In September 2023, the European Medicines Agency (EMA) reinstated its Policy 0070 requirement to publish all clinical studies submitted for regulatory approval. After almost five years of being offline (other than for COVID-19 submissions), the process and new standards that go along with Policy 0070 will likely be new to many sponsors looking to authorize … Continued
癌症治疗已从一般细胞毒性疗法发展为针对癌细胞中特定通路和变异的药物。患者对靶向疗法的耐受性更好，治疗时间也从数周延长到数年。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.
As the pharmaceutical industry continues to evolve, so too do the processes for regulatory submissions. One significant development is the introduction of eCTD (Electronic Common Technical Document) 4.0 (read this blog to get a primer on eCTD if you’re not familiar with it). This latest iteration promises to overhaul the way pharmaceutical companies submit their … Continued
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
