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

Clinical trial applications for biologicals – a UK regulatory clinical perspective

Abstract: With increasing numbers of clinical trials involving biological medicinal products, they have become a topic of much discussion regarding quality, including the upcoming quality guideline, as recently discussed in this journal. But what of the clinical aspects to these trials? This article provides some insight into the review process of biological clinical trial applications (CTAs) by the MHRA Clinical Trials Unit (CTU) that may then assist in future applications. It should be remembered that, as with all clinical trials, academic and non commercial trials are subject to the same scrutiny as commercially-sponsored biological trials regardless of the use biological products. 

Author: Kirsty Wydenbach, Medical Assessor, Clinical Trials Unit, Medicines and Healthcare Products Regulatory Agency (MHRA), London, UK.

Cited on: Regulatory Rapporteur – Vol 9, No 5, May 2012, TOPRA.

Further Information: Clinical trial applications for biologicals: a UK regulatory clinical perspective