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...
Expertise: Consulting 223 results
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...
The Sponsor had developed a game-changing therapeutic with an application. in ophthalmology—a product that could have a tremendous impact on patients the world over. The clinical studies were complete, and the rush approval was on. The Sponsor came to Premier...
Without concrete guidelines, it can be confusing when determining what nonclinical studies are needed for a Pre-Investigational New Drug application (PIND) meeting. However, in our experience, the answer is this: it is critical that the nonclinical program provides sufficient data...
Analytical Target Profile The analytical target profile (ATP) concept was first introduced in the ICH Q141 Guideline in 2022. This guideline, which compliments the ICH Q22 Guideline, describes science and risk-based approaches for developing and maintaining analytical procedures suitable for...
In 2022, ICH Q14 officially introduced the enhanced approach1 in analytical development as an alternative path to the minimal approach, the benefits of which are worth exploring further. Analytical data is essential in demonstrating the safety and quality of pharmaceutical...
I recently had the opportunity to participate in the 2024 Drug Information Association (DIA) Regulatory Submissions, Information and Document Management (RSIDM) Forum held in North Bethesda, Maryland. In this blog post, I'll share my insights and key takeaways from the...
Adherence to cGMP regulations assures the identity, potency, purity and quality of biologics or advanced therapeutics and helps ensure adequate control of manufacturing operations. A primary way to demonstrate these attributes for a biologic product under development is through assays....