Designing an adequate nonclinical program to support the safety of cell or gene therapy products is not always straightforward. In this blog, we will address common questions we receive from our clients and aspects to consider when designing those nonclinical studies. In which species should the toxicity study be conducted? Does it have to be...
Under the EU Medical Device Regulation (MDR), manufacturers are required to plan, conduct, and document a clinical evaluation in accordance with Article 61, part A of Annex XI. This evaluation must be based on clinical data providing sufficient clinical evidence to demonstrate: Despite being among the highest risk, certain implantable and Class III devices may...
Dose escalation studies are pivotal in the early phases of clinical drug development for evaluating the safety profile of a new therapeutic agent and identifying a recommended dose for further investigation. These studies lay the groundwork for understanding the pharmacokinetic and pharmacodynamic properties of novel therapies and, if designed and executed thoughtfully, can move seamlessly...
As a sponsor wisely noted, “Clinical trials have nothing without participants.” Yet, in a 2023 study, 48% of sites cited patient recruitment and enrollment as a top challenge. The downstream impacts of recruitment challenges are profound for sponsors, sites, and most importantly, for patients in need of life-changing therapies. Ironically, on examination, the causes for...
Medical devices are ubiquitous — from thermometers, bandages, and dental floss to blood glucose meters, hearing aids, and complex implantable devices such as pacemakers. The latest cutting-edge examples even extend to apps on tablets and PCs that physicians use to help monitor and treat patients. Before a medical device can be put on the market,...
Adaptive design is a progressive approach that utilizes different statistical modeling to allow for modifications to enrollment in a clinical trial after study initiation without undermining data integrity and validity. This methodology is particularly beneficial and increasingly common in phase 1 clinical trials, which focus primarily on safety, tolerability, pharmacokinetics, and pharmacodynamics. The essence of...
CE marking is mandatory for marketing medical devices and in vitro diagnostics (IVDs) in the European single market, comprising all European Union (EU) member states and European Economic Area (EEA) countries. With the introduction of the EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR), there has been a significant overhaul of the...
On September 29, 2023, the U.S. Food and Drug Administration (FDA) made public a potentially game-changing proposal concerning the regulatory framework for laboratory-developed tests (LDTs). Understanding the nuances and implications of these changes is paramount for specialists in regulatory affairs and the clinical development arena. The FDA is proposing a change to its regulations to...
CE marking provides access to a market of over 500 million consumers across all 27 member states of the European Union (EU), as well as Iceland, Norway, and Liechtenstein. For medical devices and in vitro diagnostics (IVDs), a CE mark is a must for placing products on the market. With the implementation of the EU...
Medical device development must address some unique challenges that have grown over the last decade due to increasing medical device complexity, a more complex regulatory framework catching up with the industry, and an established and variable standard clinical practice to compete with: These factors have a major impact on the medical device development cycle, which...