Certara is a leading biosimulation and technology company that uses advanced modeling and simulation to optimize drug development and regulatory approval processes in the pharmaceutical industry.
William, can you tell us a little bit about your background and how it led you to Certara?
My background is as a chemical engineer, and I spent 18 years at DuPont, where I managed various businesses. For the last several years there, I led the biotechnology business there. This role was particularly relevant because the modeling and simulation concepts we used in engineering there are now being applied to the drug development industry through Certara. The idea behind Certara is to transform drug development into something resembling an engineering project, where we use available data to model outcomes before conducting experiments.
I have been with Certara for about five and a half years. I joined right before the pandemic, and during that period, we took the company public. Over the last few years, we have seen significant growth, particularly as our modeling and simulation concepts have gained traction in the pharmaceutical industry.
Can you introduce us to the concept of Model Informed Drug Development (MIDD)?
MIDD has been evolving in the pharmaceutical industry over the past decade or so. Traditionally, drug development has been a statistical science, relying on expensive and time-consuming clinical trials. Success rates in life sciences are quite low, and development costs can range from two to six billion dollars per drug when accounting for failures and trial expenses. MIDD complements this process by leveraging scientific knowledge to build predictive models using mathematical and statistical techniques before trials begin.
These models incorporate a wealth of pre-existing data, such as how drugs interact with the body, their metabolism, and the results of similar drugs. This allows us to predict outcomes with greater confidence, reducing unnecessary experiments. The ethical considerations and the limited availability of clinical trial participants make this approach even more critical. By using MIDD, companies can minimize costs, timelines, and risks while enhancing the likelihood of success in clinical trials.
How has the advent of AI impacted Certara's models?
Our models historically relied on known scientific information, focusing on mechanistic modeling to understand how drugs work within the body. However, human biology is too complex to model entirely with traditional methods. This is where AI becomes an invaluable extension. We use AI to process large datasets, such as clinical trial results or genetic data, identifying patterns and extending our understanding where direct modeling is not possible.
Additionally, AI has helped us enhance efficiency by processing and analyzing vast amounts of scientific literature. Large language models, for example, allow us to identify relationships within metabolic pathways and augment the productivity of our experts. AI also enables us to automate the creation of reports from our models, making insights more accessible to regulators and stakeholders. While AI complements our work, we still prioritize mechanistic models because they are grounded in known facts, whereas AI is used to fill in the gaps and accelerate processes.
How much time can companies save by using Certara’s services?
It is challenging to provide a precise figure because we are often comparing scenarios that did not happen to those that did. However, our analysis of numerous drug development projects shows that our biosimulation techniques can shave years off the development timeline. This is largely due to reducing the number of required clinical trials, especially in late stages, which are typically time-consuming and costly. For example, we often replace traditional drug-drug interaction trials or food-effect studies with modeling, saving six months to a year per trial.
These reductions are especially valuable for patented drugs, where every day of extended patent life matters. By eliminating unnecessary trials, companies not only save time but also conserve resources, ensuring a more streamlined development process while maintaining regulatory compliance.
Certara’s software has been linked to 90% of FDA-approved new drugs since 2014…
Yes, our software is the most widely used in MIDD, both by the pharmaceutical industry and regulatory bodies. For instance, our biosimulation software, Simcyp, is extensively used as drugs near regulatory approval. The FDA and other regulators are strong proponents of our tools, integrating them into their evaluation processes for many approved drugs.
This widespread adoption reflects our leadership in the field. Over the years, we have identified over a hundred approved drugs with label claims directly referencing our software. This demonstrates our significant contribution to the industry, as our tools and expertise have become critical in ensuring the success of drug development projects.
Certara recently acquired Chemaxon. What motivated this acquisition?
The acquisition of Chemaxon, which we completed in October, was driven by our desire to expand biosimulation capabilities throughout the entire drug development process. Historically, we have focused on the preclinical and clinical phases, working with companies after they have selected a molecule. However, we recognized an opportunity to influence decision-making at the discovery stage by helping companies choose the right molecules in the first place.
Chemaxon is a discovery software company that predicts the properties of potential drug molecules. By integrating their tools into our biosimulation platform, we aim to simulate how drugs will perform in clinical trials before they are even synthesized. This approach could dramatically improve success rates by enabling better early-stage decisions and reducing failures further down the development pipeline, ultimately transforming the efficiency of the entire industry.
Can we dream of a future where clinical trials are entirely replaced by simulation?
While clinical trials will always play a critical role in drug development, there is significant potential to reduce their number. Physical trials are essential to validate a drug’s safety and efficacy, but many intermediary trials could be replaced by modeling based on existing knowledge. This ensures that trials focus on filling specific gaps in understanding or confirming outcomes for regulatory purposes.
For example, we have already made significant strides in pediatric and specialized populations like neonates and pregnant women. Through advanced modeling, we can predict dosing and outcomes with high confidence, reducing the need for extensive trials in these ethically sensitive groups. While physical trials will not disappear entirely, leveraging simulation allows us to streamline the process, saving time and resources while reducing the burden on trial participants.
Where do you hope to see Certara in the coming years?
Our vision is to transform how the pharmaceutical industry approaches drug development. We want to establish a model-driven mindset at every stage of the process, where every trial is specifically designed to address what we do not already know. By applying this engineering approach, we can significantly increase the probability of success and reduce inefficiencies in drug development.
Even small improvements in success rates—shifting failure rates from 90% to 85%, for instance—can result in a dramatic reduction in overall development costs. This would allow more drugs to reach patients faster and at a lower cost. Over the next few years, we aim to drive this industry-wide change while continuing to deliver tools and expertise that improve efficiency, benefiting both the pharmaceutical sector and global healthcare.
