Navigating Market Access for Healthcare Products: The Power of the Global Value Dossier
This blog defines the global value dossiers and explains how BaseCase can support creating interactive value-creation tools.
This blog defines the global value dossiers and explains how BaseCase can support creating interactive value-creation tools.
If you work at a biotechnology start-up, you’re probably excited about your compound assets, particularly if your development program has a single asset. Unfortunately, navigating the ocean of opportunity can become more of a pain than a blessing, especially when your disease area has significant investor activity. Focusing your excitement is essential! It’s beneficial to … Continued
Although the Electronic Common Technical Document (eCTD) has been around for many years, it continues to evolve as the pharmaceutical industry adapts to changing regulatory standards and innovative technologies. Because of the inevitable changes, the eCTD presents hurdles to regulatory operations professionals, particularly for those who desire to jump in headfirst and get started using … Continued
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
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.