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Certara Opens New China Office in Shanghai

Office will support rapid growth and collaboration with customers in China to accelerate biopharmaceutical R&D  PRINCETON, N.J.—Nov. 9, 2020. Certara, a global leader in biosimulation, today announced the opening of a new office in Shanghai’s Pudong District, China’s epicenter for biopharmaceutical research and development (R&D). The office will allow Certara to strengthen its collaboration with customers in the … Continued

Submerge in the Oligonucleotide Emerge: Best Practices for Developing These Complex Biologics

In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases. Certara supported the first FDA approval of … Continued

The Market Access Radar (Series)

Evidence & Access – Google Podcasts (Ep. 1-3) Welcome to the Market Access Radar Podcast, your expert briefing on the latest in Market Access and Health Economics in the Bio-Pharmaceutical Industries.

Certara Announces Strategic Initiatives to Bolster Clinical Trial Transparency and Disclosure Services

Certara strengthens transparency and disclosure leadership with launch of new Podium™ platform for patient engagement and appointment of industry veteran PRINCETON, N.J.—October 27, 2020. Certara, a global leader in biosimulation, today announced that its regulatory science division, Synchrogenix, continues to build on its clinical trial transparency and disclosure position by introducing a new technology platform … Continued

PBPK modeling supports approval of breakthrough cancer drug

Pharmacyclics’ (now AbbVie) Imbruvica (ibrutinib) is an anticancer drug targeting B-cell malignancies. Leveraging the US FDA’s accelerated approval programs, the company generated PBPK models using the Simcyp Simulator to inform dose, dosing regimens, and DDIs. Approved initially for mantle cell lymphoma as a breakthrough therapy, Imbruvica is now approved for multiple uses, including first-line CLL.

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