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Science of Stem Cells and Potential Applications

Science of Stem Cells and Potential Applications. Andrea Hunt February 22, 2008. Baxter International Inc. At Baxter, one of our primary goals is to save and sustain lives worldwide.

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Science of Stem Cells and Potential Applications

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  1. Science of Stem Cells and Potential Applications Andrea Hunt February 22, 2008

  2. Baxter International Inc. • At Baxter, one of our primary goals is to save and sustain lives worldwide. • Every day, our products and services help treat thousands of people around the world with some of the most complex conditions — from hemophilia to cancer and immune disorders to kidney disease.

  3. Company Snapshot • More than 75 years of market leadership driven by a well-recognized global brand • $10.4 billion global market leader • Over 50% of sales outside the United States • Approximately 70% of sales from products with leading market positions • More than $1.5 million invested in R&D every day • More than 3000 R&D employees

  4. Baxter’s Mission We are a global, diversified healthcare company applying innovative science to develop specialty therapeutics and medical products that save and sustain patients’ lives. Our Mission

  5. Medication Delivery Renal BioScience Baxter’s Business Portfolio

  6. Medication Delivery Renal BioScience Baxter’s Business Portfolio

  7. BioSurgery Product Portfolio

  8. Cellular Therapies’ Product Portfolio:Used in many cell processing steps Cell isolation Cell expansion/ culture Secondary cell processing Cell storage ISOLEXMagnetic Cell Selector LIFECELLCulture Bags CYTOMATECell Washer CRYOCYTE Freezing Containers

  9. Definition of Regenerative Medicine for Baxter “Regenerative Medicine” The regeneration of damaged cells, tissues or organs through the use of cells, scaffolds and/or biomolecules via tissue engineering approaches Scaffolds Scaffolds Cells Cells Other Regenerative Medicine Bioactive Bioactive Agents Agents

  10. Regenerative Medicine offers a new era in medicine … Invasive Surgery Minimally invasive surgery Regenerative Medicine 2004 National Conference Schedule NASPE ACC TCTMD The Heart.org

  11. Current Baxter CD34+ Phase II Stem Cell Trial Potential to reverse the effects of heart disease Blood Stream Blood Vessel CD 34 + Stem Cell Differentiation and/or stimulation Heart Muscle Isolex: selection

  12. Mixing device Mixing device Application device Prototype • Indication Current Status Bone Programs: Fibrin Plus (PTH) Bone cysts Long bone fractures Vertebral augmentation

  13. Current Regenerative Medicine Application in Development • Tissue engineered autologous bladder

  14. How long does it take for an idea to turninto a therapy for a patient? • 1 – 5 years • 5 - 10 years • 10 -15 years • 15+ years

  15. Basic Research Pre-Clinical Research Clinical Research Product Launch 1 – 20+ Years 1 – 3+ Years 5 – 15+ Years Typically where Baxter initially gets involved Most Drugs and Stem Cell Therapies will take 10-15 years to develop There must also be a market for your therapy

  16. Time Success Rate Now let’s add in chance of success Basic Research Pre-Clinical Research Clinical Research Product Launch 1 – 20+ Years 1 – 3+ Years 5 – 15+ Years 1 out of 1000+ 1 out of 100+ 1 out of 10 A typical drug costs $800 Million to develop

  17. Demonstration of Safety and Efficacy Why does it take so long and cost so much? • Initial research focused on finding compounds that have the potential to work • Animal research is then conducted • Clinical research is conducted in sequential stages- Phase 1- Phase 2- Phase 3 • Product is then launched into the marketplace Regulatory agencies are involved – FDA in US, EMEA in Europe and PMDA in Japan

  18. A Business Model must also be created from the start of development • What is the unmet medical need?- target patient population • What is the scientific rationale that suggests a stem cell therapy will meet this need?- pre-clinical and clinical data • What is the viable business model? A viable business model must be in place for a company to pursue development

  19. Business Model Elements • Freedom to Operate • Financials • - Funding • - Operations • Partnerships • Product Portfolio • Manufacturing • Clinical Plan • Pricing • Reimbursement • Strategic Plan • Geographic Scope • Marketing Plan • Competitive Environment • Distribution Many skillsets are required to form this plan, a science background is always beneficial.

  20. Time Business Model Viability Critical to Product Launch Basic Research Pre-Clinical Research Clinical Research Product Launch 1 – 20+ Years 1 – 3+ Years 5 – 15+ Years Technical Success 1 out of 1000+ 1 out of 1000+ 1 out of 10 Rate It takes good science, time, dollars and luck to launch!

  21. Summary • Regenerative Medicine/Stem Cell Therapies could be next wave in medicine • Novel scientific breakthroughs will be achieved over the next decade and beyond • Adult stem cell therapies look promising and are the closest to being approved • Exciting new therapies are in the pipeline that will ultimately benefit patients

  22. Saving and Sustaining Lives Worldwide Thank you

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