Volume 6.10 | Feb 28

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-CD4™ 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: [email protected]

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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