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Minimising cost of goods
- 1. Biopharm Services Adding Value to Bioprocesses Minimising CoGs Across the Enterprise, Collaboration & Standardisation Andrew Sinclair - Managing Director & Founder a.sinclair@biopharmservices.com www.biopharmservices.com © BioPharm Services Ltd
- 2. Industry Trends Healthcare providers are putting Price Breakdown pressure on the industry to reduce Manufacturing R&D Sales & G&A Profit share Pre tax profit prices 14% 37% Facility planning from construction 21% to licensure takes 5 years, and it is getting more expensive 9% 19% Sales forecasts for breakthrough therapies are highly uncertain Production output is uncertain at time of facility build decision Increase threats from biosimilars © BioPharm Services Ltd 2 CONFIDENTIAL
- 3. Industry Cost Trends Productivity in development is reducing As spend per drug increases Productivity is decreasing Now overall cost of bringing a successful biologic to market is between $0.8bn to $1.2bn Manufacturing costs are increasing proportionately 20 years ago about 3% of sales price for chemical candidate Biologics range between 10% to 20%1 Healthcare providers are putting pressure on the industry to reduce prices by looking at the cost benefit balance2 1. In a recent GE Healthcare webinar they quoted a figure of 14% 2 . The Evidence Gap British Balance Benefit vs. Cost of Latest Drugs, December 3, 2008, New York Times © BioPharm Services Ltd 3 CONFIDENTIAL
- 4. Conclusions Industry has achieved great success Costs are now a major driver In development improved success rates reduce costs Manufacturing costs are increasingly important Need greater understanding of costs Implications of process & technology choices The earlier in development the better Managing Process Knowledge Consistent & standard formats Streamline process development & deployment © BioPharm Services Ltd 4 CONFIDENTIAL
- 5. Process Economics Process Models The problem! In house solutions Individual solutions Spreadsheets many issues Not shared Poor data integrity Process Capital Costs Capital Costs Capital Costs Poor communication Process Process Maintenance Inefficient operations Development Maintenance Maintenance Development Development History Data Validation History History Data Data Validation Validation Packages Packages Packages Labour Costs Plant Design Labour Costs Labour Costs Islands of Multiple Manufacturing Plant Design Plant Design Manufacturing Manufacturing Data Sets Plant Plant Plant Performance recipes recipes recipes Process Performance Performance Process Process Data Data Performance Performance Data Performance Materials Costs Materials Costs Data Data Materials Costs Data Technology Technology Technology Analytical Data Transfer Transfer Analytical Data Analytical Data Unit Operation Unit Operation Transfer Unit Operation Package Package Data Data Package Data © BioPharm Services Ltd 5 CONFIDENTIAL
- 6. Requirements Provides the solution through Managing process information and related data Materials Consumables Equipment sets Process models Data Integration & Standardisation Defined data structure Common methods/models Integrated data sources Accessibility across the enterprise Import/export Security model Access, tracking & auditing © BioPharm Services Ltd 6 CONFIDENTIAL
- 7. BioSolve Delivers Integrated Enterprise Solution © BioPharm Services Ltd 7 CONFIDENTIAL
- 8. Terminology BioSolve Is the name of the product family BioSolve Process Process modelling package (in Excel) BioSolve Process Professional [sold on a per machine basis] BioSolve Process Enterprise [licenses are managed centrally] BioSolvePLM Manages resource data sets that includes libraries of consumables, equipment etc. Platform for a range of future products BioSolve Connect Centrally manage multiple datasets for BioSolve Process this references data from BioSolve PLMs libraries © BioPharm Services Ltd 8 CONFIDENTIAL
- 9. BioSolve Connect The Enterprise Solution Central Everyone Resource shares same Management data Central Unit Op Everyone Models shares same methods Multiple Tailor to Data Sets facilities or technologies Central Manage Management distribution & updates © BioPharm Services Ltd 9 CONFIDENTIAL
- 10. BioSolve Connect Applications Examples Application Benefits Fit a process to a Maintain different facility data sets facility quickly • Which is the best fit • Which is the least cost Maintain reference Ensure a common reference across the Enterprise processes • Effective decision making Tailored data sets for Different processes need different configurations processes • Vaccines vs. cell therapies vs. proteins etc. Sharing & transferring Move a process to different groups processes • Transfer methods & resources seamlessly Evaluating Evaluate & distribute the latest technologies technologies • Identify the right cost & application • Avoid costly mistakes © BioPharm Services Ltd 10 CONFIDENTIAL
