Volume 6.32 | Aug 8

Volume 6.32, August 8, 2005
     In this issue: Science | Policy | Business | NIH | CBER | Regulatory
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Top Stories

Story: Gene Therapy Works in Mice to Prevent Blindness that Strikes Boys

Story: Tissue Regeneration Operates Differently Than Expected


Research Casts Doubt on Circulating Stem Cells
A study currently being conducted at Bonn’s University Clinic has produced some sobering findings: although the cells are able to migrate into the muscle fibres, they do not generally take on any tissue-specific functions.
Article 1, Article 2

US Scientists Find Flexible Stem Cells In Placenta
Routinely discarded as medical waste, placental tissue could feasibly provide an abundant source of cells with the same potential to treat diseases and regenerate tissues as their more controversial counterparts, embryonic stem cells, suggests a University of Pittsburgh study to be published in the journal Stem Cells and available now as an early online publication in Stem Cells Express.

In High-Risk ALL, Stem Cells From Kin Superior to Chemotherapy
Children with very-high-risk acute lymphoblastic leukemia (ALL) in a first complete remission fared better if they received stem cell transplants from related donors than if they continued on chemotherapy, reported investigators in Europe and South America.

Stem Cells Offer Hope for Paraplegics
Kiwi doctors are planning an experimental operation to partially repair paraplegics’ damaged spinal cords, using stem cells extracted from their noses.

UofL Scientist Says Embryonic Stem Cells Key To Healing Spinal Cord Injuries
Days after Senate Majority Leader Bill First’s pledge to support federal funding for research on human embryonic stem cells, scientists at the University of Louisville announced a breakthrough in treating spinal cord injuries that may rely on embryonic stem cells to make it work.

MRC Scientists Discover Stem Cell Behaviour in Muscle Cells with Implications for Muscular Dystrophy
Scientists working for the Medical Research Council (MRC) Clinical Sciences Centre have conclusively demonstrated that a cell called the satellite cell is the main source of muscle repair and fulfills certain stem cell functions.

Master Regulatory Gene Found That Guides Fate Of Blood-producing Stem Cells
Researchers from the University of Pennsylvania School of Medicine found that a protein called NF-Ya activates several genes known to regulate the development of hematopoietic stem cells (HSC), or blood-producing stem cells, in bone marrow.

Gene Therapy Delivery Breakthough
Specialist healthcare group Ark Therapeutics has discovered a new targeted gene therapy delivery technology that avoids the harmful consequences of a therapeutic gene being inserted in the wrong place.

Licensing to Kill
Marauding immune cells called natural killer (NK) cells, which attack and kill invaders and spew inflammatory substances called cytokines, need to be “licensed” to properly carry out their work, researchers have found.

Huntington’s Help May Hit Animal Cell Hurdle
In a potential breakthrough, New Zealand scientists have helped develop “biocapsules” from pig brain cells. They are coated in a gel made from seaweed found in the North Sea.

Mayo Clinic Collaboration Invents ‘Virus in Stealth’ to Help Kill Cancer Cells
The researchers used the virus to create a disguise for an engineered measles virus that enables it to sneak past the immune system. It kills cancer cells without harming healthy cells.

Research into a New Treatment for Nerve Damage Caused by Diabetes Could Bring Relief to Millions of Diabetic Patients, say Experts
We turn on the patient’s own gene to produce a natural version of this therapeutically beneficial protein. The most significant advantage of this is that the protein is made as if the patient’s body had made it naturally.


Autotransplants with Peripheral Blood Stem Cells and Clinical Results Obtained in Children: A Review

Dendritic Cell-derived Exosomes as Cell-free Peptide-based Vaccines

Correlation Between DNA Transfer and Cystic Fibrosis Airway Epithelial Cell Correction After Recombinant Adeno-Associated Virus Serotype 2 Gene Therapy

Gene Therapy in Epilepsy

Tumor Targeted Gene Therapy with Plasmid Expressing Human Tumor Necrosis Factor Alpha In Vitro and In Vivo



ICOC to Address Governance Issues, Conflict of Interest Policy Updates, and New Scientific Member for Grants Working Group

On Friday (8/5/05), the Independent Citizens’ Oversight Committee (ICOC) for the California Institute for Regenerative Medicine (CIRM) will meet.

President Bush Reiterates Threat To Veto Stem Cell Research Enhancement Act Despite Frist Endorsement
During a roundtable interview with reporters from eight regional newspapers from across the country, Bush said, “I am confident that I have achieved the right balance between science and ethics,” adding that although Congress has “the prerogative to pass laws,” he has “the prerogative to set limits on what [he] think[s] is right” (Lightman, Hartford Courant, 8/3).



