Cell Therapy News Volume 5.09 | Nov 29 2004

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    Cell Therapy News 5.9, November 29, 2004
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Story: Stem Cell Therapy Helps South Korean Patient Walk Again
    Article

    Story: Scientists Generate Human Islet Precursor Cells in Culture from Cadaveric Insulin-Producing Cells
    Article

    Science

    Biological Tools and Cloning Technology to Create Powerful Embryonic-type Stem Cells Without Creating an Embryo
    Article

      

    First Monoclonal Antibody Treatment For MS Approved
    Article

    Stem Cells Can Repair Your Decaying Teeth
    Article

    Skeletal Muscle Cells Could Be Source Of Stem Cells For Regenerating Nerve Tissue
    Article

    Stem Cells’ Repair Skills Might Be Link To Cancer
    Article

    UCI Researchers Use Human Embryonic Stem Cells to Aid Spinal Cord Injury Repair
    Article 1, Article 2

    Tissue Engineered Blood Vessels Have Potential for Use in Heart Bypass Surgery
    Article

    Protein Stops Heart Attack Damage
    Article

    Detecting the Genes That Contribute to Transplant Rejection
    Article

    Umbilical Cord Blood Can Help Treat Adults with Leukemia: Studies
    Article

    Leukamia Drug Under the Microscope
    Article

    Arsenic Trioxide and Pixantrone Highlighted in 42 Abstracts and Presentations at The American Society of Hematology Meeting
    Article

    Cytogen Announces Publication of Novel Protein Pathway Linked to Aggressive Progression of Breast Cancer
    Article

    New Protein Structure May Aid In Design Of Therapeutics For Autoimmune Disease
    Article

    Impaired Thinking After Stem Cell Therapy Temporary
    Article

    Largest Newborn Stem Cell Bank Welcomes FDA Regulation in Fast-Growing Industry
    Article

    ABSTRACTS, REVIEWS & SPECIAL REPORTS

    Epithelial-to-Mesenchymal Transition Generates Proliferative Human Islet Precursor Cells
    Abstract

    In Vivo Tracking of Stem Cells for Clinical Trials in Cardiovascular Disease
    Abstract

    Risks and Methods for Peripheral Blood Progenitor Cell Collection in Small Children
    Abstract

    Expression of Notch1 Gene in the Differentiation of the Human Embryonic Neural Stem Cells to Neurons
    Abstract

    Mismatched Hematopoietic Stem Cell Transplantation using GIAC Protocol: Report of 100 Cases
    Abstract

    Direct Effects of Interleukin-6 on Liver Progenitor Oval Cells in Culture
    Abstract

    Can the Injection of the Patients Own Bone Marrow-derived Stem Cells Preserve Cone Vision in Retinitis Pigmentosa and Other Diseases of the Eye?
    Abstract

    Encapsulation of Biologics in Self-assembled Fibers as Biostructural Units for Tissue Engineering
    Abstract

    Exploiting Dendritic Cells for Cancer Immunotherapy: Genetic Modification of Dendritic Cells
    Abstract

    Growth Factor Displayed on the Surface of Retroviral Particles without Manipulation of Envelope Proteins is Biologically Active and Can Enhance Transduction
    Abstract

    Lead and Follow: The Dance of the Dendritic Cell and T Cell
    Abstract

    Neurally Selected Embryonic Stem Cells Induce Tumor Formation after Long-Term Survival following Engraftment into the Subretinal Space
    Abstract

    Therapeutic Use of Stem Cells II. Adult Stem cells
    Abstract

    Policy

    Student Society for Stem Cell Research: Global Petition to the UN for Stem Cell Research
    Petition

    UN Proposes Cloning Compromise
    Article


    Australian Stem Cell Policy Change
    Article

    State Stem Cell Funding Proposed in Illinois
    Article

    Business

    BUSINESS NEWS

    Amgen Published Head-to-Head Data Show Aranesp Dosed Every Two Weeks is Comparable to Epoetin Alfa Dosed Once-a-Week
    Article

    Abgenix to Receive Milestone Payment from CuraGen for Advancement of CR002 Antibody Product Candidate into Clinic
    Article

    Antisoma AGM update: AS1404 lung cancer trial on track; ovarian and prostate studies confirmed Lead candidate for trials selected from TTA programme
    Article

    BD Releases New Version of BD.ID Patient Identification System for Specimen Management
    Article

    Cambridge Antibody Technology Group and AstraZeneca Announce Major Strategic Alliance To Discover And Develop Human Antibody Therapeutics In Inflammatory Disorders
    Article

