Developing armed antibodies for cancer
Company: Seattle Genetics
Title: Vice President of Regulatory Affairs & Clinical Development Operations
Bringing more than 20 years of regulatory and clinical research experience with her, Elaine Waller joined Seattle Genetics ($SGEN) in 2008--a critical point in time for the company, which was preparing plans for a pivotal clinical trial of SGN-35 (brentuximab vedotin) for Hodgkin lymphoma at the time.
In fact, Waller's prior experience of collaboration with FDA helped her land the job in the first place.
"A strong senior management team is essential to the successful execution of our aggressive corporate goals, including moving SGN-35 into pivotal trials planned for 2009," said Seattle Genetics CEO Clay Siegall in 2008, when Waller was hired.
SGN-35 was Waller's first big win for the company, gaining FDA approval in 2011 under the name Adcetris to treat Hodgkin lymphoma and a rare lymphoma known as systemic anaplastic large cell lymphoma.
With an eye toward more approvals, Waller is leading clinical research of SGN-CD33A to treat acute myeloid leukemia and SGN-LIV1A for patients with patients with LIV-1-positive metastatic breast cancer. Both those investigational therapies are in Phase I clinical trials. Looking to expand its use of Adcetris, in August the company launched a Phase II trial for the drug in diffuse large B-cell lymphoma.
Before joining Seattle Genetics, Waller was with Sonus Pharmaceuticals, where she served as senior vice president of regulatory affairs, quality assurance and clinical research until its merger with OncoGenex Pharmaceuticals in August 2008. Prior to that, she was chief operating officer at Radiant Research, a clinical site management organization.
Waller's previous experience includes senior positions in regulatory affairs and clinical research at Hoechst Marion Roussel and Marion Merrell Dow. She began her career in academia at the University of Texas at Austin, where she taught both undergraduate and graduate pharmacy education and was assistant director of Clinical Research at the Drug Dynamics Institute.
Leading the charge in the development of ADC-s, otherwise known as antibody-drug conjugates or armed antibodies, Seattle Genetics has made a slew of deals recently with big-name partners like AbbVie ($ABBV), Genmab and Bayer.
Genmab re-ups with Seattle Genetics on a $211M armed antibody cancer drug pact
AbbVie adds a slate of $255M wagers on Seattle Genetics' 'armed' antibody cancer tech
Bayer beefs up cancer drug pipeline with $520M armed antibody deal with Seattle Genetics
-- Emily Mullin (email | Twitter)