Crossover Designs in Oncology: Statistical Perspectives
By Vanessa Beddo, PhD (VP, Global Head of Biostatistical Consulting) Introduction There are several factors to consider when adding a crossover design feature to an oncology study. These designs typically allow for patients to crossover from placebo or standard of care (SoC) to investigational product after disease progression on their randomized therapy. It is also […]
Podcast: Advancing Oncology Research: Regulatory & Development Path for ADCs & RDCs
Join Allucent experts Sugato De, MBE (VP, Regulatory Strategy, Head of MedTech) and Alex MacDonald, PhD (VP, Model Informed Drug Development) in BioPharma Dive’s new podcast. In this episode, we will delve into the innovative realm of antibody drug conjugates (ADCs) and radionuclide conjugates (RDCs) by exploring the tremendous growth potential of these targeted oncology […]
Advancing Oncology Drug Development: The Importance of Single-Arm Trials
By Marites T. Woon, PhD (Associate Director, Nonclinical) and Jessica Lee, MD, PhD (Principal, Global Head Cell & Gene Therapy) According to a report by the American Society of Gene and Cell Therapy, oncology remains one of the top areas of focus for investigational cell and gene therapy (CGT) products in Q1 of 20231, underscoring […]
How to Overcome Challenges in Combination Immunotherapy Clinical Trials
Immunotherapy has quickly become a major focus in the world of cancer research and treatment. In recent years, there has been a surge in the number of biotech companies conducting clinical trials for combination immunotherapies. What are Combination Immunotherapies? The combination immunotherapy approach involves the use of two or more different types of immunotherapies in […]
Spotlight on oncology drug development and its future
Originally published by Pharmavoice.com Of the nearly 7,000 clinical programs reported in 2022, 43% are in oncology – signaling the tremendous need for and promise of new cancer treatments. Jessica Lee is the vice president of regulatory strategy and head of cell and gene therapy at the specialized Clinical Research Organization (CRO) leader, Allucent. Here she discusses how […]
Citeline Report – Executing Early Phase Research In Hematological Oncology: What Matters To Biotech?
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Accelerating Drug Development of Innovative Oncologic Agents: Master Protocols
By Marites T. Woon, Associate Director, Nonclinical, and Jessica Lee, VP, Regulatory Strategy, Head, Cell / Gene Therapy Exponential advancements in oncology continue to drive personalized medicine and biomarker-driven therapeutics into reality. The development of innovative therapies to treat serious diseases remains a frontrunner across drug and cell and gene therapy (CGT) pipelines, with oncology […]
Benefits of Bayesian Dose Escalation Designs for Oncology Studies
As acceptance of flexible trial designs continues to advance, many sponsors are increasingly exploring alternate methods for dose escalation to support identification of a maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) in open-label Early Phase or First in Human studies. Bayesian dose escalation designs have also coincided with advances in oncology therapy […]
A Regulatory Perspective on Cell and Gene Therapy in Oncology
By Jessica Lee, VP, Regulatory Strategy, Head, Cell/Gene Therapy The past decade has produced many promising innovative cell and gene therapies (CGTs) to treat human diseases. CGT products, which use genetic material to modify cells in vitro or in vivo to treat, prevent, or potentially cure diseases, have great potential to address unmet medical needs. […]
Optimizing Trial Efficiency with Bayesian Dose Escalation Designs
By Vanessa Beddo, Global Head of Biostatistical Consulting, Biostatistics and Statistical Programming As acceptance of flexible trial designs continues to advance, many sponsors are increasingly exploring alternate methods of dose escalation to support the identification of a maximum tolerated dose (MTD) and recommended Phase II dose (RP2D) in open-label Early Phase or First in […]