Bernie Simone

Vice President, Client Strategy and Rx-to-OTC Switch


Bernie Simone has over 30 years’ experience in the OTC industry encompassing product marketing, business development and Rx-to-OTC switch. Since joining PinneyAssociates in 2018, Bernie has focused on supporting our consumer healthcare clients with:

  • Rx-to-OTC switch regulatory strategy, consumer/clinical studies, commercial opportunity assessments and inter-functional project management
  • Marketing and consumer research to drive business growth opportunities and mining for consumer insights
  • New business development across licensing, acquisition and supply agreements involving some of the leading and more innovative brands in the United States (US)


Bernie’s experience spans over 50 therapeutic categories in OTC medicines, prescription drugs, medical devices, and dietary supplements. He has extensive practical experience across the range of activities required in Rx-to-OTC switch, including regulatory strategy, consumer study methodology and reporting, commercial opportunity assessment and project management.

He has overseen marketing and consumer research for some of the top 20 brands in the US to drive business growth and identify optimal consumer targets and key consumer insights. He also led new business development for some of the leading and more innovative brands in the US.

Over his career, he has held a diverse range of strategic leadership positions including:

  • Marketing Director on Aleve, the Alka-Seltzer franchise and other flagship brands at Bayer HealthCare
  • Global Strategic Category Director for Bayer’s CardioAspirin franchise
  • Business Development, Innovation and Rx-to-OTC Switch at Bayer and Ciba-Geigy
  • Head of Rx-to-OTC Switches for Sanofi CHC North America

Bernie’s switch project leadership includes the critical task of leading multi-function teams, including regulatory, medical, clinical, safety, marketing and manufacturing functions. He led the first-in-class switch of Nasacort 24HR, and the first-in-class introduction of an OTC TENS (Transcutaneous Electrical Nerve Stimulation) medical device. He was also responsible for the licensing and the Rx-to-OTC switch of Xyzal Allergy 24HR. He led the successful licensing of the OTC switch rights for Cialis and the initial three years of the cross-functional, global Cialis switch team. He has led the licensing of several other popular OTC brands including Maalox, Rid and Rolaids.

Since joining PinneyAssociates Bernie has helped clients to strategize, prepare regulatory submissions, and interface with FDA, to conduct due diligence of licensing opportunities, develop and test high-scoring marketing concepts, and develop commercial and regulatory strategies for new products. In addition, Bernie serves as the Chief Operations Officer and the Chief Commercial Officer for Harm Reduction Therapeutics, a non-profit organization working to make naloxone available as an OTC product at the lowest cost possible in order to save lives from opioid overdose.


  • Earned a master’s in management from Stevens’ Institute of Technology
  • Graduated with bachelor’s of science in engineering from Rutgers University – College of Engineering