Parexel Unveils Oncology Center of Excellence to Support Acceleration of Patient-Focused Oncology Drug Development

• Center will be co-led by Amy McKee, former Deputy Director of the
  FDA’s Oncology Center of Excellence, and Todd Shuster, Parexel’s
  Global Therapeutic Head of Oncology/Hematology
• Parexel’s new Early Advisory Service combined with a
  multi-disciplinary team focused on oncology help bring breakthrough
  treatments to market faster for the patients who need them most

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)

Contacts

Parexel Contacts:
Media:
Wendy Ryan
Tel.: +1
781-434-5104
Email: [email protected]

Kathryn
McMahon Arrigg, PAN Communications
Tel.: +1 617-502-4300
Email: [email protected]