Joseph F. Lamendola, Ph.D.
Joe Lamendola specializes in global and US Regulatory Affairs with 25+ years of experience in the area. He served as VP of Worldwide Regulatory Affairs at Schering Plough and most recently as VP of US Regulatory Affairs at BMS, with responsibility for regulatory strategy across therapeutic areas. During his career, Joe has led US and global pharmaceutical organizations in numerous therapeutic areas including oncology, CV/metabolics, anti-infectives, antivirals, antifungals, immunology, allergy and biologics. He has directed the strategy and operations of regulatory efforts leading to global approvals of at least 14 marketed drugs, including:
· Claritin OTC and Clarinex (antihistamines)
· Cedax (Antibiotic)
· Intron, PEG Intron and Intron/Ribavirin (antivirals)
· Nasonex and Proventil HFA (asthma)
· Temodar (oncology)
· Zetia and Vytorin (cholesterol lowering, CV)
· Integrilin (antiplatele
· Onglyza and Farxiga (Type 2 diabetes)
· Myalept (lypoystrophy)
· Eliquis (antithrombotic)
Joe has established strong and longstanding relationship with FDA leadership in many therapeutic areas and has led organizations to successful advisory committee preparation and outcomes based on the integration of good science with appropriate regulatory strategies. He also has experience in leading labeling, advertising and promotion activities.
Joe earned his BS in Chemistry from the University of Notre Dame and his PhD in Organic Chemistry from Drexel University. He currently consults with clients on strategies for optimizing the path to regulatory approval.
· Claritin OTC and Clarinex (antihistamines)
· Cedax (Antibiotic)
· Intron, PEG Intron and Intron/Ribavirin (antivirals)
· Nasonex and Proventil HFA (asthma)
· Temodar (oncology)
· Zetia and Vytorin (cholesterol lowering, CV)
· Integrilin (antiplatele
· Onglyza and Farxiga (Type 2 diabetes)
· Myalept (lypoystrophy)
· Eliquis (antithrombotic)
Joe has established strong and longstanding relationship with FDA leadership in many therapeutic areas and has led organizations to successful advisory committee preparation and outcomes based on the integration of good science with appropriate regulatory strategies. He also has experience in leading labeling, advertising and promotion activities.
Joe earned his BS in Chemistry from the University of Notre Dame and his PhD in Organic Chemistry from Drexel University. He currently consults with clients on strategies for optimizing the path to regulatory approval.