Drug Shortage Prevention Recognition

ISPE Recognizes Drug Shortage Prevention in its Annual FOYA Awards Program

Beginning with the 2016 Awards, ISPE is recognizing companies who demonstrate drug shortage prevention preparedness in the Society’s Facility of the Year Awards (FOYA) program.

ISPE is recognizing companies who, by the accomplishments for which they have won a FOYA category or honorable mention, have strengthened their ability to prevent drug shortages or minimize their impact on patients.

Companies are selected based upon excellence in the drug shortage prevention dimensions which form the framework of the ISPE Drug Shortages Prevention Plan and the ISPE Drug Shortage Assessment and Prevention Tool.

Baxter BioPharma Solutions - Location:  Halle, Germany
Project:  Baxter BioPharma Solutions (BPS) Oncology Manufacturing Expansion
Recognized in the drug shortage prevention dimensions:

  • Business Continuity Planning
    • Adding additional capacity to service the CMO market of parenteral oncology and other complex liquid and lyophilized products.  
    • Expansion able to accommodate the need for life saving unit dose products
    • Adaptable equipment, built-in flexibility and efficiency with capabilities for most current formulation developments.
  • Building Capabilities
    • Being designed primarily by in-house engineering staff that was then retained to operate the plant.
  • Robust Quality System
    • State-of-the-art isolator technology and filling process quality improvements:
    • Capabilities built into all lyophilizers for continued and improved process development and detailed process analysis of lyophilization cycles.

Janssen Vaccines AG - Location:  Bern, Switzerland
Project:  ZEBOV in 81J
Recognized in the drug shortage prevention dimensions:

  • Business Continuity Planning
    • Achieving a Fast Track Refurbishment of an idle facility for the Production of Ebola Vaccine in response to the Ebola outbreak in West Africa providing a launch capacity of up to 5 million doses annually
    • Design space was able to accommodate possible process changes without impacting the schedule for completion of the facility.
    • Accelerated timelines through parallel activities in process development and facility design and construction
  • Building Capability
    • Teaming up the process developers, the tech transfer team, and the facility designers to define the facility requirements in close collaboration
  • Communications with Regulatory Authorities
    • Early and continuing involvement of local authorities to include their expectations in scope and design

NPR Addresses Drug Shortages with ISPE Board Chair

February 2016:  ISPE Board Chairman Joseph Famulare (Vice President, Global Quality Compliance and External Collaboration Genentech/Roche, Pharma Technical Operations) appeared on NPR’s The Diane Rehm Show Monday to talk about Drug Shortages.

Learn more and listen to the whole segment to hear all of Joseph Famulare’s comments.