BOSTON--(BUSINESS WIRE)--Parexel International, a leader in supporting the biopharma industry in oncology drug development, today unveiled its 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 Amy 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.”
Today, oncology is the most active area of clinical research, accounting for 36% of all clinical trials1, but it has also been found to be the therapeutic area with the lowest success rates, underscoring the need for specialized, integrated expertise in order to bring solutions to patients effectively. Parexel’s Oncology Center of Excellence provides access to global subject matter experts across various functions, including medical, regulatory, biostatistics, genomics/biomarkers, feasibility, pharmacokinetics, medical imaging, medical writing and others to provide holistic, strategic input into tailored oncology development plans. Parexel’s team has completed more than 425 clinical projects in oncology and enrolled over 70,000 patients in oncology clinical trials in the past five years.
“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,” said Todd Shuster. “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.”
Parexel will be introducing the Oncology Center of Excellence at the 2019 ASCO Annual Meeting, May 31-June 4, booth #3097. For more information on Parexel’s oncology expertise and the Center of Excellence, visit https://www.parexel.com/experience/therapeutic-expertise/oncology-study-experience.
About Parexel
Parexel is focused on the development of innovative new therapies to improve outcomes for patients. We partner with biopharmaceutical customers across the globe to transform scientific discoveries into new treatments for patients. Our therapeutic, technical and delivery ability is underpinned by a deep conviction in what we do. For more information, visit our website and follow us on LinkedIn and Twitter.
Parexel is a registered trademark of Parexel International Corporation. All other trademarks are the property of their respective owners.
1 PharmaProjects (accessed February 13, 2019)
