Bernie Simone

Senior Advisor, OTC Products

Steering OTC switch projects through regulatory and commercial challenges to success


Bernie engages with consumer healthcare clients to support Rx-to-OTC switch regulatory strategies and FDA engagements, commercial opportunity assessments and optimization, and new business opportunity identification, evaluation and implementation.


Bernie’s 40-year career spans more than 50 therapeutic categories in OTC medicines, prescription drugs, medical devices, and dietary supplements. His experience ranges from regulatory strategy to consumer research for OTC switches to leading iconic OTC brands.

As the commercial leader for some of the top 20 U.S. OTC brands, he drove double-digit growth via identification of key target audiences and compelling consumer insights.

Leadership positions he has held include:

  • Marketing Director, Aleve and Alka-Seltzer
  • Global Strategic Category Director, Bayer CardioAspirin
  • Director of Business Development, Innovation and Rx-to-OTC Switch, Bayer Consumer Healthcare and Ciba-Geigy
  • Head of Rx-to-OTC Switches, Sanofi Consumer Health Care, North America

Bernie led the first-in-class switch of Nasacort Allergy 24HR, and the first-in-class introduction of an OTC transcutaneous electrical nerve stimulation medical device for Icy Hot. He oversaw licensing and the switch of Xyzal Allergy 24HR, led licensing of the OTC switch rights for Cialis, and led the global Cialis switch team before joining Pinney Associates in 2018.

Bernie also serves as the Chief Operations Officer and Chief Commercial Officer of Harm Reduction Therapeutics, a nonprofit devoted to saving lives from opioid overdose by making low-cost naloxone available as an OTC product.


  • MA, Management, Stevens Institute of Technology
  • BS, Engineering, Rutgers University


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