2020 FOYA Category Winners for Social Impact

Learn about the two companies winning the Social Impact category for the 2020 Facility of the Year Awards:

GlaxoSmithKline

Location: Parma, Italy
Project: Attachment Inhibitor (AI) Project

This is the one of two presentations in the new Social Impact Category, awarded to GSK and ViiV Healthcare for constructing and commissioning a dedicated facility in 15 to support the development and manufacture of an investigational medicine, for people living with HIV who have few or no treatment options remaining.

The award recognizes the application of novel approaches and practices in project design and delivery at the manufacturing site in Parma, Italy, for the benefit of individuals who are considered heavily treatment-experienced and for whom there is a critical need for new ways of suppressing their virus.

The project needed to be exceptionally fast to ensure continuity of supply of fostemsavir to allow submission of a new drug application to the FDA in December 2019. The result was 15 months from ground-breaking to handover of the fully finished facility to start manufacture.

The team had to overcome unusual challenges such as their limited knowledge of the product which was acquired from a third party who stopped clinical development of the drug. This limited product knowledge meant that the team collaborated closely with colleagues across all developmental functions and regulatory authorities to first understand the impact of the drug on facility design and operation. There was also large uncertainty of product forecast demand between base case and maximum demand forecasts for both API and drug product.

In order to deliver the project, the team used the novel delivery approach of “Integrated Project Delivery” (IPD) never used before in Italy. They paid attention to creating a “can do” attitude and culture whilst implementing accelerated delivery tools such as building information modelling and 3D visualization from design inception to handover enhance collaboration. This pre-construction project visualization improved coordination of scheduling and sequencing throughout the project and was contributory to the excellent safety performance of zero reportable incidents.

As a result of this work, GSK and ViiV Healthcare was able to make enough product to continue clinical trials and has been able to make regulatory submissions to the FDA and CHMP. The company is expecting approval of fostemsavir in the US and Europe in 2020.

Supply Partners and Key Participants:

Manufacturer/Owner Name - GlaxoSmithKline
Engineer/Architects (A&E) -

Techniconsult
Bryden Wood

Construction Managers -

Techniconsult
Oneplan

Piping Subcontractor - Idroinox
HVAC Subcontractor Omega
Automation and Control Suppliers -

SIA
ER Sistemi

Major Equipment Suppliers/Contractors -

Leistritz Markgrafenstr 29-39
IMA
Korsch
Comecer

United Therapeutics

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
EwingCole

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