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Introduction In my role as a consultant and in conversations with individuals who have limited experience in clinical drug development, I often find that there is some confusion between the terms “dose” and “exposure” (the plasma or local concentration of a drug). While these terms are related, they refer to distinct concepts, and understanding the continue reading…
Advanced Therapeutic Medicinal Products (ATMPs)—which include gene therapies, cell therapies, and tissue-engineered products — represent a new frontier in medicine, particularly in addressing serious and life-threatening conditions. To ensure that these innovative therapies are safe and effective for children, the preparation of Paediatric Investigational Plans (PIPs) is crucial. Under Paediatric Regulation (EC) No 1901/2006, [1] continue reading…
Antibody-drug conjugates (ADCs) are currently at the forefront of the drug development revolution occurring in oncology delivering on the long-standing promise of a highly effective and selective cancer treatment. They are among the fastest-growing drug classes in oncology with a remarkable surge in marketing approvals in recent years. Nine ADCs were FDA approved from 2017 continue reading…
In recent years, the biotechnology industry has seen a transformative shift towards patient-driven drug development. At 3D-PharmXchange, we have experienced firsthand the impact that patient involvement can have on the development of new therapies. It has already been well described that patients bring a unique perspective that often reshapes the design of clinical trials. Their continue reading…
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