Volume 5.05 | Nov 1

Cell Therapy News 5.5, November 1, 2004
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Dr. Edward Otto New Director of the Office of Cellular, Tissue and Gene Therapies

Story: Researchers Discover Molecular Key to Blood Stem Cell Proliferation


Gene Therapy Approach Reverses Diabetic Neuropathy In Animal Model, Pitt Study Finds

Australian Reproductive Biologist has Advocated the Use of Hybrid Rabbit-human “Embryos” to Provide Urgently Needed Stem Cells

Scientists Find Key to Iron Disorders
Discovery might help treat anemia, hemochromatosis

Scientists Plan to Create 3-parent Embryos

Researchers Explain Why Incompatible Blood Type Heart Transplants are Possible in Infants

Fetal Tissue Restores Lost Sight

Tissue-regeneration Progress Reported


As the Tissue Banking Industry Readies Itself for Increased Regulatory Oversight, a New Comparative Study Proves How a Once Controversial Allograft Sterilization Method Evolved into a Major Technological and Commercial Advance

Novel Protein Detection Technique Has Potential for Cancer Diagnosis, Treatment 

Researchers Identify Brain Protein That Halts Progression Of Alzheimer’s

The Stem Cell Cover-Up 

Neurosurgeons Looking at Stem Cells from Skin to Fight Brain Tumors

Stem Cells ‘Could Restore Vision’

Jefferson Scientists Find New Way To Convert Adult Human Stem Cells To Dopamine Neurons

Article 2

ReNeuron Presents Further Pre-Clinical Stem Cell Data at US Conference

Transplanted Human Retinal Stem Cells Can Successfully Regenerate

Human Spinal Cord Cells Help Rats with Lou Gehrig’s Disease

Olfactory Bulb Stem Cells And Lou Gehrig’s Disease

New Treatment Blocks Cancer’s Spread
It keeps metastatic cancer cells from attacking other organs

Blocking Gene Opens Avenues for Treating Prostate Cancer

Babies Born After Transplant Surgery on Eggs

Kidney Transplant Brokered by For-Profit Web site

Transplant Case Raises Ethical Questions

Tabletop DNA Test Laboratory

Dendreon Corporation’s Phase 3 D9901 Trial Shows Provenge Extends Survival In Patients With Advanced Prostate Cancer

Studies Report Positive Results in Preclinical Models of Stroke,Parkinson’s Disease, and Spinal Cord Injury upon Treatment with Small Molecule Activators of the Hedgehog Signaling Pathway

Aastrom Biosciences Announces Plans to Expand Bone Graft Study Based on Results of Severe Fracture Treatments

                                                            Abstracts & Reviews

IgD Multiple Myeloma—a Clinical Profile and Outcome with Chemotherapy and Autologous Stem Cell Transplantation

Regulation of Hematopoietic Stem Cell Growth

Hematopoietic Stem Cell Gene Therapy of Murine Protoporphyria by Methylguanine-DNA-methyltransferase-mediated In Vivo Drug Selection

Chronic Myeloid Leukemia: Proving Ground for Cancer Stem Cells

Timely Reconstitution of Immune Competence Affects Clinical Outcome Following Sutologous Stem Cell Transplantation

Antibody-Cytokine Fusion Proteins: Innovative Weapons in the War Against Cancer


Stem-cell Vote Could Put California at Center of Biotech Universe

UN Delays Cloning Vote
US speaks out in support of total cloning ban, vote may take place soon

UN Secretary-General Annan Backs Stem Cell Studies, Differing with Bush

American Academy of Neurology and American Neurological Association Announce Support for Embryonic and Adult Human Stem Cell Research

India to Announce National Biotechnology Policy by Early 2005
Article 1
Article 2



Biotech Share Prices Surge Ahead of Stem Cell Vote

New Jersey is Eager to Take the Lead in Promoting Stem Cell Research

Agilent Technologies’ New Spin Cartridges Remove High-abundance Proteins from Blood Serum Using Benchtop Centrifuge
Simple, low-cost tools help scientists study potential biomarkers of drug toxicity and disease

