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Maximizing Oligonucleotide Therapeutic Development: Pre-clinical and Translational Considerations

This is the second of three blog posts discussing best practices for developing oligonucleotide therapeutics. The first blog in the series explained how these therapies work. Characterizing the pharmacokinetics (PK) of an investigational oligonucleotide drug is an important part of its pre-clinical development program as well as informing its later clinical development. In this blog, … Continued

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) Renews Licenses of Certara’s Biosimulation Software for Evaluating Regulatory Submissions

The PMDA enters 8th consecutive year of using Certara’s biosimulation software PRINCETON, N.J.—June 23, 2021. Certara, a global leader in biosimulation, today announced that the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has renewed its licenses of Certara’s Simcyp™ and Phoenix™ biosimulation software. The PMDA has been using Certara’s biosimulation software since 2014. The Simcyp … Continued

Combining active pharmaceutical ingredients (APIs): MPT Development & Regulatory Considerations

This fourth webinar in the “Let’s Talk MPTs” learning series will provide MPT product developers and other stakeholders an overview of clinical development and regulatory considerations when developing products that combine one or more active pharmaceutical ingredients (APIs) into an MPT product. Speakers • Deven Shah – Chemistry, Manufacturing, & Control (CM&C) Lead at Certara• … Continued

Development considerations for pioneering a NASH clinical program

The National Institute of Diabetes and Digestive and Kidney Diseases considers nonalcoholic fatty liver disease (NAFLD) as a condition wherein the liver stores excess fat and nonalcoholic steatohepatitis (NASH) as one type of NAFLD. Individuals with obesity and type 2 diabetes appear to be at greater risk of developing NAFLD. Many innovative and scientifically intriguing … Continued

Your First Choice in Complex Biologics Drug Development

The pharmaceutical has made massive investments in complex biologics, a drug class that includes oligonucleotide therapeutics, immuno-oncology therapies, vaccines, antibody-drug conjugates, bispecific antibodies, and cell and gene therapies. These drugs can be challenging to develop for multiple reasons. Certara provides strategic approaches needed to optimize dosing, trial designs, payer plans, and regulatory strategy.

Pharmacometrics & Clinical Pharmacology FOMO: Why the Future of Research is in Africa

Use of clinical pharmacology and pharmacometrics approaches has become the gold standard for informing optimal dosing of investigational drugs in various patient populations. At the same time, the demand for clinical pharmacologists and pharmacometricians is outstripping the current supply of practitioners as well as the number of students being trained in these disciplines in North … Continued

ASCPT Micro-Recruitment Session

Ever wondered what a career as a drug development consultant is like? In this session, Suzanne Minton, PhD, Director of Content Strategy interviewed Mark Lovern, PhD, Senior Vice President of Quantitative Science Services at Certara. Mark provided an overview of the software and services that Certara supports and discussed what it’s like to work as … Continued

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