Cell and gene therapy’s popularity has grown exponentially in the past year. However, it’s important to understand how cell and gene therapy research is different from traditional drug development.
Developing an investigational new drug (IND) application is a big milestone for organizations, especially small companies bringing their first drug
A key element to successful study startup is identifying efficiencies to help meet critical milestones. Engaging with research compliance experts
With gene therapy trials on the rise, sites must prepare biosafety protocols, facility standards, and partnerships to attract cutting-edge studies.
In the race to address the COVID-19 pandemic, researchers have worked tirelessly the past year to produce a vaccine. Operation
A common trope in sci-fi movies involves concerns about potentially smashing into uncharted objects while traveling at warp speed or
In a recent webinar, Advarra Executive Director of Biosafety Services Daniel Eisenman discussed the latest trends in genetically modified vaccine and immunotherapy studies. He also explored unique startup challenges for studies involving investigational products that contain engineered genetic materials. Due to time constraints he wasn’t able to answer all audience questions during the Q&A period, so he has answered some of the most popular questions in this blog.
In Advarra’s inaugural virtual symposium, experts from industry and academia met to discuss the unique challenges gene therapy research poses for research sites, sponsors, CROs, and study participants.
In Advarra’s inaugural virtual symposium, industry and academic experts discussed overcoming obstacles and optimizing study startup in gene therapy research. They respond to more popular Q&A topics here.
The current global pandemic has brought biosafety to the spotlight. Biosafety practices must be customized to the proposed research as well as the existing facility and local regulatory requirements.
Gene therapy research continues its rapid expansion in the clinical setting, especially in infectious disease, rare disease, and oncology. To support discussion of emerging genetic research issues, Advarra presents its first virtual symposium.
Currently the most prominent coronavirus vaccine candidates contain engineered genetic material. Sites wishing to participate in this research should be prepared for the additional requirements of research involving genetic engineering.
