For every product in our pipeline, BioLineRx designs a comprehensive development plan to take the candidate through regulatory approval. We emphasize critical path planning and indication selection in order to maximize the product’s potential. BioLineRx implements this development plan using certified CRO’s and regulatory agency compliant materials and testing. Through early and continuous dialog with the FDA, other regulatory agencies, and leading regulatory advisors, BioLineRx ensures that the product development progresses as efficiently and effectively as possible.

BioLineRx places a particular emphasis on clinical proof of safety and efficacy and all of our clinical trials are designed to produce clinical results that are medically and statistically relevant. Well implemented Phase 1 studies determine safety and tolerability and underpin the design of subsequent clinical phases when the drug is tested for efficacy.

BioLineRx’s philosophy regarding more advanced clinical trials mirrors that of the FDA where, according to John Jenkins, director of the Office of New Drugs at the FDA's Center for Drug Evaluation and Research "Companies that are good at drug development have always recognized that Phase 2 is the critical place to weed out drugs that don't have a good future in terms of safety or efficacy." Our decision to place special emphasis on and invest significant financial resources in substantial and high quality trials is driven by our commitment to identifying high potential drug candidates for further development. Once small scale proof of clinical safety and efficacy is achieved, investment in pivotal clinical trials leading to regulatory approval can be justified.