Presentation on theme: "1 Confidential Science of Stem Cells and Potential Applications Andrea Hunt February 22, 2008."— Presentation transcript:
1 Confidential Science of Stem Cells and Potential Applications Andrea Hunt February 22, 2008
2 Confidential 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 Confidential 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 Confidential We are a global, diversified healthcare company applying innovative science to develop specialty therapeutics and medical products that save and sustain patients’ lives. Baxter’s Mission Our Mission
5 Confidential Baxter’s Business Portfolio Hemodialysis Products/Services Peritoneal Dialysis Products/Services Pharmaceuticals MedicationDelivery BioScience Renal Premixed liquid and frozen drugs Infusion Systems Anesthesia Nutritional Products Therapeutic Proteins –Recombinant –Plasma Based Vaccines Regenerative Medicine - Cellular Therapies - BioSurgery
6 Confidential Baxter’s Business Portfolio Hemodialysis Products/Services Peritoneal Dialysis Products/Services Pharmaceuticals MedicationDelivery BioScience Renal Premixed liquid and frozen drugs Infusion Systems Anesthesia Nutritional Products Isolex Business Therapeutic Proteins –Recombinant –Plasma Based Vaccines Regenerative Medicine - Cellular Therapies - BioSurgery
8 Confidential Secondary cell processing Cell storage Cell isolation Cell expansion/ culture ISOLEX Magnetic Cell Selector LIFECELL Culture Bags CYTOMATE Cell Washer CRYOCYTE Freezing Containers Cellular Therapies’ Product Portfolio: Used in many cell processing steps
9 Confidential Definition of Regenerative Medicine for Baxter Other Regenerative Medicine “Regenerative Medicine” The regeneration of damaged cells, tissues or organs through the use of cells, scaffolds and/or biomolecules via tissue engineering Cells Scaffolds Bioactive Agents Cells Scaffolds Bioactive Agents approaches
10 Confidential 2004 National Conference Schedule NASPE ACC TCTMD The Heart.org Regenerative Medicine offers a new era in medicine … Minimally invasive surgery Invasive Surgery Regenerative Medicine
11 Confidential Isolex: selection CD 34 + Stem Cell Differentiation and/or stimulation Blood Vessel Heart Muscle Blood Stream Current Baxter CD34+ Phase II Stem Cell Trial Potential to reverse the effects of heart disease
13 Confidential Bone Programs: Fibrin Plus (PTH) Indication Current Status Bone cysts Long bone fractures Vertebral augmentation Mixing device Mixing device Application device Prototype
14 Confidential Tissue engineered autologous bladder Current Regenerative Medicine Application in Development
15 Confidential A.1 – 5 years B.5 - 10 years C.10 -15 years D.15+ years How long does it take for an idea to turn into a therapy for a patient?
16 Confidential Typically where Baxter initially gets involved Most Drugs and Stem Cell Therapies will take 10-15 years to develop Product Launch Basic Research 1 – 20+ Years Pre-Clinical Research 1 – 3+ Years Clinical Research 5 – 15+ Years There must also be a market for your therapy
17 Confidential Now let’s add in chance of success A typical drug costs $800 Million to develop 1 out of 1000+ Basic Research Pre-Clinical Research Clinical Research Product Launch 1 – 20+ Years 1 – 3+ Years5 – 15+ Years Time Success Rate 1 out of 100+1 out of 10
18 Confidential 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 Demonstration of Safety and Efficacy Regulatory agencies are involved – FDA in US, EMEA in Europe and PMDA in Japan
19 Confidential 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 Business Model must also be created from the start of development A viable business model must be in place for a company to pursue development
20 Confidential 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.
21 Confidential Business Model Viability Critical to Product Launch It takes good science, time, dollars and luck to launch! 1 out of 1000+ Basic Research Pre-Clinical Research Clinical Research Product Launch 1 – 20+ Years 1 – 3+ Years5 – 15+ Years Time Technical Success Rate 1 out of 1000+1 out of 10
22 Confidential 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
23 Confidential Saving and Sustaining Lives Worldwide Thank you