Oncology

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

 

Growth of Immuno-Oncology Studies

Immuno-oncology (I-O) clinical trials are emerging as an increasingly important activity within a rapidly expanding field of precision-oriented cancer drug development. PAREXEL’s I-O SWG was created to keep pace with these extraordinary and exciting new advances.  It is comprised of our leading experts in immuno-oncology across a number of functions, including medical oncology, immunology, medical imaging, biostatistics, regulatory affairs, and translational research biomarkers. The members of the I-O SWG have participated in trials for many different classes of cancer therapeutics including extensive work in cytotoxics, biologics, targeted therapeutics, cancer vaccines, immunotherapy, and supportive-care products.

The I-O SWG meets regularly to review recent advances in the field from the medical literature and recent scientific meetings, current immuno-oncology projects, recent regulatory approvals/rejections, the competitive environment, and future perspectives. Considering the fact that immunotherapy is being utilized in other disease specific indications, the I-O SWG interacts with other disease-oriented Working Groups. Members of the PAREXEL I-O SWG represent the core team that will interface with our immuno-oncology counterparts and colleagues in pharmaceutical and biotechnology companies developing novel immuno-therapeutic agents.

 

The PAREXEL Difference

Our project teams are assembled in consultation with Therapeutic Area Experts on the basis of recent and relevant experience with specific indications, expertise with the class of investigational agents and their mechanisms of action, the phase of study, the type of investigative sites and familiarity with key opinion leaders in the field.  Our teams also have an in-depth understanding of the competitive environment and global and regional standards of care for specific indications and lines of therapy.  We apply lessons learned from the development of similar agents, including provision of proactive solutions to potential issues. 

Specific Strengths of our Oncology experts 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 experience with 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 expertise 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).