Q&A: Why Seven Regulators Use One Company’s Software for Drug and Biologics Reviews

Regulatory NewsRegulatory News | 05 April 2019 |  By 

To streamline decision-making in approval processes, three regulatory authorities joined four others Thursday in increasing their adoption of drug development consultancy Certara’s Phoenix platform.

The UK’s Medicines and Healthcare products Agency (MHRA), Brazil’s National Health Surveillance Agency (ANVISA) and Japan’s Pharmaceuticals and Medical Device Agency (PMDA) are now licensing Certara’s Phoenix IVIVC toolkit for in vitro-in vivo correlation. The agencies were already licensing other Certara offerings.

In expanding their adoption of the Phoenix platform, MHRA, ANVISA and PMDA joined the US Food and Drug Administration (FDA), the European Medicines Agency (EMA) and China’s National Medical Products Administration (NMPA). The software is employed across 11 divisions of FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) for new drugs and biologics. CDER and CBER renewed and increased licensing of Certara’s offerings last October.

Certara Chief Corporate Affairs Officer Ellen Leinfuss spoke to Focus about Certara’s offerings’ value add.

Q: How is the Phoenix software employed across ANVISA, MHRA, TGA, NMPA, FDA, EMA and PMDA?

Certara Chief Corporate Affairs Officer Ellen Leinfuss: Sponsor companies submit data packages to these agencies that use in silico modeling and simulation tools, such as Phoenix, to understand the interaction between the drug and the organism (animal or human).

It’s called pharmacokinetic/pharmacodynamic (PK/PD) modeling. The PK is used to assess what the body does to the drug. The PD is the study of what the drug does to a body. The regulators need to review the sponsor’s data package and modeling results and they use Certara’s tools for those analyses.

Q: In what ways does the software add value and create efficiencies from the clinical trial phase to regulatory reviews and approvals?

Leinfuss: Modeling and simulation expedite the drug development and regulatory review process, while also giving sponsors the ability to ask “what if” questions throughout the development process, without the need to test hypotheses in people, which is a definite ethical advantage.

Q: How does adoption/use of Certara’s Phoenix software differ among regulatory authorities?

Leinfuss: Some agencies have teams of hands-on modelers that use the software directly, while others are more in the review mode. FDA is a huge proponent of modeling and simulation, with hundreds of users across 11 groups in the agency. ANVISA is a much smaller agency and many of the drugs that it is reviewing are generic versus novel drugs.

Q: What are some of Certara's other software technologies that are used by regulatory authorities and in what ways are these employed to support regulatory decision-making?

Leinfuss: Certara’s Simcyp physiologically-based pharmacokinetic (PBPK) software is used by FDA and PMDA for drug review. Those regulatory agencies have team members with the skill and acumen to use the technology themselves. PBPK has increasingly been used in drug labeling to understand drug dosing, safety and formulation and for determining the most appropriate drug doses for special populations.

There are now more than 200 label claims on FDA-approved drugs that have been made using PBPK modeling alone, in lieu of a clinical study.

Q: What are some of Certara's recent milestones and how will these contribute to Certara's mission?

Leinfuss: Certara is focused on optimizing drug development and regulatory approval by leveraging advances in science and technology.

We work in new development areas all the time and are proud to say that more than 90% of all novel drugs approved by the FDA during the past four years used Certara software or services.

During the past year, key milestones have been our entry into market access and real-world evidence solutions through our acquisitions of Analytica Laser and BaseCase and the launch of our second consortium using quantitative systems pharmacology for immuno-oncology.


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