Tiziana Life Sciences PLC (NASDAQ:TLSA, LON:TILS) has appointed a vice-president of regulatory affairs.
Dr Kevin Shutz, who has 19 years pharma industry experience, 14 of them in the regulatory field, will lead clinical trial ‘interactions’ with drug watchdogs in the US, Europe and Asia.
"Dr Schutz brings extensive hands-on experience working with regulatory agencies including the FDA [US Food & Drug Administration], EMA (European Medicines Agency], and PMDA [in Japan], among others,” said Dr Neil Graham, Tiziana’s chief medical officer.
“His background will greatly strengthen Tiziana's global development capabilities in regions where the company is actively pursuing clinical development.”
One of the key aspects of his role will be helping Foralumab, the company’s antibody treatment being developed for multiple sclerosis and COVID-19, through the regulatory hoops.
It is being assessed in some indications as the world’s first nasally-administered antibody treatment.