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Iwen Wu

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Iwen Wu

Commissioner's Fellow | Novo Nordisk

District of Columbia, Washington, United States

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Iwen Wu

Summary

Iwen Wu is a seasoned regulatory professional with a robust background in biologics and medical device regulation, particularly in advanced therapy products like CAR T cells and mRNA therapeutics. With a PhD in Biomedical Engineering from Johns Hopkins, Iwen has honed expertise at the FDA, where he has held various leadership positions, including Chief of the Pharmacology/Toxicology Branch. Currently serving as the Director and Global Regulatory Lead at Novo Nordisk, Iwen is well-versed in navigating complex regulatory landscapes. His experience encompasses the entire product lifecycle from IND to BLA, showcasing a deep understanding of both regulatory science and clinical development. Iwen's analytical skills and strategic insight enable him to effectively lead teams in delivering innovative healthcare solutions. Passionate about advancing therapeutic technologies, he is committed to improving patient outcomes through regulatory excellence. Iwen's career reflects a dedication to the intersection of science and policy, making him a valuable asset in the evolving landscape of healthcare.

General

Specialist

Technical Background

Leadership Experience

Long-Term Tenure

Professional interests

Industry-specific interests

Emerging Technologies

Leadership Development

Organisational experience

Corporate Experience

Government Experience

Iwen Wu

Work Experience

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Director, Global Regulatory Lead at

Novo Nordisk

January 2025 - Present

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Iwen Wu

Education

Johns Hopkins School of Medicine, Doctor of Philosophy (PhD), Biomedical Engineering

January 2008 - January 2013

University of California San Diego, Bachelor of Science (BS), Bioengineering

January 2008 - January 2012

Frequently Asked Questions about Iwen Wu

What is Iwen Wu email address?

Iwen Wu's primary email address is *******@fda.gov. To view the full verified email and additional contact details, sign up for free with Muraena.

What company does Iwen Wu work for?

Iwen Wu is a Commissioner's Fellow at Novo Nordisk.

Where Iwen Wu graduated from?

Iwen Wu holds a degree in null from Johns Hopkins School of Medicine.

How can I directly contact Iwen Wu?

To contact Iwen Wu directly, you can use the email address *******@fda.gov. Complete contact information is available upon registration with Muraena.

Who is Iwen Wu?

Iwen Wu is a seasoned regulatory professional with a robust background in biologics and medical device regulation, particularly in advanced therapy products like CAR T cells and mRNA therapeutics. With a PhD in Biomedical Engineering from Johns Hopkins, Iwen has honed expertise at the FDA, where he has held various leadership positions, including Chief of the Pharmacology/Toxicology Branch. Currently serving as the Director and Global Regulatory Lead at Novo Nordisk, Iwen is well-versed in navigating complex regulatory landscapes. His experience encompasses the entire product lifecycle from IND to BLA, showcasing a deep understanding of both regulatory science and clinical development. Iwen's analytical skills and strategic insight enable him to effectively lead teams in delivering innovative healthcare solutions. Passionate about advancing therapeutic technologies, he is committed to improving patient outcomes through regulatory excellence. Iwen's career reflects a dedication to the intersection of science and policy, making him a valuable asset in the evolving landscape of healthcare.

Iwen`s contact details

mail

*******@fda.gov

*******@novonordisk.com

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