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Tag: Model-informed Drug Development

Certara Strengthens Model-Informed Drug Development Team with Four Executive Hires

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New executives bring cross-disciplinary expertise and diversity to the company’s premier global Integrated Drug Development team PRINCETON, N.J.—May 17, 2021. Certara, Inc, (Nasdaq: CERT), the global leader in biosimulation, announced the appointments of four executives to its growing model-informed drug development team: Dr. Matt Zierhut as Vice President, Model-Based Meta-Analysis, Dr. James Dunyak as Senior … Continued

The Wizard of Oligos: There’s no place like having a successful drug development program!

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Oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases— are experiencing tremendous growth in the pharmaceutical industry. But, performing the needed PK/PD and clinical pharmacology assessments to optimize the safety and efficacy of investigational oligonucleotide candidates and gain regulatory approval can be challenging. It’s enough to make … Continued

Part 4: Best Practices for oligonucleotide therapeutic development: Q&A

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In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases. Certara supported the first FDA approval of … Continued

Part 3: Oligonucleotide therapeutic development: Clinical pharmacology considerations

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In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases. Certara supported the first FDA approval of … Continued

Part 2: Oligonucleotide therapeutic development: Pre-clinical and translational considerations

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In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases. Certara supported the first FDA approval of … Continued

Part 1: What are oligonucleotide therapeutics, and how do they work?

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In the last few years, the pharmaceutical industry has invested in developing Complex Biologics including proteins, oligonucleotides, viral vectors, and engineered cells. One area within Complex Biologics experiencing tremendous growth is oligonucleotide therapies— nucleic acid polymers with the potential to treat or manage a wide range of diseases. Certara supported the first FDA approval of … Continued

ICYMI: Highlights of the ASCPT 2021 Annual Meeting

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The COVID-19 pandemic has upended all our lives in ways big and small with the ability to attend in-person scientific conferences being no exception. Fortunately, many conferences have become virtual events which have allowed participants to share the latest research findings and trends while maintaining safety for everyone. Last month, I virtually attended the annual … Continued

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