Amy McKee, MD, vice president of regulatory consulting services, and former deputy director of the US Food and Drug Administration’s (FDA) Oncology Center of Excellence, will co-lead the new center with Todd Shuster, MD, corporate vice president and global therapeutic area head of oncology/hematology.
“There is an unmet need for more effective and better-tolerated therapies for patients affected by cancer, and the new Oncology Center of Excellence at Parexel enhances our ability to help our biopharmaceutical clients bring such treatments to the patients who need them, with greater efficiency and speed," Shuster told us.
"Creation of the Center of Excellence will enable us to better leverage the depth and breadth of our capabilities and to create important synergies across these different areas at a time when new immunologic, cellular, and targeted therapies demand this level of expertise," he added.
According to the company, oncology currently accounts for 36% of all clinical trials - and requires a "multidisciplinary approach," Schuster said.
In conjunction with the center’s launch, Parexel also is debuting an “Early Advisory Service” for oncology.
According to the contract research organization (CRO), the service will support sponsors with regulatory strategy, study design, operational planning and development. The service also will help quantify the value of a company’s asset for market access.
Parexel earlier this year launched a new division dedicated to the needs of small biotech.
The division – Parexel Biotech – offers a new biotech-focused team and organizational structure for customers, and is led by James Anthony, global head of biotech, and Graciela Racaro, global head of biotech operations.
Parexel Biotech will support emerging companies from development through commercialization with tailored services and customized guidance, according to the company.
