The promise of gene therapy is to provide transformative treatments that meaningfully improve quality of life for patients, many of whom are currently living with debilitating diseases. To bring these treatments to market, sponsors are tasked with conducting clinical trials that generate robust evidence with appropriate safety oversight. In addition, gene therapy trials are faced...
Gynecologic cancers continue to be a significant cause of female morbidities and mortality worldwide. Significant unmet needs exist in diagnosis and treatment. These cancers are often detected at later stages when therapeutic options are limited, and advanced or recurrent disease leads to a poor prognosis. Earlier diagnosis and more effective treatments will enhance the quality...
Substantial unmet needs exist in the diagnosis and treatment of gynecologic cancers. Often, these tumors are detected in later stages when treatment options are limited, and prognosis is poor. However, the gynecologic cancer space is on the cusp of change. The recent introduction of novel medicines, namely targeted therapies, has improved patient care and outcome....
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.
Insights into the human genome have created myriad therapeutic opportunities for previously untreatable diseases. Gene therapy offers promise for addressing unmet medical needs across therapeutic areas and even the potential for curing certain genetically based conditions. As research tools and technology become more sophisticated, gene therapy development is accelerating at an unprecedented pace. According to...
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.
On May 26, 2017, the EU Regulation 2017/746 of the European Parliament and the Council on in vitro diagnostic medical devices (IVDR) became active under the EU Regulation on Medical Devices (MDR). Recertification by May 26, 2022, became required for all previously approved products. The IVDR will replace the EU’s current Directive on in vitro...
Introduction The strongest foundation for successful widespread marketing of any diagnostic is evidence of clinical utility. Clinical validation – determining a test’s ability to diagnose a health condition or predict risk of clinical outcomes – may fail to convince physicians and especially healthcare payers to accept a new diagnostic. Failure to gain payer acceptance may...
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? Many of our sponsors have been approaching us with questions, such as: What aspects of the IVDR apply...