Pluristem Founder Dr. Shai Meretzki Takes Helm as Acting CEO

Report highlights record collections, National Contact Centre

Hong Kong’s CK Life Plans A$10M Biotech R&D Spending In Australia

Greenpeace in Germany challenges a stem cell patent granted to a leading researcher

House Of Lords Rules In TKT’s Favor On EPO Patent Claims

Transkaryotic Therapies Inc. Completes Acquisition Of Minority Interest In TKT Europe-5S AB Article

Stroke Breakthrough Buoys UK Stem Cell Company
UK-based ReNeuron has unveiled evidence which could lead to a breakthrough in stroke treatment after stem cells injected into rats appeared to repair brain damage caused by stroke.

European Commission Approves Amgen’s Innovative First-in-Class Treatment for a Serious Complication of Chronic Kidney Disease

3DM Inc. Launches PuraMatrix Through Worldwide Partnership with BD Biosciences
PuraMatrix Smart Biomaterials Available to Life Science Researchers


Sigma-Aldrich Partners with Ingex on Targeted Gene-disruption Technology

New Genomic Method can Identify Disease-causing Genes
With Roche’s latest innovation, which has up to 1,000-fold greater precision than current methods, a single researcher may accomplish the task in a single afternoon.

GeneOhm Sciences and Infectio Diagnostic Announce Plans to Merge

Israel Keen on IT, Biotech Tie-up with India

Theratechnologies AppointsYves Rosconi as President and CEO

Boost Biotech in South, Report Urges


Malachite Management has joined forces with an established and reputable author to bring you a report outlining the very latest in the Cell Therapy industry. “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

Table of Contents
Order Form

Malachite Management has joined forces with an established and reputable author to bring you a report outlining the very latest in the Gene Therapy industry. “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

Malachite Management Inc. has teamed up with an established publisher to bring you the latest reports in immunotherapeutic approaches to cancer. For more information and to order see:

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 PerspectivesTable of Contents
Immunotherapy Reports Order Form



National Chemical Genomics Center
The first component of the NIH Roadmap – marks a major step in the creation of a nationwide network that aims to provide researchers with innovative chemical tools for use in
biomedical research

NCI Launches New Integrative Cancer Biology Program
The National Cancer Institute (NCI), part of the National Institutes of Health (NIH), announced $14.9 million in funding for a new Integrative Cancer Biology Program (ICBP).

NIH Awards 1,400 New Student Loan Repayment Contracts

NIH Funds New General Clinical Research Center In Sacramento


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

Recall of ORTHO Antibody to HBsAg ELISA Test System 3 – Ortho Clinical Diagnostics, Inc
Posted: 10/26/2004, Recall Date: 9/20/2004

RAPS 2004 – Annual Conference and Exhibition (Slides)
Posted: 10/19/2004, Meeting Date: 10/12/2004

Draft Guidance for Industry: Criteria for Safety and Efficacy Evaluation of Oxygen Therapeutics as Red Blood Cell Substitutes
Posted: 10/28/2004


Docket No. 2004D-0443. Draft Guidance for Industry on Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations; Availability. Page 59256 [FR Doc. 04-22206] [TXT] [PDF] Comments due December 3, 2004

Docket No. 2004S-0233, OC 2004261. Stimulating Innovation in Medical Technologies, Public Meeting. Pages 61018-61019 [FR Doc. 04-23064]
Meeting on November 8, 2004 Comments due November 15, 2004

Docket No. 2004N-0436, CVM 2004248.  Agency Information Collection Activities: Proposed Collection; Comment Request; Medical Device Registration and Listing.  Pages  63156-63158 [FR Doc. 04-24192] Comments due December 28, 2004


ISCT’s Cell Therapy Legal & Regulatory Affairs Online Resources Center:

The Rules Governing Medicinal Products in the European Union

WHO Quality Assurance and Safety of Medicines (QSM)

ISPE Regulatory Information (International regulatory agencies and documents)

International Conference on Harmonisation (ICH) Guidances – Topics and Guidelines

Code of Practice for the Production of Human-derived Therapeutic Products (UK)

The 21CFRPart11.com Web site provides access to information on the rules and also maintains an email list that actively discusses issues and concerns with industry peers and government regulators.

