Abstract
In early-phase drug development, the success of a dose escalation study depends not just on the design, but on the speed and precision of decision-making across cohorts. Delays in moving between dosing levels can extend timelines, increase costs, and complicate data interpretation. This webinar explores how proactive cohort management—grounded in close coordination between clinical operations, safety committees, and clinical pharmacology—can streamline early-phase studies and support more confident, data-driven decisions.
Our experts will discuss different dose escalation study designs, the role of internal and external review committees, and strategies for managing dose-limiting toxicities (DLTs). We’ll also highlight the evolving role of clinical pharmacologists, who no longer simply deliver PK results, but actively contribute to ongoing dose decisions in real time. Drawing from real-world experience, the panel will share how proactive planning, ongoing monitoring, and team-wide alignment can accelerate escalation and optimize early-phase trial outcomes.
What You’ll Learn
- How proactive cohort management can reduce lag time between dosing decisions
- Considerations in selecting a dose escalation study design, including the evolution from 3+3 to more flexible Bayesian designs
- The role and impact of safety review (SRC) and safety monitoring (SMC) committees
- How real-time collaboration with clinical pharmacology supports faster decisions, including guidance from Model-Informed Drug Development support
- Best practices for monitoring and managing dose-limiting toxicities (DLTs) in early-phase trials
Speakers
Brian Abbott, MD is Executive Medical Director and Oncology Therapeutic Area Medical Lead at Allucent, with expertise in hematology, oncology, and biomedical research, specializing in clinical trial strategy and medical monitoring. As Senior Medical Director at Allucent, he provides strategic guidance on clinical trials. He previously held leadership roles at ICON plc, Myriad Genetics, and Caris Life Sciences. Before transitioning to research, Dr. Abbott focused on hematologic malignancies, BMT, and medical oncology, serving on the faculty at the University of Colorado and St. Jude Children’s Research Hospital. He holds an MD, MBA, and MS in Finance and is board-certified in Hematology/Oncology, Pediatrics, and Hospice and Palliative Medicine.
Sandra Olthaf, MSc (Biomedical Science), is Oncology/Hematology Global Operations Head, Global Project Leadership at Allucent, where she leads cross-functional project teams, manages oncology and hematology portfolios, and drives process optimization and client satisfaction within Clinical Trial Operations. With over 15 years of clinical oncology experience, she has successfully led global phase I–IV trials across immuno-oncology and hematologic oncology, ensuring operational excellence and high-quality delivery.
Rachel Kudgus Lokken, PhD (Chemistry/Clinical Pharmacology), is Senior Director, Clinical Pharmacology at Allucent, where she is responsible for providing clinical pharmacology expertise across all phases of drug development. Dr. Kudgus Lokken has broad experience in pre-clinical and clinical pharmacology, pharmacokinetics, pharmacometrics, scientific/technical writing, and teaching. She has worked in a variety of therapeutic areas with a focus in oncology and hematology, designing and executing early phase human trials. She leads clinical pharmacology contributions by preparing and reviewing clinical protocols, clinical study reports, clinical pharmacology strategic plans, INDs, clinical pharmacology and safety sections of NDAs, Investigator Brochures, FDA briefing packets, and other clinical and regulatory documents.
Titia Tjeenk Willink, MSc (Biomedical Science), is Sr. Project Director, Global Project Leadership at Allucent, with more than 15 years’ professional experience in the field of clinical research. Titia is responsible for the oversight of complex clinical trials, providing focused project management services to studies under her responsibility. She oversees the coordination and management of clinical trials by monitoring project trial status, timelines, and budgets, while ensuring a high level of customer satisfaction. Her focus is on hemato-oncology projects in various indications with a range of investigational drugs (including oral chemotherapy, immune-cell vaccine, monoclonal antibodies), from early phase/FIH to large international phase III studies.
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