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Biosimilars in China

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Biotech Resources Group was invited to Qingdao (1hr North of Shanghai) to present on the challenges of biosimilars in China given the need to keep pace with increased commercial demand.

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Biosimilars in China

  1. 1. Large-Scale Manufacturing Story:Keeping Pace with Chinaʼs futureBiosimilar DemandRobert Valdes
  2. 2. Introduction• Biosimilar Drivers & Challenges in China• Large-Scale Manufacturing Story • Business Justification - Commercialization (>10 years)• Key Success Factors
  3. 3. IntroductionRobert Valdes (Bob)GMP Consultant and V.P. Business DevelopmentBiotech Resources, USA22 years experience in biotechnology: ManufacturingHuman Genome Sciences, Lonza, Charm SciencesAdvisory 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
  4. 4. Biosimilar Drivers & ChallengesDriversNew 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: FavorablePatent Expiry: $54Bb before 2020
  5. 5. Blockbusters Lose Patent Protectionbefore 2020: US$54Bb http://www.gabionline.net/Biosimilars/Research/US-54- billion-worth-o f-biosimilar-patents-expiring-before-2020
  6. 6. Biosimilar Drivers & ChallengesChallenges• Marketing & Differentiation • Product Approval does not guarantee revenue• Innovator has 20 yrs collective experience• Switching Costs: Physicians need data • May impede adoption / market penetration / delayed revenue• Innovatorʼs 2nd/3rd generation Biobetter
  7. 7. Biosimilar Drivers & ChallengesChallenges• Competition: Innovator vs BioSimilar• Kilograms / Annum: High • Facility Expansion, Build New or Partnership • Cost ($/gram) control to hedge against expected discount and NDRC/NRDL action • Project: Strict Adherence to Quality/GMP • Manufacturing Process is complex
  8. 8. 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!
  9. 9. Large-Scale Manufacturing StoryProject map: 50,000 ft view Project Expenditures100 75 50 25 0Business Rationale Design & Project Planning Execute Release for GMP
  10. 10. 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
  11. 11. 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. Percentage of Fully Staffed Facility100 50 0Core Team Design / Plan Execute GMP (1/2 Max) Full Speed
  12. 12. Large-Scale Manufacturing StoryQuality SystemsQSIT (21 CFR Part 820)Quality Systems Inspection Technique: Evaluate effective implementation ofQuality 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 Scanhttp://www.fda.gov/downloads/ICECI/Inspections/UCM142981.pdf
  13. 13. Large-Scale Manufacturing StoryQuality Systems (conʼt)QSIT (21 CFR Part 820)Key Success Factor # 3-QA/QC will integrate very early to provide guidanceon 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
  14. 14. 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
  15. 15. 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
  16. 16. Large-Scale Manufacturing StoryStrategic Alliances & Benchmarking• Key Success Factor #4: Leverage peerʼs experience tocompress learning curve• Facility Design: Design ideas / Lessons learned / PAI trends• Optimize facility utilization and supply continuity• Internships / Training
  17. 17. 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 ASSEMBLE APPROVAL LAUNCH! Database Lock BLA Filing PAI
  18. 18. Large-Scale Manufacturing StoryKey Success FactorsKey Success Factor #1: Must alignment on cost, time,resources, and risks. All departments project awareKey Success Factor #2: Hire the CORE team earlyKey Success Factor #3: Integrate with QA/QC early in projectKey Success Factor #4: Benchmark / Learn from peersKey Success Factor #5: Celebrate along the way
  19. 19. Thank YouRobert Valdes (Bob)GMP Consultant and V.P. Business DevelopmentBiotech Resources, USAbobv@bobv.net

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