Get comprehensive support for both benign and malignant hematologic conditions
Novel treatments that have proved effective in countless disorders – of the brain, the immune and respiratory systems, internal organs, metabolism, hormones – have origins in the study of hematology. Cell and gene therapies, antibody drug conjugates, radioimmunotherapy, bi-specific antibodies: these are among the many scientific advances bringing hope to millions of patients dealing with conditions both rare and prevalent.
At Parexel, specialists in hematology have long been at the cutting edge of these innovations, treating tens of thousands of patients participating in clinical trials from first-in-human to post-market studies. We have demonstrated leadership in the success of hundreds of therapies now on the market, working with drug developers from small and midsize biotechs to large enterprises. Our medical team is experienced in management of a spectrum of hematological indications, including lymphoma, acute myelogenous leukemia (AML), myelodysplastic syndrome (MDS), multiple myeloma, and benign and malignant disorders.
Parexel excels in implementing complex and innovative study designs in hematology, including external control arms, virtual and decentralized trials, and adaptive designs. We are also capable of leveraging new data sources, including real-world data (RWD), to enhance study designs, support regulatory submissions, and inform payer decisions. Our expertise allows us to accelerate execution of clinical trials while maintaining flexibility in our approach, ensuring seamless execution of clinical research that has the potential to greatly impact patient’s lives. In addition, Parexel's regulatory team offers comprehensive expertise in hematology drug development, providing strategic guidance on complex regulatory requirements and facilitating efficient pathways to market for innovative hematological therapies.
Our experts in hematology
Scott Smith, M.D., Ph.D.
Senior Vice President, Global Therapeutic Area Head - Hematology
Heidi Cho, M.D.
Therapeutic Area Head - Hematology
Liesel Badenhorst
Senior Clinical Operations Leader
Katherine Minson, M.D.
Senior Medical Director
Sinan Sarac, M.D., Ph.D., M.Sc.
Senior Vice President, Head, Regulatory Strategy Europe
Hematology experience in the past 5 years
+
clinical projects
+
enrolled patients
+
sites
Indications
Lymphoma
Parexel is a global leader in lymphoma with significant experience in B-cell, T-cell, follicular, Hodgkin’s, non-Hodgkin’s, and mantle cell lymphoma. We maintain strong relationships with patient advocacy groups specific to this therapeutic area.
Our team conducted the first-ever comparator cohort study by a company seeking approval in the U.S. and EU for a lead product in oncology rare disease in lymphoma. For this Phase II, single-arm open-label study, Parexel deployed a unique study design bringing together real-world evidence, clinical operations, and regulatory expertise. We optimized project planning to include validation, interim analyses, and full reporting. The study was completed in 15 months, allowing the sponsor to file with regulatory authorities 9 months ahead of schedule.
Acute myelogenous leukemia (AML)
AML is a debilitating disease that progresses rapidly, requiring fast enrollment and treatment initiation for clinical trials. Over the past five years, Parexel has conducted more than 30 studies for treatments targeted to AML. For one study, a Phase II trial for patients with untreated AML, we enrolled 130 patients in France and the U.S., diligently reviewing the eligibility criteria and providing direct support to the sites. We used a single lab, with a short window for processing genetic testing related to inclusion criteria. Our team carefully managed complex data capture with dose-modification tracking of IP and disease response assessments in the EDC. Last-patient-in was completed on time against the targeted milestone.
Myelodysplastic syndrome (MDS)
Parexel has unrivalled site knowledge in MDS, with 78 alliance members and more than 400 experienced principal investigators worldwide. We have conducted studies involving more than 800 patients in 25 countries. One example is a Phase III global study involving more than 100 sites, which coincided with the COVID-19 outbreak that led to supply delays and patient travel limitations. Initially, screening and enrollment fell significantly behind schedule. By deploying 5 dedicated clinical trial liaisons for site coverage, we provided strategy, site optimization, and education to support each site. Our team succeeded in bringing the study back on track within 3 months, dramatically improving screening rates.
