ABSL-2 Expansion in Madison Enhances Scheduling Flexibility and Study Protection
Access a full suite of preclinical cell and gene therapy capabilities, including new ABSL-2 rooms and more, at our state-of-the-art U.S.-based Madison, WI site.
Reduce the time and risk in developing your cell or gene therapy– no matter what stage you’re at.
This webinar explains the steps involved in Medical Monitoring of CAR T therapy and explores additional considerations during COVID 19.
Potency evaluation, achieved through potency assays, is essential to transition an advanced therapy medicinal product or ATMP (also known as cell and gene therapy) through pivotal clinical stages to final market authorization. However, potency is a difficult parameter to assess for ATMPs, so it is important to start developing these assays early to minimize possible delays in ATMP commercialization. This blog provides insights into how and when to develop potency assays to help overcome regulatory and manufacturing barriers in ATMP commercialization.
Cell and gene therapies promise a potentially life-long cure for many rare diseases and cancers. However, despite centralized regulatory approval, high costs and long-term clinical uncertainty have resulted in variable patient access across Europe. This white paper seeks to assess how prepared Europe markets are for cell and gene therapies and compare the 'preparedness' of these markets via a scoring system that considers key indicators and categorizes them into three equally weighted components: Budget and infrastructure, finance, reimbursement and implementation and HTA and pricing processes.
Assess safety, establish proof of concept and feasibility rapidly
Successfully prepare for regulatory agency meetings and IND/IMPD/CTA submissions
Seamlessly transition to first-in-human trials
Identify, recruit and retain clinical trial participants using data-enabled solutions
Design and conduct patient-centric clinical trials
Prepare and file for BLA/MAA and other submissions
Conduct long term follow up studies, Phase IV trials, and fulfill post-marketing commitments
Test for CMC lot release and stability of manufactured product
Support patient access to your new therapies