Hematology
Built on a long history of helping advance the science of hematology, we are honored to have collaborated with leading organizations like yours in the rapidly changing world of hematopoietic stem cell transplantation (HSCT), as well as cellular and gene therapies. Every day presents new discoveries, novel applications and complex challenges.
BioFicher is known for accepting such challenges. When a client came to us with a compound that had potential to become the first bone marrow transplant product to receive Breakthrough Therapy Designation from the U.S. Food and Drug Administration, we embraced the challenge. Partnering with our client we ran successful Phase I and II trials to establish dosing and proof of concept. Building on that research, we conducted a Phase III trial in the United States, Latin America, Europe and Asia across more than 39 sites. Today, the compound has obtained Breakthrough Therapy Designation and shows great promise to be a lifesaving treatment option for bone marrow transplant candidates.
Clinical Research Experience
Hematology is a multi-faceted therapeutic area. As a full service CRO engaged in global hematology studies, BioFicher has built a broad spectrum of experience in blood and marrow disorders including research in lymphoma, leukemia, multiple myeloma, hemophilia, myelodysplastic syndrome, thalassemia, aplastic anemia and sickle cell disease. Additionally, for the past 5 years we have maintained strong relationships with leading investigators and institutions, enabling our team of hematology clinical research professionals to become adept at designing and conducting complex hematology clinical trials and natural history studies in hematology.
Since collaborating on our first major transplantation trial in T-cell depletion in 2017, BioFicher has been fortunate to work with several clients to enrich the understanding of hematology as well as test new and existing therapies. Through our unique experience in hematology, oncology and immuno-oncology experience, we have been able to support groundbreaking work including:
Hematopoietic Stem Cell Transplantation (HSCT): BioFicher collaborates with clients as they pursue practice-changing contributions to medicine and human health. Some of our projects have included research on graft sources, conditioning regimens, infection prophylaxis, treatment and prophylaxis for acute and chronic graft versus host disease, quality of life and toxicity.
Cellular Therapy: If you seek expertise in complex hematology study designs, unique regulatory strategy challenges or understanding central and local manufacturing considerations, we can help. Our experience leading the Production Assistance for Cellular Therapies (PACT) coordinating centers has allowed us to offer unique insights to clients involved in cellular therapy research.
US and Global Operations:
At BioFicher, we believe that strong, collaborative relationships empower clients to make significant advances in hematology research. As a result, we continue to grow our strategic partnerships with top institutions, investigators and thought leaders on a global basis.
Patient Outreach and Education: We share your commitment to patient outreach, community education and the need to engage groups focused on rare and critical diseases. For example, our work with the National Heart, Lung, and Blood Institute (NHLBI) has provided valuable insight into the concerns of people living with sickle cell disease. This insight is being used to support accelerated development of potentially curative genetic therapies.
Through our collaborations with public and private sector organizations, we have published more than 10 papers from 100+ global studies in Hematology, including cell therapy and HSCT. We especially value our 5+ year relationships with the National Institute of Health-funded Blood and Marrow Transplant Clinical Trials Network (BMT CTN) -- a collaboration between BioFicher, The National Marrow Donor Program/Be the Match, and The Center for International Blood and Marrow Transplant Research (CIBMTR). These long-standing partnerships help us generate insights we can apply to the needs of other companies and researchers involved in advancing the study of hematology and transplantation.
As a full service global CRO, we believe that true medical advancement depends on learning from past experience, collaborating with other researchers and sharing a common, future vision. With so much to be discovered in hematology, particularly cellular/gene therapy, liquid tumors, and transplantation, we look forward to partnering with you across all phases of clinical development, disease types and patient populations to expand therapeutic treatment options and give hope to so many people.
Supporting the Full Continuum of Clinical Research
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IND writing
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Trial design, statistical analysis plan, protocol development, and implementation
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Statistical study design and analysis
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Clinical trial oversight and monitoring
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Site identification, management and monitoring
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Laboratory and repository management
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Data system development and management
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Data and Safety Monitoring Board (DSMB) support
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Regulatory strategy
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Administrative support
Ophthalmology Leaders
At BioFicher, we value the open exchange of communication between our therapeutic area leaders and your team. We encourage you to contact us to discuss your research plan and determine how we can support your development pathway.
Clement Gayson, Ph.D.
Chief Research Officer
Ruth Clemons, B.Sn, MS, CCRA
Director and Biostatistician, Ophthalmic Therapeutic and Research Unit
Meredith Garyson, MS
Project Leader