Reducing Drug Shortages… and High Prices

  • How hospital systems and philanthropies came together to establish their own supply chain for essential quality generic medicines
  • Living the mission to make quality generic medicines accessible and affordable to everyone
  • Improving the resiliency of the supply of essential medicines used in hospitals, often for critical care, day-to-day and during a pandemic
  • Ensuring a safe and stable supply of essential medicines for U.S. patients

Donna Gulbinski
Chief Quality & Regulatory Affairs Officer
Civica Rx

Donna’s expertise spans worldwide operations, quality, and regulatory experience across vaccine, biological, pharmaceutical and device technologies where she was an operational leader with a history of delivering exceptional quality, compliance and business performance. Donna has a 30-year plus career where she held positions of significant responsibility for Quality and GxP Compliance, including various roles in drug discovery, operations, quality and regulatory affairs. Donna is currently the Chief Quality & Regulatory Affairs Officer at Civica, Inc., a new independent not-for-profit company founded by health care systems to address critical generic drug shortages caused by market failures.

Donna was previously at Lachman Consultant Services, LLC where she was Vice President of the Compliance Practice. Prior to that Donna was the Head of Quality for Bristol-Myers Squibb where she led Quality through 13 NME approvals with flawless pre-approval inspections, built, qualified and approved several biologics facilities and led transformational activities in moving from 34 sites to 12 both from a quality perspective and as the CMC regulatory leader.

Donna’s expertise spans a strong foundation in technical and quality & compliance including basic research at Merck & Co., Inc. across cardiovascular, bone biology, HIV, anti-coagulants and multiple drug resistance.