eChalk Talk: Avoid getting “lost in translation” – Increase confidence in translational research using biosimulation

One of the pivotal milestones of early drug development is obtaining approval for an investigational new drug application (IND). A proposed first-in-human (FIH) study design is required for every IND application, of which a robust FIH dose rationale is a critical component. Physiologically-based pharmacokinetic (PBPK) modeling is a methodology based upon in-depth mechanistic understanding of … Continued

Certara Announces New Clinical Science Group and Adds Senior Scientific Experts

Multi-Disciplinary Expansion and New Appointments Grow Capacity and Capabilities PRINCETON, N.J.— September 22, 2021. Certara, a global leader in biosimulation, today announced that it is expanding its Integrated Drug Development (IDD) division with a new clinical science group, headed up by Philippa Marshall, M.D., Vice President of Clinical Science.  The Company also appointed David Mitchell, … Continued

How to Build a Firm Foundation for Your Drug Development Program

Developing an investigational drug and attaining regulatory approval is much like the process of building a house. First, both require coordinating many stakeholders. Building a home requires hiring various tradespeople like carpenters, plumbers, electricians, and more. And you’ll have to oversee and coordinate all their work, which must be done in a certain order. You … Continued

Gene Therapy Based Precision Medicine Therapeutics: Clinical Pharmacology & Translational Science Considerations

The era of gene therapy may have started a couple of decades ago, but approvals of agents based on the platform have been relatively recent. In 2017, Spark Therapeutics, Inc. received FDA approval of voretigene neparvovec-rzyl (Luxturna™), a recombinant adeno-associated virus serotype 2 (AAV2) vector expressing the gene for human retinal pigment epithelium 65 kDa … Continued

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

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