Description
In this presentation, Iain Murray discusses the critical challenges in translating exciting preclinical data into effective clinical treatments in the field of biologics. Despite promising advances, there remains a significant gap in robust clinical evidence for many treatments. The key barriers identified include the ambiguity of nomenclature used to describe biologics and inadequacies in detailing experimental procedures. Murray emphasizes that unclear terminology can lead to misunderstandings about the origins and characteristics of treatments, complicate regulatory processes, and expose patients to misinformation.
He outlines how the evolving nature of scientific knowledge necessitates changes in terminology and highlights the proliferation of diverse names used for similar products, which can lead to exploitation by those seeking to market subpar treatments. Murray uses mesenchymal stem cells (MSCs) and platelet-rich plasma (PRP) as examples to illustrate the importance of clear definitions and standardization in these therapies. He notes that even within clinical studies, there is often inadequate reporting of the details of the biologic preparations used, which hinders replication and validation of research results.
To address these issues, Murray advocates for a systematic approach to improve the clarity of descriptions for cell therapies, suggesting that five key attributes should always be reported: donor type, origin of the tissue, separation details, expression profile, and delivery site. He supports the need for minimum reporting guidelines, which have already shown to improve clarity and integrity in research publications. The goal is to bridge the gap between science and bedside application through a coordinated global effort involving clinicians, scientists, industry, and regulators, ensuring transparency and comprehensiveness in the reporting of biologics.