Volume 6.04 | Jan 17

Volume 6.4, January 17, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Steady As She Goes: Spinal Cord Patient Erica Nader Makes Progress After Experimental Stem Cell Surgery

Story: Gene Transfer Technique Immunizes Mice from Anthrax Within 12 Hours


Gene Clue to HIV Origin in Humans Has ‘Significant Implications for Gene Therapy to Combat Aids’ 

Gene Vaccine Protects Mice Against Development Of Her2/neu Breast Cancer

Scientists Find Gene that Prevents Regrowth of Hearing Cells
Article 1, Article 2

Stem Cells to Be Used for Brain Injury and Parkinson’s Disease

Unique Presentation of Delirium After Stem Cell Transplantation

A New Stem Cell Transplant Technique Effective for Indians

What is a Stem Cell? The Provocative Debate Strives for a Consensus in Stem Cells and Development

Stem Cells Treat HIV-linked Lymphoma

India Ahead in Stem Cell Research, Say Scientists

Intestinal Immune Cell Network Discovered

Antibody May Salvage Sight
Scientists find way to block retinopathy in mice 

SOCS1 Silencing Dramatically Increases the Anti-cancer Efficacy of Dendritic Cell Vaccines

Researchers Tease Out One Critical Role Of Tumor-Suppressor Gene

Faulty Gene Signaling Could Lead to Development of Crohn’s Disease


Ex Vivo Generation of Fully Mature Human Red Blood Cells from Hematopoietic Stem Cells

Generation of Purified Oligodendrocyte Progenitors from Embryonic Stem Cells

How and When Should We Monitor Chimerism After Allogeneic Stem Cell Transplantation?

Human Embryonic Stem Cell Lines Available for Use in Research Funded by the US Government

Using Human Embryonal Carcinoma Cells for Studying Cellular Differentiation and Human Embryogenesis

Immunoaffinity Profiling of Tyrosine Phosphorylation in Cancer Cells

Stem Cells: Shibboleths of Development


California Guidelines to Precede Stem Cell Grants

Chico Cardiologist Named to California’s Stem Cell Oversight Panel

Missouri Stem Cell Ban Possible

New Jersey Plans $380 Mln for Stem Cell Research

South Korea Gives Green Light to Stem Cell Research But Not for Cloning



Abgenix to Receive Milestone Payment from Amgen for Advancement of Product Candidate into Clinical Trials; Eleventh XenoMouse Antibody Advances to the Clinical Phase

Beckman Coulter and Critical Therapeutics Sign Exclusive License Agreement

Canada’s Dragon Completes Merger with Chinese Drugmaker

Cord Blood Registry Reports Triple-Digit Growth Amid Second Legal Victory and News of Paralyzed Woman Walking

Crucell Announces Evaluation by Genentech of STAR Technology

Dendreon Reports Preliminary D9902A Trial Data For Provenge In Patients With Advanced Prostate Cancer

Antibodies Derived from Dyax Library Enter Clinical Trials at ImClone Systems

Enzon Announces First Patient Dosed in Clinical Trial For ATG-FRESENIUS S Polyclonal Antibody

GenData and Amgen Announce Genetics Pact

Geron Announces License Agreement with Cambrex for Distribution of Telomerase-Immortalized Human Cell Lines

Human Genome Sciences Receives FDA Clearance to Initiate Clinical Development of a New Compound for the Treatment of HIV/AIDS

InNexus and Epitomics Enter into a Co-Development Agreement for Therapeutic TransMab Antibodies

Nitto Denko and Isis Pharmaceuticals Announce High-performance Cross-linked Polystyrene Bead; Solid Support for Oligonucleotide, Antisense Drug Synthesis

PharmaFrontiers Expands Its Core Stem Cell Technology License With University Of Chicago

Sirna Launches Program to Treat Diabetes with RNAi Technology

Sirna Therapeutics and Targeted Genetics Form Huntington’s Disease Collaboration

ReNeuron Consortium Awarded UK Grant for Stem Cell Therapy Development

Xencor and Chugai Initiate Partnership for Optimized Antibodies

Xencor and Roche Collaborate for Optimized Antibodies; Roche Licenses Xencor’s XmAb Technology to Enhance Antibody Efficacy


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 Guide for Grants and Contracts – Week Of January 14, 2005

2005 NIH Director’s Pioneer Award Program Opens

NCI Announces Appointment of 15 Members to its Consumer Liaison Group

Requests for Applications

K 23 with Emphasis on Therapeutic Interventions Employing Genomic or Proteomic Technologies
(RFA-HG-05-013) National Human Genome Research Institute, National Institute on Drug Abuse, Office of Rare Diseases
Application Receipt Date(s): June 15, 2005


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

Recall of Fetal Cell Screening Kit (FETALSCREEN) – Ortho-Clinical Diagnostics
Posted: 1/11/2005, Recall Date: 1/8/2005

Fast Track Designation Request Performance – Update
Posted: 1/10/2005, Updated through: 12/31/2004

Licensed Products and Establishments List – Update
Posted: 1/10/2005, Updated through: 12/31/2004

Approved Biologics NDA and ANDA Applications – Update
Posted: 1/10/2005, Updated through: 12/31/2004

Cleared Biologics 510(k) Device Applications – Update
Posted: 1/10/2005, Updated through: 12/31/2004

Approved Biologics Premarket Approval (PMA) Device Applications – Update
Posted: 1/10/2005, Updated through: 12/31/2004

2004 Biological Approvals – Update
Posted: 1/10/2005, Updated through: 12/31/2004


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


Clinical Studies of Safety and Effectiveness of Orphan Products;
Availability of Grants; Request for Applications

2004 Adopted OMCL Batch Release European Guidelines on Batch Release of Human Blood Products and Vaccines



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. 21-22 Focus on Myeloma and Plasma Cell Disorders. Las Vegas , NV

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

Feb. 18 New Targets in Cancer Therapy III. Nice, France

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. 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 Haemotolgy’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. 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 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)

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 
Vancouver, BC (StemCell Technologies)

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

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)

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)
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:

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

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  

Meeting Report: Clinical applications of stem cells at the National Institutes of Health

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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