Nancy Isaac, Esq.
Nancy E. Isaac is of Counsel with Longwell and Associates, a Palo Alto based Food and Drug Law firm. Ms. Isaac has also been a consultant since 1993. Her projects have included developing regulatory strategies to assure earliest possible access to markets while maintaining competitive advantage for biologics, pharmaceutical, combination and medical device companies ranging from start-up to Fortune 500. In addition, she is currently Senior Vice President of Clinical and Regulatory Affairs, and Quality Assurance for Broncus Technologies, Inc., Mountain View, California. Broncus is developing a combination product (drug eluting stent) for patients with severe emphysema. Prior to joining Broncus in 2005, she was on the operating committee and served as the VP of Regulatory and Quality for Aerogen, also in Mountain View, CA, and, prior to that, was the World Wide VP of Regulatory and Quality for BD Biosciences, San Jose, CA. Ms. Isaac holds a BS in Cell and Molecular Biology from SF State, a JD from Boston University with a concentration in Health Law as well as a Masters in Public Health and Law from Harvard School of Public Health, where she received the Samdperil Health Law Essay Award. She is an active member of the California Bar (No. 202500).
She has lectured at Stanford University Medical School, Santa Clara Law School, Haas School of Business and at numerous meetings offered by professional organizations including RAPS and the Food and Drug Law Institute (FDLI) and was a certified ethics trainer. Ms. Isaac has coauthored a book chapter titled “Due Diligence Points to Consider” in the “Expert’s Guide to Healthcare Product Due Diligence” published by FDLI. She has served on the Board of numerous non profit organizations and currently serves Board of Directors and is the Secretary for the Palo Alto Medical Foundation Hospital (a Sutter Health Hospital), Menlo Park, CA.
