Led by Dr. Kinneret Savitsky, BioLineRx's pre-clinical drug development program is referred to as BioLine Innovations Jerusalem (BIJ), and is supported by the Israeli Office of the Chief Scientist's national biotechnology initiative. As the sole recipient of a $21 million grant for the development of pre-clinical compounds, BIJ is uniquely positioned to take early stage compounds through rigorous pre-clinical tests on their way to clinical trials.

The first step in the pre-clinical development process at BIJ is detailing the critical pathway to approval of a lead compound and translating the pathway into a comprehensive development plan. This plan includes the determination of initial primary indication, proactive formulation of regulatory strategy, sourcing of required materials at GLP and GMP levels, design of required preclinical experiments, and identification of appropriate models. Proper project planning focused on regulatory approval and drug marketing, in a portfolio environment where no single project or technology determines the future of the company, allows BioLineRx to follow the critical pathway and make appropriate go/no-go decisions.

Our preclinical tasks provide an additional level of comfort on safety and efficacy, and serve as the basis for Investigative New Drug (IND) applications. These tasks include chemistry and formulation, dosage form, metabolism, pharmacokinetics and toxicology and use well accepted animal models for repetition of efficacy studies using GLP materials.