Faegre Drinker announced today that Dr. Joseph Lamendola has joined the firm as senior director with Faegre Drinker Consulting in the Washington, D.C. office. He joins the firm from Advarra where he was Senior Vice President and Principal of the Regulatory Center of Excellence.
With more than 30 years of leadership experience, Dr. 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. He also advises on regulatory structure and process as well as alignment between regulatory, clinical and commercial in the drug development process. Dr. Lamendola provides companies with an assessment of drug development risk and advises on strategies to mitigate these risks.
“We are thrilled to be adding Joe to our team. He brings a wealth of knowledge on all phases of drug development and extensive regulatory experience,” said Timothy Franson, M.D., leader of the firm’s FDA regulatory consulting practice. “Joe is a trusted advisor among leaders in the biopharma and biotech industries and we look forward to offering his strategic insight to our clients.”
Dr. Lamendola 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, Dr. Lamendola 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.
Dr. Lamendola earned his bachelor’s degree from the University of Notre Dame and his Doctor of Philosophy in Organic Chemistry from Drexel University.
Faegre Drinker Consulting team members provide advisory and advocacy services at the intersection of government and the private sector at both the federal and state levels. Consultants serve clients in key industries such as health and biosciences, energy and environment, economic development, financial services, food and agribusiness, media and technology, and technology and privacy — impacting public policy, regulation and procurement to grow businesses and serve missions.