Volume 6.07 | Feb 7

Volume 6.7, February 7, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Gene Therapy Technique Could Repair Failing Hearts, Eliminating the Need for Cardiac Pacemakers
Article

Story: World-First Living Donor Islet Cell Transplant A Success
Article

Science

Bioartificial Kidney Containing Billions of Donor Cells Under Study at the Medical College of Georgia
Article

First US Kidney Cancer Vaccine Trial Underway at Columbia
Article

Pro-inflammatory Enzyme Linked to Diabetes; Immune System’s Macrophages May be Key to Treatment
Article

Researchers Find Diabetes Trigger, Possible Fix
Article

Using Gene Therapy for Heart Patients with Moderate to Severe Chest Pains
Article

Gene Therapy Promising for Growing Tooth-supporting Bone
Article

Mayo Clinic Researchers Create ‘Obedient Virus’; First Step to Use Measles Virus Against Cancer
Article

New Adult Stem Cell Could Work Like Embryonic Stem Cells
Article

Scientists Switch Stem Cells into Neurons
Article

Bone Marrow Stem Cells Generate Heart Tissue
Article

Human Neural Stem Cells Transplantation to Help Children with Batten Disease,Under Trial
Article

Adult Stem Cells Tackle HIV Lymphomas in Latest Clinical Trials
Article

SDF-1 Tells Stem Cells to Mind Their P’s and Z’s
Article

New Insight into Regulation of Blood Stem Cells
Article

Interaction Between Stem Cells and Their Niches Key to Differentiation
Article

Scientists Find Genome Structure Responsible for Gene Activation
Article

Cellular Enzyme Plays Key Role in Gene Regulation
Article

A New Mechanism Of Regulating RNA Degradation
Article

Persistence of HIV Escape Variants
Article

New Component of the ‘Brakes’ on Nerve Regeneration Found
Article

Scientists Reveal Cells’ ‘Energy Factories’ Linked to Cancer
Article

Newly Published Study Evaluates Abbott’s Humira in Crohn’s Disease
Article

Multi-purpose Protein Regulates New Protein Synthesis and Immune Cell Development
Article

NIH to Ban Deals With Drug Firms
Article

ABSTRACT, REVIEWS, & SPECIAL REPORTS

Human Umbilical Cord Perivascular (HUCPV) Cells: A Source of Mesenchymal Progenitors
Abstract

Do Stem Cells Cause Gastric Cancer?
Abstract

Nonmyeloablative Allogeneic Stem Cell Transplantation in Metastatic Renal Cell Carcinoma
Abstract

Policy

Green Light for China’s First Stem Cell Clinical Trial
Article

Bush Pledges To Support ‘Culture of Life’ in Second Term, Calls for Ban on Creating Embryos for Experimentation
Article

California on Target to Issue First Stem Cell Research Institute Grants In May
Article

Lawmakers Call for Investment in Stem Cell Research, USA
Article

Doyle, Michael J. Fox Talk Stem Cells in Madison
Article

University of Texas Receives $5 Million Donation for Stem Cell Research
Article

Stem Cells Spark Rush
Article

Need For New Stem Cells Lines Creates Business Opportunities
Article

Business

BUSINESS NEWS

Xcyte Therapies to Delay Start of Clinical Trial for Leukemia Drug for Further FDA Discussion
Article

StemCells, Inc. Announces Communications with FDA on Proposed Phase I Clinical Trial
Article

Osiris First to Announce FDA Fast Track Designation for a Stem Cell Product; Decision Seen as a Positive Sign for Both Osiris and the Emerging Stem Cell Industry
Article

Argos Therapeutics Receives $1.0 Million Grant for Lupus Research; ALR Funding to Support Antibody Research
Article

Biolex And Medarex Sign Research Collaboration Agreement
Article

Christopher J. Pugh Joins Genitrix, LLC as Vice President, Business Development
Article

CryoLife Receives American Association of Tissue Banks (AATB) Accreditation
Article

Cyntellect Announces Most Recent Cell Xpress(TM) Biopharmaceutical Customer
Article

Favrille Inc. Announces Pricing of Initial Public Offering
Article

GPC Biotech Initiates Trial With 1D09C3 Anticancer Monoclonal Antibody
Article

Northwest Biotherapeutics to Initiate Phase III Trial for Prostate Cancer
Article

Norwood Immunology Limited Announces IND for Bone Marrow Transplant Treatment Has Been Accepted by FDA
Article

OVP Venture Partners and Yaletown Venture Partners Co-Lead U.S. $5M Round in GenoLogics
Article

