In a recent article for PMLiVE and Pharmaceutical Market Europe, Dr Jorg Taubel, CEO of Richmond Pharmacology, outlines the future of new medicine development, influenced by the emergence of gene-based therapies and the reshaping of the way first-in-human clinical studies are delivered.
The article focuses on how and why first-in-human (FIH) studies are the foundation of therapeutic development and new medicines discovery, an essential stepping-stone, leading to more detailed patient studies and eventually medicines approved by regulators for mainstream use. Dr Taubel also highlights recent sector evaluation indicating that the UK is the leading location for phase I studies in Europe.
The new wave of advanced therapies presents exciting opportunities and challenges in clinical research. A series of precision medicines based on genomic technology have been approved for the treatment of cancers in recent years and this is now extending into trials in numerous conditions where there is significant need – in cardiology, neurological conditions, and rare genetic conditions. The increased development and use of genomic therapies mean that clinical research is going through a steep reform and need to adapt and plan accordingly. Volunteer enrolment is one such change, whereas previously, FIH studies demanded a selection of healthy participants, genomic medicine trials frequently require patients with the relevant condition and sometimes the genetic biomarker that the therapy will target. This presents greater challenges in sourcing and correctly managing the right type of patient.
CROs, such as Richmond Pharmacology, that specialise in delivering FIH studies and testing advanced therapies directly in patients are transforming the way trials are delivered and data is analysed. The result is substantial time and resource savings for sponsors which facilitates faster progress to phase II & III studies and eventually approved medicines reaching the patients who need them.
To read the full article, click here.