Brian Abbott, MD
Executive Medical Director,
Therapeutic Area Medical Lead,
Oncology/Hematology
Oncology & Hematology
Partnering to overcome the complex challenges in oncology studies throughout the lifecycle of your product
Oncology remains one of the most challenging therapeutic areas, with the lowest success rates in clinical trials. This underscores the need for innovative strategies and a partner who understands the complexities of this field and has deep experience across all stages of development.
At Allucent, we recognize the unique challenges our clients face in oncology drug development and offer tailored solutions designed to overcome these obstacles.
Struggling with patient recruitment for your oncology trial?
Oncology trials often face recruitment challenges due to stringent eligibility criteria and the need for specific patient populations. At Allucent, we address these issues with patient-centric strategies that leverage global reach, genetic data, and electronic medical records to identify the right patients quickly and efficiently. Our tailored solutions for hybrid and on-site trials ensure streamlined recruitment while engaging patient communities to enhance participation.
Discover more about our patient recruitment and retention strategies.
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Facing complexities with oncology study designs?
Oncology trials require highly specialized and complex study designs, including adaptive designs, basket trials, crossover designs, and single-arm trials. Our experts have deep knowledge of these novel trial designs, particularly in oncology, ensuring the flexibility needed to optimize efficacy and safety assessments.
Our biostatistics and regulatory teams collaborate closely to guide strategic decisions, from endpoint selection and data strategy to trial design, while ensuring regulatory compliance. We also incorporate biomarkers into study designs to enhance precision medicine approaches, allowing for more targeted and effective treatments.
Explore our comprehensive clinical strategy solutions.
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Concerned about the high costs of oncology trials and the added burden of site saturation?
At Allucent, we help you navigate the high costs and site saturation challenges of oncology trials by leveraging our robust network of sites and strong relationships with key opinion leaders (KOLs). These relationships provide us with valuable insights into site capabilities and patient recruitment potential, ensuring you gain access to the most suitable locations.
Our expertise in conducting thorough feasibility assessments helps identify the right sites, avoiding oversaturated locations and optimizing trial execution. With our optimized site management and ongoing support, we ensure high-quality results while managing costs effectively.
Learn how we optimize study start-up and site intelligence.
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Navigating complex regulatory requirements and evolving Health Authority guidelines?
Navigating the regulatory complexities of oncology drug development requires expert guidance from early planning through post-approval. Our expert team, including former regulators from the FDA, EMA, and other global health authorities, provides strategic support in study design, endpoint selection, and data strategy to help you overcome the unique challenges of oncology drug development.
With novel therapies, biomarkers, and complex trial designs, we ensure your oncology trials meet regulatory scrutiny while optimizing fast-track and breakthrough designations. Our expertise in initiatives like Project Optimus and Project Orbis allows us to streamline trial processes and maintain compliance, providing an efficient path to approval.
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Combining clinical expertise with research is essential for driving innovation and effective therapies. By aligning with scientific advancements and regulatory standards, we streamline development, accelerating safe treatments in hematology and oncology. This integration ensures faster patient access to transformative care while maintaining the highest safety standards.
Oksana Fabri, PhD, MD
Sr. Medical Director, Therapeutic Area Medical Lead, Hematology/Oncology
We support small to mid-sized biotechs through every phase of oncology and hematology drug development, from preclinical planning and IND submissions to the design and execution of Phase I-III trials, through marketing applications, to Phase IV and post-marketing initiatives to ensure ongoing success.
Preclinical Phase
Phase I (First-in-Human)
Phase II (Efficacy & Dose-Ranging)
Phase III (Pivotal Studies)
Phase IV (Post-Approval Activities)
Preclinical
Phase
- Expertise in toxicology studies and pharmacokinetics to ensure a smooth transition to clinical trials
- Strong support for IND submissions with regulatory agencies (FDA, EMA, etc.)
- Deep experience in biomarker discovery and target identification to accelerate drug development
Phase I (First-in-Human)
- Proven track record in dose-escalation and safety-focused trials, particularly in oncology
- Expertise in designing and conducting adaptive trial designs, especially for novel oncology therapies
- Strong emphasis on site selection early patient engagement for efficient trial execution
Phase II (Efficacy & Dose-Ranging)
- Deep understanding of biomarker-driven patient selection to increase trial success rates
- Expertise in innovative trial designs (e.g., basket trials, single-arm trials) for faster efficacy evaluation
- Strong collaborations with KOLs and oncology research sites to ensure high-quality data and recruitment (key activity in Phase I as well)
Phase III (Pivotal Studies)
- Proven success in managing multi-center, global oncology trials with complex regulatory requirements
- Extensive experience with comprehensive trial management, including risk-based monitoring and data-driven decision-making
- Robust capabilities in handling regulatory submissions, including NDA/BLA and marketing approval strategies
Phase IV (Post-Approval Activities)
- Comprehensive lifecycle management: Focused on pharmacovigilance for product safety and on ensuring compliance and inspection readiness
- Expertise in label expansions, new indications, and global approvals to extend product reach
- Support for market access and ongoing commercialization to ensure long-term success
Oncology Trials Require Multilayered Expertise
We have the hands-on knowledge to manage the complexities of cancer research and provide full-service support across various therapeutic areas. Our extensive experience across Early Phase through Phase III trials and beyond spans a wide range of oncology and hematology indications.
