CLINICAL TRIALS
What to consider when running a clinical trial
, director of Preclinical Development at Double Bond Pharmaceutical, discusses innovative product development.
Our DBP is developing SI-053, a novel drug product consisting of Temozolomide formulated as a hydrogel, intended for local administration to the tumour bed during the surgical resection in newly diagnosed glioblastoma (GBM) patients. As a micro company, aiming to perform a clinical trial might sound unrealistic. But although we face
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many challenges on a daily basis, our front-line product SI-053 is on the way to being approved to start the multisite Phase 1 clinical trial in subjects with GBM in Q1 2022.
What are the key considerations when running a clinical trial as a small biotech? As a small pharma company, we need to consider two main factors: time and money. These constraints don’t only affect micro-sized companies, but at DBP we work as smartly as possible to overcome future difficulties. We started by: building a strong and knowledgeable team internally; performing (several) risk assessments; promoting significant discussions with experts in the field; and, finally, choosing the best key opinion leaders (KOLs) and subcontractors. It’s important to work effectively when designing and running a clinical trial. Therefore, knowing the
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