Certara
Accelerating Drug Development with Software-Based MIDD

Over the last few years, model‐informed drug development (MIDD) has garnered much attention as an enabler of efficient drug development. MIDD approaches use a variety of quantitative methods to help balance the risks and benefits of drug development. And given the benefits of MIDD, it is now expected to play a critical role in the patient-centric healthcare system, where numerous cases demonstrate its enormous value in streamlining and accelerating the development cycle and supporting breakthrough treatment options tailored for every patient. MIDD can be used to elucidate the complexities of drug development, including those related to combination therapies, drug-drug interactions, and other safety issues, and identifying more informative endpoints. However, despite exponential uptake in recent years and increasing bullishness on the part of the regulators, MIDD is still being underutilized signaling a missed opportunity for many stakeholders.

Helping pharma companies flip this script and strengthen their MIDD capability is where Certara [NASDAQ:CERT] cements its cornerstone. As a trusted partner for pharma companies, Certara is currently helping these pharma companies unleash the complete benefit of MIDD and reduce cycle times, lower costs, and improve outcomes for patients throughout the entire biopharma R&D process.

How it All Began

In 2008, Tripos International and Pharsight Corporation came together to form Certara. Since then, Certara has witnessed incredible growth, and today, Certara positions itself as the global leader in biosimulation and quantitative drug development. Certara offers platforms and software solutions to modernize and accelerate the process of bringing not only the right drugs to the right patients. Certara’s tools are designed to make pharma companies’ work easier so that they can spend more time on the science and insights and less time on administrative tasks and error checking.

We are thrilled to offer new capabilities that accelerate modern drug development with the launch of our latest Simcyp Simulator

Notably, Certara’s Phoenix™ PK/PD (pharmacokinetic and pharmacodynamics) platform is the crown jewel of the company’s solution stack. The Phoenix platform can easily automate repetitive analytical processes and is widely considered the industry standard for noncompartmental PK analysis (NCA), toxicokinetics (TK), and PK/PD modeling. Alongside this, the Phoenix platform also includes tools for creating turnkey visualizations and submission-ready reporting. Pharma companies can, therefore, use the platform to get fast and easy software validation for MIDD in less than 30 minutes.

What’s more? In addition to the Phoenix platform, Certara has developed Simcyp physiologically-based PK (PBPK) Simulator that enables the extrapolation of relevant endpoints from in vitro and clinical trial data and answers multiple drug development questions. The simulator includes extensive libraries on demographics, developmental physiology, and the ontogeny of drug elimination pathways. Simcyp PBPK models can thus describe the drug concentration in different organs, behavior across different body tissues, and thus helps to inform clinical trial design, first-in-human dosing, formulation design, dose differentiation for special populations, and predictions related to potential drug-drug interactions. “We are thrilled to offer new capabilities that accelerate modern drug development with the launch of our latest Simcyp Simulator,” says William Feehery, , Ph.D., CEO of Certara.

Moving ahead, Certara is now poised to bring more robust solutions in the MIDD space and augment the clinical trial and drug development processes even further. The company is also looking forward to many new partnerships as well as acquisitions. With these planned steps into the future, Certara is definitely set to reach newer heights in the coming months.