Lee Mia Nagao Ph.D.

Senior Director Science, Regulation & Policy

Overview

Lee Mia Nagao partners with pharmaceutical innovators to identify and overcome regulatory and product-development obstacles as they shepherd their products from the lab to the marketplace. Driven by her own background as a scientist, Lee is passionate about helping clients maximize efficiency in the product development lifecycle so that high-quality, life-saving products reach patients quickly and clients have more time to focus on new innovations.

Advising Pharmaceutical and Biopharmaceutical Companies

Lee advises domestic and international clients on current and emerging regulatory oversight of biologics and pharmaceutical drug development and manufacturing, including drug-device combination products. She works with clients to address complex issues related to pharmaceutical packaging, drug-device combination products, supply chains, nonclinical toxicology and clinical pharmacology. Lee is skilled in providing strategic counsel on aspects of chemistry, manufacturing and controls (CMC), risk assessment and management strategies, lifecycle management, current good manufacturing practices (CGMPs), and regulatory frameworks for drug master files and other regulatory submissions.

Clients value Lee’s guidance on detailed regulatory requirements for pharmaceuticals as well as on the creation of industry collaborations, including public-private partnerships. She represents industry groups before regulatory agencies and industry and scientific organizations throughout the world, including:

  • U.S. Food & Drug Administration
  • Health Canada
  • European Medicines Association
  • United Kingdom Medicines and Healthcare Products Regulatory Agency
  • China National Medical Products Administration
  • Brazilian Health Regulatory Agency (ANVISA)
  • Japan Pharmaceuticals and Medical Devices Agency
  • United States Pharmacopeia

Personal Interests

Lee is an avid runner, cyclist and hiker. She also enjoys reading mysteries by international authors.

Credentials

Education

Yale University
Ph.D. (1998)

University of California, San Diego
B.A. (1990)

Insights & Events

Insights
Updates April 2020

Testing Employees for COVID-19: Responses to FAQs From Employers

4 min read  
Updates March 2020

FDA Relaxes Modification Restrictions for Non-Invasive Remote Monitoring Devices During COVID-19 Public Health Emergency

4 min read  
Updates March 2020

FDA Issues Final Guidance on Conduct of Clinical Trials of Medical Products During COVID-19 Pandemic

3 min read  
Updates Dec-06

Quarterly Publication of the Drinker Biddle Gardner Carton Health Law Pharmaceutical Practice Group: Focusing on Regulatory Science News and Issues

1 min read  
Updates Aug-06

Quarterly Publication of the GCD Health Law Pharmaceutical Practice Group; Focusing on Regulatory Science News and Issues

1 min read  
Updates Jun-06

Quarterly Publication of the GCD Health Law Pharmaceutical Practice Group; Focusing on Regulatory Science News and Issues

1 min read  
Updates Mar-06

Quarterly Publication of the GCD Health Law Pharmaceutical Practice Group; Focusing on Regulatory Science News and Issues

1 min read  
Updates Dec-05

Quarterly Publication of the GCD Health Law Pharmaceutical Practice Group; Focusing on Regulatory Science News and Issues

1 min read  
Updates June 2005

Quarterly Publication of the GCD Health Law Pharmaceutical Practice Group; Focusing on Regulatory Science News and Issues

1 min read  
Updates March 2005

Quarterly Publication of the GCD Health Law Pharmaceutical Practice Group; Focusing on Regulatory Science News and Issues

1 min read  

Leadership & Community

Professional Associations

  • American Association for the Advancement of Science
  • American Chemical Society
  • Parenteral Drug Association

Firm Leadership

  • Diversity and Inclusion Committee 
  • Drinker Biddle & Reath LLP — Diversity & Inclusion Committee
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