FACILITIES OF THE FUTURE. Innovating the Future of Manufacturing FEBRUARY REGISTER NOW!
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1 FACILITIES OF THE FUTURE C O N F E R E N C E Innovating the Future of Manufacturing FEBRUARY 2018 Marriott Hotel & Conference Center Bethesda, MD Register by 11 January and Receive $200 OFF REGISTER NOW!
2 WELCOME LETTER Dear ISPE Members and Friends: I d like to personally invite you to join us at the 2018 ISPE Facilities of the Future Conference in Bethesda, Maryland. We ll be meeting at the Bethesda North Marriott Hotel & Conference Center on February This year s theme Innovating the Future of Manufacturing, focuses on the evolution of pharmaceutical manufacturing facilities and will feature inspirational presentations from diverse industry leaders already planning and building Factories of the Future. I am proud of the current speakers and sessions that we have lined up, and very excited to provide you with a glimpse of what you can expect at the conference. We will kick off the conference with an opening plenary and a warm welcome from ISPE President and CEO, John Bournas followed by a keynote presentation with Dr. Antonio Moreira about the Workforce of the Future and an FDA presentation on Accelerated Approvals and Programs to Support Them. A few of the other featured plenary sessions will include: - A dinner keynote presentation on Industry X.0 as well as a panel discussion with futurist thought leaders from Accenture, GE Digital, Pfizer and the University of Maryland, Baltimore County; - A round of rapid fire discussions from start-up companies on lessons learned, innovation, disruptive technologies, as well as planning for and managing change; and - A fireside chat with Dr. Robert Blouin on Building a Culture of Collaboration and Innovation at the University of North Carolina at Chapel Hill s School of Pharmacy. I would like to acknowledge the efforts of our planning committee. Jim McGlade Conference Co-Chair, Jeff Biskup (CRB), Mark Butler (Integrated Project Services, Ltd.), Austin Lock (PM Group), Robert Chew (Commissioning Agents, Inc.), Margaret Prendergast (BioBots), Mark Butler (Integrated Project Services, Ltd.) and Sergi Roura-Adell (Grifols). My personal respect and thanks goes out to all of you. I d also like to thank all of our conference exhibitors and sponsors. So please mark your calendars and plan to attend the Facilities of the Future Conference. I look forward to seeing you in February. For more information, please visit the Facilities of the Future Conference website. Best Regards, James Breen Vice President, Lead Biologics Expansion Janssen Pharmaceuticals and Program Planning Chair 2
3 CONFERENCE AGENDA TUESDAY, 20 FEBRUARY Registration Open Welcome, Opening Remarks John Bournas, President and CEO, ISPE Keynote Introduction James Breen, Vice President, Lead Biologics Expansion, Janssen Pharmaceuticals and Program Planning Chair Opening Plenary and Keynote Presentation Biologics Expansion, Janssen Pharmaceuticals and Program Planning Chair Accelerated Approvals and Programs to Support Them FDA Representative (Invited) Workforce of the Future Dr. Antonio R. Moreira, Vice Provost for Academic Affairs, University of Maryland, Baltimore County Refreshment Break Exhibit Hall Opens CONCURRENT EDUCATION SESSIONS CONTINUOUS MANUFACTURING TRACK Session Leader: Robert Chew, President, Commissioning Agents, Inc Process, Product, and Patient Advanced Technology in Janssen Manufacturing Dr. Mauricio Futran, Vice President, Advanced Technology, Johnson & Johnson Continuous Manufacturing Approaches in Oral Solid Drug Product, API, and Parenteral Processing David Pappa, Director, Technical Services/Manufacturing Science, Eli Lilly & Company INDUSTRY 4.0 TRACK Session Leader: Mark Butler, President, Managing Director of the Americas Unit, Integrated Project Services, Ltd From Industry 4.0 to Pharma 4.0 The Holistic Manufacturing Control Strategy Christian Wölbeling, Senior Director, Global Accounts, Werum IT Solutions Asset Management Lifecycle Costing Rich Tree, Vice President, Strategy and Development, Commissioning Agents, Inc Welcome Reception 3
4 TUESDAY, 20 FEBRUARY PLENARY: Dinner and Keynote Presentation: Futurist Biologics Expansion, Janssen Pharmaceuticals Emerging Technologies Eric Schaeffer, Senior Managing Director, Accenture Industry X.0 Panel Discussion Chaz Calitri, Vice President, Global Engineering, Pfizer FDA Representative (Invited) Chris Larkin, Vice President, Analytics and Machine Learning, GE Digital Dr. Antonio R. Moreira, Vice Provost for Academic Affairs, University of Maryland Baltimore County Anne Marie O Halloran, Managing Director, Life Sciences, Accenture Eric Schaeffer, Senior Managing Director, Accenture WEDNESDAY, 21 FEBRUARY Registration Open Coffee Service CONCURRENT EDUCATION SESSIONS CONTINUOUS MANUFACTURING TRACK Session Leader: Dr. Sergi Roura-Adell, President of North American Facilities, Grifols Transforming