrows and say, “wait, does that mean fruit is bad for you?” (The answer is Continue reading “What’s in a Name?”

Emergent Phenomena

“Reductionism: Instagram approach to science”

One of the greatest strengths, and one of the greatest failings, of modern science is reductionism. Reductionism has allowed us to dissect and understand some of the most important natural phenomena. Some would argue that reductionism is at the heart of the Scientific Method. Marvin Minsky has said, “In science one can learn the most by Continue reading “Emergent Phenomena”

Decision Making

One mystery of drug productivity at large pharma is the persistent low productivity despite the fact that there are tremendously talented scientists at every large pharma company. Their expertise is often encyclopedic, and their creativity is often very evident. Despite this, productivity at large companies have been less than impressive. The productivity appears to be low in comparison to small biotechs, but even more shocking, Continue reading “Decision Making”