Relive the Magic of the 2022 Facility of the Year Awards (FOYA) Banquet!

FOYA Committee, Past Chair, Dave DiProspero, CRB, serving as Master of Ceremonies for his 12th year, welcomed everyone to the celebration. “This evening is about celebrating award winning projects, companies, and people. FOYA is about innovation, creativity, and facility design.” ISPE President Tom Hartman added, “These are stories of people in the pharmaceutical industry as they endeavored to overcome seemingly impossible odds.”

We receive a lot of excellent submissions this year and it was incredibly difficult to narrow down to these select winners. The winners tonight represent the best of our community. They inspire us to take on new challenges.

Avril Vermunt

Tonight’s winners join an elite league of 122 winners from 20 countries around the globe. Winners of these awards exemplify the ideals of FOYA and demonstrate ISPE’s dedication to enhancing patient health thru advancements in pharmaceutical manufacturing.

Tony Crincoli

FOYA awards were presented in the following categories:

• Innovation - CRISPR Therapeutics for their facility in Framingham, Massachusetts. CRISPR won the award for creating a flexible, digitally-enabled facility that brings the promise of innovation to life. The manufacturing facility was designed thoughtfully and innovatively. Brad Ebel, Site Head, was personally inspired to join CRISPR because of his good friend,Devon, a 6-year-old, who died of a rare cancer. He said CRISPR was able to build the facility in under a year, during COVID, and have it GMP operational within a year. He added, “Cancer, watch out, we’re going to come kick your ass.”
• Project Execution - Janssen Biologics, BV for their Vaccine Launch Facility Expansion in Leiden, the Netherlands. The fast-track project included designing and building a new facility in 9 months and securing regulatory approval for the initial commercial batches in 12 months. The ambitious timeframe required a Herculean effort and flawless collaboration on the part of all involved parties, including best-in-class design and construction partners and an integrated, cross-functional team. “It was a privilege to lead a team of highly experienced professionals,” said Hans Weverling, Program Director for Janssen Biologics. “Working together we were able to complete the project in record time. The team faced multiple challenges and only by close collaboration were we able to overcome them. We were drive by the understanding that patients were waiting. Everyone knew someone affected by COVID”
• Supply Chain - Takeda Pharmaceuticals International AG for their project Alofisel Global Program with locations in Madrid, Spain; Grange Castle, Ireland; Osaka, Japan; and Thousand Oaks, California. The program’s implementation included the introduction of a bespoke world-class end-to-end supply chain introducing a made-to-order process under one IoT solution. Pilar Redondo, Site Head, said, “Only 4 years ago, we would not have believed that we could deliver doses of personalized medicine to patients within 72 hours. The development has been possible by a digital environment that allowed us to put together a platform that puts all the stakeholders together. But the real success was the energy, the passion, and the commitment of the team. All of them focused on the patient to transform innovation into better health.”
• Pharma 4.0™– The Takeda Pharmaceuticals International AG TaSiVa Facility features the utilization of autonomous mobile robots to transport materials, electronic batch records, robotics to improve ergonomics in packaging, automated colony counting in the lab, automated visual inspection of lyophilized cakes, and a virtual reality training center. Takeda Pharmaceuticals International AG also applied a control tower concept across the facility which enables real-time performance monitoring. Alan Kelly, Head of Alofisel Manufacturing said the first commercial vaccines were realized from the facility this week. “Milestones like that is why we do these projects. We search for excellence, and we drive innovation in all the projects we do.”

There were two Social Impact winners this year.

• Catalent won for Project Mercury located in Bloomington, Indiana. During the COVID-19 pandemic and faced with an unknown manufacturing process for a vaccine candidate under development, the Catalent team pivoted to ensure success, adding 40% more scope including secondary packaging and inspection. The team beat the clock while managing the complexities of execution within the COVID-19-restricted environment and delivered the needed capacity to meet important pandemic demands. “Catalent did some amazing things between April 2020 and April 2021. We started getting phone calls, but did not have the capacity to meet the demands originally. But by January 2021 we had one vaccine complete and 3 months later had another ready,” said John Machulski, Vice President Engineering, Biologics, and Gene Therapy.
• Janssen Biologics also won for their work on the COVID-19 vaccine, one that was critical to resolving an unmet medical need by providing the world with a single-shot vaccine available on a not-for-profit basis for emergency pandemic use. The project tam for their project Vaccine Launch Facility Expansion located in Leiden, the Netherlands invested the equivalent of 300-man years in realizing the facility and rapidly hired and onboarded more than 250 new employees at their Leiden facility. The construction activities were executed during an increased level of positive COVID cases in the Netherlands; however, they always kept the personal safety of all project team members as their top priority. Jim Shovlin, Director of Project Management EMEA, said, “We had a fantastic team and a fantastic outcome. The Johnson & Johnson team worked around the clock to deliver the COVID-19 vaccine in an unprecedented timeline and under very challenging conditions.”

The final award of the night was Honorable Mention given to Iovance Biotherapeutics, a late-stage oncology company focused on developing, manufacturing, and commercializing novel cancer immunotherapies based on Tumor-Infiltrating Lymphocytes (TIL). This critical and personalized treatment requires a facility that eliminates all errors, cross-contamination, failure, or shutdown. It must also work according to other people’s schedules – surgeons, transport, air travel – and quickly get the treatment back to the patient. The facility is the first of its kind in the world to produce this kind of personalized cancer treatment at a commercial scale and it joins similar facilities in setting the bar for this next-generation approach to personalized cell therapies.

The 2022 FOYA Overall Winner will be announced during the ISPE Membership and Awards Meeting on Tuesday, 1 November, 1215 – 1345.