Volume 6.03 | Jan 10

Volume 6.3, January 10, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Amgen Named Company of the Year by Forbes

Story: Cell Therapy for Cardiovascular Disease: What Cells, What diseases and for Whom?


Nanoparticles Could Improve Gene Therapy

Israeli Researchers Develop Vaccine that Enables Recovery of AIDS Patients’ Immune System

Stem Cell Therapy For Ailing Hearts

Stem Cells from Umbilical Cord Treat Heart Attack

Animal Studies Show Stem Cells Might Make Biological Pacemaker

Stem Cells Help Paralyzed Rats Walk

Gene-tweaked Stem Cells Enlisted to Battle Cystic Fibrosis
People’s own cells could be used for treatment
Article 1 , Article 2

Transplantation Of Monkey Embryonic Stem Cells Reverses Parkinson Disease In Primates

Stem Cells Could Reveal Secrets of Illness in Later Life

No Blind Mice, Thanks to UF Scientists

Stem Cells Transplanted to Female Fetus
Article 1 , Article 2

Pioneer Stem Cell Therapy Could Save Thousands of Heavy Drinkers Waiting for Transplants

New Method May Overcome the Shortages of Donated Blood
Article 1, Article 2

Researchers Find ‘Switch’ that Regulates Stem Cells’ Self-renewal & Differentiation
Article 1, Article 2

Researchers Discover a Stem-Cell Switch Lurking Within Leukemias

Human Cloning — The Science and Ethics of Nuclear Transplantation

Altered Nuclear Transfer in Stem-Cell Research — A Flawed Proposal

Stem Cell Panel Expects to Award Grants

Is Heaven Populated Chiefly by the Souls of Embryos?
Harvesting stem cells without tears

Harvard Biologists Criticize Compromise Plan for Stem Cells Use

Stem Cell Method May Cheat Death 

UCSD Discovery Shows How Embryonic Stem Cells Perform ‘Quality Control’ Inspections

Stem Cells Use Inflammatory Signals to Find Injured Tissue

Neural Crest Stem Cells In Skin Could Provide Alternative To Embryonic Stem Cell Use

Improved Procedure Gives Superior Results for Stem Cell Transplants
Article 1 , Artcle 2

Stem Cell Lung Therapy Progress

Fundamental Finding Yields Insight into Stem Cells, Cancer; Opens Door to Drug Discovery

Old T Cells Cripple Immune Function In The Elderly

‘Hijacked’ Immune System’s Machinery Generates Large Varieties of Mutant Genes, Resulting in Proteins with New Properties

Novel Cellular Pathway Increases Sensitivity of Body’s Immune Detectives

Surgeon/Immunologist Looks For Better Ways To Protect Transplanted Organs

UNC Scientists Develop Promising New Assay for Studying Cancer-causing Breaks in DNA

‘Dolly’ Scientists May Clone Human Embryos


Design Principle of Gene Expression Used by Human Stem Cells: Implication for Pluripotency

Gene-mediated Restoration of Cartilage Matrix by Combination Insulin-like Growth Factor-I/interleukin-1 Receptor Antagonist Therapy

Gene Therapy Progress and Prospects: Gene Therapy for Diabetes Mellitus

Generation of Purified Oligodendrocyte Progenitors from Embryonic Stem Cells

Mechanisms of Hair Graying: Incomplete Melanocyte Stem Cell Maintenance in the Niche.

Multidrug Resistance-1 (MDR-1): A New Target for T Cell-based Immunotherapy

Turning on Stem Cell Cardiogenesis with Extremely Low Frequency Magnetic Fields


South Korea to Allow Human Embryo Stem Cell Research Next Year

Britain Opens National Stem-Cell Bank



New California Stem Cell Agency Under Fire

Isonics Begins Supplying Rare Cancer-Fighting Isotope to National Institutes of Health

Agilent Technologies Announces Breakthrough for Cancer Researchers Studying Chromosomal Changes

Amgen’s Kevin Sharer Named CEO Of The Year By IndustryWeek.com

Biotech Investors: Mark Your 2005 Calendars

Canadian Government Opens the Window on Biotechnology

Cel-Sci Files Phase III Clinical Application with FDA For Their Immunotherapy Drug, Multikine

Geron Corporation Receives U.S. Patent For Differentiating Human Embryonic Stem Cells Into Neural Cells

Genmab A/S And Medarex Announce Positive Safety And Efficacy Data In Phase I/II Trial With Monoclonal Antibody Humax-Inflam/MDX-018

