Pharma EXPO 6 9 November 2016 Chicago, IL

Transcription

1 DESIGN TO VALUE: An End-to-end Lifecycle Methodology, Enabling Customer-centric, High-quality Products, Made Efficiently and Reliably Susan Neadle Senior Director Design to Value & Product Quality Management Head, Combination Products CoE Janssen Pharmaceuticals Caleb Dailey Senior Director Launch Management Johnson & Johnson Supply Chain November 8, 2016 At Johnson & Johnson, Our Credo Guides our Actions Our first responsibility is to the doctors, nurses and patients We must constantly strive to reduce our costs in order to maintain reasonable prices. everything we do must be of high quality. 2 1

2 Design-to-Value (DtV) 1 What is it? 2 Why do we need it? 3 How can we succeed? Design-to-Value «1 What is it? An End-to-End lifecycle methodology enabling customercentric, high-quality products reliably, efficiently and costeffectively 2

3 Design to Value translates Our Credo into Action 2 All Stakeholders needs are understood and incorporated into the product. 3 Supply Chain considerations are proactively factored into the design. 1 Customer Value starts with Scientific and Clinical Greatness. 4 Product and Process are tightly connected. Design-to-Value «2 Why do we need it? Maximizing the value of our products, by improving quality, speed to launch and profitability 3

4 Maximizing the Value of our Products Customer Value Sales & Profits Launch Growth Maturity Decline Product Life Cycle Launch Earlier Adopt Faster Peak Higher Sustain Longer Design-to-Value «3 How can we succeed? Through the implementation of standardized & harmonized integrated DtV processes 4

5 DtV: An Integrated Approach for Value Optimization DtV Principles Embedded into New Product Development Stage Gates Re-Design Processes to Enhance Value and Reduce Complexity How We Succeed in Janssen Pharmaceuticals Strengthening Connections End-to-End 10 5

6 DTV: Investing in Value Throughout Product Lifecycle Reactive troubleshooting / Lifecycle Management Reliable Supply, Proactive customer-driven product roadmaps Limited reliability and responsiveness Speed to launch AND stabilization Supply/ Lifecycle Management Launch Product Quality Target Product Profile Customer Value Business Value Suboptimal integration of customer input into product & supply chain design Customer-Centric, Design attribute decision-making guided by marketplace input Product/ Process Development Process Criticality Product by product development Platform-based development, robust product & process capability, knowledge management Limited understanding of CTQs Deep understanding of CTQs, CPP s, CMA s Approval delays Right first time approval Regulatory Filing Control Strategy Make then test Real time monitoring, control and release, clinically based specifications Optimizing Product and Process Design of a drug candidate can add 30-50% to its value over its lifetime McKinsey study 11 Design to Value Pillars 6

7 Customer Value Improving Customer Experience, Satisfying Unmet Needs Capture, analyze and integrate customer insights & value and competitive benchmarking into our offerings 13 Remember the Customer: Patient Centered Design & Customer Value Attribute Process Consider the needs of all stakeholders who may interact with our products on their way to the patient Proprietary & Confidential 14 7

8 Theoretic al Pharma EXPO Quality by Design Transforming the way we do business Proactive and risk-based design of quality into products and processes across the product lifecycle Achieve robust and reliable products and processes Highest quality standards, and Value to customers, regulators, and business. 15 Quality by Design Metric Component Product Methods Process Robustness Index Metric Subcomponent Clinically Relevant Specifications Measurement System Capability Process Design Manufacturability Control Strategy Special Causes Score Active Risk Management DtV embedded across CMC Stage Gates Risk register Robustness Index PAT Modeling Process Analytical Technology Probe 16 8

9 Design to Affordability: Technology Platforms Increase standardization in product development and manufacturing by setting up guidance documents for preferred: Dosage forms Materials, excipients Manufacturing modes Process types Primary packaging Associated components Equipment typicals Best Practices Includes information on customer insights 17 Knowledge Management Data Transparency & Accessibility What Data Transparency & Accessibility: Data translated into actionable insights How Customer Value Portal Recipe Management E-Reporting Impacts Knowledge Institutionalized and Re-purposed Efficiency Data-driven decisions 18 9

10 Governance Make DtV our natural way of doing things Process-enabled success: What DtV elements embedded in Processes, Procedures & Roadmaps so that the DtV framework shapes our everyday business. How DtV embedded in CMC Stage-gate deliverables DtV embedded in Site & Platform Master Plans DtV Maturity Model Metrics Impacts Consistent execution and monitoring A natural way of doing business 19 How to Make Lasting Change R&D, Supply Chain and Commercial collaborate with a focus on customer value. Design to Value practices are embedded into core business processes and organizations. Design to Value activities evolve to stay aligned to business strategies and marketplace dynamics

11 Design to Value translates Our Credo into Action Thank you for your time! Questions? BACK-UP SLIDES 11

12 Design-to-Value: Governance Delivering End to End Value across the Product Lifecycle Governance: Embedding DtV in Processes & Procedures Customer Value Processes People Capabilities QbD Processes Technology Platforms Quality Processes and Risk Management Regulatory Manufacturing Knowledge Capabilities Readiness Management Outputs Clinical & Commercial Material; Robust Product & Process Knowledge & Understanding Leading to Efficient Development, Reliable Manufacturing, and High Quality Products, IND, NDA, BLA, etc., Filing CMC Subsections, Improved customer experience, and our ability to deliver effective medicines to more patients in need 12