Biosimilars in China
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Transcript of Biosimilars in China
Robert Valdes
Large-Scale Manufacturing Story:Keeping Pace with Chinaʼs future Biosimilar Demand
Introduction
• Biosimilar Drivers & Challenges in China
• Large-Scale Manufacturing Story
• Business Justification - Commercialization (>10 years)
• Key Success Factors
IntroductionRobert Valdes (Bob)GMP Consultant and V.P. Business DevelopmentBiotech Resources, USA
22 years experience in biotechnology: ManufacturingHuman Genome Sciences, Lonza, Charm Sciences
Advisory Board—Johns Hopkins (2011)Co-Founder—Biotech Resources (2000)Founder—RRMS Inc. Supporting the MS Community (2002)
BA Microbiology—University of New HampshireMSc Biology / BioProcessing—University of MassachusettsMBA—Johns Hopkins Carey School of Business
Biosimilar Drivers & ChallengesDrivers
New Sector / High Economic Potential
• 12th 5-Year Plan: Healthcare Reform
• Expected Discount vs. Innovator• Rising Prosperity / Treatment naïve
• Customer price sensitivity: High• Large Market / High CAGR %
• Success, Time, Cost: Favorable
Patent Expiry: $54Bb before 2020
Blockbusters Lose Patent Protection before 2020: US$54Bb
http://www.gabionline.net/Biosimilars/Research/US-54-billion-worth-o f-biosimilar-patents-expiring-before-2020
Biosimilar Drivers & ChallengesChallenges
• Marketing & Differentiation • Product Approval does not guarantee revenue
• Innovator has 20 yrs collective experience
• Switching Costs: Physicians need data • May impede adoption / market penetration / delayed revenue
• Innovatorʼs 2nd/3rd generation Biobetter
Biosimilar Drivers & ChallengesChallenges
• Competition: Innovator vs BioSimilar
• Kilograms / Annum: High
• Facility Expansion, Build New or Partnership
• Cost ($/gram) control to hedge against expected discount and NDRC/NRDL action
• Project: Strict Adherence to Quality/GMP
• Manufacturing Process is complex
Large-Scale Manufacturing Story• Project map: 50,000 ft view
• Business Rationale & Justification• Core Team Hiring and Training
• Quality Systems• Design Development—Procurement—Start-up -Comm/Val
• Equipment / New Technologies• Strategic Alliances & Benchmarking
• BLA Approval & Celebration!
Large-Scale Manufacturing StoryProject map: 50,000 ft view
0
25
50
75
100
Business Rationale Design & Project Planning Execute Release for GMP
Project Expenditures
Large-Scale Manufacturing StoryBusiness Rationale & Justification
• Facility: Capital appropriation >$100MM ($1000/ft2 US)
• Working Capital = Raws + WIP +BDS+FDP
• Financial Evaluation: pipeline, customer need (kg), pricing, royalty burden, 2-4 years, innovator / FOB / BioBetter
• Scenarios: CMO vs Build vs JV
• Scenarios: Scale vs Titer vs $/gram
• Key Success Factor #1: Alignment on cost, time, resources, and risks. All departments highly participative
Large-Scale Manufacturing StoryCore Team Hiring, Ramp-up, and Training
• Key Success Factor #2 : Hire the core team early
• You will always be training / Develop training system with QA (Quality Assurance) as workers commission the facility.
• Hiring takes time. Training takes time. Priority.
0
50
100
Core Team Design / Plan Execute GMP (1/2 Max) Full Speed
Percentage of Fully Staffed Facility
Large-Scale Manufacturing StoryQuality Systems
QSIT (21 CFR Part 820)Quality Systems Inspection Technique: Evaluate effective implementation of Quality Systems / Subsystems and satellite programs
• Goal: Determine the firmʼs state of compliance by focusing on the key elements from a top-down perspective.
• Quality Policy, Quality Plan: translated into procedures/activities/Instructions relevant to the product produced
• Management Reviews (suitability and effectiveness of the Quality System)
• Evaluate subsystems for adequacy based on findings, trends; Metrics
• Leverage electronic systems early: CAPA, Training, Documents, Metrology, Inventory
• Leverage electronic systems early: Data Monitoring, EBR, Barcode, Wireless Scan
http://www.fda.gov/downloads/ICECI/Inspections/UCM142981.pdf
Large-Scale Manufacturing StoryQuality Systems (conʼt)
QSIT (21 CFR Part 820)Key Success Factor # 3-QA/QC will integrate very early to provide guidance on design as it pertains to:
• Material Systems
• Facility/Equipment System Management
• Production Systems—Batch Records, Tech Transfer
• Microbiology—Environmental Control, Facility/Personnel Hygiene
• Training (always training)
• Personnel Flow, Waste Flow, Segregation, Facility Protection
• Product Sampling / Testing: Analytical Chemistry, Immunoassay, PCR
Large-Scale Manufacturing StoryDesign Development
• Conceptual/Prelim Design: Process Description, PFD, Facility Energy/ Utility balances, Major Equipment Lists, General Arrangement , Site Plan, Design Bases (Piping, Electrical, Equipment, Civil, Structural), Cost estimate summary
• Detailed Design: Utility Summary, Equipment Specs, Diagrams, 3D-model
• Procurement & Construction Management, Safety, Quality, and Permitting
• Definitive Cost estimate
• Start-Up/Commissioning / Validation
• Engineering Runs and Release for GMP
Large-Scale Manufacturing StoryEquipment and New Technologies
• Manufacturing Strategy must be designed for ease of scale-up and tech transfer
• Insource and Outsource as part of facility utilization model
• Innovator and Biosimilar companies have access to modern technologies
• Expression systems, Upstream, Bioseparation, etc
• Deploying new technology platforms should have thorough regulatory review
• Long lead times and price: bioreactors, columns, Centrifuge, BDS freeze units
• Lead times will force the order of procurement and resource deployment
Large-Scale Manufacturing StoryStrategic Alliances & Benchmarking
• Key Success Factor #4: Leverage peerʼs experience to compress learning curve• Facility Design: Design ideas / Lessons learned / PAI trends• Optimize facility utilization and supply continuity• Internships / Training
Large-Scale Manufacturing StoryBLA Approval and Celebration
• >10 years
• Design, Build, Operate 24/7 to provide phase III and commercial supply
• Key Success Factor #5: Celebrate along the way
Database Lock BLA Filing PAILAUNCH!
ASSEMBLE APPROVAL
Large-Scale Manufacturing StoryKey Success Factors
Key Success Factor #1: Must alignment on cost, time, resources, and risks. All departments project aware
Key Success Factor #2: Hire the CORE team early
Key Success Factor #3: Integrate with QA/QC early in project
Key Success Factor #4: Benchmark / Learn from peers
Key Success Factor #5: Celebrate along the way
Thank YouRobert Valdes (Bob)GMP Consultant and V.P. Business DevelopmentBiotech Resources, [email protected]