Celebrating the 2017 Facility of the Year Awards Winners
ISPE celebrated the thirteenth annual Facility of the Year Awards (FOYA) banquet on Tuesday, 6 June, with a lively group of participants from the ISPE/FDA/PQRI Quality Manufacturing Conference and beaming category award winners in attendance. Guests mingled for cocktails and conversation before the main event, emceed by Dave DiProspero, Associate/Director, Pharmaceutical Process Technology, CRB Consulting Engineers, and Chair of ISPE’s FOYA Committee.
DiProspero began by introducing ISPE CEO and President John Bournas. “Tonight,” he said, “we highlight the best of the best—exemplary projects that epitomize the spirit of FOYA.” The evening’s honorees hailed from the United States, Puerto Rico, Ireland, as well as Indonesia, which, Bournas noted, was receiving the country’s first FOYA award. “We are proud to honorable Mention recipients.
Cook Pharmica—L to R: Hamid Farzad, Brok Weichbrodt, Lauren Smith, Alex Haig, Kavya Kumar,
Cook Pharmica won in the Equipment Innovation category for its Flexible Filing Line project. Designed to add flexibility and capacity within an existing cGMP space by leveraging new technologies, this project was a collaborative development between owner, suppliers, and engineering experts. Together, they delivered a novel application of commercially available and custom-developed equipment manufacturing solutions. Project sponsor and COO Ryan Hawkins accepted the award, thanking his “great partners” and “talented team that made the difference.”
Bristol-Myers Squibb—L to R: Muris Kobaslija, Dan Post, Bryan Mann, Dave Wilson, Morrey
Atkinson, Anthony Haskell, Norm Stoffregen, Mike Borys, Tony Crincoli
The Facility Integration category award went to Bristol-Myers Squibb for its Biologics Development and Clinical Manufacturing Building project, an example of how to integrate new these facilities for their shared commitment to innovation—for advancing pharmaceutical technology by demonstrating creativity and excellence in facility design, construction, and operations.”
Mike Arnold, ISPE Board of Directors Chair and Investigational Product Business Process Owner, Pfizer Global Clinical Supplies, also addressed the gathering, noting FOYA’s significance to ISPE. He applauded the winners for being “creators of disruptive innovation.”
Jim Breen, Vice President and Lead, Biologics Expansion, Janssen Pharmaceuticals, and current Chair of the FOYA Judging Committee, welcomed incoming Committee Chair and ISPE Board member Tony Crincoli, Executive Director and Head of Global Engineering Services, Bristol-Myers Squibb. Together they presented awards to the 2017 Category Winners and Hon-capabilities within an existing plant through careful design, good collaboration, and creative engineering. The results were impressive, integrating the facility within the company’s broader mission and network of the assets. As Morrey Atkinson, PhD, project owner and Vice President, Biologics Development and Clinical Manufacturing accepted the award, he explained that he was doing so in memory of a friend who had died from melanoma. “I’m working to make that [melanoma] a thing of the past,” he said.
Eil Lilly and Company—L to R: Ian Leavesley, Ken Weerts, Peter Waite, Bret Huff, Kevin Trivett,
Paul Collins, David Pappa, Tim Pletcher
Eli Lilly and Company earned two FOYA awards for its Continuous Direct Compression Manufacturing Kits 2 and 3 project. With a mission to design and implement a network of continuous manufacturing process facilities, Lilly was recognized with its first award in the Facility of the Future category for process development, production platform commitment, and deployment of three replicate operational continuous oral solid dosage (OSD) production facilities. Bret Huff, Vice President of Small Molecule Design and Development accepted the award. Noting the team’s refusal to compromise on speed, quality, or costs, he called the project a “win for everyone, but especially for the patients.”
