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DOMAIN EXPERT ENGAGEMENTS

Number of executives repeatedly engaged by snail & email outreach*

POOL + OUTREACH

656

Interactions with Platform & by Email *

INTERACTIONS

131

Unique # Participated *

PARTICIPANTS

26

Responses Validated *

VALIDATIONS

11

* Platform engagements are dynamic. Stats are published quarterly.


  •  CODE

  •  PAGES

  •  DATE

  •  PRICE

    $

  •  DATA EXHIBITS

    125


TABLE OF CONTENTS


   Pages :    | $

   Study Reliability and Reporting Limitations.....I-1  
   Disclaimers.....I-2
Data Interpretation & Reporting Level.....I-2
Quantitative Techniques & Analytics.....I-2
  
   Product Definitions and Scope of Study.....I-3  
   Gene Therapy – Promising Therapy for Future.....II-1
Approved Gene Therapies Fail to Gather Momentum.....II-1
1$100
   Manufacturers Eye International Markets.....II-21$100
   2009 – A Tumultuous Year for Gene Therapy Industry.....II-3
Hope Floats in Gene Therapy.....II-3
1$100
   China – First to Approve Gene Therapy Worldwide.....II-4
The Wait Continues for First Gene Therapy in Major Markets.....II-4
Table 1: Gene Therapy Clinical Development (2009): Percentage Share Breakdown by Stage (includes corresponding Graph/Chart).....II-4
1$350
   Cancer Remains the Key Target for Gene Therapy.....II-5
Table 2: Clinical Development of Gene Therapy by Targeted Indication (2009): Percentage Breakdown of Number of Trials for Cancer Diseases, Cardiovascular Diseases, Infectious Diseases, Monogenic Diseases, Neurological Diseases and Others (includes corresponding Graph/Chart).....II-5
Adenovirus – The Leading Vector Employed in Gene Therapy.....II-5
Table 3: Gene Therapy Clinical Development by Vectors Used (2009): Percentage Breakdown of Number of Trials for Adenovirus, Retrovirus, Plasmid DNA, Vaccinia Virus, Lipofection and Others (includes corresponding Graph/Chart).....II-5
Efficacy – The Key Challenge for Gene Therapy.....II-5
1$350
   Gene Therapy Pipeline Strengthens in Asia.....II-6
Counting on the Success Factors.....II-6
1$100
   Factors Influencing Gene Therapy Future Development.....II-7
Human Genome Analysis.....II-7
Gene Therapy - The Next Generation Cardiovascular Therapy.....II-7
Public Support for Gene Therapy.....II-7
RNAi Bodes Bright Prospects.....II-7
1$100
   Factors Hampering Market Growth.....II-8
Stringent Regulatory Laws in US and Europe Prolong Gene Therapy Development.....II-8
Identifying Genetic Fault.....II-8
Immune Response.....II-8
Delivering Genetic Materials into Patient Cells.....II-8
1$100
   Multigene Disorders.....II-9
Side Effects.....II-9
Push Towards Germline Gene Transfer.....II-9
Technical Limitations.....II-9
1$100
   Alliances and Acquisitions – Strategy for Success.....II-10
Patent Pooling: Yet Another Obstacle.....II-10
Commercialization: A Road Uphill.....II-10
1$100
   Time Line in Gene Therapy Drug Development.....II-11
Target Diseases and Players Involved.....II-11
1$100
   Key Players by Application Area.....II-12
Table 4: Gene Therapy Clinical Trials Worldwide (2009): Percentage Breakdown by Gene Type Transferred for Antigen, Cytokine, Tumor Suppressor, Growth Factor, Deficiency, Suicide, and Others (includes corresponding Graph/Chart).....II-12
1$350
   Table 5: Gene Therapy Clinical Trials (2007): Percentage Breakdown by Geographic Region for US, Europe, Canada, Japan and Rest of World (includes corresponding Graph/Chart).....II-13
Select Gene Therapy Products in Phase III Development (2010).....II-13
1$350
   Select Gene Therapy Products in Phase II Development (2010).....II-14
Select Gene Therapy Products in Phase I and Pre-Clinical Development (2010).....II-14
1$100
   Overview of Select Drugs in Pipeline.....II-15
Allovectin-7® (Vical Inc.).....II-15
Generx (Cardium Therapeutics).....II-15
Trinam® (Ark Therapeutics).....II-15
1$100
   TroVax® (Oxford BioMedica).....II-16
Collategene™ (AnGes MG Inc.).....II-16
1$100
   The United States.....II-17
Regulatory Environment.....II-17
Food and Drug Administration.....II-17
FDA Requires Additional Toxicology and Biodistribution Studies.....II-17
1$100