Amgen Strengthens Focus on Oncology Pipeline, Names David R. Parkinson to New Role in Research and Development Organization
Amgen, a leading human therapeutics company in the biotechnology industry, today announced that David R. Parkinson, M.D., formerly vice president and head of Global Clinical Oncology, will assume a new role as vice president, Oncology Development and Commercialization.

Biogen Idec, Inc. And Protein Design Labs, Inc. Form Global Alliance To Develop And Commercialize Three Phase II Antibody Products; Biogen To Pay Protein Design $40 Million, Buy Stake In Drug Development Partnership
Biogen Idec and Protein Design Labs, Inc. (PDL) today announced a broad collaboration for the joint development, manufacture and commercialization of three Phase II antibody products.

Northwest Biotherapeutics Announces Appointment of Paul Zeltzer, MD as Medical Director
Dr. Zeltzer will provide medical expertise and direcion for NWBT’s clinical trial programs, focusing initially on DCVax®-Brain, a personalized dendritic cell vaccine for Glioblastoma Multiforme (GBM), the most lethal form of brain cancer.

Oxford Biomedica Awarded Grant For Monudin® From Motor Neurone Disease Association
Oxford BioMedica the leading gene therapy company, announced today that the UK Motor Neurone Disease (MND) Association has awarded a research grant to support preclinical evaluation of MoNuDin for the treatment of Amyotrophic Lateral Sclerosis (ALS), the most common form of motor neurone disease.

Pall Corporation Awarded Exclusive Contract From Green Cross For Leukoreduction Filters In Korea
Pall Corporation announced today a long-term agreement with the Green Cross Corporation to exclusively purchase its leukocyte reduction filters for whole blood, red cells, platelets and plasma.

A Protection Cocktail for the Brain – LCT Announces Pre-clinical Results for Treating Huntington’s Disease
Living Cell Technologies Ltd (ASX:LCT) announced pre-clinical results today showing its brain protection product, NeurotrophinCell (NtCell) produces a marked reduction in the size of brain lesions in a Huntington’s disease (HD) model.

SFBC International Announces Dr. Joyce Lea Frey-Vasconcells Joins as Executive Director, PharmaNet, Consulting Division
SFBC International, Inc., a provider of drug development services to branded pharmaceutical, biotechnology, generic drug and medical device companies, announced today that PharmaNet, its wholly-owned subsidiary, has appointed Joyce Lea Frey-Vasconcells, PhD, as Executive Director, PharmaNet, Consulting Division.

Stem Cells Seen As Big Business In Pittsburgh
Dr. Calvin Johnson said the commonwealth already has a vibrant infrastructure ready to tackle stem cell research, with 2,000 bioscience companies employing 84,000 people at an average salary of $65,000.

Stewart Craig, PhD, Joins Progenitor Cell Therapy as Vice President and Chief Technology Officer


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, including order forms, please 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



NIH Guide for Grants and Contracts – Week Of August 5, 2005

Extramural Loan Repayment Program for Clinical Researchers(NOT-OD-05-058)

Guidelines for Inclusion of Clinical Practice Compensation in Institutional Base Salary Charged to NIH Grants and Contracts (NOT-OD-05-061)

New Process for Reimbursement of NIH Peer Reviewers (NOT-OD-05-062)

Biology of RNA Interference: Stability, Delivery and Processing by Tissues (RFA-HL-05-019)


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

Approved Biological NDA and ANDA Applications – Update

Cleared Biological 510(k) Device Applications – Update

PMA) Device Applications- Update


Workshop on Leukocyte Reduction of Blood and Blood Components: “An Update” (Slides)

Compliance and Surveillance


For Country-Specific & International Regulatory Resources, Including Regulatory Agencies Such As the FDA, EMEA, & More, Please Visit The Regulatory Page On The Cell Therapy News Website 


Contact Malachite Management if your company is interested in hosting an educational symposia at a future conference. Upcoming symposia opportunities include:

– World Transplant Congress (WTC). July 22-27, 2006. Boston, MA. Symposia dates: July 20, 21 or 28. Application Deadline: September 11, 2005

– Canadian Blood & Marrow Transplant Group (CBMTG) Biennial Conference. April 22-24, 2006. Edmonton, AB. Symposia dates: April 22. Application Deadline: January 2006.

– American Society for Apheresis (ASFA) Annual Conference. May 23-26, 2006. Las Vegas, NV. Symposia date: May 23. Application Deadline: March 15, 2005.

– International Society for Cellular Therapy (ISCT) Annual Conference. May 4-7, 2006. Berlin, Germany. Symposia dates: May 4, 5, or 7. Application Deadline:  January 2006.

