Global Biological Production Summit

Transcription

1 Global Biological Production Summit 12./13. December 2016 San Diego Timo Simmen Director Technical Operations Parenterals Platform Janssen Supply Chain

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3 Environment is changing

4 «The world is changing» Top 10 Market Cap Companies (Public traded) Rank Apple new Exxon 2 Alphabet new GE 3 Microsoft Microsoft 4 Amazon new Citigroup 5 Berkshire new BP 6 Exxon Shell 7 Facebook new P&G 8 JNJ new HSBC 9 GE Pfizer 10 Wells Fargo new Wall Mart out out out out out out out

5 Healthcare is Changing Consumers & Patients Millions of new patients and consumers Aging population Personalization & commoditization Broader accessibility More focus on experience and outcomes Environment Increasing total cost of care Increased price pressures and transparency Heightened regulatory scrutiny Risk sharing Consolidation Expanding care venues

6 A New World of Healthcare intersecting with A New World of Technology will present huge opportunities to transform healthcare. Personalized health solutions Better outcomes and improved experience Serve unmet needs and disease states Provide novel products and services Move from sick care to well care

7 Industrial & Technology Revolutions

8 What is the 4th Industrial Revolution? The era of the digitization and the cyberphysical interconnectivity, the confluence of physical & digital world, that will transform the E2E manufacturing ecosystem to create enhanced customer experiences, help fulfill the unmet needs, and establish new business models through enhanced and new capabilities.

9 End to End Parenteral Manufacturing Platform

10 Parenterals MFG Platform API & FF Sites (Internal and External) External Internal Cork, Ireland Malvern Beerse, Belgium Leiden, Netherlands Incheon, Korea Schaffhausen, Switzerland Gurabo, Puerto Rico + strategic partners + strategic partners

11 Parenterals MFG Platform End to End (Development MFG - Patient) External Internal

12 Technology Management

13 External Technology Management requires alignment Internal PDMS Support Functions (Finance, HR) COE (AT, Packaging, Device) Sourcing / Procurment Parenteral Technology Strategy Parenteral Operations Network Regulatory Quality

14 ..Governance and Process BUSINESS (GOVERNANCE PROCESS) OWNERS TECHNOLOGY SOLUTIONS & STANDARDS External Internal Own and govern Technology Introduction process (with stage gates) Technology Strategy Process Reward & Recognition Process THROUGH FUNCTIONAL STRONGHOLDS Lead and develop People in the strongholds Upstream Processing Downstream Processing Advanced Formulation Advanced analytics Robotics, Modular and Mobile Real time data and recipe management Packaging Device IMPLEMENT E2E accountability for evaluation, development, delivery and governance of Process, Technology solutions and standards DELIVER Develop and govern Compliant and need oriented technology solutions Innovation management Expertise across strongholds Platform standards Added Value DRIVE One Aligned technology strategy from development to commercial Reduction of risk, variability & complexity Technology readiness for pipeline products (staying ahead of the curve) Capex efficiency Avoiding duplication of efforts The strong Technology Partner for the sites 14

15 ..as well as Focus & Governance Technology Governance Levels Technology Stronghold Program Management Steering Team Technology Core Team Stronghold Work Streams Stronghold Champion(SHC) Subject Matter Expert (SME)

16 Technology Strategy - Internal Pipeline - Benchmarking Externally - Technology Evolution Project action plan with milestones Technology Strongholds and projects through Governance structure and stage gates - J&J Credo - JSC Vision & Objectives - Stakeholders (COEs, Site, MTO Strategy) 16

17 Identifying Opportunities Immersion sessions Technology Strategy: Observe 17 Industry & outside industry collaboration Company Culture + Incubators, Innovation centers Benchmarking

18 Ideas need to be processed IDEA FEASIBILITY PILOT IMPLEMENTATION New Idea / Proposal Theoretical Feasibility Select site Develop Implementation Plan Technical Recommendation Operational project team selection Project Execution Develop Business Case Develop Test Plan Closed with lesson s learned Execute test and prepare report Recommendation to proceed Stage Gate 1 Fast Track Ideas Stage Gate 2 Stage Gate 3 Stop Stop Stop On -hold Stage Gate 1: Stage Gate 2: Stage Gate 3: Governance: Stronghold Team Description of idea Documented reasons for accepting or rejecting idea Linkage of idea with stronghold roadmap Governance: Core Team, Steering Committee Stronghold recommendation / narrative for proposed idea Impact of new technology on existing system High level business case Resource requirement High level timeline for Pilot Governance: Steering Committee Executive Summary of pilot tests and Stronghold recommendation narrative Impact of introducing new technology on existing network Business Case Resource requirement Detailed timeline for implementation

19 Processes need to be measured Trend vs. Last Update Increase Decrease Equal Bluesky Feasibility Pilot Active Idea Tracking (Current = 62) 13 Stage Gate 1 29 Stage Gate 2 17 (Prior Report = 55) Stage Gate 3 In-progress Stop Approve In-progress Stop Approve In-progress Stopped Complete API LM Upstream 1 [1] 5 API LM Downstream 6 [5] [2] 3 1 Advanced Formulation [2] 7 6 Advanced Analytics 3 [1] 10 5 Real Time Data and Recipe Mgmt Robotics, Modular & Mobile 1 [1] [3] 2 [1] [3] 3 Packaging and technologies [2] [1] 1 Device & Technologies Subtotal (Current) 13 [8] [10] 29 [1] [3] 17 [0] 3 (Prior Report) 23 [1] [7] 17 [1] [2] 15 [0] 1 Note: [ ] Not in active project total Highlights Overall, a noteworthy increase in Feasibility as teams focus on evaluating theoretical feasibility, determining technical requirements, and drafting a business case.

