Biosimulation Contributing to Safety, Speed, and Efficacy in Trials

Thomas Kerbusch, PhD, Chief Growth Officer, Certara

Rapid evolution in the science surrounding COVID-19 is going hand-in-hand with advances in biosimulation techniques that should increase the probability that vaccine candidates entering human trials are both safe and effective enough in various populations that time will be saved honing in on optimal dosing practices, experts in the technology said Wednesday (August 5).

According to a webinar presentation for reporters from biosimulation platforms developer Certara, there are many unknowns when it comes to vaccine development for COVID-19. For example, how can we tell which vaccine candidates will be appropriate for the elderly, children, and other potentially vulnerable populations?

Biosimulation can be thought of as computer-aided, mathematical modeling of human biology, drug behavior, and disease to accelerate researchers’ understanding of how a drug works, how much drug do different people require and when, and how to better prevent or cure diseases with it. Thomas Kerbusch, PhD, chief growth officer for Certara, noted that the practice “has helped reshape the drug development process, and is an important tool that can be used to answer some of the unknowns traditional vaccine development can’t answer fast enough.”

Saying that “vaccines are enormously hard to make” despite their success as saving hundreds of millions of lives, Kerbusch added that developing them by “trial and error is too costly, too slow. Failing first in the computer is fast and cheap.” Whereas Phase I trials may run for weeks and Phase III for months or years, computer simulations of thousands of virtual patients can be done in hours.

By building virtual patient populations in collaboration with pharmaceutical company clients, biosimulation developers allow them to answer “what if?” questions long before investments are triggered and the first volunteer receives a drug in a clinical trial. This condenses the time frame for locking in on dosages and, hopefully, decreases the likelihood of failure in Phase III.

Certara is now supporting more than 20 COVID-19-related programs, Kerbusch said, with many of them being tied to the COVID-19 Therapeutics Accelerator initiative from the Bill & Melinda Gates Foundation, Wellcome, and Mastercard. Data for the company’s COVID-19 biosimulations come from a new database that is specific to the disease, and from 45 older databases covering a wide range of conditions and thousands of trials, Kerbusch explained. Such depth of data is important, he added, because “this isn’t our last pandemic. We need systems and platforms for [use in] the long term.”

Piet H. van der Graaf, PhD, senior vice president for quantitative systems pharmacology (QSP) at Certara, added that, in partnership with seven pharmaceutical companies, Certara is now using a QSP platform originally developed for immunology studies to pursue COVID-19 vaccine development. “One major company is now using the platform to fast-track its vaccine candidate,” he noted.

With QSP technology, “We can generate not just one, but hundreds or thousands of virtual patients,” covering differences in demographics, genetics, medications, comorbidities, ethnicity, immune baselines, standard of care, adverse events, disease physiology, drug mechanism, and other factors, van der Graaf said. Then, “when the first data from healthy volunteers are available, the model can be refined to other populations,” he explained.

Author: Gary Cramer