
Readying Your Science for the Real World
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Oncology is the largest therapeutic area in clinical trials today at 27%[1]. Conversely, it’s also the therapeutic area with the largest Phase III failure rate.
In today’s complex environment, biopharmaceutical companies require an innovative partner that has proven clinical and scientific oncology experience to help them navigate the drug development journey.
To meet this need, PAREXEL has made significant investments in growing our global team of 40+ oncology-hematology multifunctional experts, as well as understanding the monumental advances being made so rapidly in clinical cancer research. It is also why we created a number of focused Strategic Working Groups (SWG) which bring together our most experienced physicians and other multifunctional experts (including medical imaging, translational research, biostatistics, operational strategy, and regulatory) to offer a higher level of expertise internally within PAREXEL and externally to our clients. These SWGs include Immuno-Oncology, Hematologic Malignancies, Lung Cancer, Breast Cancer, GI Malignancies, Early Product Development, Benign Hematology, and Biosimilars. Based on program design expertise, operational excellence and project leadership, PAREXEL can help clients achieve their development goals and bring safer, more effective treatments to patients without delay.
[1] Pharmaprojects Pharma R&D Annual Review, 2016, pg. 12.
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.
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).
Learn why drug development today is more than a process. It's a journey. Click here.