The 2025 American Society of Clinical Oncology (ASCO) Annual Meeting offered a compelling look into the future of cancer care—one that is increasingly shaped by innovation, data, and a deeper commitment to the patient experience. From artificial intelligence (AI) transforming...
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,...
In the realm of clinical trials, patient involvement is not just a nicety—it's a necessity. The patient voice has become central to the success of clinical trials, shifting the focus from traditional stakeholders like healthcare providers and regulatory bodies to...
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...
In the rapidly evolving landscape of clinical research, sponsors are under increasing pressure to conduct efficient, high-quality trials that meet stringent regulatory standards. The International Council for Harmonisation's Good Clinical Practice (ICH GCP) E6 (R2) guidelines and the forthcoming E6...
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...
Bringing a new therapeutic to market is a complex and multifaceted process culminating in submission and approval of a new drug application (NDA). Within the NDA, the chemistry, manufacturing, and controls (CMC) section plays a pivotal role in demonstrating drug...
Qualitative exit interviews are emerging as a valuable addition to clinical trials for central nervous system (CNS) disorders like schizophrenia, offering crucial insights into patient and caregiver experiences for sponsors, regulators, and others involved in the development, approval, and commercialization...
Process validation is a critical regulatory requirement in pharmaceutical manufacturing. It ensures that a production process consistently yields products of predetermined quality and safety. The goal is to verify that all stages of drug production—from raw materials to final dosage...