Cell Therapy News Volume 6.10 | Feb 28 2005

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    Volume 6.10, February 28, 2005
         In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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    Top Stories

    Story: Gene Therapy Transforms Dead Bone to Living Tissue
    Article

    Story: CryoLife Announces First Implant of Cryopreserved Osteoarticular Allograft
    Article

    Science

    Antibody That Neutralizes Most HIV Strains Described By Scripps Scientists 
    A group of scientists from The Scripps Research Institute and several other institutions has solved the structure of a rare human antibody that broadly neutralizes human immunodeficiency virus (HIV), which causes acquired immunodeficiency syndrome (AIDS). 
    Article

    Vaccine May Complement Conventional Treatment For Chronic Leukaemia
    A vaccine that boosts the immune response could improve the effect of conventional treatment for patients with chronic myeloid leukaemia (CML).
    Article

    Protein Promoting Stem Cell Survival Might Be Key to Poor Leukemia Prognosis
    Article

    University of California Team Discovers Specialized, Rare Heart Stem Cells In Newborns
    Article

    Stem Cell Research May Be Boon to Fertility Clinics
    Insight gleaned in lab could help couples conceive.
    Article

    Stem Cells Hint at ‘Pangenes’
    Scientists at the University of Pennsylvania School of Medicine say adult stem cells found in one’s skin may provide clues to a new class of gene.
    Article

    Adult Stem Cells Repair Damage Caused by Deadly Parasites
    Article

    New Bone Marrow Model Could Help People with Sickle Cell Disease
    Article

    Nerve Factor Infusion Improves Parkinson’s Disease
    Article

    Crushed Optic Nerve Made to Regrow
    Article

    Biochemical Marker Aids Prognosis in Liver Transplant Patients
    A new study on whether the model used to identify patients most in need of a liver transplant can be improved upon found that measuring serum sodium in potential transplant patients helps to better predict those with a poor prognosis.
    Article

    Source of Molecular Triggers in Cutaneous T Cell Lymphoma Identified
    Article

    ABSTRACT, REVIEWS, & SPECIAL REPORTS

    Human Embryonic Stem Cells Maintained in the Absence of Mouse Embryonic Fibroblasts or Conditioned Media are Capable of Hematopoietic Development.
    Abstract

    Characterization of Cord Blood Natural Killer Cells: Implications for Transplantation and Neonatal Infections.
    Abstract

    Safety of Long-term Interruption of Successful Antiretroviral Therapy: The ATHENA Cohort Study.
    Abstract

    Policy

    UN Still Deeply Divided on Cloning Declaration
    Article


    Chinese Medical Research on Stem Cells to Continue

    Article

    Business

    BUSINESS NEWS

    Miltenyi Obtains CE Mark for Four New Reagents to Be Used with the CliniMACS® Cell Separation System
    Article

    Geron Wins Favorable Final Judgment In Third Nuclear Transfer Patent Interference
    Article

    Genmab’s HuMax-CD4â„¢ Continues to Show Long Lasting Responses in T-cell Lymphoma Patients
    Article

    Genentech Says Study Shows Positive Results in Plaque Psoriasis Patients
    Article

    Benitec Announces NIH Funded AIDS Collaboration
    Article

    Chemicon International, Inc. Expands Stem Cell Franchise Through Acquisition of Specialty Media
    Article

    Chromos & Apptec Announce Strategic Alliance to Provide Integrated Services for Biopharmaceutical Manufacturing
    Article

    Halozyme Therapeutics Signs Commercial Manufacturing Agreement With Avid Bioservices
    Article

    Millennium Announces Promising Findings from Novel Antibody-Chemotherapeutic MLN2704 Prostate Cancer Clinical Trial
    Article

    Sirna Therapeutics Granted Two UK Patents on its RNAi Technology
    Article

    Targeted Genetics Reports Preliminary Safety Data From HIV Vaccine Trial
    Article

    MARKET REPORTS

    Malachite Management has joined forces with established and reputable authors and publishers to bring you the following market reports outlining the very latest in Cell Therapy, Gene Therapy, and Immunotherapeutic Approaches to Cancer. 

    “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 and to order see:

    Cell Therapy Report Summary
    Cell Therapy Sample Chapter
    Cell Therapy Table of Contents Vol. 1 Vol. 2
    Cell Therapy Order Form

    “Gene Therapy – Technologies, Markets, and Companies” is over 500 pages of the basic technologies, clinical applications, market analysis, and company profiles related to the gene therapy industry worldwide.
    For more information, including order forms, please see:

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

    The Immunotherapy Reports cover the most recent developments in the immunotherapeutic approaches to cancer.

