One of the biopharmaceutical industry’s most closely watched forthcoming regulatory developments is the FDA’s imminent reauthorization of the Prescription Drug User Fee Act (PDUFA). PDUFA VII, as the reauthorization is commonly known, will cover the fiscal years 2023-2027. Many of the advancements included in PDUFA VII are driven in large part by an increase in...
The gene therapy era can be said to have begun in 1990, when the first gene therapy clinical trial took place. Some 3,000 clinical trials have followed that first study, a resounding affirmation of innovators’ increasing recognition of gene therapy’s breakthrough possibilities for treating a diverse range of disorders — especially afflictions with limited or...
Rare cancers account for 27% of all new cancer diagnoses in the US and 22% of all new cancer diagnoses in the EU. With the shift toward grouping cancer based on molecular subtypes rather than by location and tissue type, some common cancers are now categorized as groups of rare cancers. For example, melanoma as...
Advanced therapy medicinal product (ATMP) development is on the rise. According to the American Society of Gene + Cell Therapy, there were 1,745 gene therapies in development in May 2021, 70% of which were in preclinical studies, and more than 1,300 of these candidates were in development for oncology, the most active therapeutic area. Given...
WebinarDecember 1511 AM EST Despite the impact on women’s health worldwide, significant unmet needs exist in the diagnosis and treatment of gynecologic cancers. Located in the female reproductive system, many have a reputation for being “silent,” as they are often detected in later stages when treatment options are limited. However, the recent introduction of novel...
Patient recruitment comprises one of the most significant initial challenges in any oncology study, but engaging and retaining patients throughout the trial can prove to be the challenge requiring the most up-front planning and coordination. However, during the initial planning stages of clinical trial implementation, the intensity of focus is usually placed predominately on speedy...
Advanced therapies – including gene-, cell-, and tissue-based products – offer groundbreaking new opportunities for the treatment of disease. As of the end of 2020, there were 1,085 active developers of these therapies and 152 ongoing Phase 3 trials worldwide. According to the Alliance for Regenerative Medicine, regulatory decisions are expected on a record eight...
“Patient centricity” has long been a guiding principle of clinical trial design and conduct, and it has become even more critical in the COVID era as trial sponsors and regulatory authorities have had to adapt to a continually shifting landscape. Pandemic-related restrictions have prompted substantial changes in how clinical trials are developed and implemented, requiring...