The efficient translation of discovery projects to clinical trials is necessary to improve productivity, decrease the risk of R&D projects, and ultimately deliver better medicines to patients faster.
Clinical and discovery groups in pharmaceutical and biotechnology companies are increasingly working together to share insights about the potential clinical impact of biomedical discoveries much earlier in the process.
Biomarkers are an essential part of such a translational effort and are critical to understanding human disease. Human biospecimens can provide a bridge between the early discovery and molecular mechanism of the disease and the clinical utility. Commonly, human biospecimens are used to:
In the discovery phase of a project, it’s important to use biospecimens that accurately reflect the phenotype of patients who will be involved in clinical trials later. For example, if they’re studying potential markers or drug responses for a disease that has several different subtypes, researchers should acquire specimens from patients with that specific subtype of the disease. Or if the trial revolves around certain responses in patients who exhibit early stages of a disease, the biospecimens should be taken from patients in those early stages.
There are typically three main areas that need to be considered when planning biospecimen collections: the characteristics of the biospecimen (biological), the characteristics of the patient (clinical), and the budget and timeline required (operational).
Unfortunately, it can be difficult for researchers in discovery and preclinical areas to apply a comprehensive understanding of patient clinical data, even when trying to find the right biospecimens.
Additionally, budgets and timelines are often hard to predict at the beginning of a project. Unlike an online search engine, however, there’s usually no single source of information to find out whether available specimens meet the exact criteria. Therefore, the procurement can be a slow, manual process of calls and emails between researchers and vendors trying to identify what kinds of biospecimens might be available. It can take days, weeks, or even months to obtain the necessary samples, depending on the specific requirements.
Further complications arise when information gets lost in translation. A vendor may not ask for particulars, such as the necessary subtype of the disease in question, and the researcher might not know to specify. Such details, if ignored, can impact the biological significance of the discoveries made with the use of biospecimens, resulting in failure during the validation, translational, or clinical phases.
The risks can be mitigated when researchers have clear, comprehensive clinical information, in addition to biological information, as early as the discovery and preclinical phases.
When researchers have reliable, transparent data on the biospecimens early on and can choose those that most accurately reflect the types of patients who will be enrolled in the clinical trial, the risks of failure are substantially reduced.
Here are four areas to consider to accurately plan projects that require human biospecimens:
Published by Kate Torchilin Ph.D. in Pharma iQ
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