Dr. Joseph F. Lamendola
Senior Director - Government & Regulatory Affairs
Overview
With more than 30 years of leadership experience, Dr. Joe Lamendola advises biopharma and biotech companies on all key aspects of drug development and agency interactions, including pre-IND, end of phase 2, pre-NDA and Advisory Committee meetings. Joe also advises on regulatory structure and process as well as alignment between regulatory, clinical and commercial in the drug development process. Joe provides companies with an assessment of drug development risk and advises on strategies to mitigate these risks.
A trusted advisor to CEOs and R&D leaders in the biopharma and biotech industries, Joe brings strategic insight to support all stages of the product development life cycle. Joe has held key executive positions at companies including Schering Plough and Bristol Myers Squibb, where he guided the strategy eventually leading to the transformation of the U.S. Regulatory Organization.
In addition, Joe has led efforts throughout his career resulting in the approval of nearly 40 NDAs in over 10 different therapeutic areas, including oncology, cv/metabolics, antiinfectives, antivirals, immunology, antifungals, allergy and biologics with products such as Nasonex, Zetia, Eliquis and Farxiga. His experiences span the development of new chemical entities, 505B2 applications and Orphan Drugs. He is also knowledgeable about labeling, advertising and promotion activities.
Faculty Positions
- George Washington University School of Medicines and Health — Adjunct Professor
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Credentials
Education
Drexel University
M.S. in Physical Organic Chemistry
University of Notre Dame
B.S. in Chemistry
Drexel University
Ph.D. in Physical Organic Chemistry