Developing a novel gene therapy requires a level of comfort with change and unpredictability. The path to regulatory approval is rarely straightforward, and roadblocks can enter at any turn. Premier Research was approached by a sponsor of an adeno-associated virus (AAV)-based gene silencing technology to conduct a natural history study, with a goal to identify...
Introduction When approached for an early-in-illness schizophrenia trial, Premier Research knew that patient recruitment would be challenging and require creative approaches for success. Based on our experience in mental illness studies and with this indication, we recognized the importance of identifying sites where patients were already being diagnosed and treated. To achieve this, the Premier...
Introduction For those who have been through it, a rescue study transition from one contract research organization (CRO) to another can be a difficult ordeal, often accompanied by logistical hurdles and communication challenges. When a sponsor of a Phase 1 dose expansion trial for a novel oncology therapy contacted Premier Research, they were more than...
Background Cervical cancer is the fourth most common cancer in women. Despite being highly preventable, over 600,000 women were diagnosed and more than 340,000 died from the disease worldwide in 2020. The majority of cervical cancers are caused by infection with human papillomavirus (HPV) and the implementation of HPV vaccines has been shown to reduce...
Background Prostate cancer (PC) is among the most commonly diagnosed cancers overall, and the most frequently diagnosed cancer in men. The 2018 global estimate of new PC cases exceeded 1.2 million with more than 350,000 deaths worldwide. Over the last decade, new treatments combined with better use of existing therapies in early-stage disease have transformed...
If you develop or manufacture in-vitro diagnostic products, you know the May 2022 roll-out date for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) is just around the corner. But what, exactly, does that mean? In this resource document, we highlight eight new elements of the IVDR.
If you develop or manufacture in-vitro diagnostic products, you know the May 2022 roll-out date for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) is just around the corner. But what, exactly, does that mean? In this infographic, we highlight eight new and revised concepts presented to the IVDR.
Background Psychiatric conditions are complex, chronic, often debilitating diseases, and there remains a persistent need for novel medications with proven efficacy and safety. Many of the established antipsychotic agents are highly effective but are associated with significant side effects that may negatively impact adherence and patients’ experiences with treatment. Thus, recent research has focused on...
Background Point-of-care (POC) tests offer significant convenience for patients and physicians, as well as cost-savings for payers. Yet, achieving regulatory approval can be daunting. Sponsors not only have to show safety and efficacy, they have to prove that the test is simple and poses an insignificant risk of an erroneous result. Assembling such proof requires...
Background Colorectal cancer (CRC) is the second most deadly form of cancer – although it is among the most curable and the easiest to detect in its early stages. The reason: patients notoriously avoid colonoscopy, placing themselves at unnecessary risk. Our client developed a unique solution – a multi-target, noninvasive screening test that could be...