Factory of the Future Jim Breen September 30, 2015 1 New Jersey, USA
Agenda: 1. Introduction & Background 2. Industry Trends 3. Factory of Future 4. What can you do with ISPE ? 5. Questions 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 2
Back to the Future Sept 30 20 16 1 3 32 Sept 30 20 20 1 3 32 1 3 32 Sept 30 2050
Some Industry Pressures 1. Margins under pressure 2. Business Models Challenged 3. Commoditization is taking hold 4. Product Shortages 5. Product Recalls 6. High cost to bring a product to market 7. Attrition rates during long trials 8. Digitalization 9. Customization 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 4
http://www.wearecain.com/blog-cain/2011/12/reverse-innovation-for- May 2013 entrepreneurship/ http://www.mckinsey.com/ 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 5
http://www.mckinsey.com/ 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 6
http://www2.deloitte.com/us/en.html 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 7
Governments are interested: 1. Employment 2. Academic linkage 3. Industry Clusters 4. Manufacturing Ecosystems 5. Quality of Life 6. Workforce for future 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 8
http://www.mckinsey.com/ 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 9
Gartner’s Rankings of Its 2014 Supply Chain Top 25 Is the Pharmaceutical Supply Chain optmized ? 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 10
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Factory of the Future: Future Technology Opportunities 1. Additive Manufacturing / 3D Printing 2. Continuous Manufacturing 3. AI & ML 4. Automation 5. Big Data 6. Modeling Simulation Convergence 7. Rapid Changeability 8. IOT 9. Convergence Bio and Devices 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 18
Cutting Edge Technologies in R&D Organ on a Chip Stem Cell Organs 3D Printed Organs 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 19
Big Data Analytics at your fingertips 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 20
Linkage with ISPE 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 21
Next Generation Processes, Equipment and Facilities
Next Generation Process, Equipment and Facilities Items to be considered: Baseline: 1) Factory of Future 1) Virtual Factory 2) Business Environment 2) Leverage / Partnerships 3) Dedicated Manufacturing 3) Industry Standardization Facilities 4) Future Skillsets 4) Continuous vs Batch Manufacture 5) Detection and Control Systems 10/2/2015 ISPE NJ Del Valley - Sept 23 30 2015
What can be done with ISPE ? • Facility of Future Programs Globally – USA Carolina – March 2015 – India – April 2015 – EMEA Germany – May 2015 – USA NJ / DV – September 2015 – China – November 2015 – EMEA Germany – April 2016 Gert Moelgaard Mark Butler Vice President at NNE Pharmaplan Owner, Integrated Project Services 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 24
Welcome to the 2014 Facility of the Year Awards Banquet 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 25
Honorable Mention: WuXi AppTec Biopharmaceutical Co. cGMP Bulk Cell Culture Production Facility Location: Wuxi City, China • Designer/Architect: Sino Pharmengin • Corporation, Wuhan China Engineer: NNE Pharmaplan, Shanghai, • China Construction Manager: Chen Ze, • Shanghai, China Major Equip Supplier: Sartorius- • Stedim Biotech 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 26
Thank you Any Questions ? 10/2/2015 ISPE NJ Del Valley - Sept 30, 2015 27
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