    Human Genome Sciences Names H. Thomas Watkins As CEO to Replace Founder William Haseltine 
    Article

    MedImmune and Medarex Announce Collaboration To Develop And Commercialize Fully Human Antibodies For Autoimmune Diseases
    Article

    Roche Diagnostics to Release Diabetic Patient Data Management Software
    Article

    Sanofi-Aventis, CDC Invest 75 mln Eur to Launch Biotech Venture Capital Fund
    Article

    V.I. Technologies Provides An Update On The Development Program For INACTINE(TM) Pathogen Inactivation System For Red Blood Cells; Suspends Phase III Enrollment
    Article

    Vitro/Chemicon Sign Supply Agreement for Vitrocell Products
    Article

    MARKET REPORTS

    Malachite Management has joined forces with an established and reputable author to bring you a report outlining the very latest in the Cell Therapy industry.  “Cell Therapy – Technologies, Markets, and Companies” is over 400 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the cell therapy industry worldwide.
    For more information see:

    Cell Therapy Report Summary
    Cell Therapy Sample Chapter
    Cell Therapy Table of Contents
    Cell Therapy Order Form

    Malachite Management has joined forces with an established and reputable author to bring you a report outlining the very latest in the Gene Therapy industry. 
    “Gene Therapy – Technologies, Markets and Companies” is 560 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the gene therapy industry worldwide.
    For more information see:

    Gene Therapy Report Summary
    Gene Therapy Table of Contents
    Vol. 1
    Vol. 2
    Gene Therapy Order Form

    Malachite Management Inc. has teamed up with an established publisher to bring you the latest reports in immunotherapeutic approaches to cancer.

    A Shift in Cancer Immunotherapy Stategies?
    Immunotherapy Strategies Executive Summary
    Immunotherapy StrategiesTable of Contents

    Future Perspectives in Cancer Immunotherapy
    Future Perspectives Executive Summary
    Future Perspectives Table of Contents
    Immunotherapy Reports Order Form

    NIH


    Pre-Application Meeting for RFA NS-05-005,
    “Centers of Excellence in Translational Human Stem Cell Research”
    (NOT-NS-05-002)
    National Institute of Neurological Disorders and Stroke National Heart, Lung, and Blood Institute National Institute of Diabetes and Digestive and Kidney Diseases
    Link

    HLA Region Genetics in Immune-Mediated Diseases – Addendum to RFA-AI-04-039 
    Link

    CBER

    All new CBER information can be reached from the What’s New page

    Human Cell and Tissue Establishment Registration (HCTERS) Public Query Application
    Posted: 11/26/2004
    Link

    Substantially Equivalent 510(k) Device – wBlood Care 1.0 – Care Fusion, Inc
    Posted: 11/22/2004, Clearance Date: 11/10/2004
    Link

    Regulatory

    NEWS & UPDATES

    UNITED STATES:
    Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products.
    (Agency Information Collection Activities; Announcement of Office of Management and Budget Approval) Docket No. 1997N-0484S, OC 2004287. [PRE-PUB] OMB approval no. 0910-0543 expires May 31, 2007
    Link

    FDA clinical trial statutory and regulatory requirements; public workshop  
    The public workshop is scheduled for Wednesday,  January 12, 2005, from 8:15 a.m. to 4:15 p.m. and Thursday, January 13, 2005, from 8:15 a.m. to 4 p.m
    Link


    CANADA:
    The National Research Council (NRC) is now accepting applications for the 2005 H.L. Holmes Awards
    .
    This award is available to assist Canadian citizens in carrying-out post-doctoral studies in the fields of chemistry, physics, biology or mathematics as they relate to medical and biological processes at outstanding research institutes in Canada or abroad.
    Link


    ASIA
    Singapore Bioethics Advisory Committee Releases Report on Human Tissue Research
    Link

    Singapore Bioethics Advisory Committee Releases Guildines for Research Involving Human Subjects
    Link

    REGULATORY BODIES

    NORTH AMERICA

    The US Food & Drug Agency:
    Home Page
    Current Guidances
    Dockets Management Homepage
    Electronic Freedom of Information 
    Investigations Operations Manual 2004
    Medical Device GMP Reference Information
    Modernization Act of 1997 (FDAMA)

    Canada’s Health Products and Food Branch:
    Homepage
    Biologics and Genetic Therapies
    Biologics and Genetic Therapies Fact Sheet

    EUROPE

    European Agency for the Evaluation of Medicinal Products:
    Homepage
    Gene Therapy Expert Working Group