    A Shift in Cancer Immunotherapy Strategies?
    Immunotherapy Strategies Executive Summary
    Immunotherapy Strategies Table of Contents

    Future Perspectives in Cancer Immunotherapy
    Future Perspectives Executive Summary
    Future Perspectives Table of Contents

    Immunotherapy Reports Order Form

    NIH


    NATIONAL INSTITUTES OF HEALTHNIH Guide for Grants and Contracts
    – Week Of February 25, 2005
    Link

    Guidance on Prompt Reporting to OLAW under the PHS Policy on Humane Care and Use of Laboratory Animals
    Link

    NIA Intervention Testing Program Solicits Proposals for Compounds to Test for Anti-Aging Activity in Mice
    Link

    NIMH Areas of Interest for the Ruth L. Kirschstein Institutional National Research Service Award (T32)
    Link

    Requests for Applications

    Training in Genomics and Hemoglobinopathies
    Link

    Program Announcements

    Targeting Diseases Caused by Protein Misfolding or Misprocessing
    Link

    CBER

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

    Recall of Additional Lot of Leukocyte Reduction BPF4 High Efficiency Filter – Pall Medical Corp
    Link

    510k Summary: ACCURUN 803 Nucleic Acid Negative Quality Control (HIV, HCV, HBV)
    Link

    510k Summary: wBlood Care 1.0 – (Care Fusion, Inc)
    Link

    510k Summary: Trima Automated Blood Component Collection System- Blood Component Sampling Accessary – (Gambro BCT, Inc)
    Link

    510k Summary: Blood Bank Control System (BBCS) 5.0 – (Blood Bank Computer Systems, Inc)
    Link

    510k Summary: Misys Laboratory Blood Bank and Blood Donor 6.0.1– (Misys Healthcare Systems)
    Link

    510k Summary: ACCURUN 315 HIV-1 RNA Positive Control – (Boston Biomedica, Inc)
    Link

    510k Summary: stemCXP System for the FC 500 with CXP Software – (Beckman Coulter, Inc)
    Link

    Deciding When to Submit a 510(k) for a Change to an Existing Device: Manual of Standard Operating Procedures and Policies
    Link

    Scientific Considerations Related to Developing Follow-On Protein Products:Public Workshop
    Link

    Manual of Standard Operating Procedures and Policies – Required Biocompatibility Training and Toxicology Profiles for Evaluation of Medical Devices
    Link

    Regulatory

    For Country-Specific & International Regulatory Resources, Including Regulatory Agencies Such As the FDA, EMEA, & More Please Visit The Regulatory Page

    NEWS & UPDATES

    UNITED STATES

    FDA

    Cellular, Tissue and Gene Therapies Advisory Committee (formerly the Biological Response Modifiers Advisory Committee); Notice of Meeting
    Link

    Cellular, Tissue and Gene Therapies Advisory Committee (formerly the Biological Response Modifiers Advisory Committee); March 4, 2005 Draft Agenda
    Link

    Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens From Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products: Guidance for Industry
    Link

    Manufacturing Biological Drug Substances, Intermediates, or Products Using Spore-Forming Microorganisms: Draft Guidance for Industry
    Link

    Meetings

    To View an Up-to-Date List of Cell Therapy-Related Meetings, Please Visit Our Meetings Page

    This Week’s Newest Meetings Include:

    Mar. 30 Global Issues in the Commercialization of Tissue Engineering. Webcast

    May 22-27 WilBio – Europe: Process Development and Production Issues for Cell Derived Products. Amsterdam, The Netherlands

    Oct. 1-3 Epithelial Mesenchymal Transition (EMT) Conference. Vancouver, BC 

    Journals

    To View a List of Cell Therapy-Related Journals Please Visit Our Journals Page

    Careers

    JOB POSTINGS IN CELL THERAPY NEWS ARE FREE!
    For information on posting an opportunity email: info@connexoncreative.com

    Acting President
    San Diego, California (California Institute of Regenerative Medicine)

    Cellular Production Lead Technician
    Seattle, WA (Fred Hutchinson Cancer Research Center)

    Director of Biostatistics & Epidemiology NEW!
    Rockville, MD (Center for Biologics Evaluation and Research)

    Director of Cell Therapy
    New York, NY (New York Blood Center)

    Microbiologist NEW!
    Rockville, MD (Center for Biologics Evaluation and Research)

    Post Doctoral Fellow (enter Requisition Code 0408577)
    Somerville, New Jersey (Ethicon)

    Principal/Senior Scientist (enter Requisition Code 0408581)
    Somerville, New Jersey (Ethicon)

    Product Manager (Immunology)
    Vancouver, BC (StemCell Technologies)

    Project Manager (Research & Development) 
    Vancouver, BC (StemCell Technologies)

    Scientist (enter Requisition Code 0408593)
    Somerville, New Jersey (Ethicon)

    Stem Cell Specialist
    Philadelphia, PA (Children’s Hospital of Philadelphia)

    Quality Control Technologist
     Vancouver, BC (StemCell Technologies)

    ISCT


    International Society for Cellular Therapy
    www.celltherapy.org

    International Society for Cellular Therapy Facility Sanitization Survey
    The Facility Sanitization Working Group (organized by the ISCT) has created a survey to assess the current cleaning practices from a wide range of cellular therapy practitioners.The results from this survey will help the working group draft guidelines that strike the appropriate balance between regulatory compliance, product safety and relevance to our varied constituents.

    Upcoming Meetings & Conferences:

    2005 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 University) & 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

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

    Interested in Advertising in Cytotherapy?
    For more information and advertising rates, Visit: http://www.celltherapy.org/journalrates.htm

    Current Volume: Volume 6 Number 6/December 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 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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