Speaking to Outsourcing-Pharma Rami Efrati, CEO of BrainStorm Cell Therapeutics, explained that his business will only outsource to well known companies because of the benefits they bring.
According to Efrati trials conducted at a well known and reputable contract research organisation (CRO) will be better received by regulatory authorities, which is an important factor for BrainStorm as it prepares to enter clinical trials.
BrainStorm has contracted Harlan Biotech Israel (HBI) to conduct safety trials of its amyotrophic lateral sclerosis in mice in preparation for applying to the Israeli Ministry of Health to conduct Phase I.
The decision to outsource was motivated by a lack of in-house capacity but Efrati added that even if BrainStorm had the capabilities he would have used a CRO.
This is in part motivated by the perceived benefits with regulatory agencies but also because Efrati believes there are advantages to having external personnel view the product and data.
The deal with HBI was preceded by a contract manufacturing deal with Protein Production Services (PPS), which will provide materials for the preclinical safety trial.
BrainStorm entered into the two contracts after it received funding from the Israeli government’s Office of the Chief Scientist and from a private investor, which enabled the company to commence the final preclinical steps.
Once this is complete BrainStorm intends to enter Phase I trials and Efrati said that further outsourcing will be needed at this stage. He explained that BrainStorm lacks the capacity to do clinical trials or manufacture current good manufacturing practice (cGMP) compliant materials.