Oncology

Arming you in the fight against cancer.

We put all we’ve got into cancer clinical development. Because for many families, it’s all they’ve got. And while oncology is the largest therapeutic area in clinical trials today at 27%[1], it’s also the area with the largest Phase III failure rate.

That’s why we work with more urgency than ever in today’s complex development environment. Our Strategic Working Groups (SWG) make use of networks of knowledge, bringing together our most seasoned physicians and other knowledge-leaders in the industry specializing in medical imaging, translational research, biostatistics, operational strategy, and regulatory experts.

This depth of knowledge allows our Strategic Working Groups to support:

  • Immuno-oncology
  • Hematologic malignancies
  • Lung cancer
  • Breast cancer
  • GI malignancies
  • Early product development
  • Benign hematology
  • Biosimilars
  • Cytotoxics
  • Targeted therapeutics
  • Cancer vaccines
  • Immunotherapy
  • Supportive care therapies

 

Growth of Immuno-Oncology Studies

As new avenues of personal and precision treatment open, Parexel created our immuno-oncology SWG to keep pace. We’ve formed this group with people who have dedicated their careers to immuno-oncology and can therefore help with a range of development activities, including medical oncology, immunology, medical imaging, biostatistics, regulatory affairs, and translational research biomarkers.

As immunotherapy expands in other disease areas, this group shares cross-functional knowledge to develop better solutions for more advanced care.

Strengths of our Oncology team include:
  • Experience in all solid tumor types (particularly breast cancer, lung cancer, melanoma, gastrointestinal cancers, genitourinary cancers, and brain tumors) as well as hematological malignancies (particularly non-Hodgkin lymphoma, chronic lymphocytic leukemia and acute myeloid leukemia), including in depth understanding of epidemiology, pathogenesis, diagnosis, prognosis, biomarkers, global standards of care and state-of-the-art investigational therapies
  • Extensive leadership in medical feasibility studies, providing critical data about regions, countries, sites, and investigators, including local patterns of care, quality of care, and competing trials
  • Expertise managing complex oncology trials in Phase I-IV in every region. Our experience in Early Phase Development (Phase I to Proof of Concept) is expanding more rapidly than any other phase of clinical development and creation of site alliances with experienced Phase I Oncology Units globally has significantly increased our capabilities in this growing area
  • Industry-leading knowledge in central review of medical imaging/clinical data for all phases, including reviews for regulatory submission for Breakthrough Therapy designations, accelerated and full approval. Highlighting this expertise is our applied experience with immune-related RECIST criteria and recently introduced Lugano Criteria (Cheson) for lymphomas
  • Previous experience in academic medicine, hospital-based clinical practice, clinical and laboratory research, and in some cases, ongoing appointment on the medical faculty at teaching hospitals
  • Deep expertise in non-clinical and early drug development and regulatory consulting
  • Maintenance of oncology board certification and service on editorial boards of major oncology journals
  • Maintenance of relationships with key investigators and key opinion leaders
  • Active participation in international professional organizations including the American Society of Clinical Oncology (ASCO), American Association for Cancer Research (AACR), American Society of Hematology (ASH), and European Society of Medical Oncology (ESMO)/ European Cancer Conference (ECCO)

 

[1] Pharmaprojects Pharma R&D Annual Review, 2016, pg. 12.

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