Therapeutic drug monitoring for biologics is a potentially valuable tool for improving patient treatment outcomes. For small molecules, TDM has traditionally been used to inform safety. However, with protein therapeutics the potential for ADA to impact clinical response by reducing drug concentrations presents a different application. TDM therefore falls at the intersection of a range of disciplines, where clinical care meets precision medicine, pharmacokinetics, immunogenicity, healthcare economics and bioanalytical sciences. This talk will discuss the potential for its use in patient treatment, the current practice and potential future applications.
Learning Objectives:
• Discuss the benefits of TDM of biologics (proactive or reactive TDM) in terms of impact on efficacy and patient outcomes in the inflammatory disease space and, potentially, other therapeutic areas.
• Identify challenges to adoption and implementation of TDM of biologics, including regulatory and economic considerations, from the initial phases of drug development through marketing and clinical practice
• Discuss the logistics of TDM programs for biologics, in particular: for which drugs is this strategy appropriate, the relevant patient populations, methodological considerations (proactive vs reactive), as well as enabling technologies and bioanalytical methods