   IRB and IBC.....II-18
NIH.....II-18
1$100
   Europe.....II-19
Germany and UK- The Hub of European Gene Therapy Market.....II-19
1$100
   Table 6: Gene Therapy Clinical Trials in Europe (2007): Percentage Breakdown of Number of Trials by Country for UK, Germany, Switzerland, France, Belgium, Netherlands and Others (includes corresponding Graph/Chart).....II-20
Regulatory Environment.....II-20
Gene Therapy Advisory Committee.....II-20
1$350
   European Society of Gene and Cell Therapy (ESGCT).....II-21
Study of Regulatory Environment in Select European Countries.....II-21
United Kingdom.....II-21
Germany.....II-21
1$100
   Italy.....II-22
Sweden.....II-22
The Netherlands.....II-22
Switzerland.....II-22
Gene Therapy Industry in Europe and the US – A Comparison.....II-22
1$100
   Japan.....II-23
Asia-Pacific.....II-23
Gene Therapy Industry in Europe and the US – A Comparison.....II-23
1$100
   World's First Gene Therapy Medicine Approved in China.....II-24
Prospects for Gendicine.....II-24
Competition.....II-24
1$100
   Rest of World.....II-251$100
   Molecular Basics – The Gene.....II-26
Genome – The Information Pool.....II-26
Functional Cloning.....II-26
Random Sequencing.....II-26
1$100
   Positional Cloning.....II-27
What is Gene Therapy?.....II-27
A Backdrop.....II-27
1990 Highlights - The Preliminary Gene Therapy Trial.....II-27
1995 Highlights.....II-27
1$100
   2000 Highlights – Clinical Trials Reaches 400- Milestone.....II-28
2004 Witnesses the First Gene Therapy Drug.....II-28
Classical Theory of Gene Therapy.....II-28
Ex-Vivo Approach of Gene Therapy.....II-28
In-vivo Approach of Gene Therapy.....II-28
1$100
   Types of Gene Therapy.....II-29
Monogenic Gene Therapy.....II-29
Suicide Gene Therapy.....II-29
Antisense Gene Therapy.....II-29
Various Approaches.....II-29
1$100
   Vector.....II-30
Delivery Vehicles and Challenges in Use of Viral Vectors.....II-30
Gene Delivery – Without Virus.....II-30
1$100
   Non-Viral Products in Pipeline.....II-31
Well-known Delivery Approaches for Gene Therapy.....II-31
1$100
   Viral and Non-viral Vectors in Use.....II-32
Retroviruses.....II-32
Adenoviruses.....II-32
Adenoassociated viruses.....II-32
Herpes simplex viruses.....II-32
Lentiviruses.....II-32
Liposomes.....II-32
Viral Vectors by Companies involved.....II-32
1$100
   Gene Cassette.....II-33
Target cells.....II-33
Stem cells.....II-33
Differentiated cells.....II-33
The Disc: An Excellent Target for Gene Therapy.....II-33
1$100
   Antisense Technology.....II-34
Catalytic Ribozyme Technology.....II-34
Triple Helix DNA.....II-34
2$200
   Gene Therapy for Cancer Treatment.....II-36
Gene Transfer and Gene Therapeutic Concepts in Cancer.....II-36
1$100
   Competitive Landscape in Cancer Gene Therapy.....II-37
Gene Therapy Mechanism in Cancer.....II-37
1$100
   Advantages Over Chemotherapy.....II-38
Developments in Cancer Gene Therapy.....II-38
P53 Gene Therapy – A Novel Approach in Cancer Treatment.....II-38
1$100
   Gendicine – From Concept to Reality.....II-39
Vaccines.....II-39
Gene Therapy for Cardiovascular Disease.....II-39
1$100
   Cardiovascular Gene Therapy Products under Trial.....II-40
Gene Therapy for Cystic Fibrosis Disease.....II-40
Gene Therapy for Haemophilia B.....II-40
1$100
   Gene Therapy for AIDS/HIV.....II-41
Gene Therapy for Parkinson’s Disease.....II-41
The Disease.....II-41
1$100
   Therapy.....II-42
Development Pipeline of Gene Therapies in Parkinson’s Disease.....II-42
1$100
   Gene therapy and Regulatory Environment.....II-43
Gene Patents - An Overview.....II-43
1$100
   Amsterdam Molecular Therapeutics to Develop Gene Therapy for Parkinson's
  Disease.....II-44
Researchers Develop Synthetic Gene Vectors to Reduce Body Immune Responses.....II-44
1$100
   Illumina Brings Digital Gene Expression Applications.....II-45
MolMed Develops Gene Therapy Based Treatment for Skin Cancer.....II-45
Santaris Pharma Develops New Therapy to Lower Cholesterol Level.....II-45
Researchers Develop Gene Therapy for Severe Burns.....II-45
1$100
   AMT Develops (AAV) Vector-Based Gene Therapy.....II-46
Ark Comes Up with New Gene Therapy Delivery Technology.....II-46
