April 9th, 202411 a.m. EDT An estimated 350 million people around the world live with major depressive disorder (MDD) and more than 700,000 die due to suicide every year. While existing treatments such as medications and psychotherapy can make a difference, there remains a critical need for more effective drugs that offer sustained relief and...
The integrity of clinical trials depends on accurate and reliable data, making the protection of endpoints a critical aspect of the entire process. Endpoints, which are specific outcomes used to measure the effectiveness of an intervention, must be safeguarded to ensure the validity and credibility of the trial results. Endpoint protection is particularly important in...
April 5th, 202411 a.m. EDT In vitro diagnostic (IVD) testing has become a cornerstone of modern medicine, with an estimated 70% of medical decisions made based on laboratory test results. Given the vital role IVDs play in guiding care, regulatory agencies frequently review approval requirements and the regulatory frameworks governing these devices are constantly evolving....
Speaker: Angi RobinsonSenior Vice President, Specialty Areas, Premier Research
March 19th, 202411 a.m. EDT Product development from translation to registration has become increasingly more difficult and costly. Ambitions are high but success rates are low. If development is a tough path, commercialization is even harder. In 2022, the average year one sales per branded product were a mere $65MM. In 2021, 45% of all...
March 7th, 202411 a.m. EST For cell therapies, the roadmap to first-in-human studies is marked by critical scientific and regulatory milestones that require careful planning, expertise, and collaboration from various stakeholders. From rigorous nonclinical studies, to cell manufacturing processes, to overcoming regulatory complexities, each milestone represents a significant step forward in bringing these transformative treatments...
February 22, 202411 a.m. EST The integrity of clinical trials depends on accurate and reliable data, making the protection of endpoints a critical aspect of the entire process. Endpoints, which are specific outcomes used to measure the effectiveness of an intervention, must be safeguarded to ensure the validity and credibility of the trial results. Endpoint...
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 age—a patient-centered mindset is essential...
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 of nitrosamine contamination and potential...