Consulting
Expertise: Consulting 228 results
Consulting
Laura Kilgore, RAC
Consulting
Daniel Quach
Asking the appropriate questions during a pre-IND meeting with the FDA is a critical step in planning a development program. A Pre-Investigational New Drug Application (pre-IND) meeting can be a valuable component in planning a development program. For companies that...
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...
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...