LSIPR 50 2018: Elaine Waller
Name: Elaine Waller
Organisation: Seattle Genetics
Position: Executive Vice President, Regulatory Affairs
Elaine Waller joined Seattle Genetics in September 2008, bringing with her more than 20 years of experience in regulatory affairs and clinical research.
During her tenure, the US Food and Drug Administration accepted for filing a supplemental Biologics License Application (BLA) for a Seattle Genetics drug to fight advanced Hodgkin lymphoma.
"She previously worked with Sonus Pharmaceuticals where she served as senior vice president, regulatory affairs/quality assurance and clinical research."
The drug, Adcetris (brentuximab vedotin), is used in combination with chemotherapy. The BLA was granted based on positive results from a phase 3 clinical trial that was designed to see whether Adcetris, in combination with chemotherapy, could extend modified progression-free survival in previously untreated advanced classical Hodgkin lymphoma patients.
Prior to her position at Seattle Genetics, Waller gained years of experience in her chosen field. She previously worked with Sonus Pharmaceuticals where she served as senior vice president, regulatory affairs/quality assurance and clinical research until its merger with OncoGenex Pharmaceuticals in 2008.
Other experience includes roles as chief operating officer at clinical site management organisation, Radiant Research, and senior positions in regulatory affairs and clinical research at Hoechst Marion Roussel and Marion Merrell Dow—predecessor companies to Sanofi.
Waller’s career began at the University of Texas where she taught pharmacy education at both graduate and undergraduate levels. She was also assistant director of clinical research at the Drug Dynamics Institute.
