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
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 Human studies. Bayesian dose escalation designs have also coincided with advances in oncology […]
The Potential of Biosimilars – for Drug Makers and Patients
The production of biosimilar drugs remains at a rapid pace and represents not only an advantage for patients but also a remarkable profit opportunity for drug makers. And for patients, the approval of biosimilars may represent the only alternative of treatment due to the extremely high cost of many original biologic drugs. That said, in […]
Expediting Treatments to Oncology Patients in Need: Understanding the FDA’s Accelerated Pathways
By Jessica Lee, VP, Regulatory Strategy, Head, Cell/Gene Therapy In recent years, we have observed a significant increase in use of expedited programs offered by the U.S. Federal Drug Administration (FDA). These programs are specifically intended to facilitate the development and review of novel drugs that address unmet medical needs in treating serious or life-threatening […]