Learn about United Therapeutics winning the Social Impact category for the 2020 ISPE Facility of the Year Award:
Location: Silver Spring, Maryland, USA
Project: Dinutuximab-Dedicated Oncology Medical and Analytical Laboratory
The origin story of United Therapeutics (UT) is rooted in a parent’s love, a tireless mission to save lives, and a willingness to break convention to achieve this objective. Dr. Martine Rothblatt, an American attorney, author, and founder of Sirius XM, learned in 1994 that her 7-year-old daughter had a life-threatening orphan disease, pulmonary arterial hypertension (PAH). With no viable medicine on the market, Dr. Rothblatt took matters into her own hands and made it her life’s mission to find a lifesaving treatment.
In 1996, she established the public biopharmaceutical company United Therapeutics to focus on the development and commercialization of unique products to address the unmet medical needs of children with chronic and rare life-threatening conditions.
In 2016, United Therapeutics extended its focus on a pediatric neuroblastoma product, Unituxin. Approved in 2015, the FDA granted Unituxin priority review and orphan product designation, the first treatment option for neuroblastoma to be given this designation. Unituxin has proven effective in treating and even reversing neuroblastoma in children, a rare form of cancer that forms on immature nerve cells.
This project is the category winner for Social Impact, not only because of the dedicated efforts behind a product for an unmet medical need, but also for the unique challenges and obstacles that had to be overcome to build the facility, including:
- Site location and restricted footprint, essentially constructing in the middle of an active urban area
- The need to change local government ordinances to facilitate construction
- The ability to build and maintain community relations and manage with other significant projects occurring simultaneously
- Overcoming constructability challenges around the atypical cylindrical facility shape and significant underground work
- Driving high speed commissioning and validation processes
The judging team was especially impressed by the sheer number of challenges this project had to overcome, while never losing focus on why they were doing this work. The project also took the time to consider the impacts to the community both during and after construction, even including external artwork for the facility. The collective execution across this project in service of young patients with an unmet need, makes this project a solid winner for Social Impact.
Supply Partners and Key Participants:
Manufacturer/Owner Name - United Therapeutics
Engineer/Architects (A&E) -
- IPS-Integrated Project Services, LLC
Construction Manager - The Whiting-Turner Contracting Company
Main/General Contractor - The Whiting-Turner Contracting Company
Piping Subcontractor (HVAC, Plumbing, Lab Gas Piping) - Heffron Company
Piping Subcontractor (Process Piping) - High Purity Systems
HVAC Subcontractor - Heffron Company
Automation and Control Supplier - Process Controls - Omni Instrumentation & Electrical Services
Automation and Control Supplier - Process Controls - Avid Solutions, Inc.
Automation and Control Supplier - Process Controls - BAS - Critical Systems by Schneider Electric
Major Equipment Suppliers/Contractors
- Process EquipmentMillipore Sigma