Category: Blog

Cancer treatment has evolved from generally cytotoxic therapies towards drugs that target specific pathways and alterations in cancer cells. Patients tolerate targeted therapies better, and their treatment continues over a period of years, instead of a few weeks. These improvements in cancer treatment spurred the FDA’s Project Optimus initiative which has altered the criteria used … Continued

Clinical trials always pose a challenge to demonstrating a drug’s safety and efficacy.  Sometimes, the challenges are beyond difficult, presenting situations where it isn’t ethical or feasible to demonstrate efficacy in humans.  Consider the following scenarios (which have occurred):    A bioterror attack with people exposed to a dangerous disease (anthrax, plague, Ebola)  A natural hazard … Continued

Deep learning/artificial intelligence concepts have been around for decades, with significant advancements made in the late ‘80s and throughout the ‘90s as scientists experimented with recurring neural networks (RNNs). As our concept and expectations of deep learning evolved over the years, data quality and the computing power needed to train and deploy new models often … Continued

Drug development continues to be painfully slow and mind-bogglingly expensive. In a 2010 article, Stephen Paul estimated that developing a new drug cost $1.8 billion and took thirteen years on average from discovery to regulatory approval. These excesses occurred because drug development is a fundamentally complex and risky process that is also subject to rigorous … Continued

Investigational New Drug Applications (INDs) and Clinical Trial Applications (CTAs) are regulatory submissions needed for the initiation of clinical drug trials, and these applications have commonalities and differences throughout the world. If you’re initiating clinical trials in multiple countries, then planning for these different submissions is critical to the efficiency of your drug program. Many … Continued

This blog explains how Certara’s Simcyp team developed and tested a model in the Simcyp PBPK Simulator for rectal drug absorption.

The Standard for Exchange of Nonclinical Data (SEND) is a standardized, electronic format for exchanging nonclinical data related to drug development. SEND was developed by the Clinical Data Interchange Standards Consortium (CDISC), a globally recognized, not-for-profit organization that develops data standards with the input of pharmaceutical industry experts. The FDA requires drug developers to use … Continued

With nine FDA-approved drugs today, 100+ in clinical development and several hundred in the preclinical stage, the market for bsAbs is projected to grow to >$30B by 2028. The distinct advantages of bsAbs, such as improved selectivity and specificity, increased efficacy, and lower toxicity, will result in measurable benefits for cancer patients. But bsAbs are … Continued

Do you remember the 1990s? The Soviet Union fell, Friends was the most popular TV show, and for some inexplicable reason, hammer pants were a viable fashion option. But while 90’s era political, entertainment, and fashion trends may have come and gone, many regulatory guidances from that time are still in effect. In my role … Continued