Multiple myeloma
Participating in a clinical trial for multiple myeloma, which is particularly difficult to diagnose, typically places a heavy burden on patients. Patients often visit multiple doctors before being appropriately diagnosed, then must undergo a series of invasive tests such as bone marrow biopsy and genome sequencing to further define their disease and guide treatment decisions. Conducting clinical trials requires a deep understanding of patient characteristics and current treatment patterns for insight on the patient journey.
In the past five years, Parexel has conducted more than 50 studies for multiple myeloma across the globe. As one example, we managed a Phase III program encompassing nearly 30 counties and more than 2,000 patients. We worked with well-known site networks with a history of conducting trials for multiple myeloma. The program involved thorough planning for country and site supply and leveraged Parexel depots for importing and exporting. Our team completed last-patient-in 5 weeks ahead of schedule, resulting in early regulatory approval.
Benign and malignant disorders
Benign hematology encompasses a wide range of conditions, from anemia to hemophilia to sickle cell disease with patient populations ranging from pediatric to geriatric. Many benign hematological disorders are rare diseases, which can add an additional layer of complexity for trial planning and conduct. Parexel understands the unique challenges inherent to conducting trials in these disorders and has a team of experts available with intricate knowledge and exceptional experience in order to ensure seamless execution of trials. Parexel has conducted over 50 trials in the field of benign hematology globally, including pediatric and adult studies, ranging from phase I to phase IV trials. For a pivotal phase III trial for a novel therapeutic option in hemophilia, Parexel provided excellent leadership during study start up and ongoing clinical conduct culminating with the trial meeting its primary endpoint with a significant reduction in annualized bleeding rates.
Advantages
Innovative trial designs and technology
Parexel excels in implementing complex and innovative study designs in hematology, including external control arms, virtual and decentralized trials, and adaptive designs. We are also capable of leveraging new data sources, including real-world data (RWD), to enhance study designs, support regulatory submissions, and inform payer decisions. Our expertise allows us to accelerate execution of clinical trials while maintaining flexibility in our approach, ensuring seamless execution of clinical research that has the potential to greatly impact patient’s lives. Furthermore, Parexel integrates precision and translational medicine approaches, including advanced sensor solutions as needed, to create comprehensive strategies that span from preclinical to first-in-human clinical studies through commercialization. Our specialists in biomarkers and genomic medicine collaborate closely with your team, leveraging these innovative tools to optimize study designs and drive more targeted, personalized therapeutic development.
Medical expertise
Parexel has a formidable hematology medical team with extensive experience across a wide spectrum of benign and malignant hematological disorders. Our medical monitors possess expertise in a wide range of diseases, including Hodgkin’s and non-Hodgkin's lymphoma, acute leukemias, myelodysplastic syndromes (MDS) as well as knowledge of various benign hematologic conditions such as hemophilia and sickle cell disease. The team is experienced in managing cell and gene therapies clinical trials, including CAR-T cell therapies and stem cell transplantation, which are revolutionizing the treatment landscape in hematology. Furthermore, our medical team also has experience in pediatric hematology, allowing for a comprehensive understanding of childhood blood disorders and their unique challenges. Many of our medical monitors maintain active clinical practices or have recently transitioned from clinical medicine, providing them with up-to-date insights into the current medical landscape, standard of care protocols, and real-world patient management strategies. This practical experience enhances their ability to design and oversee clinically relevant and patient-centric trials, ultimately contributing to the advancement of hematological therapies and improved patient outcomes.
In-house regulatory experts
Our regulatory team includes former regulators from FDA, EMA, NMPA, MHRA, and PEI, among other bodies, capable of providing invaluable consulting and insights on regional requirements. These experts bring invaluable insights into the evolving regulatory landscape for hematological therapies. They are well-versed in the unique challenges and requirements for hematology drug development, including orphan drug designations, accelerated approval pathways, and special considerations for cell and gene therapies in blood disorders. They provide strategic guidance on regulatory requirements from first-in-human studies to pivotal phase III trials, ensuring compliance with regional and international standards. Additionally, our regulatory experts offer critical insights on endpoint selection, biomarker validation, and risk-benefit assessments specific to hematological indications. This comprehensive regulatory knowledge enables us to develop robust strategies for global hematology drug development programs, facilitating efficient interactions with regulatory bodies and potentially expediting the path to market for innovative hematological therapies.