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Optimize drug development with public data and predictive models – model-based meta-analysis (MBMA)

Properly understanding the probability of successful drug development requires utilization of all available information. Critical drug development decisions cannot be made with internal data alone. Model-based meta-analysis (MBMA) extracts important insights contained within both proprietary data and publicly available clinical trial results, thus enabling critical R&D, financial (e.g., in/out-licensing), and commercial decision-making with the highest … Continued

3 Takeaways from the FDA Oligo Guidance You Need to Know

In June 2022, the FDA published their first oligonucleotide clinical pharmacology specific guidance [1]. This is a welcome addition and clarifies the position of the agency on some key aspects regarding development of oligonucleotide therapies. Whilst the guidance still leaves a few open questions, it provides drug developers with a starting point and acknowledges that … Continued

Key development considerations for cell therapies

What is a “cell therapy”? It is a phrase that has been used in nearly every recent oncology clinical conference. Cell therapies, such as CAR-Ts (chimeric antigen receptor T-cells), are not small molecules or a simple, straightforward biologic. They’re a whole new class of therapeutics! How does CAR-T technology work? In simplistic terms, it’s a … Continued

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

TOPRA sponsored webcast: Understanding Key Components of a Medical Device Clinical Evaluation

Join us on November 15th for this webcast being held in partnership with TOPRA. In 2016, the European Commission (EC) released MEDDEV 2.7/1 Revision 4 (MEDDEV) Clinical Evaluation: A Guide for Manufacturers and Notified Bodies Under Directives 93/42/EEC and 90/385/EEC, which was the first indication of sweeping regulatory changes that would occur in Europe affecting … Continued

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