2022 ISPE Facilities of the Future Conference

Feb 1, 2022 ‐ Feb 2, 2022



Sessions

Opening Plenary: COVID's Impact on Pharma Facilities of the Future

Feb 1, 2022 8:30am ‐ Feb 1, 2022 10:15am

The opening session will take a high-level look ahead at global pharmaceutical manufacturing and related regulatory systems. We will discuss how COVID has impacted our business and the applications of future manufacturing operations and the facilities required to adequately produce product that is safe, cost effective and meets the needs of the patients we serve. Key industry leaders will share their perspectives and their insights into how they see the industry changing as we move forward from COVID.

Session Leader(s): Speaker(s):
  • Thomas B. Hartman, President and CEO, ISPE
  • Antonio R. Moreira, PhD, Vice Provost, Academic Affairs, University of Maryland, Baltimore County
  • Louis S. Schmukler, President, Global Product Development & Supply, Bristol-Myers Squibb
  • James Stephanou, Vice President Global Engineering Solutions, Merck
  • Matthew Hepburn, M.D., Senior Advisor To the Director, Pandemic Prevention, U.S. Office of Science and Technology Policy, Executive Office of the President

Pharma 4.0 iconPharma 4.0

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Pharma 4.0

Feb 1, 2022 11:00am ‐ Feb 1, 2022 1:00pm

Historically, industrial manufacturing has advanced from mechanization to mass production and then to automation/computerization. The next phase of manufacturing (referred to as Industry 4.0) involves integration of equipment and communication systems. The pharmaceutical industry is undergoing these same transformations (with the most recent phase referred to as Pharma 4.0). This session will explore aspects of Pharma 4.0 including IoT based technology and analytics, robotics in pharma manufacturing, a data mindset. This will include: The vision to integrate data and to easily visualize and analyze data providing insights across sites The future of pharmaceutical manufacturing with robots and cobots. The fundamental mindset shift to achieve a data driven decision.

Session Leader(s): Speaker(s):
  • Yury Y. Gomez, Global Strategy Leader, WW Manufacturing & Supply Chain, Microsoft
  • Richard Denk, Senior Consultant Aseptic Processing & Containment, SKAN AG
  • Julien Janda, Head of Process & Technology, GMS Global Engineering, Takeda Pharmaceutical International AG
  • Shanshan Liu, Director, No Deviation Pte Ltd

Bio Manufacturing of the Future

Feb 1, 2022 11:00am ‐ Feb 1, 2022 1:00pm

Bio Manufacturing of the Future requires cost effective, scalable solutions that can be implemented quicker than the traditional stainless steel facilities of yesterday. This session explores aspects of bio manufacturing that challenge the status quo and push the boundaries of bio manufacturing as we know it. From continuous methodologies to disposable technologies, we explore the industries response to the bio manufacturing capacity challenge.

Session Leader(s):
  • Tara Tibbs, Sr Director Engineering API/DP, Eli Lilly & Co
Speaker(s):
  • Scott Keetch, Vice President Strategic Program Management Lead - BioTech, Bayer
  • Robert K. Allen, Executive Technical Director |Advanced Technologies & Life Sciences, Fluor Life Sciences
  • Jon Van Pelt, Vice President/General Manager - BioProcess Single Use and Enterprise, Cytiva
  • James Weidner, Executive Director, Engineering, Amgen

Emerging Technologies I iconEmerging Technologies I

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Emerging Technologies I

Feb 1, 2022 2:00pm ‐ Feb 1, 2022 3:30pm

It can be argued that the pharmaceutical industry is changing at its fastest rate in decades, driven in part by the requirement to manufacture new process modalities, as well as the need to deliver new facilities in a quicker and more cost effective manner. Speed to market and accelerating first-in-human has never been as important. Companies are having to respond to challenges such as increased development complexity, demand volatility, and CoG challenges as a result of increasing competition, pricing pressures and profitability.  Furthermore, growing demand for more flexible and sustainable facilities, together with the advancement of new processing and Pharma 4.0 technologies, such as digitization and robotics, requires that Site Master Planning needs to advance accordingly. This session will hear about how two major pharma companies have responded to the above challenging industrial landscape. Merck KGaA will explain how they have introduced a fully continuous bioprocessing platform into a new dedicated bioprocessing centre that facilitates end-to-end convergence of Discovery, CMC Innovation, Development, and Clinical and Commercial supply. Additionally, Bayer will explain how they have adopted a Site Master Planning of the Future approach to accommodate new process modalities, delivery methods, and Pharma 4.0 technologies.

