BIO 2020

Together we are accelerating medicines for biotech

Model-informed drug development (MIDD) enables the carryover of the knowledge and wisdom from one phase to the next and from one indication to the next both in terms of successes and failures.


Our people and process are what set us apart

ALIGN:
Your success is our guiding principle.

INTEGRATE:
Modern drug development is a team sport.

DESIGN:
We help you design a robust clinical and regulatory strategy to demonstrate proof-of-concept or get to approval.

DELIVER:
Navigating complexity through flawless execution and stewardship.


Clinical and Economic Value Assessment


We’ve helped partners across all therapeutic modalities and areas of expertise find success through model informed drug development.



Cubist Pharmaceuticals sought to develop the novel antibacterial agent Zerbaxa™ (ceftolozane/tazobactam).
Our model-based analyses incorporated data collected in 10 studies to support go/no go decisions, improve understanding of drug exposure, and address regulatory needs for the drug’s expedited review and approval.

Our partner needed to determine the optimal design for clinical equivalence trials to evaluate a fixed-dose combination (FDC) of two previously approved drugs, ezetimibe and atorvastatin. Using model-based meta-analysis, we predicted the impact of changes in exposure for the FDC on efficacy and informed the trial design. The model’s predictions helped to reduce the trial size by 17% while maintaining 90% probability of success.

Our biotech partner had a submission deadline in nine months for their first NDA. In addition to having a large clinical study, we were relying on historical data on the active ingredient for nonclinical requirements and had to integrate a parallel clinical program conducted in Japan. We developed a detailed daily timeline through to submission, led weekly submission team meetings, and authored all documents to beat the deadline.

Alkermes needed to understand the impact of variable dosing on its antipsychotic aripiprazole lauroxil (AL) and evaluate drug-drug interaction potential. We predicted the impact of co-administration of CYP3A4 and CYP2D6 inhibitors/inducers in patients with varying metabolizer status on aripiprazole exposure with Simcyp’s physiologically-based pharmacokinetic simulator and facilitated successful regulatory approval.

Contact Us to Learn More

Certara’s Biotech Experts

Gary Kusha
Vice President
Business Development
gary.kusha@Certara.com

Hans Schumann
Director
Business Development
hans.schumann@Certara.com

Patrick Smith
Sr. Vice President,
Integrated Practice
Areas (Global)
patrick.smith@Certara.com

Oliver Leatham
Vice President,
Value & Access Services

oliver.leatham@Certara.com

Ulrich Neumann
Sr. Director,
US Access & Commercial Strategy

ulrich.neumann@Certara.com

Maximilian Vargas
Sr. Director,
US Access and Account Management

maximilian.vargas@Certara.com

Max Goldstein
Director,
Business Development

max.goldstein@Certara.com