On February 24, 2016 Kite Pharma, Inc. (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous cell therapy (eACT) products for the treatment of cancer, reported the formation of the company’s integrated commercial leadership team with the appointment of three senior-level industry executives (Press release, Kite Pharma, FEB 24, 2016, View Source [SID:1234509179]). The team will be responsible for all aspects of commercial and medical affairs strategy, planning, and analysis for the potential launch of KTE-C19, an investigational engineered T cell therapy for patients with relapsed and/or refractory B cell malignancies.
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The new commercial and medical affairs leadership team includes Diane L. Parks, Senior Vice President, Marketing, Sales & Market Research; Elizabeth A. Faust, Ph.D., Vice President, Medical Affairs; and Kimberly A. Metcalf, Vice President, Customer Engagement, Training & Development. The group will report to Shawn Tomasello, Kite’s Chief Commercial Officer. Dr. Faust will also report to Jeff Wiezorek, M.D., M.S., Senior Vice President of Clinical Development.
"Commercial readiness is a top priority for Kite as we prepare for pivotal data from the ZUMA-1 study and potential U.S. regulatory filing for KTE-C19 this year," said Arie Belldegrun, M.D., FACS, Chairman, President, and Chief Executive Officer. "Such a potentially transformative therapy as KTE-C19 will require a creative and strategic commercialization model to optimize access and impact for patients. We believe this proven and accomplished team, under the direction of Shawn Tomasello, can deliver on this promise."
"It is a privilege to welcome Diane, Elizabeth, and Kimberly to Kite," said Shawn Tomasello, Chief Commercial Officer. "As a group, they bring the range of critical skills and proven capabilities needed to prepare for commercialization. They have been closely involved in the launch of several major oncology therapies, and they understand how markets are reshaped by therapeutic innovations that improve patient outcomes. Our team is already fully engaged in market analysis and strategy development activities."
Diane L. Parks, Senior Vice President, Marketing, Sales & Market Research
Ms. Parks joins Kite from Pharmacyclics, where she was Vice President of Marketing. During her tenure at Pharmacyclics, Ms. Parks led the development and execution of all global marketing strategies for IMBRUVICA. Previously, she held senior leadership roles as Vice President of Sales for Amgen, representing oncology and nephrology products, and Senior Vice President of Specialty Biotherapeutics and Managed Care at Genentech, where she led the launches of multiple products as well as commercial development of LUCENTIS and RITUXAN. Ms. Parks began her career at Marion Merrell Dow. She holds a BS from Kansas State University and an MBA from Georgia State University.
Elizabeth A. Faust, Ph.D., Vice President, Medical Affairs
Prior to joining Kite, Dr. Faust was Vice President of Medical Affairs at Pharmacyclics, during which time she planned and successfully executed four IMBRUVICA launches for various indications. Before Pharmacyclics, Dr. Faust was Vice President of Clinical Sciences Research at Celgene Corporation, serving as the national lead for oncology Regional Medical Liaisons in the US, and as Senior Director of Medical Affairs at Gloucester Pharmaceuticals, which was acquired by Celgene in 2010. From 1995 to 2007, Dr. Faust held roles of increasing responsibility in research, development, and medical affairs at Amgen, including Executive Director, Oncology Regional Medical Liaisons. Dr. Faust has co-authored numerous publications and was the former President-Elect for the Pacific Southwest Chapter of the American Medical Writers Association. She holds a BS in microbiology from Auburn University, a MA in biology from University of California Riverside, and a PhD in microbiology and molecular genetics from University of California Los Angeles.
Kimberly A. Metcalf, Vice President, Customer Engagement, Training & Development
Ms. Metcalf most recently served as Vice President of Commercial Training and Administration at Pharmacyclics, where she was responsible for developing and executing commercial and medical affairs training including launch plans for IMBRUVICA. Previously, she spent eight years at Celgene Corporation where she contributed significantly to building the commercial training department and assumed roles of increasing responsibility in commercial training, market access, and sales and marketing operations, including Executive Director, US National and Regional Accounts. During her tenure at Celgene, she launched POMALYST, ISTODAX and OTEZLA. Ms. Metcalf began her career in biopharma at Pfizer. She holds a BS from Northwestern University, an MBA from West Chester University, and a Master of Health Systems from The University of Medicine & Dentistry of New Jersey.
About KTE-C19
KTE-C19 is an investigational therapy in which a patient’s T cells are genetically modified to express a CAR designed to target the antigen CD19, a protein expressed on the cell surface of B cell lymphomas and leukemias. Kite is currently enrolling four pivotal studies (also known as ZUMA studies) for KTE-C19 in patients with various B cell malignancies. The U.S. Food and Drug Administration has granted Breakthrough Therapy Designation status to KTE-C19, for the treatment of patients with refractory diffuse large B cell lymphoma, primary mediastinal B cell lymphoma, and transformed follicular lymphoma. KTE-C19 has also secured Orphan Drug Designation in the U.S. for DLBCL and in the EU for various hematological indications.