The FDA home page
 Electronic FOI 
 The  FDA Dockets 
 The FDA Modernization Act of 1997 (FDAMA) 
 Current Guidances 
 Regulatory Affairs Professionals Society 
 RAPS Combination Products Resource Page


Advanced Cell and Gene Therapy Consulting

Biologics Regulatory Training Institute

The Biologics Consulting Group




Nov. 3-6  4th Annual Stem Cell Network Annual General Meeting, Montreal, Canada. 


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


by The BioMaterials Network 
by The Pittsburgh Tissue Engineering Initiative
by The Tissue Engineering Pages 
by the American Society of Hematology
by the International Society for Stem Cell Research


Nov. 3-6  4th Annual Stem Cell Network Annual General Meeting, Montreal, Canada. 

Nov. 4-6  BioStar Congress in Stuttgart, Germany

Nov. 4-7.  European Society of Gene Therapy (ESGT) 12th Annual Meeting. Tampere, Finland. 

Nov. 10-12 2nd Annual International Clinical Trials Summit, Westin Grand Hotel, Washington, DC 

Nov. 17-20 7th International congress of the Cell Transplant Society.  Boston, MA. 

Nov.18-19  Commercialisation of Tissue Engineering and Regenerative Medicine. London, UK.

Nov. 19 Advances In Bone Marrow Transplantation Conference– Sydney Australia

Nov. 19 – 21   2004 Hanson Symposium “Stem Cells: From Biology to Therapy”.  Adelaide, South Australia. 

Nov. 22-24  2nd National Stem Cell Centre Annual Scientific Conference.  Sydney, Australia. 

Dec. 1-3 Immunogenicity for Protein-Based Therapeutics – Washington, DC

Dec. 3 Cellular Therapy: Progressing to Clinical Practice?- San Diego Marriott Hotel & Marina, San Diego, CA

Dec. 3-7  Amer. Society for Hematology: 46th Annual Mtg – San Diego, California – San Diego, CA

Dec. 4-8  American Society for Cell Biology (ASCB) 44th Annual Meeting. Washington, D.C.

Dec. 9-10 DIA/EMEA Workshop on Gene Therapy & Cell Therapy Products.  London, UK. 


Oct. 5-Nov. 15 The Zitter Group: Managed Care Webcast Series – New series for biotech and pharma marketers aiming to enhance reimbursement, coverage, managed care strategy, and tactical effectiveness.

Oct. 26 Inside FDA’s New cGMP Guidance: Map Your Quality System to the Requirements

Nov. 5 Analytical Validation and Regulatory Compliance Issues for the Pharma, Biotech, Medical Device and Related Industries – San Francisco, California.

Nov. 29-Dec. 1: Current Good Tissue Practice– Amsterdam, Netherlands

Nov. 30-Dec. 1: Monitoring Clinical Trials – Malvern, Pa. 

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

NIH and other stem stem cell training courses – Link

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


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

Feb. 10-14 Tandem BMT Meetings (Combined ASBMT and IBMTR/ABMTR annual meetings).  Keystone, Colo.

Feb. 23-25: The Clinical Trials Congress – Philadelphia
Featuring 80+ leading clinical experts incorporating Clinical Technologies, Patient Recruitment, Regulations, Strategic Partnerships, Study Design & Management and Contracts and Budgeting into 4 dynamic tracks. Janet Woodcock, MD, CBER, FDA provides a highly-anticipated update on the FDA Clinical Path Initiative. 

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

March 20–23  European Group for Blood & Marrow Transplantion Annual Mtg.  Prague, Czech Republic.

April 27-30 American Society for Apheresis 26th Annual Meeting Chicago, IL.  

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

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)

June 1-5  American Society of Gene Therapy Annual Meeting.  Saint Louis, MO. 

June 23-25  3rd Annual Meeting of the International Society for Stem Cell Research. San Francisco, CA. 

Sept. 21-25  International Society of Pediatric Oncology Conference.  Vancouver, Canada. 

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


International Society for Cellular Therapywww.celltherapy.org

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

Profiled Journal

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

The Current Issue is: Volume 6, Number 5 / October 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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