Biotech Showcase 2022 | JP Morgan Healthcare Week

Why meet with Certara during Biotech Showcase?

Did you know that Certara’s clients who use our solutions have received 90% of all novel drug approvals by the FDA since 2014?   

We are the leading model-informed drug development consultancy in the world and advance our clients’ drug programs from discovery to regulatory and commercial success, using quantitative and technology-driven approaches. And then, we integrate drug development and global regulatory strategy to assure and accelerate submission approval success. 

Since 2019, Certara has supported our clients as they have raised more than $65 billion in funding from venture capital and M&A deals. Furthermore, we have delivered more than 250 regulatory submissions in the past 4 years.   

Our support for clients includes:

• Due Diligence/Asset Evaluation
• Gap Analysis
• Clinical Pharmacology
• Model-Informed Drug Development
• Regulatory Consulting and Writing

Success Stories:

Our experts in model-based drug development worked with Cubist Pharmaceuticals to bring the novel antibacterial agent Zerbaxa™ (ceftolozane/tazobactam) from pre-clinical studies through market approval to treat adults with complicated infections. Our model- based analyses incorporated subject data collected in 10 clinical studies to support confident go/no go decisions, to improve understanding of drug exposure in diverse populations, and to anticipate and address regulatory needs for the drug’s expedited review and approval.

Alkermes needed to understand the impact of variable dosing on its antipsychotic, aripiprazole lauroxil (AL). They also sought to evaluate the drug-drug interaction potential for AL and the effect of CYP2D6 metabolizer status on its pharmacokinetics. Together, we leveraged Simcyp’s physiologically-based pharmacokinetic modeling to predict the impact of co-administration of CYP3A4 and CYP2D6 inhibitors/inducers in patients with varying metabolizer status on aripiprazole exposure to facilitate successful regulatory approval, and waive the need for some clinical trials.

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. Our scientists used model-based meta-analysis to understand the impact of dosing regimen and formulation on low-density- lipoprotein cholesterol levels, to predict the impact of changes in exposure for ezetimibe + atorvastatin FDC on efficacy, and inform the design of clinical equivalence (CE). Insights from the model’s predictions from simulations supported reducing the sample size for the CE trials by 17% while still maintaining a 90% probability of success thus saving time and decreasing costs.

Our Attendees Include:

Fran Brown

SVP, Drug Development Services
Fran.Brown@certara.com

Lynne Georgopolous

Vice President, Regulatory Strategy
Lynne.Georgopolous@certara.com

Alberto Bryan

Assoc Director, Bus Development & Market
Alberto.Bryan@certara.com

Michael Eckstut

SVP, RCS Commercial & Products
Michael.Eckstut@certara.com

Shawn Bates

VP, US Sales & Business Development
Shawn.Bates@certara.com

Drayton Virkler

Chief Commercial Officer
Drayton.Virkler@certara.com

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