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Despite their designation, rare diseases affect over 400 million people worldwide and represent a major unmet medical need. The gene therapy market is poised to offer hope as a growing number of therapies enter Phase 1 clinical trials, progressing these therapies to offer hope to patients and their families. The challenge for many drug developers is successfully bringing these therapies to clinic while navigating difficulties around scaleup, low patient numbers, and minimal standardization and guidance for emerging technologies. To help execute a successful journey to clinic, consider partnering with a contract development and manufacturing organization (CDMO) that has ample development, manufacturing, engineering, quality, and regulatory expertise.
In a recent webinar hosted by FUJIFILM Diosynth Biotechnologies (FDB), FDB’s Director of Viral Gene Therapy Operations, Dr. Joanna Norman, and Director of Strategic Technical Marketing, Dr. Rebecca Abram, spoke to the evolving gene therapy landscape, the increasing number of treatment possibilities for rare disease patients, and the benefits of working with an experienced CDMO to manufacture these therapies for clinic. In the following post-webinar Q&A session, Norman and Abram provide insight to audience members on how to recognize the capabilities of potential CDMO partners.