Insight

Hung Trinh: How CGT innovations may languish without a concerted focus and investment within AMCs

Hung Trinh/LinkedIn

Jan 29, 2025, 10:12

Hung Trinh: How CGT innovations may languish without a concerted focus and investment within AMCs

Hung Trinh, CMC/MFG Consultant and Managing Director at Vertex Biopharm Consulting, shared on LinkedIn:

“As new cell and gene therapies emerge from academia, we must RISE to the opportunity

Academic medical centers (AMCs) have a considerable role in the origination and development of CGTs. To date, the majority of discoveries that have ultimately led to CGT approvals have stemmed from academic research3.

To advance a new cell or gene therapy to the clinic, academic investigators must embark on an arduous, nonlinear development path, balance the interests of numerous stakeholders and traverse the so-called translational Valley of Death. Given this complexity and the substantial resources needed to translate CGTs into clinics, how can AMCs nurture early-stage discoveries from academic laboratories and ensure that CGTs fulfill their potential?

We acknowledge that the field must address several challenges including, but not limited to, patient access and acceptance, manufacturing costs, regulatory frameworks, commercial viability and reimbursement.

Here, we highlight how CGT innovations may languish without a concerted focus and investment within AMCs; moreover, we define a model we call RISE (resource sharing; interdisciplinary collaboration and expertise; sustainable financial model and funding support; and education) that can guide AMCs in building sustainable translational pipelines for CGTs.”

As new cell and gene therapies emerge from academia, we must RISE to the opportunity | Nature Biotechnology

Authors: Nandhitha Uma Naresh, Dana Hammill, Mark Kessel, Roger J. Hajjar and Nathan L. Yozwiak

Hung Trinh: How CGT innovations may languish without a concerted focus and investment within AMCs