PUBLICATIONS

Fit-for-Purpose Biotech – CRO Collaboration: The FSP Model In the evolving landscape of biotechnology and pharmaceutical research, the right level of collaboration is paramount. When working with Contract Research Organizations (CROs), many biotech professionals are turning to Functional Service Provider (FSP) models to enhance efficiency, flexibility, and the seamless integration of external expertise. What is an FSP Model? An FSP model is a Read more

Enhancing Oncology Drug Dosage Optimization: Project Optimus In the quest to balance timely access to new cancer drugs with a profound understanding of patient response variability, the FDA is taking pioneering steps within the realm of oncology. Factors such as patient diversity, disease variations, and the need for individualized dosages underscore the critical importance of dosage optimization. Project Optimus, a groundbreaking initiative Read more

Clinical Research Focus. 21st Edition Should All US Biosimilars Have an “Interchangeable” Designation? Debating the Role of Interchangeability in Biosimilar Development The world of biotechnology and pharmaceuticals has seen remarkable advancements in recent years, particularly in the development of biosimilars. Biosimilars, biologic drugs that are highly similar to already approved reference biologics, have become a pivotal part of modern medicine, Read more

Debating the Role of Interchangeability in Biosimilar Development Should All US Biosimilars Have an “Interchangeable” Designation? Introduction: The world of biotechnology and pharmaceuticals has seen remarkable advancements in recent years, particularly in the development of biosimilars. Biosimilars, biologic drugs that are highly similar to already-approved reference biologics, have become a pivotal part of modern medicine, offering cost-effective alternatives to expensive originator biologics. However, Read more