Opinion

Tanja Obradovic

May 10, 2025, 15:49

Tanja Obradovic Highlights FDA’s input and critical role in advancing cell therapy field

Tanja Obradovic, Oncology Medical Strategy Advisor at Mercurial AI, shared a post by Friends of Cancer Research on LinkedIn, adding:

“Very important points shared today on FDA input and critical role in advancing cell therapy field in the context of product characterization, efficacy, and overall patient benefit. Also, from wider community ideas on tackling establishment of prospective registries and possibilities for cross-collaboration across all stakeholders including regulators, payers, Pharma and health systems. Many hurdles but also great opportunities.

Many thanks to Nicole Verdun for truly insightful and detailed sharing of experiences and points from FDA.”

“Very informative report on strategy navigation over regulatory and manufacturing hurdles toward expanded cancer patient access to genetically modified cell-based therapies ahead of the meeting that is certain to bring many valuable exchanges.”

Quoting Friends of Cancer Research‘s post:

“Only 3 days left until the “Unlocking Next-Generation Therapies: Exploring Innovative Development and Manufacturing Models for Cell Therapies” meeting! Join us and Parker Institute for Cancer Immunotherapy this Friday at 10AM ET virtually or in-person in Washington, DC. Experts will discuss practical frameworks to advance regulatory and manufacturing approaches for delivering promising cell-based therapies to rare disease patients.

Register.

Ahead of meeting, read our White Paper, “Regulatory and Manufacturing Pathways to Expand Access to Genetically Modified Cell-Based Therapies,” which outlines potential strategies to address regulatory, manufacturing, and cost recovery barriers to patient access.”

FDA