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 prevent relapses. North America dominates...
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. The issuance of new regulations,...
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 prescriptions were rejected or blocked....
May 17, 202410 a.m. EDT Post-market clinical follow-up (PMCF) studies are necessary for continuously monitoring the clinical benefits, performance and safety of a medical device once it is released on the market. As part of a broader post-market surveillance (PMS) strategy, these studies are crucial for assessing the long-term behavior of the device and ensuring...
May 14, 202411 a.m. EDT Selecting appropriate sites is one of the most crucial determinants of study success and yet efficient clinical trial site selection continues to be a prominent industry-wide challenge. Inability to meet planned recruitment timelines and failure to enroll participants imposes an economic burden on sponsors, with downstream impacts to patients in...
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 to patients in need. In...