Beyond mRNA Design to Truly Programmable Medicines

The voyage of a cell or gene therapy from initial hypothesis to commercial delivery is complex and challenging. It requires a broad spectrum of scientific expertise, innovative technologies, and optimized processes to ensure these advanced therapeutics make it to market. In this GEN webinar, our panelists—two industry leaders—will discuss what it takes to develop a cell or gene therapy from concept to commercialization, alongside a conversation about innovations that are likely to shape the future of advanced therapy discovery and biomanufacturing.

Privately held Aprecia Pharmaceuticals, LLC (Aprecia) and CMIC CMO Co., LTD (CMIC CMO) today announced that both companies will collaborate to develop business opportunities in Japan for Aprecias ZipDoseTechnology. CMIC CMOs services will include identifying prospects in Japan, generating awareness and facilitating discussions of technology licensing agreements, research collaborations and distribution partnerships. Through this engagement Aprecia seeks to expand its 3DP products globally, and this agreement highlights the importance of Japan in its long term strategy.

The impacts of blood culture contamination result in unnecessary antibiotic treatment, extended length of stay and increased hospital costs. Join Kevin Garey, professor and chair at University of Houston College of Pharmacy, as he discusses research findings recently published in the Journal of Clinical Microbiology.

The management of cancer patients in clinical practice is undergoing a revolution due to the introduction of effective immunotherapy. Several different strategies currently rely on harnessing the immune system to fight tumors, leading to unprecedented therapeutic success. However, immunotherapy has also created the need to revisit the assessment of treatment benefit, possibly because its mechanism of action leads to effects on short- and long-term outcomes in a manner that differs from those of other modalities. For example, clinical trials of immune checkpoint inhibitors have disclosed novel issues related to the assessment of objective responses and have reinstated overall survival as a reliable primary endpoint, often to the detriment of progression-free survival (PFS). Moreover, pseudoprogression has become an issue in some tumor types, and the duration of responses has emerged as a relevant endpoint. In parallel, the limitations of current statistical methods of survival analysis that are based on the proportional-hazards assumption have become more apparent, and novel methods have been proposed.