    The Rules Governing Medicinal Products in the European Union

    European Commission:
    DG Enterprise: Pharmaceuticals and Cosmetics: Human Tissue Engineering

    UNITED KINGDOM

    National Institute for Biological Standards and Control:
    Homepage
    Code of Practice for the Production of Human-derived Therapeutic Products

    ASIA & THE PACIFIC

    Australia:
    Australian Therapeutic Goods Administration
    Australian Research Council
    Australian Stem Cell Centre
    Biotechnology Australia

    Indonesian Ministry of Health
    Homepage

    Japan’s Pharmaceuticals and Medical Devices Evaluation Center:
    Homepage

    Korean Food and Drug Administration:
    Homepage

    New Zealand:
    New Zealand’s Medicines and Medical Devices Safety Authority

    New Zealand Bioethics Council

    People’s Republic of China:
    National Institute for the Control of Pharmaceutical & Biological Products (in Chinese)
    State Drug Administration (in Chinese)
    Ministry of Health (in Chinese)

    Singapore:
    Singapore’s Health Sciences Authority
    Singapore Bioethics Advisory Committee Homepage

    Taiwan’s National Laboratories of Foods and Drugs (in Chinese):
    Homepage

    INDIA

    Central Drug Standard Control Organization:
    Homepage

    INTERNATIONAL

    World Health Organization:
    Quality Assurance and Safety of Medicines

    International Society for Cellular Therapy:
    Legal & Regulatory Affairs Online Resources Center

    International Society for Life Sciences Professionals:
    International Regulatory Information

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH):
    Topics and Guidelines

    Regulatory Affairs Professionals Society:
    Home Page
    Combination Products Resource Page

    The 21CFRPart11.com
    Provides access to information on the rules and also maintains an email list that actively discusses issues and concerns with industry peers and government regulators. 
    Homepage
                                                  

    Meetings

    FEATURED EVENT

    Free CME Program:
    Prophylaxis & Pre-emptive Therapy in Patients at Risk for CMV Infection After Stem Cell Transplant
    This activity has been designated to meet the educational needs of physicians involved in the management of patients undergoing stem cell tranplantation

    MALACHITE’S ONLINE
    CONFERENCE CALENDAR

    For a more complete listing of conferences, see Malachite Management’s new online, interactive
     Cell Therapy Calendar

    CONFERENCES 2004

    Nov. 30 – Dec. 1 FDA Information Management Summit. Bethesda, Md

    Nov. 30-Dec. 3 IBC’s 2nd Annual Antibody Therapeutics.San Diego, California

    Nov. 30-Dec. 3 IBC’s 15th Annual Antibody Engineering. San Diego, California

    Dec. 1 Error Avoidance By Using Electronic Information Systems in Transfusion Medicine. (Part of the Cellular Therapy Audioconference Series)

    Dec. 1-3 Immunogenicity for Protein-Based Therapeutics – Washington, DC

    Dec. 3 Cellular Therapy: Progressing to Clinical Practice?- San Diego Marriott Hotel & Marina, San Diego, CA

    Dec. 3-7  Amer. Society for Hematology: 46th Annual Mtg – San Diego, California – San Diego, CA

    Dec. 4-8  American Society for Cell Biology (ASCB) 44th Annual Meeting. Washington, D.C.

    Dec. 8 Cyberspace: e-Tools for Transfusion Medicine. (Part of the Cellular Therapy Audioconference Series)

    Dec. 9 Negative Results of Clinical Trials: SEC & FDA Ramifications. Palo Alto, California

    Dec. 9-10 EuroConference: Stem cells. Paris, France
     
    Dec. 9-10 DIA/EMEA Workshop on Gene Therapy & Cell Therapy Products.  London, UK. 

    COURSES

     Nov. 29-Dec. 1: Current Good Tissue Practice– Amsterdam, Netherlands

    Nov. 30-Dec. 1: Monitoring Clinical Trials – Malvern, Pa. 

    cGMP in the Transfusion Service. An online training course. Link

    NIH and other stem stem cell training courses – Link


    Weekly – UCSFs Human Embryonic Stem Cell Training Program (3-day training course).  Link

    CONFERENCES 2005

    Jan. 5 Complete Quality Competency.(Part of the Cellular Therapy Audioconference Series)

    Jan. 10-13 CHI’s PepTalk Conference: The Protein Information Week. San Diego, California

    Jan. 17-28, BMRC-EMBO Practical Course on Advanced Optical Methods in Cell and Developmental Biology. Biopolis, Singapore 
    Application deadline: Nov. 15, 2004 (Selected Participants pay only travel costs)

    Jan. 24-26  Phacilitate Cell & Gene Therapy Forum.  Washington DC

    Jan 26 Complications of Blood Donations. (Part of the Cellular Therapy Audioconference Series)

    Feb 1-3 FDA and the New Paradigm for Tissue Regulation Conference. Dallas, Texas

    Feb. 2 Transfusion Service and Blood Center Cooperation in the Management of Serious Transfusion Reactions. (Part of the Cellular Therapy Audioconference Series) 

    Feb.10-15 Molecular Regulation of Stem Cells. Banff, Alberta
     
    Feb. 10-14 Tandem BMT Meetings (Combined ASBMT and IBMTR/ABMTR annual meetings).  Keystone, Colo.

