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Oncology Resources
Julie Bullock, VP, Global Head of Clinical Pharmacology and Translational Medicine at Certara discusses the FDA’s Oncology Center of Excellence’s new initiative called “Project Optimus” which addresses issues relating to dose optimization…
Project Optimus is an initiative proposed by the U.S. Food and Drug Administration’s Oncology Center of Excellence (OCE) which will develop new expectations for cancer drug makers…
Historically, the dosing strategy for oncology drugs has focused on the maximum tolerated dose. This has resulted in drugs’ pharmacokinetic (PK) profiles, pharmacokinetic/pharmacodynamic (PK/PD) relationships, and clinical target inhibition largely being ignored.
Antibody-Drug Conjugates (ADCs) can be an ideal drug treatment for cancer because they deliver a cytotoxic anti-cancer drug directly to the tumor site with reduced off-target damage.
Traditional mechanisms of drug action rely on the reversible, noncovalent interaction of a ligand with its biological target. On the other hand, a targeted covalent inhibitor (TCI) drug is designed…
With nearly 10 million deaths in 2020 and despite great progress, cancer remains the leading cause of death worldwide [1]. Antibody Drug Conjugates (ADCs) when first approved in 2000,…
Antibody drug conjugates (ADC) are a unique way to obliterate tumor cells and represent an underutilized immunotherapeutics option in oncology, whether as monotherapy or in combinations. The first FDA approval of an ADC was in 2011, with the introduction of brentuximab vedotin (trademarked Adcetris) by Seattle Genetics (1).
Amongst the real world data sources in Europe, the French Healthcare database SNDS is the largest and potentially the most comprehensive healthcare data resource, covering ~65 million lives, more than 99% of the French population and about 10% of Europe.
One fundamental tenant of pharmacology is understanding how a drug works. One can glean
over product package inserts to the mechanism of action section to see how the approved
drug works for its approved indication.
According to the Institute of Health Metrics and Evaluation, cancer was the second leading cause of death in 2018
with an estimated 9.6M deaths worldwide.
Model-informed drug development (MIDD) leverages a range of quantitative methods
(modeling and simulation or in silico tools) to inform critical R&D decisions such as…