– American Society for Hematology (ASH) December 9-12, 2006. Orlando, FL. Symposia date: December 8. Application Deadline:  early April 2006

New this Week:

The 4th Annual International Umbilical Cord Blood Transplantation Symposium. Los Angeles, California
May 19-20, 2006


Emerging Cardiac Cellular Therapies: Incorporating cGMP Federal Regulations into Clinical Trials. Bethesda, MD
Co-sponsored by AABB and ISCT
September 15 – 16, 2005
This year, a Cardiac Cell Therapy Workshop has been created to precede the annual Somatic Cell Therapy Symposium. This workshop was designed to address questions related to the various cell types being used in the context of cardiac repair.

Fifth Annual Somatic Cell Therapy Symposium. Bethesda, MD
Co-sponsored by AABB, ISCT and FDA
September 16 – 18, 2005
The annual Somatic Cell Therapy Symposium is a forum provided to engage FDA and industry in an ongoing dialogue regarding the regulatory issues pertaining to somatic and other cell therapies.

To View an Up-to-Date List of Cell Therapy-Related Meetings, Please Visit The Meetings Page  On The Cell Therapy News Website


To View a List of Cell Therapy-Related Journals, Please Visit The Journals Page On The Cell Therapy News Website


For information on posting an opportunity email: [email protected]

Acting President
San Diego, California (California Institute of Regenerative Medicine)

Cell Therapy Specialist 
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

Cell Therapy Supervisor 
New York, New York (New York Blood Center)

Cell Therapy Technologist 
New York, New York (New York Blood Center)

Cellular Production Lead Technician
Seattle, Washington (Fred Hutchinson Cancer Research Center)

Clinical Laboratory Scientist
Los Angeles, California (Cedars-Sinai Medical Center)

Clinical Consultant  
Deerfield, Illinois (Baxter Healthcare)

Clinical Trials Coordinator 
Vancouver, British Columbia (Malachite Management)

Consultant– (AABB)

Director of Cell Therapy
New York, New York (New York Blood Center)

Director of Research Programs 
Toronto, Ontario (Ontario Genomics Institute)

Director of Scientific Business Development (Regenerative Medicine)
Cambridge, Massuchusetts/San Francisco, California (3DM PuraMatrix Hydrogels Inc.)

Instrumentation Engineer II 
Gaithersburg, Maryland (Maxcyte)
Laboratory Manager 
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

Laboratory Supervisor (Stem Cell Lab)
Charlottesville, Virginia (University of Virginia Health System)

Manager, Device Engineering
Gaithersburg, Maryland (Maxcyte)

Manager, Quality Assurance 
Gaithersburg, Maryland (Maxcyte)

Marketing Manager 
Denver, Colorado (Gambro BCT)

Medical Laboratory Technologist (Stem Cell)
Roswell Park Cancer Institute (Buffalo, New York)

Program Leader: Cell Biology (Professor/Associate Professor) 
Melbourne, Australia (Peter MacCallum Cancer Centre)

Quality Assurance Associate
Hackensack, New Jersey (Progenitor Cell Therapy, LLC)

Quality Control Technologist 
Vancouver, British Columbia (StemCell Technologies)

Research Associate II 
Gaithersburg, Maryland (Maxcyte) 
Scientific Review & Program Officers 
San Diego, California (California Institute of Regenerative Medicine)

Scientific Sales Representative
Vancouver, British Columbia (StemCell Technologies)

Scientific/Technical Officer,Stem Cell Transplant Laboratory/Haematology 
Sydney, Australia (SWAPS, Liverpool Hospital)

Senior Hospital Scientist 
Sydney, Australia (Australian Stem Cell Facility Sydney Children’s Hospital)

Senior Officer for Medical & Ethical Standards 
San Diego, California (California Institute of Regenerative Medicine)

Stem Cell Lab Lead Technologist
Boston, Massachusetts (Beth Israel Deaconess Medical Center)

Stem Cell Specialist
Philadelphia, PennsylvaniaA (Children’s Hospital of Philadelphia)

Supervising Medical Laboratory Technologist (Quality Assurance)
Buffalo, New York (Roswell Park Cancer Institute)

Supervising Medical Laboratory Technologist (HLA, Stem Cell, Therapeutic Apheresis) 
Buffalo, New York (Roswell Park Cancer Institute)

Therapy Scientist
(Therapeutic Aphaeresis and Cell Therapy)
Denver, Colorado (Gambro BCT)


Upcoming Meetings & Conferences:

2005 Cell Therapy Audioconference Series

5th Annual Somatic Cell Therapy Symposium. Bethesda, Maryland
Sept. 15-18, 2005

Profiled Journal

Cytotherapy now incorporates “Cytokines, Cellular & Molecular Theory”

Join ISCT ($130) and receive the journal as a benefit of membership

Current Volume: Volume 7, Number 2 / May 2005

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.

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