Abhishek Gupta, BS, on Addressing Friction Points in the Commercialization of Gene Therapies

“These are one-time treatments, but that also means we only have one time to get them right.”

Over the past few years, gene therapy has rapidly become a commercial stage modality, with a number of companies having brought gene therapy products out of clinical trials and into the real-world setting after securing FDA approval. This process for many companies, however, has been far from smooth, with a myriad of difficulties having been encountered from preclinical research, in clinical trials themselves, and during the commercialization process. In the face of struggles like scaling manufacturing and selecting end points for clinical trials that will be seen as acceptable by regulatory bodies, many companies are now looking back on ways that they can streamline the process of gene therapy development in order to bring these products to patients quicker and in a more cost-effective manner.

At the American Society of Gene & Cell Therapy (ASGCT) 27th Annual Meeting, held May 7 to 10, 2024, in Baltimore, MD, Abhishek Gupta, BS, the senior vice president of genetic medicines at Syneos Health, discussed this topic in a sponsored symposium entitled “Unlocking the Promise of Genetic Medicines: From Clinical to Commercial Development.” Shortly before the symposium began, CGTLive® sat down with Gupta to get an overview of the main points he would be discussing in the session and the challenges to commercializing gene therapy products in general. Gupta emphasized the need for companies developing gene therapy candidates to incorporate end-to-end thinking from the beginning and for them to maintain a focus on the individual sites where gene therapy products will be delivered to patients. He pointed out that the “one-time treatment” advantage of many gene therapies is a double-edged sword because it also means there is only one chance to get them right for each patient. Gupta also highlighted the need for collaboration between contract development and manufacturing organizations, contract research organizations, and sponsors, as well as the importance of a practical mindset.

Click here to view more coverage of the 2024 ASGCT Annual Meeting.

REFERENCES
1. Gupta A. Unlocking the Promise of Genetic Medicines: From Clinical to Commercial Development. Presented at: ASGCT Annual Meeting 2024, May 7-10; Baltimore, Maryland.