Session Leader(s): Speaker(s):
  • Jonathan Souquet, PhD, Global Head of Process Development and Clinical Manufacturing, Merck KGaA
  • Jordaan Kemp, Director of Architecture and Process Architect SME, PM Group
  • Jessica Hays, Project Manager, Strategic Projects, Bayer

Cell & Gene Therapy iconCell & Gene Therapy

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Cell & Gene Therapy

Feb 1, 2022 2:00pm ‐ Feb 1, 2022 3:30pm

New facilities for the GMP manufacture of cell and gene therapies are starting to come online. This session includes presentations on two recently constructed facilities that represent the latest industry best practices in design, construction, and flexible, sustainable operation. Speed of construction is a common thread, along with innovative facility designs intended to accommodate future conditions. Join us for an informative session and the opportunity to interact with industry leaders in this segment.

Session Leader(s): Speaker(s):

Pharma Collaborations in the COVID Era

Feb 1, 2022 4:15pm ‐ Feb 1, 2022 5:45pm

The pandemic has had significant impact to industries around the world and the Pharma Industry has been no exception.  Early on, the Pharma Industry responded with unprecedented speed to bring treatments to patients through collaborations, leveraging expertise and creative solutions.  Today, we continue to navigate the pandemic with resilience and continued partnership.  This session covers a few of these collaborations and extraordinary responses COVID-19 Pandemic.

Session Leader(s):
  • Tara Tibbs, Sr Director Engineering API/DP, Eli Lilly & Co
Speaker(s):

Executive Forum Panel iconExecutive Forum Panel

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Executive Forum Panel

Feb 1, 2022 7:15pm ‐ Feb 1, 2022 8:30pm

Hear from government authorities and industry experts on the lessons learned through the pandemic and the innovative development opportunities as a result.  The panel will discuss these topics and more with questions from attendees in this town hall style session.

Session Leader(s):
  • James A. Breen, PE, Vice President, Lead Biologics Expansion, Janssen Pharmaceuticals
Panelist(s):
  • Matthew Hepburn, M.D., Senior Advisor To the Director, Pandemic Prevention, U.S. Office of Science and Technology Policy, Executive Office of the President
  • Patrick J. Poisson, Executive Vice President, Technical Operations, United Therapeutics Corporation
  • Felix Velez, VP Engineering & Property Services, Johnson & Johnson
  • Thomas Warf, Director, Manufacturing, Facilities and Engineering, DHHS/OS/ASPR/BARDA
  • Ylva Ek, Chief Quality Officer, KeyPlants AB

Women in Pharma Breakfast Session: Utilizing Innovative Technology for Growth

Feb 2, 2022 7:00am ‐ Feb 2, 2022 8:30am

Biotech is adapting and evolving to have more automation, digitalization, and we need to be ready for the new challenges while continuing to break barriers in our industry. How can we use innovative technology for both personal and professional growth? What types of technologies are smart facilities using for learning? How has virtual reality transformed how we learn?

Join this think tank during the Women in Pharma® breakfast and be part of innovative group discussions to transfer new and emerging knowledge to everyone. Facilitators will encourage creative and innovative design thinking (No prior knowledge required, just creative flow) and participants will be able to contribute and share ideas on different ways, types, and areas to use innovative technology for both personal and professional growth. Ideas from each group will be submitted and shared with the Women in Pharma® community of practice. Top Ideas will be selected as part of the Think Tank pilot and participants can support idea development teams.

Session Leader(s):
  • Tanya Sharma, Principal Consultant & Women in Pharma International Mentor Circle Leader, Assurea, LLC
Panelist(s):

Benefiting from Emerging Technologies

Feb 2, 2022 8:45am ‐ Feb 2, 2022 10:30am

This session provides insights from industry experts in meeting the extraordinary challenges of pharmaceutical production and development in the COVID age.  Hear about their experiences implementing new and emerging technologies and how these lessons learned can benefit future opportunities.

Session Leader(s): Speaker(s):
  • Sau (Larry) Lee, PhD, Deputy Director of Science Chair, Emerging Technology Program, Office of Pharmaceutical Quality/CDER/FDA
  • David Estape, PhD, Technology Manager Biotechnology, CRB Group
  • Oliver Hennig, Senior Vice President Operations, BioNTech SE

Modular Facility iconModular Facility

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Modular Facility

Feb 2, 2022 11:15am ‐ Feb 2, 2022 12:45pm

This session will explore novel ways to reduce project time lines and demonstrate how PODular manufacturing will increase facility flexibility to meet potential future changing business needs. The presentation is directly applicable to flexible manufacturing facilities and responsiveness of drug supply.  It will address key lead time challenges in traditional manufacturing and offer an option for manufacturing closer to the customer.

Session Leader(s): Speaker(s):
  • Michael K. O'Brien, Ph.D., President & CEO, NGT BioPharma Consutlants
  • Dennis Powers, Vice President of Business Development & Design Consulting, G-CON Manufacturing
  • Doug DeVeny, NCARB, Global Technical Lead, Architecture / HVAC, Genentech Inc