the Pharmaceutical Production Paradigm with Integrated Continuous Manufacturing (ICM) Dr. Bayan Takizawa, Co-Founder and Chief Business Officer, CONTINUUS Pharmaceuticals Reducing Room Classification Peter Larsson, Engineering Management Director, Novo Nordisk INDUSTRY 4.0 TRACK Session Leader: Austin Lock, Technical Director and Deputy Pharmaceutical Sector Director, PM Group Accelerated Approvals Dr. George Millili, Senior Principal, Technical Advisor, Genentech, A Member of the Roche Group Implementing a 4,000 Single-Use Bioreactor for Large Scale Flexible Manufacturing Brad Sepp, Director Manufacturing Sciences and Technology, Emergent BioSolutions, Inc. Paul Kubera, Vice President, Process Technology, ABEC, Inc Refreshment Break - Exhibit Hall 4
5 CONCURRENT EDUCATION SESSIONS CONTINUOUS MANUFACTURING TRACK Session Leader: Jeffrey Biskup, P.E., CEO and Board Chairman, CRB Novel Facilities in the Plasma Industry Dr. Dieter Fassnacht, Director, Process Engineering, Grifols Accelerating the Delivery of Biosimilars to Chinese Patients Chaz Calitri, Vice President, Global Engineering, Pfizer Bob Myers, Director, Global Engineering, Pfizer Jon Van Pelt, General Manager, Enterprise Operations, General Electric INDUSTRY 4.0 TRACK Session Leader: Robert Chew, President, Commissioning Agents, Inc Biomanufacturing Technology Road Map Biophorum Representative (Invited) Aseptic Fill Finish: No Human Intervention and Integrated Quality Control is Just One Step Way Volker Sigwarth, Board Director of SKAN, Aseptic Technologies Lunch - Exhibit Hall CONCURRENT EDUCATION SESSIONS CONTINUOUS MANUFACTURING TRACK Biologics Expansion, Janssen Pharmaceuticals Prefabricated Modular Cleanroom Systems: An Update and Future Outlook Maik W. Jornitz, President and CEO, GCon Technological Innovations and Flexible Mobile Platforms Jeff Serle, Senior Vice President, Germfree Laboratories Refreshment Break - Exhibit Hall INDUSTRY 4.0 TRACK Session Leader: Dr. Sergi Roura-Adell, President of North American Facilities, Grifols Core Concepts for Future Facilities Andrew Harris, Associate, Lead Process Engineer, CRB Flexible Facilities Austin Lock, Technical Director and Deputy Pharmaceutical Sector Director, PM Group Refreshment Break - Exhibit Hall 5
6 WEDNESDAY, 21 FEBRUARY PLENARY: Startup Rodeo: Hear from Start-Up Companies on Subject Matter Related to Facilities of the Future Networking Reception Exhibit Hall Session Leader: Margaret Prendergast, Bioengineer, BioBots PLENARY: Dinner and Keynote Presentation: Innovation Biologics Expansion, Janssen Pharmaceuticals THURSDAY, 22 FEBRUARY Registration Open Coffee Service PLENARY: Continuous Manufacturing Biologics Expansion, Janssen Pharmaceuticals Control Strategies for Continuous Manufacturing Pharma Integration Representative (Invited) Emerging Technologies FDA Representative (Invited) Refreshment Break PLENARY: Connecting with Academia Biologics Expansion, Janssen Pharmaceuticals Building a Culture of Collaboration and Innovation at the UNC Eshelman School of Pharmacy: Important Lessons Learned Dr. Robert Blouin, Provost, University of North Carolina at Chapel Hill Conference Wrap Up 1200 Conference Adjourns WHY SHOULD YOU ATTEND? The most valuable sessions were those given by industry representatives describing how they are designing the Factory of the Future. The general presentations by industry leaders were the best. Networking and catching up with colleagues across the industry was great. 6
7 REGISTRATION DETAILS FULL EDUCATION PRICES TYPE EARLY BEFORE 13 DEC REGULAR 13 DEC11 JAN LATE AFTER 11 JAN Member US$1,545 US$1,745 US$1,945 Non-member (See join discount opportunity) US$1,854 US$2,094 US$2,334 Committee US$1,159 US$1,309 US$1,459 Government Young Professional Member Student Member - Full Package US$62 US$70 US$78 Academia Member US$1,159 US$1,309 US$1,459 SPECIAL EVENTS EVENT FULL EDUCATION EXHIBITOR Dinner and Keynote Presentation 20 February, Free US$60 Dinner and Keynote Presentation 21 February, Free US$60 HOTEL AND TRAVEL INFORMATION HOTEL DETAILS Bethesda North Marriott Hotel & Conference Center Hotel Address: 5701 Marinelli Road Rockville, MD Hotel Number: Reservations Numbers: Hotel Link: Hotel Cutoff Date: Monday, 29 January 2018 HOTEL INFORMATION Check In: 1600 Check Out: 1200 Guest Room Internet: Complimentary for ISPE attendees Reservations Link: Reservation Instructions: Call or make your reservation online at When making your reservation by phone, mention ISPE for the discounted rate of US$169 single/double. This rate is good until Monday, 29 January 2018, or until the room block is full, whichever comes first. Please contact the hotel as early as possible to make your reservations to ensure you are in the headquarters hotel. 7
8 FACILITIES OF THE FUTURE C O N F E R E N C E FEBRUARY 2018 Marriott Hotel & Conference Center Bethesda, MD REGISTER NOW! 600 N. Westshore Blvd., Suite 900 Tampa, FL USA
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