Abbott—L to R: Michael Cryan, Ellen Muldoon, Helena Warnock, Everett Tucker, Ciaran
Corcoran, Stephen Kelleher, Ciara Mulleady, John Williams
The winner in the Operational Excellence category went to Abbott Diagnostics for its New Quality Approach project to create a sustainable continuous improvement culture. The facility has increased productivity, improved changeover efficiencies, eliminated backorders, and enhanced product quality while also reducing cost per unit, cycle times, equipment downtime, and inventory holdings. Everett Tucker, executive sponsor for the program and Division Vice President, Operations Strategy and Engineering, accepted the award, praising the “industry-leading body of work on display” among the honorees’ projects, and thanked his team for their “exceptional job delivering real results.”
Jazz Pharmaceuticals was the Project Execution category winner, for its “Project Rock.” The project team—which had never built a pharmaceutical facility before—resolved to create a fully operational FDA-approved manufacturing plant in two years. The approach was highly pragmatic, and a model for lean project execution and integration of the investment from project phase to licensed GMP operations. Accepting the award, Alan Mac Neice, Executive Director and site leader, said that the team “did something truly remarkable by not recognizing where boundaries were.”
Eli Lilly and Company’s second award for its Continuous Direct Compression Manufacturing Kits was awarded in the Process Innovation category. The company’s forward-thinking approach was recognized for the implementation of continuous direct compression and other process innovations in OSD facilities across its manufacturing network. Bret Huff also accepted this second award saying, “This is much more than just a facility—it’s all of the systems that go into it.”
Jazz Pharmaceuticals—L to R: Alan Mac Neice, Bob Chew, Lee Arnold, Ronan McGrane, Jennifer
Lauria Clark, Jeremy Freeman
Nephron Pharmaceuticals—L to R: Bryan Beck, Hunter Gordy, Sandra Watson, Lou Kennedy,
Lindsey Miles, Lance Rogers, Jonathan Burgess, Hank Jibaja
UPenn/Novartis —L to R: Erik Terry, Stephan Blair, Joseph Palombit, Myung Kim
Kalbio—L to R: Christopher Sweeney, John Bournas (ISPE)
Three projects earned Honorable Mentions.
Nephron Pharmaceuticals was recognized for its South Carolina project which integrated industry-leading technologies such as laser-guided vehicles, automated warehousing, robotics, and track-and-trace technology. CEO and Owner Lou Kennedy also wanted to create a plant that would inspire children to want to learn about technology and science, so viewing and access areas were designed to facilitate visitor exposure to the pharmaceutical industry and advance pharmaceutical manufacturing careers. Kennedy accepted the award with obvious delight. “It’s like an Oscar! Thank you so much!” she said.
Novartis and University of Pennsylvania were honored for their Center for Advanced Cellular Therapies Project, an innovative center to advance personalized medicine that leverages pharmaceutical engineering principles to merge academic, corporate, and medical considerations. The project advances the development of new operating models to harness the potential of personalized cancer treatments. Joseph Palombit, MBA, RA, LEED-AP, Senior Project Manager for Real Estate, Design, and Construction for the University of Pennsylvania Health System accepted the award, thanking his team for working through the challenges of construction in an occupied facility.
The young and highly motivated project team on the PT Kalbio Global Medika biotechnology facility project in Indonesia exemplifies the can-do spirit and the potential for biomanufacturing in Southeast Asia. A point of pride for the company is its quality management system, designed in accordance with PIC/S standards, which integrates all aspects of manufacturing. Christopher Sweeney, Senior General Manager, praised his “very young, hardworking, and dedicated team.” Noting that biotech is taking off in Asia, he also asked ISPE to “help bring knowledge and skills to the region.”
The Overall FOYA Winner will be announced at the ISPE 2017 Annual Meeting & Expo on 31 October 2017 in San Diego, California, United States.
Before traveling to the 2019 ISPE Annual Meeting & Expo in Las Vegas, the ISPE Japan Affiliate held its annual phar-maceutical plant tour over five days (21–25 October), visiting two plants in Los Angeles, one in Boston, and one in In-dianapolis.
The 2019 ISPE Max Seales Yonker Member of the Year Award was presented to Charlie Wakeham, a data integrity and compliance specialist based in Sydney, Australia, who has played an instrumental role in the development of GAMP®.