Parexel International has unveiled its new Oncology Center of Excellence. The center combines the company’s experienced, multi-disciplinary team specialized in oncology with early advisory services to bring breakthrough treatments to market faster for the patients who need them most. The center will be co-led by Amy McKee, MD, vice president of regulatory consulting services, Parexel and former deputy director of the FDA’s Oncology Center of Excellence, and Todd Shuster, MD, corporate vice president and global therapeutic area head of oncology/hematology, Parexel.
 
With the unveiling of the Oncology Center of Excellence, Parexel is debuting its Early Advisory Service for oncology, through which sponsors have access to the expertise needed to optimize the development pathway at the earliest stages, including regulatory strategy, strategic consultation on study design, operational planning and development as well as the incorporation of evidence generation to quantify the value of an asset for market access.
 
“In oncology drug development, the involvement of specialized experts and regulators early in the process is critical to success down the line,” said Dr. McKee. “Globally, we are seeing shifts in the regulatory environment that have produced increased opportunities for early collaboration with regulators. With the Oncology Center of Excellence, Parexel combines access to insights from former regulators as well as expertise in early protocol design and development to expedite, optimize and simplify trial design and execution.”
 
Dr. Shuster added, “With extensive experience in global oncology drug development, our therapeutic area team has seen the impact of clinical trial success as well as failure in the journey to bring much-needed treatments to the patients who need them. Our team understands and sincerely cares about these patients, and we are each personally committed to ensuring that clinical trials are optimally designed and operationalized to efficiently and accurately evaluate the safety and efficacy of new therapies. By working alongside our biopharma industry colleagues from the very earliest stages in the development process, we can help decrease timelines, improve the likelihood of study success and bring potentially life-changing new therapies to patients faster.”