Volume 6.06 | Jan 31

Volume 6.6, January 31, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Experiment Shows Bone Marrow Cells Help Heart Failure
Article

Story: Study: Stem Cell Lines Contaminated
Article

Science

Herastatin Protein Stops Growth of Brain Tumor
Article

Columbia Research Lifts Major Hurdle To Gene Therapy For Cancer
Article

Columbia Researcher Identifies Cellular Defect That May Contribute To Autism
Article

Researcher Believes She Has Vaccine that Protects Against Cervical Cancer
Article

U.S. Fertility Group Offers Embryo Stem Cells
Article

Biologists Find Stem Cell Regulator
Article

Stem Cells in Need of a Fresh Start
Article

Emory Study Tests Bone Marrow Stem Cells To Improve Circulation In Legs
Article

Genetic Technique Bolsters Immune Cells to Battle Cancer
Article

Device Shows Promise for Spinal Cord Injury
Article

DNA Molecules Used to Assemble Nanoparticles
Article

Protein’s Role in Immune Defense Uncovered
Article

RMBI’s Tissue Sealing Technology Proves Successful
Article

ABSTRACT, REVIEWS, & SPECIAL REPORTS

New Strategies for Disc Repair: Novel Preclinical Trials
Abstract

Understanding the Response to Immunotherapy in Humans
Abstract

The Transcription Factor Profile of Human Mast Cells in Comparison with Monocytes and Granulocytes
Abstract

Policy

Connecticut: Biotech Looks To Be Next Wave Of Technology
Article

Business

BUSINESS NEWS

ReNeuron Comments on Research Highlighting Contamination of Certain Stem Cell Lines
Article

Startling Results from New Biomedical Research International Conference
Article

Amgen 4Q Earnings Fall Below Expectations
Article

Aastrom Biosciences Says It Uses Adult Stem Cells
Article

Alnylam to Develop RNAi Therapeutics for Spinal Cord Injury
Article

LifeStem Launches Project to Develop Stem Cell Delivery Device
Article

Bolder BioTechnology Awarded NIH Grant to Develop Novel Arthritis Treatment
Article

Chugai Pharmaceutical and Xencor Conclude Licensing Agreement for Antibody Engineering Technology
Article

Genetronics Acquires Inovio
Article

Merck’s Investigational HIV/AIDS Vaccine Candidate Advances To Phase II Efficacy Testing in Collaborative Clinical Trial
Article

Peregrine and New Approaches to Brain Tumor Therapy (NABTT) Consortium Receive Approval for Cotara(R) Brain Cancer Protocol
Article

RNAi Licenses MetaCore From GeneGo and Collaborates In Platform Development
Article

ThermoGenesis’ Cryoseal(R) Fibrin Sealant Reduces Blood Loss and Pain in Total Knee Arthroplasty (TKA) Study
Article

ViaCell Raises More Than $68M in IPO
Article

YM BioSciences, Oncoscience Achieve Clinical Milestone in Brain Cancer Study
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
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

NIH



NATIONAL INSTITUTES OF HEALTH

NIH Guide for Grants and Contracts – Week Of January 28, 2005
Link

Elizabeth G. Nabel, M.D., Named New Director of The National Heart, Lung & Blood Institute
Link

NIAID Begins Enrolling Volunteers for Novel HIV Vaccine Study
Link

NIH Names Four to NIAID Advisory Council
Link

NOTICES

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

NIH Policy on Late Submission of Grant Applications
Link

Notice of Comprehensive Identification of Tumor Mutations: Request for Information
Link

REQUESTS FOR APPLICATIONS

Biology of the Perimenopause: Impact on Health and Aging in Non-Reproductive Somatic and Neuronal Tissues
Application Receipt Date(s): May 16, 2005
Link

PROGRAM ANNOUNCEMENTS

Molecular Approaches to Diet and Pancreatic Cancer Prevention
Link

Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) to Improve The Chemistry and Targeted Delivery of RNAi Molecules
Link

Directed Stem Cell Differentiation for Cell-Based Therapies for Heart, Lung, And Blood, and Aging Diseases (R21)
Link

Directed Stem Cell Differentiation for Cell Based Therapies for Heart, Lung, Blood, and Aging Diseases (SBIR/STTR)
Link

CBER

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



Security Resource Sheet For Manufacturers of Biological Products Regulated by the Food and Drug Administration, Center for Biologics Evaluation and Research (CBER)
Posted: 1/28/2005
Link

Vaccines and Related Biological Products Advisory Committee Meeting
Posted: 1/26/2005, Meeting Dates: 2/16-17/2005
Link

Biological Product Deviation Reporting – Updated Codes and Instructions
Posted: 1/25/2005
Link

Tissue Action Plan – Reference Group 2004 Annual Report
Posted: 1/25/2005
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

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 1-3 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).

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 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
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 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.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
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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