Certara: A Game-Changer in Drug Development

Pharma Tech Outlook: Pharma Tech Magazine

Certara: A Game-Changer in Drug Development

CIO VendorDr. Edmundo Muniz, CEO The modern pharmaceutical practices came into being around the early 19th century with the isolation and purification of compounds, chemical synthesis, and computer-aided drug design. The tempo continues to speed up as the global pharmaceutical market today has reached a valuation of around $980 billion per year. Against this backdrop, data and its analytics and sophisticated modeling solutions form the core of modern pharmaceutical software. This is where Princeton-based Certara has etched its name as a forerunner in offering some of the most advanced software solutions for the pharmaceutical industry. Formed in 2008 by the merger of Tripos International with the Pharsight Corporation, Certara today is one of the leading providers of decision support technology and consulting services for optimizing drug development and improving health outcomes. The company offers a variety of applications and services that span from drug discovery to pre-clinical and clinical testing, ensuring decision-making with solid data. The company’s broad solution portfolio harnesses the potential of scientifically advanced modeling and simulation technologies as well as regulatory strategies to increase the probability of commercial success.

“Today, our pharmacometrics drug development and informatics software solutions are among the most wide-ranging in the industry. Certara’s solutions are the unique combination of the legacy brands such as Pharsight, Tripos, Simcyp, and Quantitative Solutions. Certara’s technologies are used extensively in the drug development lifecycle,” says Dr. Edmundo Muniz, CEO, Certara. Biostatisticians, pharmacologists, toxicologists, pre-clinical scientists, geneticists, chemists, and other scientists leverage Certara’s expertise and software to drive essential safety and efficacy decisions, which includes target identification and optimization. The company’s software suite is also widely adopted for analyzing the first-in-human dose and dosing regimen, target validation, trial design, compound triaging, comparative efficacy, and mechanistic drug performance.

The Game Changer

The backbone of the company’s software offerings is Certara’s Phoenix platform—one of the leading pharmacokinetic/ pharmacodynamic (PK/PD) modeling and simulation software. Phoenix is a framework or platform onto which various analysis tools can be seamlessly connected. Multiple types of additional medical support devices and objects are connected to the platform, which then serves as a stable area for connections.

Phoenix is used worldwide by around 6,000 researchers across biopharmaceutical companies, global regulatory agencies, and academic institutions

Phoenix 8.0 provides robust capabilities for managing, analyzing, and reporting PK/PD, and toxicokinetics (TK) data.

The platform continues to set the premium standards in PK/PD software, by delivering innovative features that streamline PK/PD analysis and outcomes, saving time and reducing errors. Regulatory agencies can have more transparency in their analytical process with Phoenix. Furthermore, the solution’s criteria customization capability for the terminal slope calculation in NCA ensures compliance with organizational policies. Those rules can be implemented directly in Phoenix 8.0’s updated NCA tool.

With the new validation suite being integrated into Phoenix 8.0, there is no wait to validate a Phoenix WinNonlin 8.0 (a pharmacokinetics software package) implementation, without any need for separate application installation. Unlike the competitive solutions which may take even days, Certara’s average run time for the validation suite takes only less than 30 minutes.

Meanwhile, the advanced Phoenix 8.1 offers features including fully-integrated WinNonlin validation suite for fast, automated software validation. The solution’s advanced visual workflows can be reused as well as locked to increase efficiency, maintain compliance, and create reports. While offering Clinical Data Interchange Standards Consortium— Study Data Tabulation Model and SEND data preparation, Phoenix’s project-centric design enables to store, share, and reuse projects easily.

“Today, Phoenix is used worldwide by around 6,000 researchers across biopharmaceutical companies, global regulatory agencies, and academic institutions. At the backdrop of Phoenix’s winning formula is WinNonlin,” says Muniz. By combining its sophisticated algorithms with built-in graphical user interface and textual editor for advanced analysis, Phoenix is engraving its name in the top solutions list.

Certara’s value proposition in the pharmaceutical industry can be best explained with a case study that involved PKPD Bioscience—a Pennsylvania-based clinical pharmacology and pharmacometrics contract research organization providing computer-aided data analysis, modeling, and simulation consultancy services.
PKPD Bioscience’s research teams were spending too much time on the tedious and labor-intensive management of paper trails associated with regulatory documentation for study data. With Certara’s Phoenix WinNonlin, scientists have been able to perform their non-compartmental and compartmental analyses of PK/PD study data. Phoenix WinNonlin offers a comprehensive analysis environment, workflow templates, and the ability to create high-quality outputs with minimum errors. This, however, is one of the many success stories that highlight the prowess of Phoenix in bringing efficiency to the table.

Mission and Vision

Various acquisitions and partnerships have fueled Certara’s early drug development analysis and modeling and simulation capabilities. Backed by the expertise of multiple industry leaders, the company has been able to foster strong and long-lasting relationships with some of the leading organizations in the industry. Synchrogenix joined Certara around 2014 to add global regulatory writing and submission services to Certara’s drug development consulting expertise. Later through its merger with quantitative solutions, Certara created the preeminent global strategic modeling and simulation consultancy—Certara Strategic Consulting (CSC). Besides, Certara in association with Simcyp created a division that focuses on Quantitative Systems Pharmacology through the acquisition of XenologiQ. The company then expanded its strategic consulting unit by acquiring d3 Medicine—one of the leading global organization that focuses on integrated drug development and clinical pharmacology. The company’s client base includes various leading global biopharmaceutical companies, academic institutions, and key regulatory agencies. Customers such as Bayer and Bristol-Myers Squibb, are some of the most valued among them.

"Certara’s solutions are the unique combination of some of the legacy brands such as Pharsight, Tripos, Simcyp, and Quantitative Solutions"

Today, Certara plays a significant role in enabling patient care decision-making and superior drug development through model-informed drug development, real-world evidence, regulatory science, and knowledge integration. It is Muniz’ twenty-five-year’s of scientific and business management ex-perience that drives Certara to success. Muniz has held several senior executive roles in various pharmaceutical and public health organizations, which is the key driving factor behind Certara’s growth. Dr. Muniz earned an MD degree from the Autonomous University of Santo Domingo in the Dominican Republic, a Ph.D. in Population Planning and International Health and an MS in Population Planning, both from the University of Michigan.

Under the leadership of Muniz, the company is experiencing rapid growth both economically and geographically. In the long run, Certara’s focus is on expanding its portfolio and enhancing the capabilities of the solutions to meet the changing pharmaceutical requirement.
- Vishnu Santhosh
    August 06, 2018
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