ASCO Annual Meeting 2025

Certara is an industry-leading practitioner of Model Informed Drug Development (MIDD). MIDD, which uses both mechanistic models based on preclinical and literature data and more statistical models derived

from clinical data to inform drug development decisions, prominently features in sponsors’ clinical development strategies, and is enshrined in the FDA’s legislative goals (PDUFA VI).

Implementing MIDD systematically in oncology research and development programs offers a host of benefits, particularly in early stages, with the ultimate aim of reducing failure rates during clinical trials by 50%.

As an industry-leader and advocate for the systematic adoption of MIDD approaches from molecule to market, Certara is uniquely positioned to advise biopharmaceutical sponsors on how and when to integrate MIDD into their programs to inform critical decisions and solve problems.

Our MIDD consulting team boasts a cross-section of scientific expertise including 125+ Pharmacometricians and 40+ Clinical Pharmacologists.

Extensive oncology experience

• 20+ clinical pharmacology scientists with >10 years of oncology experience
• 3 former FDA oncology reviewers
• Currently supporting >100 oncology programs with MIDD

A track record of results and demonstrated success

• Helped our partners successfully bring >250 new drugs to market with an integrated MIDD approach (all therapeutic areas)
• Navigated 80+ assets through Project Optimus requirements since 2022
• 160+ oncology submissions completed or in progress
• 40+ oncology IND/CTA submissions