Gary Maier

Gary Maier

Senior Advisor: Clinical Pharmacology & Early Development Strategy
Worldwide Consulting Associates
Gary Maier, PhD, is a senior clinical pharmacology and drug development executive with over 30 years of experience supporting assets from early research through regulatory approval and commercialization. He brings deep expertise in clinical pharmacology, dose strategy, and model-informed development, with a focus on improving development efficiency and reducing regulatory risk.

Dr. Maier previously served as Vice President of Clinical Pharmacology at Sunovion Pharmaceuticals, where he led global strategy across IND through late-stage development and served as a primary FDA-facing leader for clinical pharmacology and modeling. His work has contributed to multiple approved products and successful regulatory submissions.

Dr. Maier advises biopharma companies and investors on development strategy, clinical pharmacology, and regulatory readiness. He is frequently engaged in diligence and decision-making where early clinical assumptions and pharmacology strategy materially impact timelines, approval probability, and asset value.

He holds a PhD in Pharmaceutical Sciences from the University at Buffalo and has authored approximately 50 scientific publications.

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