In the complex and costly world of new drug development, pharmacokinetic (PK) modeling has emerged as a promising method for driving more efficient and cost-effective clinical trials. This scientific approach leverages mathematical models to describe the relationship between drug dose,...
Expertise: Consulting 219 results
On April 10, 2025, the US FDA announced that it has a long-term plan to eliminate conventional animal testing in drug development, starting with monoclonal antibodies (mAbs).1 Instead, within 3-5 years, the expectation will be to leverage an integrated safety...
Alzheimer’s Disease (AD) is a progressive, irreversible brain disorder that affects memory, thinking, and language skills. Age is the best-known risk factor for AD, with symptoms usually appearing after 60 years of age. According to the Alzheimer's Association and the...
Epilepsy is the fourth most common neurological disorder in the world1, affecting over 68 million people globally, and approximately 2.2 million people in the US2. In pediatric populations, it is estimated that about 470,000 US children under the age of 14...
The journey of developing effective treatments for rare diseases, particularly in a pediatric population, has its own unique challenges, including (but not limited to), a small population size, disease heterogeneity, and the absence of established endpoints to support regulatory decisionmaking....
The FDA’s Oncology Center of Excellence (OCE) plays a pivotal role in fostering innovation, collaboration, and efficiency in the development and evaluation of oncology products. Established in 2017 under the 21st Century Cures Act, the OCE brings together multidisciplinary scientific...
Clinical Development
RAPS San Francisco Bay Area Chapter In-person 2025 Kick-Off Meeting
New drug development is a long and expensive process that can be fraught with obstacles, including unexpected delays, poor efficacy results, safety issues, or regulatory challenges. Pharmaceutical companies may, at times, find themselves at an impasse during development, facing weighty...