    Feb. 16 Basic Antibody Identification. (Part of the Cellular Therapy Audioconference Series)

    Feb. 23-25: The Clinical Trials Congress – Philadelphia

    Feb. 23 Process Validation/Qualification for Cell Therapy Procedures. ( Part of the Cellular Therapy Audioconference).

    Mar. 2 Introducing the 23rd Edition of Standards for Blood Banks and Transfusion Services. ( Part of the Cellular Therapy Audioconference).

    Mar 3-4 Commercialisation of Stem Cells: Are Stem Cells Commercially Viable? London, UK

    Mar. 4-5 Stem Cell 2005: Progress to Therapy? EICC, Edinburgh, Scotland 

    Mar. 16 Advanced Transfusion Reactions. ( Part of the Cellular Therapy Audioconference).

    Mar. 17-18 3rd International Symposium on Cellular Therapy. Regensburg, Germany

    Mar. 16-20  American Society of Transplantation (AST) and Canadian Society of Transplantation (CST) Annual Winter Symposium. Banff, Canada.

    Mar. 20–23  European Group for Blood & Marrow Transplantion Annual Mtg.  Prague, Czech Republic.

    Mar. 30 Cord Blood Banking and Transplantation: Decision Making for Selection of Cord Blood Units.( Part of the Cellular Therapy Audioconference).

    Apr. 6 Team Approach to Red Blood Cell Exchange.( Part of the Cellular Therapy Audioconference).

    Apr. 11-13 R&D Leaders’ Forum Spring 2005. The Biltmore Hotel, Coral Gables, FL

    Apr. 13 Reimbursement Guide for Blood Products and Services. ( Part of the Cellular Therapy Audioconference).

    Apr. 20 Biology of Stem Cell Mobilization. ( Part of the Cellular Therapy Audioconference).

    Apr. 27-30 American Society for Apheresis 26th Annual Meeting Chicago, IL.  

    May 3-4, Current Good Tissue Practice. Vancouver, BC
    Workshop Chairs: Janice Davis-Sproul, MAS, MT (ASCP) SBB (John Hopkins Univeristy) & John McMannis, PhD (MD Anderson Cancer Center)

    May 3-7.  11th Annual Meeting and Scientific Conference of the International Society for Cellular Therapy (ISCT) Vancouver, Canada.  (combined with Good Tissue Practices Workshop & Flow Cytometry for HSC Transplantation Workshop)

    May 4 West Nile Virus and SARS: Challenges to Transfusion Safety, Then and Now. ( Part of the Cellular Therapy Audioconference).

    May 4-7th, 11th Annual Meeting of the International Society for Cellular Therapy. Vancouver, BC

    May 4-7th, Applications of Flow Cytometry in Marrow and Stem Cell Transplantation. Vancouver, BC

    May 11 Increasing Collections: Three Successful Case Studies ( Part of the Cellular Therapy Audioconference).

    May 18 Leadership and Self-Deception ( Part of the Cellular Therapy Audioconference).

    May 18-20  2nd World Congress on Regenerative Medicine.  Leipzig, Germany. 

    May 23-25 Phacilitate Vaccine Forum Spring 2005.Amsterdam

    June 1 Facility Requirements for a Cell Therapy Laboratory ( Part of the Cellular Therapy Audioconference).

    June 1-5  American Society of Gene Therapy Annual Meeting.  Saint Louis, MO. 

    June 5 Serological Case Studies: They Didn’t Tell Me about This in School.( Part of the Cellular Therapy Audioconference).

    June 22 Two Sides of the Same Coin: Getting the Most from External Assessments.( Part of the Cellular Therapy Audioconference).

    June 23-25  3rd Annual Meeting of the International Society for Stem Cell Research. San Francisco, CA. 

    July 13 Unrelated Donor Hematopoietic Cell Transplantation: The Effect of Hematopoietic Cell Source, Cell Dose and Conditioning Regimen on Recipient Outcome. ( Part of the Cellular Therapy Audioconference).

