FDA Insights Seminar series returns on Jan. 30


UNeMed will continue a seminar series dedicated to regulatory insights on Tuesday, Jan. 30, when FDA project manager Erik Laughner leads a discussion on regulatory issues related to biologics.

He is also expected to cover how to write better Investigational New Drug applications, and explain the review process.

The hour-long seminar is free and open to all, and will be held via Zoom (https://bit.ly/FDAinsights_Jan30) beginning at noon.

Laughner is a project manager at the FDA’s Center for Biologics Evaluation and Research, which is within the Office of Regulatory Operations. He holds a master’s degree in biotechnology from Johns Hopkins University. He then spent eight year at John Hopkins as a researcher in molecular biology, working with Nobel laureate Gregg Semenza, MD, PhD.

UNeMed plans to host two more events in the FDA Insights series, with the next discussion tentatively planned for April. Specific topics have not yet been determined.

Amanda Hawley, PhD, a senior licensing specialist at UNeMed, is producing the seminar series as a way to help University innovators navigate a sometimes arcane regulatory process.

“Essentially, we want to provide introductory webinars relevant to FDA filings of pre-INDs (investigational new drug) or 510(k) clearances for medical devices, so our researchers can obtain a better understanding of the process, expectations and requirements when filing with a regulatory agency,” she said.

UNeMed opened the series during Innovation Week in October 2023 when Margaret Kober led a discussion related to her work in the FDA’s Center for Drug Evaluation and Research.

Additional information about future events in this seminar series will be announced as soon as those details are known.

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