U.S. BioDefense Develops Open Source Stem Cell Research Platform
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 HEALTH

The National Heart, Lung, and Blood Institute Hosts Red Dress Collection 2005 Fashion Show on National Wear Red Day
Link

NIH Announces Sweeping Ethics Reform
Link

NIH Calls on Scientists to Speed Public Release of Research Publications
Online Archive Will Make Articles Accessible to the Public
Link

Policy on Enhancing Public Access to Archived Publications Resulting from NIH-Funded Research
National Institutes of Health

Link

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) Grant Programs – Addendum to  NOT-OD-05-027
Link

Ruth L. Kirschstein National Research Service Award (NRSA) Stipend and Other Budgetary Levels Effective for FiscalYear 2005
Link

Policy Revisions of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) for Competing Program  Project (P01) Grant Applications
Link

HHMI-NIBIB Partnership for Interdisciplinary Graduate Research Training
Link

ELSI Small Grant Research Program (R03)
Link

Request for Information (RFI): Programs in Systems Biology for HLBS Research
Link

Notice of Limited Competition: NCMHD Endowment Program for Increasing Research and Training Capacity in Section 736 Health  Professions Schools
Link

Research Supplements to Promote Diversity in Health-Related Research
Link

Second Phase of the NIH Roadmap Exploratory Centers for Interdisciplinary Research
Link

CBER

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



CBER – Organizational Listings
Posted: 2/3/2005
Link

Manual of Standard Operating Procedures and Policies – Participation in or Planning of Outside Regulatory and Scientific Events (Update)
Posted: 2/1/2005, Effective Date: 1/11/2005
Link

Exceptions and Alternative Procedures Approved Under 21 CFR 640.120 – Update
Posted: 1/31/2005, Updated through: 1/28/2005
Link

Compliance Program 7342.001 – Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors – Contact Updates
Posted: 1/31/2005
Link

Reopening of Comment Period – Public Workshop – From Concept to
Consumer: Center for Biologics Evaluation and Research Working With Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies (10/7/2004)
Posted: 1/31/2005, Issue Date: 1/27/2005
Link

Regulatory

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

UNITED STATES
FDA


Cell Therapies For Joint Repair/Regeneration To Be Discussed By New Committee
Link

Cellular, Tissue and Gene Therapies Advisory Committee (formerly the Biological Response Modifiers Advisory Committee); Notice of Meeting
Link

Center for Biologics Evaluation and Research Working With Stakeholders on Scientific Opportunities for Facilitating Development of Vaccines, Blood and Blood Products, and Cellular, Tissue, and Gene Therapies; Public Workshop; Reopening of the Comment Period
Link

Office of Drug Safety to Use Data Mining to Analyze AERS
Link

Oncologic Drugs Advisory Committee
Link

NEW ZEALAND
Bioethics Council Calls for Submission on Animal-to-human Transplant
Link

RAPS
Combination Products Report Focus of RAPS Summit

Link

Meetings

MALACHITE’S ONLINE CONFERENCE CALENDAR

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

CONFERENCES 2005

FEBRUARY

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).

Feb 25-26 Western Regional Bioethics Conference. Tempe, Arizona

MARCH
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

APRIL
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 Haematology’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
May 3-4, 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 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 4- 7 10th, Congress of IPITA International Pancreas and Islet Transplantation Association. Geneva, Switzerland

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
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
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 24-27 2005 Cryo 2005: 42nd Meeting of the Society for Cryobiology. Minneapolis, Minnesota

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 

AUGUST
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

SEPTEMBER

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. 26-29 10th Annual Cell & Tissue BioProcessing Conference. Newport Beach, California

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. 

OCTOBER
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

COURSES

 cGMP in the Transfusion Service. An online training course.
Link

NIH and other Stem Cell Training Courses
Link


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

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
Link


Journals

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

JOB POSTINGS IN CELL THERAPY NEWS ARE FREE!
For information on posting an opportunity email: [email protected]

Administrative Support Clerk  NEW!
Bethesda, MD (CBER)

Cellular Production Lead Technician 
Seattle, WA

Director: Office of Biostatistics & Epidemiology NEW!
 Rockville, MD (CBER)

Director of Cell Therapy 
 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)

Quality Control Technologist  NEW!
Vancouver, BC (StemCell Technologies)

Sales Representative
Vancouver, BC (StemSoft)

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

Senior Software Developer
Vancouver,BC (StemSoft)

Stem Cell Specialist 
Philadelphia, PA 

ISCT

International Society for Cellular Therapy
www.celltherapy.org



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)
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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