PAREXEL Expands Oncology Expertise Through FDA and Medical Oncologist Appointments
“As oncology trials increase and become more complex, it is imperative to PAREXEL that we bring together the perspectives of key stakeholders in drug development – including regulatory bodies and the patient perspective,” said Peyton Howell, Chief Commercial and Strategy Officer, PAREXEL. “Coming from world-renowned organizations, these experts will work across PAREXEL to implement an approach for our clients that takes diverse viewpoints into consideration, and ultimately drives the delivery of important new therapies to patients battling cancer.”
Amy McKee, M.D., will serve as Vice President, Regulatory Consulting Services and brings 11 years’ experience in the FDA. During her time at the FDA she held several positions such as Deputy Center Director of the Oncology Center of Excellence, Supervisory Associate Director of the Office of Hematology and Oncology Products (OHOP) and Deputy Office Director of OHOP, among others. While at the FDA, Dr. McKee was the signatory authority for products within OHOP. She was responsible for four divisions performing the scientific review and evaluation of hematology and oncology therapeutic drugs and biologics subject to regulation by the Center for Drug Evaluation and Research (CDER). Dr. McKee reviewed numerous new molecular entities for marketing approval in oncology, with a focus on targeted therapy drug development and clinical trial endpoints. Dr. McKee also has expertise in early-phase drug development and improved dose-finding, including work on new methodologies for early dose-finding trials. Globally, Dr. McKee managed an international regulatory program with outreach and program development with the European Medicines Agency (EMA) and other regulatory bodies. Dr. McKee is a board-certified Pediatric Hematologist-Oncologist with specific expertise in the treatment of neuroblastoma.
Matthew M. Cooney, M.D., joined PAREXEL in January 2019 as a Senior Medical Director, Global TA Lead Oncology/Hematology within Global Medical Services. Dr. Cooney is board-certified in Medical Oncology, Hematology, and Internal Medicine. He graduated from Case Western Reserve University School of Medicine and completed his residency and fellowship at University Hospitals and the Case Comprehensive Cancer Center. Dr. Cooney practiced clinical hematology and oncology for over 15 years with and was the Interim Division Chief as well as the Program Leader for Genitourinary Oncology. Dr. Cooney has significant expertise in the areas of genitourinary malignancies including prostate, bladder, and kidney cancer and in the use of wearable technologies and patient-reported outcomes in oncology.
About PAREXEL International
PAREXEL International Corporation is a leading innovator of global biopharmaceutical services. We simplify our clients’ journey of transforming scientific discoveries into new medical treatments for patients with high-quality Phase I-IV clinical research, regulatory, consulting and market access services. PAREXEL helps to develop innovations and solutions by leveraging its comprehensive therapeutic, technical and functional expertise, in more than 100 countries around the world. For more information, visit our website and follow us on LinkedIn and Twitter.
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Source: PAREXEL International