Volume 6.11 | Mar 7

Volume 6.11, March 7, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Superior Growth and Differentiation of Embryonic Stem Cells on 3-Dimensional Bio-Scaffold Reported in Tissue Engineering
Article

Story: FDA Suspends Gene Therapy Experiments
Article

Science


Novel HIV Gene Therapy Yields Exciting Results in Phase I Clinical Trial

Article

Scientists Find Key to Producing Cancer-killing Cells
A team of South Korean scientists say they have found a way to produce the human body’s own cancer-killing cells through gene therapy, offering new hope to cancer sufferers.
Article

The Best Muscle Gene Therapy of All?
Researchers have identified the optimal means of delivering therapeutic genes to muscle tissues with a single intravenous injection.
Article

Johns Hopkins Researchers Find that “Smart” Immune Cells Kill More Cancer
Article

Researchers Using Stem Cells To Make Insulin
Cells From cadavers could make insulin-producing cells
Article

Closing in on a Vaccine for Breast Cancer
Clinical trials could begin soon
Article

ABSTRACT, REVIEWS, & SPECIAL REPORTS

Embryonic Stem Cells: Differentiation into Cardiomyocytes and Potential for Heart Repair and Regeneration
Abstract

Engineering High Affinity Superantigens by Phage Display
Abstract

Optimising Gene Therapy of Hypoparathyroidism with Hematopoietic Stem Cells
Abstract

Skeletal Myoblast for Cell Therapy
Abstract

Policy

Hall Tapped to Be California Stem Cell Chief
Article

New York Seeking $100M for Stem Cells
Despite concerns about cloning, research getting bipartisan support from lawmakers who don’t want NY falling behind in biotech race
Article

Business

BUSINESS NEWS

Avidex Technology Yields Novel Immunotherapeutic Protein Platform
Key data on phage display engineering of mTCRs published in Nature Biotechnology.
Article

Bio-Matrix Scientific Group in Contract Negotiations with Engineering Firm for Product Development and Manufacturing of Its Stem Cell Instruments
Article

Cord Blood Registry Files Suit Against ViaCell and Viacord for False and Misleading Advertising
Article

Genzyme Begins Phase II Gene Transfer Trial for Peripheral Arterial Disease
Article

Geron and Hong Kong’s Biotechnology Research Corporation Form Strategic Alliance for Telomerase Activation Therapies
Article

Geron Announces Publication of Phase 1-2 Telomerase Vaccine Study Results in Patients With Metastatic Prostate Cancer
Article

StemCells, Inc. Names Alan Jacobs Chief Medical Officer and Vice President of Clinical Research, Neural Program
Article

Cook, CorMatrix Announce Agreement for Engineered Tissue Products
Article

The Immune Response Corporation Announces New Phase II NeuroVax Study; NeuroVax Data Support Additional Research on Promising Therapy
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, including order forms, please 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

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


NIH/NHLBI-Funded PACT Group Announces Several Initiatives in Advancement of Cell Therapy Product Development

Link

PACT to Host Free Internet Seminar Series on Issues in Cell Therapy Product Manufacturing
First seminar scheduled for March 31, 2005 at Noon EST.
Link

NCI Creates Gene Expression Database of Normal Human Organ Tissue
Link

NIH Guide for Grants and Contracts – Week Of March 4, 2005
Link


NOTICES

Delays in Grant Application Submission due to Recent Severe Winter Weather
Link

Request for Proposal NIH-NIDDK-O5-04 Preclinical Study of Efficacy in Animal Models of Diabetic Complications
Link

Request for Proposal NIH-NIDDK-O5-05 Preclinical Study of Efficacy in Animal Models of Type 1 Diabetes
Link

REQUEST FOR APPLICATIONS

Beta Cell Regeneration for Diabetes Therapy
Link

NICHD Cooperative Multicenter Neonatal Research Network
Link

Summer Institute Program to Increase Diversity in Health-Related Research
Link

Innovative Technologies for Engineering Small Blood Vessels
Link

PROGRAM ANNOUNCEMENTS

Lung Response to Inhaled Highly Toxic Chemicals
Link

Correlative Studies with Specimens from Multi-Site Trials
Link

Solicitation of Assays for High Throughput Screening (HTS) in the Molecular Libraries Screening Centers Network (MLSCN)
Link

Aging Research Dissertation Awards to Increase Diversity
Link

Collaborations with National Centers for Biomedical Computing
Link

CBER

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


Substantially Equivalent 510(k) Device – Magellan Autologous Platelet Separator System – (Medtronic Sofamor Danek)
Link

FDA and the New Paradigm for Tissue Regulation Workshop (Slides)
Link

Human Cell, Tissues and Cellular and Tissue-Based Products (HCT/P) List of Registered Establishments
Link

Substantially Equivalent 510(k) Device – BBCS Lab Interface Application (BBCS Lab) 5.0L – (Blood Bank Computer Systems, Inc)
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

21 CFR Part 803 Medical Devices; Medical Device Reporting; Companion to Direct Final Rule
Link

Blood Products Advisory Committee; Notice of Meeting
Link

Blood Products Advisory Committee; Briefing Information for the 03/17/05 meeting
Link

Blood Products Advisory Committee;Briefing Information for the 03/18/05 meeting
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:

April 6-7 4th Annual Biological Production Forum: Europe’s only event dedicated to biomanufacturing excellence. Edinburgh, UK

June 1 – 4 REGENERATE 2005. Atlanta, Georgia

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 
Rockville, MD (Center for Biologics Evaluation and Research)

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

Director of Research Programs NEW!
Toronto, Ontario (Ontario Genomics Institute)

Faculty Positions in Stem Cell Research NEW!
Ottawa, Ontario (Ottawa Health Research Institute)

Lead Quality Assessor NEW!
Bethesda, MD (AABB)

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

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

Post Doctoral or Engineer Positions NEW!
Toronto, Ontario (Centre for Computational Biology Hospital for Sick Children)

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)

Regulatory Information Specialist NEW!
Rockville, MD (Center for Biologics Evaluation and Research)

Senior Scientist NEW!
Brussels, Belgium (Beta-Cell NV)

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

ISCT ACQUIRES NEW JOURNAL TO MERGE WITH CYTOTHERAPY
Cytotherapy now incorporates Cytokines, Cellular and Molecular Therapy Journal
 

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



Current Volume
:Volume 7, Number 1 / March 2005

Table of Contents

Two journals merge  
  
A tribute to David W Golde   
  
BM stem cells and cardiac repair: where do we stand in 2004?  
   
Natural killer cell-based immunotherapeutic strategies  

IL-15: targeting CD8+ T cells for immunotherapy   
  
Mesenchymal stem cells: progress toward promise 
  
Cost-effective manufacture of an allogeneic GM-CSF-secreting breast tumor vaccine in an academic cGMP facility  pp. 46 – 56 
  
Wilms’ tumor 1 (WT1) gene in hematopoiesis: a surrogate marker of cell proliferation as a possible mechanism of action?  pp. 57 – 61 
     
B-cell expansion in the presence of the novel 293-CD40L-sCD40L cell line allows the generation of large numbers of efficient xenoantigen-free APC 
    
Implantation of genetically manipulated BM cells for cardiac repair   
 
Abstracts from the 4th Annual Conference on Mesenchymal and Non-Hematopoietic Stem Cells: Focus on Adult Stem Cells    

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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