Imclone Commences Patient Treatment in U.S. Phase I Trial of IMC-1121B

ImmunoGen Announces Departure of Chief Financial Officer

Immunomedics’ Epratuzumab On FDA Fast Track For Lupus Therapy

Introgen Announces New Clinical Data for ADVEXIN and Submits Request to Food and Drug Administration for Initiation of Accelerated Approval Biologics License Application

Osiris Therapeutics, Inc. Strengthens Executive Team: Cary Claiborne named Chief Financial Officer.  Harry Carmitchel named Chief Operating Officer

Oxbow Files a 510(k) Submission with the FDA for its M2000A Blood Processing Device

Oxford Biomedica Enters Into Agreement With Biogen Idec

Roche Renews Internal Research License for Patented Gene Targeting Technology from Lexicon Genetics

Sigma Introduces New Whole Genome Amplification Kit

Senetek Announces Positive Results from Intitial Preclinical Testing of Zeatin & Other News Compounds Representing New Cytokinin Classes

StemCells Files IND for Human Neural Stem Cell Transplant Treatment for Batten Disease

Targeted Genetics and Celladon Announce Collaboration to Develop Adeno Associated Virus (AAV)-based Gene Therapies for Congestive Heart Failure

ViaCell Sets IPO At 7.5 Million Shares


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
Cell Therapy Order Form

“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 and to order 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 Stategies?
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 Implementation of Office for Human Research Protections (OHRP) Guidance on Research Involving Coded Private Information or Biological Specimens

National Institutes of Health

Centers for Medical Countermeasures Against Radiation – Addendum to RFA-AI-04-045
National Institute of Allergy and Infectious Diseases

Requests for Applications

Molecular Screening Assay Development for SCD (RFA-HG-05-001)
National Human Genome Research Institute,National Heart, Lung, and Blood Institute
Application Receipt Date(s): April 26, 2005

Critical Issues in Post-phlebitic Syndrome(RFA-HL-05-014)
National Heart, Lung, and Blood Institute
Application Receipt Date(s): May 24, 2005


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

Establishing a Docket for the Development of Plasma Standards Public Workshop; Notice
Posted: 1/3/2005, Publish Date: 1/3/2005

Guidance for Industry: Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing User Fees
Posted: 1/3/2005, Publish Date: 1/3/2005

Biological Products; Bacterial Vaccines and Toxoids; Implementation of Efficacy Review; Withdrawal; Final Rule and Proposed Rule
Posted: 12/29/2004, Publish Date: 12/29/2004

Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis – Update
Posted: 12/22/2004

ICH Guidance for Industry: M-4: CTD — Efficacy: Questions and Answers (Revision 3)
Posted: 12/22/2004

ICH Guidance for Industry: M4: The CTD — General: Questions and Answers (Revision 3)
Posted: 12/22/2004

Gene Therapy: State of the Art – Conference
Posted: 12/22/2004, Conference Dates: 4/25-26/2005

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update
Posted: 12/22/2004

Variances for Collection of Blood and Blood Products from Patients with Hemochromatosis – Update
Posted: 12/22/2004

Substantially Equivalent 510(k) Device – Haemonetics Model 215 Automated Glycerolization/Deglycerolization – Haemonetics Corp
Posted: 12/22/2004, Clearance Date: 12/21/2004

Extension of Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection Systems (Haemonetics Corp) – Update
Posted: 12/20/2004, Notification Date: 10/18/2004


For Country-Specific & International Regulatory Resources, Including Links to Regulatory Agencies Such as the FDA, EMEA, & More Click Here



Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Third-Party Review Under the Food and Drug Administration Modernization Act, Third-Party Premarket Submission Review, and Quality System Inspections Under the United States/European Community Mutual Recognition Agreement

Annual Comprehensive List of Guidance Documents at the Food and Drug Administration



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


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. 20-22 Stem Cell Transplantation in Children: Current Results and Controversies. Scottsdale, Arizona

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

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

Jan. 24 Overview of Staged Implementation of GMP During Biological/Biotechnological Product Development. Alexandria, VA

Jan. 25 Current Best Practices in Purification Development & Validation. Alexandria, VA

Jan. 26 Best Practices in Analytical Test Method Validation. Alexandria, VA

Jan. 27 Best Practices in Commissioning cGMP Laboratory Equipment. Alexandria, VA

Jan 27-28 Cytokines & Inflammation. San Francisco, California

Jan.28 Operational Factors for Improved Laboratory Quality and Compliance. Alexandria, VA 

