LIFE SCIENCES

Breakthrough Designations – How Can Quality Enable Speed to Innovation?

  • Offering an overview of how breakthrough therapy designations have historically worked and how that process is changing
  • Are we as an industry ready for major changes in how drug development is expedited?
  • Discussing how our organizations’ Quality Culture must be an integral part at all stages of this transition
  • Working with all stakeholders to ensure we do not sacrifice safety and quality as we increase the pace of innovation
  • What should we be doing right now to prepare for the future of these developments?

Christie Bielinski, Vice President of Product Quality Management at Janssen Pharmaceuticals, leads a world-wide organization of quality professionals accountable for the development, manufacture and launch of pharmaceutical products across the Janssen therapeutic areas. The scope of her responsibilities include assuring that the quality requirements are built into the product in early and late-stage development, that proactive identification of ‘critical to quality attributes’ are identified, and that the associated risk is quantified so that defects can be prevented during the entire lifecycle of the product. In her 11-year career with Johnson & Johnson, Christie has held positions in both the Medical Device and Pharmaceutical segments and has had responsibility for marketed products that span a diverse portfolio of Pharmaceuticals, Biologics, Devices and Combination Products. Her responsibilities during this tenure have included new product development and lifecycle management, supplier quality, validations/site qualifications, laboratories, quality operations and network optimization.