Real-world evidence is increasingly important in drug development as the medical and pharma communities recognize the data’s potential for predicting the benefits of treatment interventions. Accelerating this trend is the Food and Drug Administration’s growing understanding of how RWE has helped researchers better understand and use COVID-19 treatments. While placebo-controlled trials continue to have a...
The landscape for Alzheimer’s disease diagnosis has changed significantly over the past decade, but there is still only one conditionally FDA-approved medication. Despite extensive research and many expensive clinical trials, more than 200 investigational programs have failed or been abandoned in the past 10 years alone. New treatments are needed to prevent Alzheimer’s, delay its...
In clinical research and development, comparison to a control is highly recommended by regulatory agencies for the purpose of demonstrating evidence of clinical efficacy of a drug or device. The control could be a placebo, a known standard-of-care or an available market-approved drug or device. With some diseases or certain classes of devices, a viable...
CAR T-cell therapies have transformed the therapeutic landscape for hematologic malignancies, offering substantial benefit to patients with few alternative treatment options. While these innovative therapies represent a breakthrough in immuno-oncology, their impact thus far has been limited to a small subset of patients, and challenges to development and commercialization remain a hurdle. These challenges range from...
In this era of personalized medicine, biomarkers can provide important insights at every stage of drug discovery and development. By advancing our understanding of cancer pathophysiology and tumor profiling, they play a critical role in the rational development of novel therapies. Despite their many potential advantages, biomarker development and biomarker-guided trials can be complex and...
As liquid biopsies become more commonplace, gaining wider FDA acceptance and even becoming standard of care in some instances, the technology is giving rise to important new questions. In this webinar, we will explore the technique’s growing importance in early cancer detection and address common questions about its use. Topics will include: Speakers: Charlie Chrisawn,...
Speakers: Charlie Chrisawn, Executive Director, Program Strategy, In Vitro Diagnostics Michael Edwards, Senior Director, Regulatory Affairs, MedTech
There is increasing focus on the development of new cell and gene therapies (CGT) in rare disease. The majority of CGT approvals have been based on small, open-label, non-randomized, single-arm studies which either evaluate treatment effectiveness without a comparator or utilize a historical control comparator to evaluate treatment efficacy. Among the several unique study design...
CAR T-cell therapies have transformed the therapeutic landscape for hematologic malignancies, offering substantial benefit to patients with few alternative treatment options. While these innovative therapies represent a breakthrough in immuno-oncology, their impact thus far has been limited to a small subset of patients, and challenges to development and commercialization remain a hurdle. These challenges range from...
Radiopharmaceutical therapy is emerging as a safe and effective targeted approach to treating many types of cancer. Clinical trials for these therapies are complex requiring a multi-disciplinary approach and careful coordination to produce meaningful and conclusive results. In this webinar, we look at the history and future trajectory of radiopharmaceuticals, describe their potential advantages, examine...