Table of Contents

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C. Sources of Additional Unpublished hESC Lines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)

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