Geron Corporation reinforces in-house development team to boos phase 3 trial of imetelstat

Geron Corporation has included the first of several key leadership positions in rebuilding its in-house development team to boost a Phase 3 clinical trial of imetelstat in lower risk myelodysplastic syndromes by mid-year 2019.

Geron on Thursday announced hiring Israel Gutierrez, M.D., as Vice President, Pharmacovigilance and Drug Safety, as of January 16, 2019.

Geron said Dr. Gutierrez will lead and direct the oversight of clinical drug safety risk management and compliance at Geron and will be responsible for product safety-related recommendations and decisions. Additionally, he will be responsible for ensuring compliance for all current and planned imetelstat clinical trials in accordance with domestic and international requirements for drug safety oversight and reporting from late-stage development through commercialization. As the senior pharmacovigilance expert, Dr. Gutierrez will lead and oversee pharmacovigilance signal detection and risk management activities and risk mitigation strategies, as well as represent medical safety at all meetings with regulatory authorities, the company said.