Overcoming key challenges in global cell and gene therapy trials with Labcorp
Cell and gene therapies (CGT) represent the future of precision medicine, offering the potential to improve patient outcomes across a range of diseases. However, bringing these complex therapies from bench to bedside presents unique challenges at every stage of development. As the CGT landscape continues to evolve rapidly, developers need an experienced partner who can provide integrated solutions to overcome key hurdles at every stage from early research through commercialization. In a recent presentation for the Korea Biomedicine Industry Association (KoBIA), Maryland Franklin, PhD, vice president and enterprise head of CGT at Labcorp, shared how Labcorp’s comprehensive CGT capabilities support all aspects of global CGT development, including preclinical pharmacology, companion diagnostics (CDx) development and validation.
Five common challenges in global development of CGTs
Advancing global CGTs requires several considerations, from complying with complex regulatory guidelines and precedents to optimizing risk management strategies. Key challenges include finding solutions for:
- Chemistry manufacturing and controls (CMC) analytical testing
- Nonclinical testing
- Clinical development and testing strategies
- Biomarkers and CDx
- Patient identification and recruitment
Given that the industry is still in its early stages, finding the right scientific and operational leaders who have the experience and know-how to get these complex therapeutics through to approval can prove difficult. Working with a collaborative partner that can flexibly scale operations to meet your program’s capacity is crucial to success.
The Labcorp approach to CGTs
Labcorp provides comprehensive CMC support, including vector design and production, analytical characterization and release testing. Our global facilities offer cGMP (current Good Manufacturing Practice) viral vector manufacturing and a full range of CMC assays to ensure product quality and safety.
Another hurdle in CGT development is executing complex nonclinical programs to demonstrate proof of concept and safety. Our integrated nonclinical capabilities span study design, model development, safety/toxicology testing and data analysis, all of which are customized for CGT mechanisms and regulatory strategies.
Labcorp is also experienced in developing, validating and commercializing diagnostics and genomic tests to pair with novel therapies. Bioanalysis and pharmacokinetics testing are critical throughout clinical trials. Labcorp provides pharmacokinetic/pharmacodynamic (PK/PD) modeling, immunogenicity assessments and assays to quantify gene expression and measure transgene persistence. Our global capacity and harmonized systems enable seamless phase-appropriate bioanalytical support.
With six FDA-approved chimeric antigen receptors (CAR) T-cell therapies supported and decades of experience across thousands of trials, Labcorp supports CGT developers in their mission to advance the future of medicine through deep scientific experience and connected insights, global resources and scalable support.
Watch our presentation to learn more about our global CGT solutions and explore our capabilities.
