Volume 6.05 | Jan 25

Volume 6.5, January 25, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Scientists Successfully Grow Human Brain Cells

Story: Stem Cell Gold Rush Spreads Beyond California


Healing Injured Hearts with Adult Stem Cells

Cord Blood Transplantation Now a Viable Option for Adult Leukemia Patients

Spleen Surprise Source Of Stem Cells

Transplanted Saliva Gland Brings Tears to Man’s Eyes

Discovery Moves St. Jude Scientists One Step Closer to a Curing Brittle Bone Disease

Spinal Repair Pioneer Professor Geoffrey Raisman speaks on the Next Steps in Spinal Repair Science

Inflammation Directs Stem Cells To Injured Tissue

Cancer Therapy Targets Stem Cells

Pokemon Gene Controls Cancer Development

Cancer Vaccines: A Two-pronged Attack?

Jump-starting T Cells in Skin Cancer

Penn Researchers Find that Residual Tumor Cells are a Barrier to Targeted Cancer Therapeutics

Melanoma Vaccine Triggers T-Cells to Attack Tumors
New research offers insights into ways immune system fights the disease

T Cell Escape from Thymic Alcatraz

T Cells Target HIV in a Relationship on the Rebound


Anti-interleukin-12 Antibody for Active Crohn’s Disease

Cord Blood Banking

Dendritic Cells and HNSCC: A Potential Treatment 0ption?

Pharmacokinetic Interactions of Immunosuppressive Agents After Organ Transplantation

Isolation and Characterization of Neural Stem Cells from Human Fetal Striatum.


What Are We to Think About Embryonic Stem Cell Research? – Seeking Information and Consensus

3-state ‘Biotech Corridor’ to Promote Stem Cell Research Considered



California’s Developers Target Biotech Startups

Antibodies Derived From Dyax Library Enter Clinical Trials at Imclone Systems

Beckman Coulter, Inc. Names Scott Garrett Chief Executive Officer

Cambrex Licenses Powerful Technologies for Conditionally Immortalized Cells For Use in Drug Discovery

Chromos Announces Completion of Private Placement

Immunomedics Announces Canadian Approval Of Leukoscan

Maxim Reports That Additional Phase 3 Trial of Ceplene Therapy in the Treatment of Acute Myeloid Leukemia Patients in Complete Remission Will Be Required by the FDA

MorphoSys Acquires Biogenesis Group in U.K. and U.S.A.: Positions MorphoSys Within Top 5 of European Research Antibody Suppliers

Seattle Genetics Receives Key U.S. Patents for SGN-40 Program

Sigma-Aldrich Corporation (SIAL) To Acquire JRH Biosciences To Broaden Life Science Capabilities For $370 Million

Stem Cell Therapeutics Wins Patent on Parkinson’s Disease Treatment

The Scientific Advisory Board of TheraVitae Holds Its First Meeting

ViaCell, Inc. Announces Its Initial Public Offering


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 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



Scientists Detect Probable Genetic Cause of Some Parkinson’s Disease Cases



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

Perspectives in Regulating Human Cells and Tissues (Slide Presentation)
Posted: 1/18/2005

Important Information Relating to Recall of Fetal Cell Screening Kit (FETALSCREEN) – Ortho-Clinical Diagnostics
Posted: 1/19/2005

Substantially Equivalent 510(k) Device – Aldecount Progenitor Cell Enumeration Kit – Stemco Biomedical, Inc
Posted: 1/21/2005


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



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


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

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

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

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

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. 28-31 1st ESH-EBMT Euroconference on Biobanking. Dublin, Ireland

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. 1-7 Dendritic Cells at the Centre of Innate & Adaptive Immunity: Eradication of Pathogens & Cancer & Control of Immunopathology. Vancouver, BC

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. 5-10 Cancer & Development. Banff, AB

Feb. 7-11 Compliance Boot Camp 2005: Validation, Quality and Communications Training for FDA Compliance. San Diego, CA

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 17 – 21 AAAS Annual Meeting Washington, DC

Feb. 17-22 Antibody-Based Therapeutics for Cancer. Sante Fe, MN

Feb. 19 Hematopoietic Progenitor Assay Training Course. Vancouver, BC

Feb. 20 Cell Separation Training Course. Vancouver, BC

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

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

Mar. 1-6 Leukocyte Trafficking: Cellular & Molecular Mechanisms. Taos, Mexico

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

Mar. 3-6 Innovative Therapies in Autoimmune Diseases Conference. Washington, DC

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. 7-8 Cancer Progress New York, USA

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

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

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

Mar. 17-25 Tissue Repair and Ulcer/wound Healing: molecular mechanisms,therapeutic targets and future directions. Paris, France

Mar. 19-24 Basic Aspects of Tumor Immunology. Keystone, CO

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. 28- Apr. 3 B Cell Development, Function, & Disease. Steamboat Springs, CO

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

Mar. 31- Apr. 5 International Congress of Physiological Sciences. San Diego, CA

Apr. 2-6 Experimental Biology 2005. San Diego, CA

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. 7-10 Canadian Society for Immunology’s 18th Annual Meeting. Whistler, BC

Apr. 9-16 American Academy of Neurology’s 57th Annual Meeting. Miami Beach, FL

Apr. 11- 13 British Society for Haemotology’s 45th Annual Scientific Meeting. Manchester, UK

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. 14-15 Second Symposium on Gene and Stem Cell Therapy. Valladolid, Spain

Apr. 15- 18 1st ESH-EBMT Eurocord Conference on Stem Cell Research. Cascais, Portugal

Apr. 16-20 96th Annual Meeting of the American Association for Cancer Research. Anaheim, CA

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, Applications of Flow Cytometry in Marrow and Stem Cell Transplantation. Vancouver, BC

May 5-7 European Society for Paediatric Haematology & Immunology. Budapest, Hungary

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 11-15 9th ESH-EMBT Training Course on Blood & Bone Marrow Transplantation. Cascais, Portugal

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 19-20 2nd International Conference on Cytokine Medicine. Manchester, England

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

May 20-21 Frontiers in Human Embryonic Stem Cells Symposium. Pittsburgh, PA

May 23-25 Phacilitate Vaccine Forum Spring 2005.Amsterdam

May 26-30 23rd World Congress of Pathology & Laboratory Medicine. Istanbul, Turkey

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 5-8 Society of In Vitro Biology. Baltimore, MD

June 16-19 1st ESH-EBMT Euroconference on GvHD/Gvl: A Paradigm of Haematopoietic Stem Cell Transplantation. Sesimbra, Portugal

June 19-22 Biotechnology Industry Organization. Philadelphia, PA

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. 

June 25  Hematopoietic Progenitor Assay Training Course. Vancouver, BC

June 26 Cell Separation Training Course. Vancouver, BC

July 2-6 International Society of Blood Transfusion. Athens, Greece

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).

Aug. 21-24 European Congress on Biotechnology. Copenhagen, Denmark


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. 21-24 German Society of Immunology. Kiehl, Germany

Sept.28-Oct. 2 30th World Congress of the International Society of Hematology. Istanbul, Turkey

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

Oct.1-5 German & Austrian Societies of Hematology & Oncology, SGH & SGMO Meeting. Hannover, Germany

Oct. 27-30 2nd ESH-EHA Focus on Paediatric Haematology & Oncology. Sestri Levante, Italy


 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)

Cellular Production Lead Technician NEW!
Seattle, WA

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

Director of Cell Therapy NEW!
 New York, NY

Marketing Assistant 
Vancouver, BC (StemCell Technologies)

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)

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

Stem Cell Specialist NEW!
Philadelphia, PA 


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:

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)

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
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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