Opportunities in Human Embryonic Stem Cell (hESC) Product Development

I. Background

• A. Human Embryonic Stem Cells (hESC)
• B. Brief History
• C. Use in Treatment of Disease
• D. Human Embryonic Stem Cell Line Availability

II. Available Stem Cell Lines

• A. NIH Registry Approved
• B. Sources of Additional Published hESC Lines
• C. Sources of Additional Unpublished hESC Lines

III. Applications

• A. Basic Stem Cell Biology
• B. Cellular Therapies
  • 1. Overview
  • 2. Heart Regeneration
  • 3. Pancreatic Islet Cell Replacement
  • 4. Neural Regeneration
• C. Tissue Engineering
• D. Toxicology Testing

IV. Application Priorities

• A. Overall
  • 1. Cell-Based Therapies: Greatest shared priority across research community
    • a. Beneficial hESC Characteristics
    • b. hESC Safety Concerns
    • c. hESC Characterization in Vitro
    • d. hESC Characterization in Vivo
  • 2. Toxicology Assessment: Another area of huge potential
    • a. Overview
    • b. Commercial Interest
• B. By Segment
  • 1. Academic
  • 2. Biotech
  • 3. Pharma

V. Patent Environment

• A. Landmark hESC Patents: WARF “Composition of Matter” Patents
  • 1. Background
  • 2. Licensing of WARF Patent Rights
    • a. Overview of WARF Licensees
    • b. Most Recent WARF Licensee: Pfizer, Inc. (May 2009)
  • 3. WARF Patent Exemption: Federal Rights to hESC Research
  • 4. U.S. WARF Patent Challenges
  • 5. Circumventing WARF Patent Rights Using Geographic Limitations
• B. Global Stem Cell Patent Landscape
• C. U.S. Patents of Importance
  • 1. Geron Corporation Patents
  • 2. Regents of the University of California Patents
  • 3. BresaGen, Inc. Patents
  • 4. Regeneron Pharmaceuticals, Inc.
  • 5. Vanderbuilt University Patents
• D. Worldwide Patents of Importance
  • 1. ES Cell International PTE Ltd. Patents (Singapore)
  • 2. DNAVEC Research Inc. Patents (Ibaraki, JP)
  • 3. University of Edinburgh Patents (Edinburgh, GB)
• E. Summary of the hESC Intellectual Property Landscape

VI. Historical and Future Growth Projections

• A. PubMed Analysis
  • 1. Historical Analysis (Trailing 10 Years)
  • 2. Future Growth Predictions (5-Year Forecasts)
  • 3. Breakdown of ESC Research by Species
• B. CRISP Analysis
• C. Patent Analysis
  • 1. All Fields
  • 2. Abstract Only

VII. hESC PRODUCT COMPETITORS

• A. Cellartis AB
  • 1. Human embryonic stem cell lines
  • 2. Monoclonal Antibodies for hESC Research
  • 3. Differentiated Cell Products
  • 4. Associated hESC products
• B. Vitrolife
• C. Tataa Biocenter
• D. Invitrogen
  • 1. hESC Culture Media & Reagents
  • 2. hESC-qualified Basement Membrane Extract
  • 3. hESC cDNA Libraries
  • 4. hESC Reporter Cells
  • 5. hESC PCR Kits
  • 6. hESC Stem Cell Antibodies
  • 7. hESC Stem Cell Growth Factors
• E. Stem Cell Technologies
  • 1. hESC Culture Media & Reagents
  • 2. hESC Primary & Secondary Antibodies
• F. BD Biosciences
• G. Chemicon
  • 1. hESC Culture Media and Reagents
  • 2. hESC Lines
  • 3. hESC Kits
  • 4. hESC Antibodies
• H. R&D Systems
• I. SA Biosciences
• J. Thermo Scientific
• K. Australian Stem Cell Centre

VIII. Specialty Pharmaceutical Companies developing hESC Therapies

• A. Geron
• B. Novocell
• C. Cell Cure Neurosciences Ltd
• D. Cell Dynamics International
• E. Advanced Cell Technology

IX. Featured Labs (Potential Customers)

• A. Academic Labs
• B. Private Labs
• C. Government Labs
• D. International Labs

X. Toxicology Testing Legislation

• 1. European Union to Ban Animal-Testing for Cosmetic Development in 2009
• 2. Responses to the European Ban on Animal Testing for Cosmetic Development
  • a. Overview
  • b. Skin Irritation
  • c. Eye Irritation
  • d. Skin Sensitisation
  • e. Mutagenicity/Genotoxicity
  • f. Reproductive Toxicity
• 3. EU Legislation Regarding Animal-Based Testing for Drug Discovery

XI. Product Development Suggestions

• A. Product Categories
  • 1. hESCs
  • 2. hESC Derivative Cells
  • 3. hESC Reporter Cells
  • 4. hESC Antibodies
  • 5. hESC Characterization & PCR Kits
  • 6. hESC Qualified BME
  • 7. hESC cDNA Libraries
  • 8. hESC Growth Factors
  • 9. hESC Media and Culture Reagents
• B. Product Ideas & Suggestions
  • 1. Areas of Underdeveloped Competition
  • 2. Mouse ESC Products
  • 3. iPS Cells Products
  • 4. Non-animal-derived Culture Reagents for hESCs
  • 5. Strategic Collaborations
  • 6. Products for generating Pure ESC populations
  • 7. hESC Toxicity Assay Kit

XII. Events of Interest

• A. Annual Wisconsin Stem Cell Symposium
• B. World Stem Cells & Regenerative Medicine Congress
• C. World Stem Cell Summit 2010
• D. Stem Cells 2010, Achieving Success in Science and Commercialization
• E. International Society for Stem Cell Research, Upcoming Events
  • 1. This Year (2010)
  • 2. Next Year (2011)