1$100
   Sanofi-Aventis Snaps Up Genzyme Corp......II-47
Ceregene Initiates Enrolment for Phase IIb Study for CERE-120 in Parkinson’s
  Disease.....II-47
Oxford BioMedica Releases Phase III Trial Results of TroVax® in Renal Cancer.....II-47
AnGes To Carry Out Additional Trial for Collategene™.....II-47
1$100
   Vical Receives Positive Review for Allovectin-7® Phase III Trial.....II-48
Cardium and bioRASI Ink Master Services Agreement for Generx.....II-48
Ceregene Commences New Phase I/II Trial for CERE-120 in Parkinson's Disease.....II-48
1$100
   GeneVec Discontinues TNFerade Trial in Pancreatic Cancer.....II-49
Transgene Grants Novartis an Option to Acquired License to TG4010.....II-49
Helmholtz and SIRION Team Up to Develop Gene Therapy for Lymphoid Tumors.....II-49
1$100
   Targeted Genetics to Merge with Biocontrol.....II-50
BioSante Merges with Cell Genesys.....II-50
Targeted Genetics Sells Off Gene Therapy IP to Genzyme.....II-50
Ark Therapeutics Obtains Clearance for Cerepro for Named Patient Use.....II-50
1$100
   StemCells Acquires Stem Cell Sciences.....II-51
FDA Clears Ark Therapeutics to Commence Phase III Clinical Trial of Trinam®.....II-51
1$100
   Introgen Therapeutics Files for Bankruptcy.....II-52
Cell Genesys Terminates ITAL-2 Trial of GVAX Vaccine in Advanced Prostate
  Cancer.....II-52
Roche Takes Over Mirus Bio Corp......II-52
1$100
   FDA Declines Accepting Approval Application for Advexin.....II-53
Transgene's TG4010 Therapeutic Vaccine Meets Primary Endpoint in NSCLC.....II-53
Ark Therapeutics Obtains SPA for Phase III Study of Trinam® from FDA.....II-53
International Consolidated Acquires China Gene.....II-53
1$100
   Ark Therapeutics Acquires Lymphatix.....II-54
Oxford BioMedica Obtains Rights for RNAi Technology.....II-54
Gene Bridges Inks Licensing Agreement with Genencor.....II-54
AMT Enters into R&D Agreement with NIH.....II-54
1$100
   VGX Inks Supply Agreement with a U.K. Consortium.....II-55
Cardium Therapeutics Receives Fast Track Designation for Generx™.....II-55
Oxford Biomedica’s ProSavin Enters Phase I/II Trial.....II-55
Lentigen Acquires Gene Delivery Technology from Cell Genesys.....II-55
1$100
   VIRxSYS Acquires SMaRT™ RNA Technology.....II-56
Gene Logic Divests Genomics Assets.....II-56
Genzyme Inks Agreement with Ceregene.....II-56
Silence Therapeutics Extends Agreement with Quark.....II-56
Benda Inks HIV Vaccine Joint Venture with DNAVEC.....II-56
1$100
   Research Dynamics Bags Contract for Multicenter Clinical Study.....II-57
Thermo Fischer Collaborates with Lentigen to Develop Gene-Silencing Technology.....II-57
Fovea Enters into Collaboration with GENZYME Corporation.....II-57
Oxford BioMedica Inks Licensing Agreement with Children’s Hospital.....II-57
1$100
   Sigma and Oxford Sign Joint License Agreement for LentiVector Technology.....II-58
Benda Attains Additional Stake in SiBiono.....II-58
Oxford BioMedica Acquires Oxxon.....II-58
Oxford BioMedica and Sanofi-Aventis Agrees to Co-Develop and Market TroVax.....II-58
Illumina Completes Acquisition of Solexa.....II-58
1$100
   RheoGene Plans Merger with Intrexon.....II-59
Covalon Acquires Gene Therapy Technology from Perfusion.....II-59
Inovio Takes Over DNA Expression and Delivery Assets of Valentis.....II-59
Mologen Inks Agreement with ONCO.....II-59
1$100
   Aida Acquires Controlling Stake in Qiaer.....II-60
Neurologix Inks Licensing Agreement with Diamyd Medical’s Subsidiary.....II-60
Takara Inks Collaboration Agreement with Chinese Center for Disease Control.....II-60
JDRF Collaborates with Genzyme Corp and AGTC.....II-60
1$100
   Galapagos Collaborates with Arthrogen.....II-611$100
   AnGes MG, Inc. (Japan).....II-62
BioSante Pharmaceuticals (US).....II-62
1$100
   GenVec (US).....II-631$100
   Oxford BioMedica (UK).....II-64
Shenzhen SiBiono GeneTech Co., Ltd (China).....II-64
Transgene (France).....II-64
1$100
   Vical, Inc. (US).....II-651$100
   Table 7: World Current & Future Market Analysis for Gene Therapy – Annual Sales Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart).....II-661$350
    
 
 


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