Highlights of the Quebec “Drug Discovery to Development” Symposium

In today’s drug development climate, we’re encouraged to “think global, act local.” I have had the privilege of supporting the development of important new therapies for clients around the globe. But sometimes, it is helpful to take a step back and look at the exciting science going on in your own backyard. With that spirit … Continued

The Rise of Model-informed Drug Development in China

China’s pharmaceutical market is poised for growth. By 2020, it is expected to grow to approximately $120 billion. Today, China’s 1.36 billion people represent 20 percent of the world’s population. Yet, they comprise only 1.5 percent of the global drug market. From a demographic perspective, nine percent of the Chinese population today is over 65 … Continued

How Modeling and Simulation Can Bring New Immuno-oncology Treatments to Patients

Immuno-oncology, which harnesses the patient’s own immune system to fight cancer, is one of the hottest areas in drug development today. In recent years, the FDA has granted breakthrough therapy designations to multiple immuno-oncology drugs for a variety of oncology indications including advanced non-small cell lung cancer and melanoma. Over the last two decades, PK/PD … Continued

The Anatomy of a Great Modeling and Simulation Project

In therapeutic areas with tough competition, it is challenging to establish a complete, confident understanding of a drug’s safety and efficacy profile. Any misunderstanding of a drug’s characteristics can derail the entire development program. Modeling and simulation, also known as model-based drug development, uses a number of techniques, such as population PK modeling, model-based meta-analysis, … Continued

A Change of Heart at the Cardiac Safety Research Consortium

The ICH E14 guidance recommends that all new drugs with systemic bioavailability are assessed for the ability to delay cardiac repolarization as measured by the QT/QTc interval on the surface ECG. For most drugs, this evaluation is performed in the Thorough QT/QTc (TQT) study. Could using model-based approaches during routine early studies influence the current … Continued

The Challenges of Determining Drug Dosing for Rare Diseases

Most people are familiar with the leading causes of morbidity and mortality in the United States—heart disease, cancer, and diabetes. However, did you know that an estimated 350 million people worldwide suffer from rare diseases? In this blog post, I’ll be discussing what constitutes a rare disease, how developing orphan drugs to treat rare diseases … Continued