Healthcare & Life Sciences Partner Michael Werner will speak at Terrapin's Stem Cells USA & Regenerative Medicine Congress on "Regulatory Issues Affecting Commercialization of Regenerative Medicine Products." Mr. Werner will also speak on two panels titled "Developing Cell Potency Assay Standards for Industry" and "Patients, Physicians and Phonies: Resetting Public Expectations to Lever Patient Advocacy for RM."
In Mr. Warner's section on "Regulatory Issues Affecting Commercialization of Regenerative Medicine Product," he will discuss when cell potency assay is good enough for the FDA, the current outlook for developing a standardized protocol for cell potency assessment, the ARM project and the top challenges identified by the project.
The first panel, "Developing Cell Potency Assay Standards for Industry," will address the primary challenges faced by companies in assessing cell potency for date to take to the FDA, the critical standards which must be demonstrated to meet regulatory requirements and the outlook on standardized cell potency assays for therapeutic stem cells. The second panel, "Patients, Physicians and Phonies: Resetting Public Expectations to Lever Patient Advocacy for RM," will address how to harness the power of patient advocacy, what the impact is of medical tourism on mobilizing patients to fight for the stem cell industry and if an active plan to harness patient advocacy can help RM companies accelerate product commercialization.
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