Jan. 31 Establishing Realistic Process and Test Method Specifications. Alexandria, VAFEBRUARY
Feb 1-3 FDA and the New Paradigm for Tissue Regulation Conference. Dallas, Texas

Feb. 1-4 International Congress on Anti-Cancer Treatment. Paris, France

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

Feb. 3 Key Issues in Formulation Development for Biotechnology Products. Alexandria, VA

Feb. 4 Auditing In-House and Contract Labs for CMC Development Studies and GLP/GMP Compliance. Alexandria, VA

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 5th Human Islet Isolation and Transplantation Techniques Training. Banff, Alberta, Canada

Mar. 20–23  European Group for Blood & Marrow Transplantation 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. 6-8 Preservation of Cells, Tissues, and Gametes. University of Minnesota

Apr. 11-12 Stem Cells Research & Therapeutics. San Diego, California

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
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, 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 11-14 International Symposium on Technological Innovations in Laboratory Hematology (ISLH). San Francisco, California, USA

May 12-16 5th Annual Conference of the Federation of Clinical Immunology Societies (FOCIS). Boston, Massachusetts

May 14-16 American Society of Pediatric Hematology/Oncology (ASPH/O) 18th Annual Meeting. Washington, D.C.

May 14-17 American Society of Clinical Oncology (ASCO). Orlando, FL, USA

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

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

May 20-25 American Society of Transplantation (AST) American Transplant Congress. Seattle, Washington

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 2-5  European Hematology Association Meeting. Stockholm, Sweden

June 3-4 3rd Annual International Umbilical Cord Blood Transplant Symposium.Los Angeles, California

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).

Jul.30- Aug 2 International Society for Experimental Hematology Tradition Meets Innovation 34th Annual Scientific Meeting.Glasgow, Scotland 

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. 


 cGMP in the Transfusion Service. An online training course.

NIH and other Stem Cell Training Courses

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

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 transplantation


To View a List of Cell Therapy-Related Journals Click Here

For information on posting an opportunity email: [email protected]


Business Development Associate
Vancouver, BC (StemCell Technologies)

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)

Bethesda, MD (CBER)

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

Consumer Safety Officer (Biological Drug & Device Compliance Branch)
Rockville, MD. (CBER)

Director of Cellular Therapies
Baltimore, Maryland (AABB)

Director of Oncology/Hematology Medical Communications 
New Jersey (Confidential)

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

Marketing Assistant NEW!
Vancouver, BC (StemCell Technologies)

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

Post Doctoral Fellow (enter Requisition Code 0408577) NEW!
Somerville, New Jersey (Ethicon) 
Principal/Senior Scientist (enter Requisition Code 0408581) NEW!
Somerville, New Jersey (Ethicon)  

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

Quality Manager
Dublin Ireland (St. James Hospital)

Regulatory Information Specialist (Office of Biostatistics and Epidemiology)
Montgomery County, MD (CBER)

Regulatory Information Specialist (Division of Viral Products)
Montgomery County, MD (CBER)

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

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


International Society for Cellular Therapy

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

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 University) & John McMannis, PhD (MD Anderson Cancer Center)

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

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

Profiled Journal

Read Cytotherapy in 2005.  Join ISCT ($130) and receive the journal as a benefit of membership

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

This issue contains the following:

Are stem cells and T cells best transplanted separately? 
Transplantation of allogeneic CD34+-selected cells followed by early T-cell add-backs: favorable results in acute and chronic myeloid leukemia   

Isolation and characterization of mesenchymal progenitor cells from chorionic villi of human placenta  
GMP production and testing of Xcellerated T CellsT for the treatment of patients with CLL
Clinical-grade manufacturing of DC from CD14+ precursors: experience from phase I clinical trials in CML and malignant melanoma 
Peripheral blood and BM CD34+ CD38- cells show better resistance to cryopreservation than CD34+ CD38+ cells in autologous stem cell transplantation  

Stem and progenitor cell therapies: insights from non-human primate models 

Factors affecting engraftment of allogeneic hematopoietic stem cells after reduced-intensity conditioning 
The transition from bench to bedside: lessons learned in the creation of a new T-cell product for the clinic 
Mesenchymal stem cell-based cartilage tissue engineering: cells, scaffold and biology 
Cardiovascular potential of BM-derived stem and progenitor cells

Delivery and tracking of therapeutic cell preparations for clinical cardiovascular applications 
Using stem cells in multiple sclerosis therapies 

Methods for magnetically labeling stem and other cells for detection by in vivo magnetic resonance imaging 

Innovation meets quality: moving cellular therapies at the National Institutes for Health from bench to bedside 

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.

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