EPISODE 9: Where There’s A Risk, There’s A Way: De-risking Drug Development at the Earliest Stages

Lonza’s wide array of analytical tools and professional experience create a go-to solution for small biotechs looking to decrease risk in their drug development process.

A successful drug can easily take up to 15 years and cost over 2 billion US dollars to de-velop. Considering that nine out of ten drug candidates fail in clinical trials, companies are incentivized to reduce the risk of drug attrition at the earliest stages of development. Many of the drugs currently in the manufacturing process around the world are initially developed by small biotech companies—companies that often do not have the tools and experience necessary to assess the risks of developing their therapeutic drug can-didates properly. This is where Lonza’s Early Development Services steps in, headed by today’s guest Raymond Donninger.

To start the de-risking process, Donninger and his team employ the latest computer modeling tools to predict how the molecule will react with a human body. And while these in silico tools are very powerful, several other steps are needed to fully assess risk potential, including novel cell-based assays and a full economic viability appraisal. The de-risking process is highly technical and relies on years of research experience since no novel algorithm or new in vivo testing technique—regardless of its power—can fully replace the analytical acuity of the human brain combined with decades of market know-how.

Curious to Know More?

We previously addressed the importance of immunogenicity in decreasing risk in drug production in Episode 5. To take an even deeper dive into the whole process, listen to the conversation between Martina Hestericová and Raymond Donninger, the Senior Di-rector of Commercial Development for Lonza’s Early Development Services.

KEY TERMS:

In silico vs. human cell in vitro assays are two essential ways to test a molecule’s safety and market viability. In silico tests run computer models to assess a molecule’s interaction with, for example, a human immune system; conversely, in vitro testing assesses the molecule’s interactions with cells and even human cell tissue.

The attrition of a drug candidate occurs when it reaches clinical trials but fails for one reason or another. According to Donninger, an attrition rate of nine out of ten candidates has remained stubbornly high over the years.

Wanted attrition is when a drug candidate fails because even though the science looks good, the molecule would be inescapably harmful to humans.Unwanted attrition happens when a molecule has true therapeutic potential but is not developed properly. The de-risking process addresses unwanted attrition to improve the chances for viable and safe therapies to make it to market.

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