Often I get asked by other environmental health and safety (EHS) professionals and conference organizers, “What are the top trends in potent compound safety that I need to watch out for in the coming year?” While predicting trends is often a futile effort and because of the “Gradually, then suddenly” effect, things can change overnight, I will give it a shot. So here it is:
In June 2018, the International Council for Harmonization released its final concept paper on continuous manufacturing in a new guideline called “ICH Q13: Continuous Manufacturing of Drug Substances and Drug Products.” After reviewing the paper, it is exactly that, a concept paper with little substance to it. However, with a 3-year timeline to further elaborate the paper we should see some activity. Since there was no mention of safety in the concept paper, it will be important for potent compound safety experts to be involved in this process.
While we are several decades from reaching artificial general intelligence, it is quite clear that we are making progress at making a toxicologist’s job easier. In July 2018, an article was written that “Machine Learning of Toxicological Big Data Enables Read-Across Structure Activity Relationships (RASAR) Outperforming Animal Test Reproducibility.” Here at Affygility Solutions, we have been working with machine learning and using IBM Watson to improve our ease of extracting information that is buried deep within numerous data sources. We will continue to move forward on this development.
As the number of potential potent compounds enters the market place, the focus on risk assessments will increase. Online tools to perform rapid risk assessments will become more prevalent. This will be most useful for contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) that have a rapid turnaround of new compounds that are early in drug development.
Highly-sophisticated, low-cost sensors are now becoming the norm. Recently, companies like Chargepoint have released high-containment valves that contain sensors that will determine if there is a potential problem with a high-containment valve. Look for other containment companies to follow this path.
The speed at which the industry is changing is unreal. Companies are now expecting to obtain a potent compound occupational health categorization in a matter of days instead of weeks, and a fully-documented occupational exposure limit report in the same amount of time. Delays in obtaining these type of reports costs companies significant money and delays in clinical development. No longer is it acceptable for companies to wait weeks for internal resources to “get around to it.” Systems like OEL Fastrac will become the norm.