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Tuesday
08:30am - 08:45am EDT - January 31, 2023 | Room: Ballroom D
Thomas B. Hartman, President and CEO, ISPE

Tuesday
08:45am - 09:15am EDT - January 31, 2023 | Room: Ballroom D
Dr. Matthew Hepburn, M.D., Senior Advisor To the OSTP Director on Pandemic Prevention, U.S. Office of Science and Technology Policy, Executive Office of the President
Track: Opening Keynotes

Innovation in Manufacturing to Address Future Pandemics
American Pandemic Preparedness Plan focusses on transparency, portfolio approach, partnerships and pivoting. Manufacturing USA is a national network created to secure US leadership in advanced manufacturing. It contains 16 manufacturing innovation institutes covering a broad range of industrial sectors relevant to pandemic response and preparedness. The network leverages large-scale public-private collaboration on technology, supply chain, and workforce development and it includes two recent announcements of grants for advanced research to address the COVID pandemic.


Tuesday
09:15am - 09:45am EDT - January 31, 2023 | Room: Ballroom D
Jessica Ballinger, President and Chief Operating Officer, Lyndra Therapeutics
Track: Opening Keynotes

Tuesday
09:45am - 10:15am EDT - January 31, 2023 | Room: Ballroom D
James Stephanou, VP Global Engineering Solutions, Merck
Track: Opening Keynotes

Tuesday
10:45am - 11:15am EDT - January 31, 2023
Jeffrey N. Odum, CPIP, Practice Leader: ATMPs & Biologics, Genesis AEC; John Machulski, VP Engineering, Biologics & CGT, Catalent; Kingkini Roy, Senior Project Architect, Genesis AEC
Track: Track 2: Bio Manufacturing

Tuesday
10:45am - 11:15am EDT - January 31, 2023 | Room: Ballroom D
Teresa Minero, Founder & CEO, LifeBee - Digitalizing Life Sciences
Track: Track 1: Digital Transformation and Pharma 4.0™

Pharma 4.0 6th Survey – Latest Results and Trends
The Pharma 4.0™ Survey is at its 6th edition and the aim is to get the ISPE Pharma 4.0 SIG yearly update on the state of the art, the goals, the mindset and also the sentiment about 4.0 from the Life Science protagonists.Previous editions have been carried out since 2017, having always around 300 to 400 respondents. We have received meaningful results appreciated by the whole industry, the vendor ecosystem and also by the regulators.Changing with the evolving reality, this edition presents a more structured and focalized set of questions along with a review of the topics suggested from the latest and current events, mainly with reference to concerning benefits and particularly related to Quality and Compliance, as requested by Regulators during our 2022 Annual Conference.


Tuesday
11:15am - 11:45am EDT - January 31, 2023 | Room: Ballroom D
Alex Grace, Vice President, Sales & BD, Clockworks Analytics
Track: Track 1: Digital Transformation and Pharma 4.0™

Tuesday
11:15am - 11:45am EDT - January 31, 2023
Josef Herzog, Associate Director Automation, Zeta Automation GmbH
Track: Track 2: Bio Manufacturing

Islands in the (Work) Stream
Single Use technology is a good way to realize flexible facilities within a short period. By customizing the automation, it is possible to use common standards to shorten the implementation- and test time, as well as a reduction of the effort for qualification. New technologies, like MTP (Module Type Package) will support this approach in the near future. To allow the analyzation of the production data an implementation of interfaces for data exchange with other systems (MES, historian,..) has to be standardized as well.


Tuesday
11:45am - 12:15pm EDT - January 31, 2023 | Room: Ballroom D
Ms. Yvonne Duckworth, PE, Fellow - Digital Technology, Associate, CRB; Felix Kern, Associate Director - Head of Compliance Launch and Technology Center, Merck KGaA
Track: Track 1: Digital Transformation and Pharma 4.0™

Lessons Learned Chartering a 4.0 Digital Tranformation
Pharma, just like every industry, faces unique opportunities and challenges in deploying Industry 4.0. Opportunities include that innovation is part of our industry DNA as we develop new, life-changing drugs. Many pharma firms also have access to capital to build state of the art new facilities or upgrade existing facilities. On the downside, our industry is highly regulated. Stringent requirements for making changes (improvements), documenting our work, and validating our processes are examples where we can get slowed down as compared to other, less regulated industries. How would you have done things differently if you could start your digital transformation project over? That is the golden question, and it is exactly what this session aims to answer for attendees. This session will provide multiple case studies, real-world lessons, and a "start with the end in mind" strategy to help your next digital project succeed. The session explores topics like increased productivity, governance and internal alignment, impacts on your workforce, modifications to facility design, and the absolute need for unwavering security.


Tuesday
11:45am - 12:15pm EDT - January 31, 2023
Thomas Harris, ME, AE, Reliability Engineering Manager, AstraZeneca; Hamid Teimourian, Energy Program (Sustainability) Lead, AstraZeneca
Track: Track 2: Bio Manufacturing

Factory of the Future Predictive Maintenance: Implementation of Wireless IoT Sensors at AstraZeneca's Largest Biologics Manufacturing Center
As one pillar of TPM program, AstraZeneca is driving the implementation of thousands of new wireless IoT sensors at their largest Biologics Drug Product facility in Frederick, MD. The project functions as example and the program will be scaled globally in future. The implementation leads to better predict failures of equipment and to avoid losses and unplanned downtime.