260+
Studies
3,900+
Sites
24,000+
Patients
40+
Countries
All-time years of experience
With global breadth and depth across a wide range of oncology and hematology indications, Allucent partners with biotech companies to bring innovative therapies to light.
SOLID TUMORS
- All comer (all solid tumors)
- Brain tumors (including GBM)
- Bladder cancer
- Breast cancer
- Cervical cancer
- Colorectal cancer
- Endometrial cancer
- Gastric cancer
- Head and neck cancer
- Liver cancer
- Lung cancer (including NSCLC)
- Melanoma
- Neuroendocrine tumors
- Ovarian cancer
- Pancreatic cancer
- Prostate cancer
- Renal cancer
- Sarcoma
HEMATO-ONCOLOGY
- All comer (all hemato-oncology)
- Acute lymphoblastic leukemia (ALL)
- Acute myeloid leukemia (AML)
- Chronic lymphocytic leukemia (CLL)
- Chronic myeloid leukemia (CML)
- Lymphoma
- Multiple myeloma
- Myelofibrosis
- Myelodysplastic syndromes
- Graft versus host disease
- Veno-occlusive disease
HEMATOLOGY
- Anemia
- Anticoagulant reversal
- Autoimmune hemolytic anemia
- Blood loss
- Essential thrombocythaemia
- Graft versus host disease
- Hereditary angioedema
- Hyperbilirubinemia (genetic)
- Neutropenia
- Paroxysmal nocturnal
- Sickle cell anemia
- Thrombotic thrombocytopenic purpura (TTP)
BIOLOGICALS
- Antibodies (e.g., monoclonal, bi-specific, antibody drug conjugates (ACDs), checkpoint inhibitors)
- Peptides
- Cell-based
- Autologous & allogenic (e.g., dendritic cell (DC), natural killer (NK), T cell, stem cell)
- Hormonal (e.g., hormone receptor inhibitors, liposomal corticosteroids)
- Vaccines (e.g., bacterial vaccines, DNA vaccines, peptide vaccines, RNA vaccines, tumor-derived vaccines)
- Oncolytic viruses
- Radiolabeled compounds
OLIGONUCLEOTIDES
- Antisense oligonucleotides
- miRNA compounds
SMALL MOLECULES
- Chemotherapy (e.g., alkylating agents, anthracyclines, antimetabolites, anti-microtubule agents, taxanes, topoisomerase inhibitors)
- Inhibitors (e.g., angiogenesis inhibitors, HDAC inhibitors, integrin receptor antagonists, PARP inhibitors, protein kinase inhibitors, tyrosine kinase inhibitors (TKIs)
Meet Some of Our Oncology and Hematology Experts
- Over 25 years of professional experience in hematology and oncology, including the past 6 years in the CRO industry
- Clinical trial strategy expertise for hemato-oncology trials and medical monitoring oversight
- Leadership of the oncology medical team at Allucent
Brian Barnett, MD
Executive Medical Director,
Medical Affairs
- 20+ years of experience in translational research, clinical practice (hematology and oncology), and work within the biomedical research industry
- Provides expert guidance on both early- and late-stage drug and cell therapy development
Oksana Fabri, PhD, MD
Sr. Medical Director,
Therapeutic Area Medical Lead,
Hematology/Oncology
- Over 16 years of experience in the fields of hematology, oncology, and stem cell transplantation
- Extensive knowledge of current treatment approaches, emerging therapies, and regulatory developments
- Offers expert guidance in medical oversight and strategic planning for clinical trials in related areas
Sandra Olthof
Global Operations Head,
Oncology/Hematology
- 15+ years of industry experience, with extensive
experience in oncology clinical research - Highly skilled in clinical project management and project oversight, focusing on clinical trial delivery
- Extensive expertise in global (haemato-) oncology clinical studies, subject matter expert in dose escalation studies
Allucent Center of Expertise (ACE): Oncology & Hematology
Pioneering Cancer Therapies for Tomorrow's Cures
We have extensive experience with both traditional and cutting-edge therapies, including molecularly targeted agents, immunotherapies, and cell and gene therapies. We also specialize in combination therapies, and have substantial experience with anticancer vaccines, antibodies (monoclonal, bispecific, and ADCs), nanoparticle formulations, and modified chemotherapies to improve efficacy and patient outcomes.
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Comprehensive Expertise Across Traditional and Advanced Therapies in Oncology
- Deep expertise in early-phase, late-phase, and post-marketing studies, including compassionate use programs
- Proven track record with advanced therapy medicinal products (ATMPs), including gene, tissue, and cell-based medicines
- Successful collaboration on over 60 research projects involving cell and gene therapies and similar biologics in oncology
- Specialized knowledge in novel trial designs
