Typically, when people talk about a full-service contract research organization (CRO) they mean a group that handles every aspect of a clinical study, supplying the personnel, the systems, and the processes. The sponsor is spared all operational involvement with the full-service model, simply receiving key information at specified intervals. This model works very well for...
The In Vitro Diagnostic Regulation (IVDR) has fundamentally changed how in vitro diagnostics (IVD) are regulated in the EU. As a result, scrutiny for review and documentation has increased substantially, including a dramatic increase in required reviews by notified bodies (NB). For IVD companies, the challenge of adapting to a significant set of regulatory updates...
The EU has been working to strengthen its regulations for better patient protection and more effective implementation of the rules for in vitro diagnostic medical devices. As a result, in May 2017, a five-year in vitro diagnostic regulation (IVDR) transition plan went into effect. While some of the dates have been extended1 to allow for...
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...
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...
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...
Regulatory approval is the final hurdle sponsors face when launching an in vitro diagnostic (IVD). After spending many years and millions of dollars on development, it can prove frustrating when the finish is in sight, but there are barriers to success. Fortunately, many of those barriers can easily be avoided. In more than 30 years...
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 medicines — targeted therapies...
In a multilateral paradigm shift, sponsors, payers, regulators, physicians, and patients are increasingly recognizing the value of real-world late-phase (RWLP) trials. The increasing use of real-world data (RWD) and real-world evidence (RWE) to support clinical development has been informed by recent regulatory guidance and accelerated by the global COVID-19 pandemic. Stakeholders across the spectrum are...
According to the Alliance for Regenerative Medicine, there were 1,085 active advanced therapy medicinal product (ATMP) developers and more than 150 phase III trials underway at the end of 2020. These numbers are not small, and they make it clear that ATMPs have much to offer in helping us overcome as-yet undefeated diseases.ATMPs are different...