Louis Cicchini

Pharmaceutical Executive — A successful transition from clinical development to commercial launch in cell and gene therapy requires early, structured collaboration with health systems to address operational, financial, and workflow challenges that shape real-world patient access and therapy adoption.

Cencora — Navigating the complex world of ATMPs and CGTs? Explore this Q&A to better understand the key regulatory differences between the US and EU, and potential implications. From product classification to early access pathways, a top priority for innovators should be to engage with experts and regulators early in the development journey.

Pharmaceutical Executive — How cell and gene therapy manufacturers can lessen the chances of receiving FDA complete response letters through the use of proactive chemistry, manufacturing, and controls strategies.

Pharmaceutical Executive — How cell and gene therapy developers can lessen the chances of receiving FDA complete response letters through the use of proactive chemistry, manufacturing, and controls strategies.

Industry Dive — The cell and gene therapy (CGT) field is advancing rapidly. An ongoing parade of standout innovations is now poised to transform patient care and enable unprecedented outcomes, including more potential cures for previously untreatable conditions. There are many reasons for optimism about the current state of these transformative medicines, which have regulatory momentum and stable investment on their side.

Modern Retina — Cell and gene therapies in development for unmet needs.

Pharmaceutical Executive — What biopharma companies need to know about this evolving regulatory pathway.

Drug Discovery & Development — FDA cell and gene therapy guidance in a FAQ format provides insights on regulatory strategies and safety. This article has the details.

cencora — Explore complexities of cell therapy categorization and its evolution to understand how naming conventions aid in advancing innovative therapies to market.

Cell & Gene — Collaboration, communication, and competition are key to advancing cell and gene therapy. Experts share insights from Cencoras inaugural CGT summit.

Cencora — A deep dive into the transformative value of cell and gene therapy.