- 11. BioSolve Connect Platform for Process Deployment BioSolve Process Users Operation Library Innovative Technologies Centrally managed Understand and evaluate Scaling rules, recipes Assembled for deployment In a trusted environment Standard operations Target key clients Selected distribution Standard processes © BioPharm Services Ltd 11 CONFIDENTIAL
- 12. BioSolve Connect Helping you make informed decisions quickly Application Benefits Managing process & • Everyone shares the same data resources centrally • Seamless automated updates • Consistent and informed decisions Custom data sets • Quickly evaluate the cost effective process • Rapid technology adoption • Screen processes for manufacturability • Optimise cost and minimise risks Controlled distribution • The right people get the information • Avoid mistakes through consistent data © BioPharm Services Ltd 12 CONFIDENTIAL
- 13. BioSolve Process Supporting decision making early on Understand impact of choices Identify the cost drivers Identify fit early on Solving problems before they happen Optimising for the facility Screening processes Supporting Tech transfer Standard reports © BioPharm Services Ltd 13 CONFIDENTIAL
- 14. BioSolve Process Addressing your needs Process optimisation Technology evaluation Capacity analysis Facility fit Sensitivity analysis © BioPharm Services Ltd 14 CONFIDENTIAL
- 15. Manufacturability Assessments Reduce risk Stages Reports First pass analysis Fit analysis Rapid analysis Yes, no or nearly Based on BioSolve Process, processes Main constraints Basis Support equipment Equipment list specific to Required equipment a facility Equipment has a defined Capabilities capability All main equipment Review support equipment Impact of Fit process to facility constraint data set removal © BioPharm Services Ltd 15 CONFIDENTIAL
- 16. Continuous Processes Evaluate the latest technologies Template unit operations available within the process library: Perfusion production bioreactor Depth filtration Bind & Elute chromatography UV virus inactivation Flow through membrane adsorber Viral filtration Concentration Diafiltration Sterile filtration © BioPharm Services Ltd 16 CONFIDENTIAL
- 17. Capacity Analysis Understanding constraints Define shift durations Used to assess the number of shifts that a unit operation spans Downtime added to adjusted duration if multiple shifts spanned Impacts upon production capacity if the unit operation is a bottleneck Shading highlights the production bottleneck © BioPharm Services Ltd 17 CONFIDENTIAL
- 18. BioSolve Process Analysis & reports Scenario analysis Cashflow & NPV Sensitivity analysis © BioPharm Services Ltd 18 CONFIDENTIAL
- 19. BioSolve Process Flexible, User configured, Scaleable Uses Therapeutic proteins Vaccines Cellular therapy DNA Vaccines Egg based flu Peptides Oligosaccharides And more….. © BioPharm Services Ltd 19 CONFIDENTIAL
- 20. BioSolve Process Helping you make informed decisions quickly Application Benefits Optimise process in • Identify cost drivers early early development • Optimise the process where the opportunity exists Assess • Screen processes for manufacturability manufacturability • Ensure key issues are addressed early on in development • Identify the cost effective manufacturing sites Screen and evaluate • Assess a new technology rapidly technologies • Apply the right technology in the right application • Maximise the opportunity © BioPharm Services Ltd 20 CONFIDENTIAL
- 21. BioSolve Service Offering Annual cost database update Development upgrades Access to online helpdesk Optional Training packages (highly recommended) Consultancy support for custom configuration Setting up your technologies Setting up your processes © BioPharm Services Ltd 21 CONFIDENTIAL
- 22. Real Demonstrable Value Case studies and Process cost & facility considerations when selecting cell culture clarification technology Integrating technologies Process models guiding Developing business cases for new in BioSolve: Pall Cadence process development products & new technologies single-pass TFF Magdalena Stepien, Crucell "BioSolve enables us to develop robust , cost Jim Velez, Merck & Co effective downstream processes in our "Use the right tool. For our case development group" to assess impact of innovative technology BioSolve was the right Jean-Marc Guillaume, Sanofi Pasteur tool. We were able to generate "In these challenging times BioSolve helps you multiple scenarios and sensitivity deliver the optimum process technology mix rapidly." wherever you are in the product lifecycle" © BioPharm Services Ltd 22 CONFIDENTIAL
- 23. Coming Soon 2. How Well Does Your Process Fit into a Facility? 3. What Cost Antibody Drug Conjugates? 4. Potential of Continuous Processing in Downstream 5. When and where to use Pre-packed columns a cost perspective 6. Optimising Design During Concept Case Study Clinical Supply Facility Sign up now for these webinars on: http://www.biopharmservices.com/webinars Any questions? Contact us at: webinars@biopharmservices.com © BioPharm Services Ltd 23 CONFIDENTIAL