Development of cell and gene therapies is growing rapidly, given the major advances in genomic technologies and increasing scientific understanding of genetic regulation and immunology. The Cell and Gene Therapy (CGT) field has unprecedented potential to effectively treat and/or cure genetic-based rare and orphan diseases and expand the reach of personalized medicine. This blog will...
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...
As regulatory requirements become increasingly harmonized across the globe, the development and marketing of pharmaceutical products worldwide are also becoming more streamlined. However, global regulations are not one-size-fits-all, and sponsors aiming to market their products in multiple regions should be aware of the current standards and processes they may encounter during the development process. The...
All pharmaceutical companies share a common goal, regardless of their size or history: for their products to achieve commercial status and success through the most time- and cost-efficient development path. The 505(b)(2) regulatory pathway was established to offer efficiency benefits for clinical, nonclinical, and chemistry, manufacturing, and controls (CMC) product development. Often sponsors, particularly start-ups...
With drug discovery completed and your lead asset identified, it’s time to initiate IND-enabling activities, moving one step closer to clinical deployment. Because a very small percentage of nonclinical lead assets move into the clinic, your nonclinical program plays a critical role in whether your program advances to Phase 1 and how long it takes to...
A dilemma that medical device developers often face is where to launch their products first—whether it’s in Europe, the US, or both. In our experience, the decision of which initial market to target should not be taken lightly and should be guided by more than just the path of least regulatory resistance. Instead, successful launch...
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...
A dilemma that medical device developers often face is where to launch their products first—whether it’s in Europe, the US, or both. In our experience, the decision of which initial market to target should not be taken lightly and should be guided by more than just the path of least regulatory resistance. Instead, successful launch...
Significant risk studies of medical devices require an investigational device exemption (IDE), which allows the device to be used in a clinical study to collect data on its safety and effectiveness.1 Often, device developers wonder whether—and how—the cost of those investigational devices might be covered not only to offset the cost of development, but also...