    July 20 Therapeutic Apheresis in Practice: What’s New? ( Part of the Cellular Therapy Audioconference).

    July 27 My Ideal Donor Center. ( Part of the Cellular Therapy Audioconference).

    Aug. 10 Creative Training Techniques: Stepping Out of the Training Box.( Part of the Cellular Therapy Audioconference).

    Sept. 14 Hematopoietic Progenitor Cell Transplantation: Transfusion Requirements and Immunohematologic Complications. ( Part of the Cellular Therapy Audioconference).

    Sept. 21 Changes in the New AABB Technical Manual. ( Part of the Cellular Therapy Audioconference).

    Sept. 21-25  International Society of Pediatric Oncology Conference.  Vancouver, Canada. 

    Sept/Oct  Second International Epithelial Mesenchymal Transfer Conference.  Vancouver, Canada. 

    Careers

    JOB POSTINGS

    Cell Therapy Laboratory Positions
    Houston, Texas (MD Anderson Cancer Center)

    Cellular Therapy Laboratory Manager
    Seattle, Washington (Seattle Cancer Alliance Center)

    Chief Medical Scientist
    Dublin, Ireland (St. James Hospital)

    Clinical Laboratory Scientist- Cellular Therapies Laboratory
    Cinncinatti, Ohio (Hoxworth Blood Center)

    Director of Cellular Therapies
    Baltimore, Maryland (AABB)

    Manager, Regulatory Affairs- Transplant Production Facility
    Omaha, Nebraska (The Nebraska Medical Center)

    Medical Technologist- Stem Cell Lab
    Salt Lake City, Utah (University of Utah)

    Quality Manager
    Dublin Ireland (St. James Hospital)

    Section Chief Technologists-Stem Cell
    Amman, Jordan (King Hussein Cancer Center)
     
    Senior Scientist, Process Development: TVAX Product
    Menlo Park, California (Geron)

    Technical Writer
    Vancouver, BC (StemCell Technologies)

    CAREER DEVELOPMENT

    University of Cinncinatti Masters of Science in Transfusion and Transplantation Sciences
    Hoxworth Blood Center, through the College of Allied Health Sciences, University of Cincinnati, offers the two year graduate program leading to a Master of Science degree. The graduate program in Transfusion and Transplantation Sciences contains two tracks: Blood Transfusion Medicine and Cellular Therapies.

    ISCT

    International Society for Cellular Therapy 
                     www.celltherapy.org

    ISCT’s Quality Assurance Group launches online discussion board to discuss Quality Management issues via open, honest discussion by experienced, interested parties.

    Advertise in the Telegraft!

    The Telegraft is the Society’s newsletter. It provides the membership with current information on new developments, items of interest, regulatory updates, and contact information. Special issues are also published as required to cover developments of particular importance or interest to the membership
    For more information including advertising rates, Click here

    Upcoming Meetings & Conferences:

    2003-4 Cell Therapy Audioconference Series

    May 3-4, 2005 Current Good Tissue Practice. Vancouver, BC
    Workshop Chairs: Janice Davis-Sproul, MAS, MT (ASCP) SBB (John Hopkins Univeristy) & John McMannis, PhD (MD Anderson Cancer Center)
    Email

    May 4-7th, 2005 11th Annual ISCT Meeting. Vancouver, BC
    Program Themes Include: Tissue Engineering, Mesenchymal Stem Cells, Immunotherapy, & Hematopoietic Stem Cells
    Email

    May 4-7th, 2005 Applications of Flow Cytometry in Marrow and Stem Cell Transplantation. Vancouver, BC
    Email

    Profiled Journal

    Interested in Advertising in Cytotherapy?
    For more information and advertising rates, Click here

    Read Cytotherapy in 2005!  Join ISCT ($130) and receive the journal as a benefit of membership
    http://www.celltherapy.org/mem_app.htm

    The Current Issue is: Volume 6, Number 5 / October 2004

    Cytotherapy publishes original research, reviews, meeting reports, special focus issues and letters in the general field of cell therapy. The scope of the journal includes includes basic and applied research with hematopoietic and non-hematopoietic stem cells , immune cells, and antigen-presenting cells. Therapeutic topics within the scope of Cytotherapy include ex-vivo and in-vivo aspects of gene therapy, immunotherapy, stem cell transplantation and tissue regeneration. Cytotherapy particularly welcomes
    contributions from researchers, clinicians, technicians and individuals involved in regulatory aspects of cell therapy.
    www.cytotherapy.com


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