A new award category for 2020, the Social Impact Award recognizes companies who have developed new standards and practices that have prevented drug shortages and increased patients access to medicine, reduced the cost of drug products through the use of new tools or techniques, or accelerated a shift to sustainable facility design which has significantly reduced environmental impact.
United Therapeutics is one of two companies that won the Social Impact Award this year. GlaxoSmithKline is the other.
Project: Dinutuximab-Dedicated Oncology Medical and Analytical Laboratory
This project faced unique challenges and obstacles to build the facility but never lost focus on why they were doing this work – to provide medicine for an unmet medical need.
FOYA Judges
United Therapeutics, a public biopharmaceutical company, was established in 1996 to focus on the development and commercialization of unique products to address the unmet needs of patients with chronic and rare life-threatening conditions. The concept of United Therapeutics was born a few years earlier when Dr. Martine Rothblatt, an American attorney, author, and founder of SiriusXM, learned that her 7-year-old daughter had pulmonary arterial hypertension, a life-threatening orphan disease, with no viable medicine on the market. Since orphan diseases affect a small percentage of the population, cures are not typically being researched, so Dr. Rothblatt took matters into her own hands and made it her life’s mission to find a life-saving treatment.
She and her team at United Therapeutics were successful and several years later they expanded their focus to include the development and commercialization of unique products to address more unmet medical needs, including those of children with chronic and rare life-threatening conditions.
However, as the company grew, they realized their manufacturing and research capability was limited due to existing biologics manufacturing capacity. In order to treat more pediatric patients, conduct research on other life-threatening illnesses, and bring hope to more families, United Therapeutics knew they had to expand their operation and so they decided to build a new facility – the Dinutuximab-Dedicated Oncology Medical & Analytical Laboratory (DDOMAL).
United Therapeutics wanted to build adjacent to its existing campus in downtown Silver Springs, Maryland, but they only had 14,000 available square feet and needed 25,000. To overcome this challenge, they partnered with local government to pass legislation that allowed for the floor area housing mechanical, engineering, and plumbing equipment required to support the drug manufacturing process to be exempt from the total gross square foot calculation. This legislation not only made the project feasible but will promote the future development of the life science industry in Montgomery County, Maryland.
Pioneering design solutions were created early on such as using space trusses to avoid interior columns, optimizing manufacturing space, and segregating the elevator and stairwell from the process areas. The construction team excavated down almost as far as they built up and every possible inch of space has a purpose including the cellar for process utility equipment and the roof for black utilities.
From the beginning, United Therapeutics wanted to stay connected to their local community – and the company did not lose sight of that during or after construction. Throughout the project, the team went above and beyond to create a positive experience for those around them by installing covered walkways, organizing social events for the local community to discuss the project, installing a project signboard to inform neighbors of what they should expect to see, hear, and smell, and providing noise-cancelling headphones to residents of a nearby nonprofit Catholic organization.
“DDOMAL was born of a mission to improve the lives of patients,” said Patrick Poisson, EVP, Technical Operations. “Against all odds, the DDOMAL team showed an unparalleled commitment to getting Unituxin® into production and to market, building strong local relationships, and executing the project to an outstanding level.”
ISPE congratulates United Therapeutics on the successful completion of the Dinutuximab-Dedicated Oncology Medical and Analytical Laboratory, for their achievements in advancing research and development of medicines for rare diseases, and for their FOYA award-winning entry for Social Impact. Learn more about the 2020 FOYA Social Impact winner.
Has your company recently designed, built or renovated a state-of-the-art pharmaceutical or biotechnology facility that is best in its class?
ISPE is now accepting entries into the 2021 ISPE Facility of the Year Awards (FOYA) Program, and your facility may be eligible to apply. Learn more about the Facility of the Year Awards submission process and your company could be the next Facility of the Year Awards Category winner. Nominate your facility in 2021
Want to learn more about the 2020 FOYA winning projects? Get inspiration for future innovations at these complimentary digital events.
Get a free Facility of the Year Awards Day Pass to take an in-depth look at each of the 2020 FOYA winning projects during the 2020 ISPE Annual Meeting & Expo. Claim your complimentary pass today to benefit from 3 hours of compelling and insightful sessions.
Join ISPE and prominent industry leaders on Tuesday, 3 November, as we come together to recognize the outstanding achievements of all the FOYA winners during the 2020 Facility of the Year Awards Virtual Banquet.
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