Considerations in the clinical development of biotech medicines

Article from TOPRA,  Regulatory Rapporteur –  Vol 10, No 1, January 2013

Overview: Development of biotech medicinal products presents a number of challenges. These can arise from the therapeutic area under investigation – many product applications are in therapeutic settings such as oncology or rheumatology, where ethical considerations must be observed. However, by the very nature of protein therapy, immune responses can lead to a lack of efficacy or adverse events in the patient. Immunogenicity can be triggered not only through the nature of the product but also external influences on the protein structure. Manufacturing development and scale-up to meet demands of large-scale clinical trials should be considered in parallel with clinical scrutiny – comparability is critical in this process. Therefore the design of the clinical programme must take into account many factors, but also generate compelling data to establishing therapeutic efficacy

Authors: Cecil Nick, Vice President Technical, PAREXEL Consulting

Reference: Considerations in the clinical development  of biotech medicines