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...
November 16th, 202311:00 a.m. EST At the heart of every therapeutic breakthrough are patients—and their loved ones—whose noble contributions to medical research pave the path to market for innovative treatments that improve outcomes and quality of life. In hematological malignancies—where global incidence is increasing and the median age for most diseases is 65-70 years of...
October 19th, 202311:00 a.m. EDT Nitrosamines in pharmaceuticals became a topic of special concern when their presence at unacceptable levels in common medicines hit the news in 2018. Drug substance and drug product manufacturers have since been required to conduct risk assessments and, when necessary, perform confirmation tests and recall products to address the risks...
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...
With billions of neurons, the brain is the most complex organ in the body, so it’s not surprising that neuroscience clinical trials—more so than trials in other medical specialties—face major challenges. Despite volume of research and funding, neuroscience clinical trials continue to fail for many reasons. Among them, lack of reliable biomarkers, subjective outcome parameters,...
Meet Our Speakers: Andreas Schreiner, M.D.Senior Vice President, Medical Affairs, Neuroscience and Analgesia Adam SimmonsExecutive Director, Program Strategy, Neuroscience
September 28th, 202311:00 a.m. EDT Pediatric rare disease trials combine rarity of disease with a restricted and geographically-dispersed population of vulnerable subjects for research, creating unique challenges for study design and execution. Recruitment is challenging, as patients, parents, and caregivers need to juggle school schedules, work responsibilities, and family obligations to accommodate study participation. Incorporating...
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...
July 20th, 202311:00 a.m. EDT With billions of neurons, the brain is the most complex organ in the body, so it’s not surprising that neuroscience clinical trials—more so than trials in other medical specialties—face major challenges. Despite volume of research and funding, neuroscience clinical trials continue to fail for many reasons. Among them, lack of...