20 At the end it is about people Innovation Management Training to all levels Empower the lowest levels Establish reward and Recognition program for TECHNOLOGY Innovation Establish a momentum Prepare your workforce for required capabilities Automation, Data Analytics, PAT, RTR Robotics New Materials New Processes

21 Technology Strategy

22 Technology Megatrends important for Parenterals Platform Modularity & Flexibilty Robotics, Automation New Materials (Glas, plastics,..) Unique Identification & Traceability Smart Sensing / Sensors 3D Printing Natural ressources, alternative energy & sustainability

23 Technology Megatrends important for Parenterals Platform cont. Modelling, Control, Inline release, PAT, Real Time release Process Intensivation continuous processing Miniaturization Big data, traceability Customer adherance (Self dose,..) Suppliers move to service providers Augmented Reality

24 High level Technology Benchmarking results and relation to E to E MFG process

25 Parenteral Platform Technology Roadmap

26 Technology Investments Simplified Parenteral Technology Roadmap Strategic Intent Drivers Develop an innovative Parenteral manufacturing network that delivers technological competitiveness for a multi-modal pipeline of products New product modalities in the pipeline require new technologies and processes Demand for high and low volume products requires flexible manufacturing footprint with more efficient production Industry leading performance, reliability, and control strategies require Process Analytical Technology & Real Time Release Testing Cost competitiveness required and enabled by minimizing human labor and incorporating quality during design Timeframe Strategic Direction Batch to semi-continuous unit operations Single product to multi-product facilities High and Low volume products Mabs to Multi-Modal Products High density innoculation with continuous bioreactor feed and downstream processing; New technology integration Parenteral Manufacturing of the Future Innovative, Modular, agile E2E manufacturing with minimal human intervention Outcome Metrics Incremental Change Breakthrough Technology Titer Time to release DS, DP Cost to supply (Cycle Time, RFT, Capex, Tech TRF Time) Disposables & Single Use Titer Time to release DS, DP Cost to supply Media Improvement / process intensivation E2E Process Modeling 100% CCIT & Automatic Visual Inspection Buffer on demand Fast Tech Tranfers Robotic Aseptic filler with minimal human intervention New and Optimizaed Cell LInes Continuous Lyophilization PAT and RTRT Patient adherence packaging Titer Time to release DS, DP cost to supply Scale Up/Out Capability Conventional ComboProducts: Agile Devices Platforms at Any Scale RT storage for biologics Implementation of J4.0 Leading Academia Technology Partnerships Self buffering formulations Innovative ComboProducts: New Devices Platforms at Any Scale

27 Parenteral Platform Stronghold Structure Lead Technology Strategy and Robotics, Modular- Mobile Champion - Drive Parenteral technology strategy program - Global Business Process Owner technology introduction - Own robotics, modular & mobile stronghold - Align with all stakeholders - Communication strategy - Training Head technology strategy & Standardization and Advanced Analytics Champion - Leads E2E Network for Analytics - PAT and associated modeling - Review new ideas - Support core team and steering committee in taking right investment decision API LM Upstream Champion (PDMS) - Leads upstream stronghold - Review all ideas in field of upstream SH - Support core team and steering committee in taking right investment decision - Training on technology introduction API LM Downstream Champion - Leads Network for downstream processing SH - Support core team and steering committee in taking right investment decision - Training on technology introduction Advanced Formulation Champion (PDMS) - Leads Network for Advanced Formulation SH - Support core team and steering committee in taking right investment decision - Training on technology introduction Real Time Data and Recipe Management Champion - Leads Network for real time data and recipe management SH - Support core team and steering committee in taking right investment decision - Training on technology introduction Device and Technology Champion (COE Device) - Leads Network for Device and technology SH - Support core team and steering committee in taking right investment decision - Training on technology introduction Packaging and Technology Champion (COE Packaging) - Leads Network for Packaging and technology SH - Support core team and steering committee in taking right investment decision - Training on technology introduction TO PDMS COE-Packaging COE - Device

28 Parenteral Stronghold example Advanced Analytics

29 Factory of the Future

30 BPOG Industry Roadmap on I4 1st Industry Roadmap in development Mayor Big Pharma will drive I4 TOGETHER!

31 Problems to solve in Up- and Downstream Typical API Up/Down streams unit operations are inefficient by design Suboptimal Platforms Low titers <5 g/l Prolong Cell Culture harvest cycle time Limited in-line fast analytics tools (e.g. to measure generic CQAs e.g. HMW, DNA, host cell proteins) Expensive chromatography resins Extensive cleaning and changeover processes Large preparation and hold tanks for buffers Multiple filtration steps Labor intensive driven by multiples small handling steps Limited robotic applications in API mfg.

32 Industry 4.0 will significantly Impact the Way Companies Operate and Transform Businesses Smart Services Smart Factory Smart Plant Smart Products Source: ZVEI following PwC

33 Influencers Customer Personalization Solutions & Outcomes Lower Cost Agility Access Regulatory Manufacturing Digitization (J4.0) Essential Resources Disruptive Technology, Materials & Services Vendors, External Partners Policy Makers Legal Commercial 3D Printing Systems Integration Smart Sensing Augmented Reality Robotics Big Data & Analytics People: Skills & Capabilities Natural Resources, Alternative Energy & Sustainability Foundational Enablement Technology Systems Process EHS Innovation Technology Materials Services Proactive Quality R&D ICs Sourcing, IT, VCM Partnerships HR, Quality, Plan, Deliver Organization Design Structure Culture Talent

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36 Collaboration needed between Suppliers Industry Regulators and many more Framework

37 Thank you.. Questions?