Optimized Antibody Drug Conjugate Development
Summary: The logistical and regulatory challenges associated with clinical trial supply distribution can rise exponentially when certain regions of the world are included. Underestimating the complexity of the logistics involved in the handling of sensitive and highly regulated materials such as clinical supplies has the very real potential to put patients at risk and jeopardize both the study budget and timeline. Past success managing the flow of clinical supplies in one region does not automatically work in another. From geopolitical and cultural differences, to infrastructure availability and quality, environmental conditions to regulatory requirements, each country, and sometimes regions within the same country, must be considered individually.
Having a thorough understanding of a country’s regulatory requirements is critical. This includes understanding both the written and unwritten regional differences and business practices. Proactive awareness of these differences, which can be subtle, can make the difference between successfully moving clinical supplies between countries or being detained in Customs or rejected entirely.