Real World Evidence Marches Forward in Drug Development

Ulrich Neumann

The end of 2018 ushered in a flurry of new regulatory guidance and sponsor enthusiasm on real-world evidence (RWE) and its adoption in the drug development process. While the collection of real-world data (RWD) and use of RWE is not new, they are now poised to have a profound impact on our industry.  Today, it […]

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Topics: Evidence and Market Access

Certara Acquires Analytica Laser, a Leader in Market Access, Health Economics and Outcomes Research (HEOR), and Real-world Evidence Solutions

PRINCETON, NJ – Apr. 12, 2018 – Certara today announced that it has acquired Analytica Laser, a global research consultancy that uses health economics and outcomes research (HEOR) and real-world data to provide the highest level of scientific evidence of the value of medicines and health technologies.

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FDA’s PDUFA VI Goals Highlight Model-informed Drug Development

Ellen Leinfuss

On July 15, the US FDA published its goals and commitment letters for the re-authorization of its Prescription Drug User Fee Act (PDUFA) for fiscal years 2018-2022, known as PDUFA VI. The document reflects the agency’s performance and procedural goals to expedite bringing safer therapies to patients.  It also reflects and incorporates the advances in […]

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Topics: PBPK Modeling & Simulation