Adopting Advanced Drug Development Technology – A Stage by Stage Overview

Technology plays a big role in rapidly improving drug development technologies. Advanced technologies enhance the ways that new medications are discovered and developed. Here is an brief guide to the drug development process, and an overview about how technology plays a critical role.

Stage-By-Stage Overview

It takes anywhere from 12-15 years to develop a new drug. While there are five main stages of the drug development process, the process is complex—each of the five stages has multiple layers of phases and stages within. Below is a brief overview of the five critical stages of drug development and how technology is used to enhance them.

1. Discovery. The first stage of drug discovery is called discovery. This stage is where ideas for new drugs are implemented and screened to determine which may show promise as a pharmaceutical drug. The process uses advanced processes like microscale thermophoresis (MST technology) to assess the biophysical molecular interactions between test compounds and biomolecules found in the body. Through high throughput screening, researchers can test thousands of compounds at a time, drastically reducing the time and money spent on this stage.
   
   Stage 1 ends when one of the tested compounds shows the potential for exhibiting a desired therapeutic behavior on a disease process. At this point, drug development begins.
   
2. Research. During the preclinical research stage, researchers determine the efficacy and safety of the developing drug. Most importantly, researchers aim to uncover potential drug details such as ideal dosage, side effects, side benefits, absorption, metabolism, and potential interactions with other mechanisms. At this stage, machine learning can help researchers predict how a clinical animal model might behave.
   
3. Clinical development. Once preclinical research has ended, drug development may begin. This stage includes human clinical trials under the purview of the FDA as the drug is prepared for human use. The stage of clinical development is extensive and rigorous—as well as very expensive—with many moving parts to ensure optimal safety. During this stage, AI often takes on a data monitoring and generation role, saving time and ensuring clinical participant retention.
   
4. FDA review. After completing the appropriate clinical trials, researchers submit the resulting data to the FDA for review. This review process timeline varies, but averages about a year from start to finish. Not all applications for drug review receive approval as there are multiple reasons that a drug could be denied. Much like the previous stage, AI often takes the form of data generation and monitoring during FDA review.
   
5. FDA monitoring for safety. Post-market monitoring occurs once the drug has made it through the approval process and begins manufacturing. This surveillance program is in place to organize reported problems with approved drugs as well as to keep track of developing issues. Advanced data collection technology is critical during this phase for record-keeping and analysis.

Technology Improves Drug Discovery at Each Stage

While there are many different advanced technologies used in modern drug development, each serves to improve the process by reducing the time needed for each phase, enhancing the accuracy of clinical trials, and eliminating errors.