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July 5, 2006 |
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Top
Stories |
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Legislation and Regulation |
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Clinical
Research |
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Pharmaceutical News |
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Association
News |
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Calendar |
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Job &
Fellowship Connections |
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Monthly Journal |
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eNews
Archives |
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BMT Tandem
Meetings
Feb. 8-12, 2007
Keystone, Colorado |
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Calendar |
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• July
World Transplant Congress 2006
American Society of Transplant Surgeons (ASTS)
and the American Society of Transplantation (AST)
July 22-27
Hynes Convention Center
Boston, Massachusetts
Society for Cryobiology
Cryo 2006: 43rd Meeting
July 24-27
Hamburg Chamber of Commerce
Hamburg, Germany
• August
International Society of Hematology (ISH)
31st World Congress
Aug. 9-12
Puerto Rico Convention Center
San Juan, Puerto Rico
Back to the Science of Stem Cell Research
Cambridge Healthtech Institute
Aug. 14-16
Marriott Boston Long Wharf
Boston, Massachusetts
Cytokines 2006: Molecular Biology & Human Diseases
International Cytokine Society (ICS)
Aug. 27-31
Hilton Stadtpark
Vienna, Austria
• September
Targeted and Tailored Therapies in Hematology/Oncology
Loyola University Chicago Cardinal Bernardine Cancer Center
Sept. 9
Swissotel
Chicago, Illinois
Molecular Diagnostics in Cancer Therapeutic Development:
Maximizing Opportunities for Treatment
American Society for Cancer Research (ASCR)
Sept. 12-15
Hyatt Regency Chicago
Chicago, Illinois
Myeloproliferative Disorders: Molecular Pathogenesis and Therapy
European School of Haematology
Sept. 14-16
Grand Savoy Hotel
Madeira, Portugal
German Society for Transfusion Medicine and Immunohematology (DGTI)
in collaboration with the International Society for Cellular
Therapy-Europe (ISCT-Europe)
39th Annual Congress
Sept. 19-22
Congress Centre Messe
Frankfurt, Germany
American Society of Multicultural Health and Transplant
Professionals (ASMHTP)
14th Annual Conference
Sept. 22-24
Hyatt Regency
Dearborn, Michigan
6th Annual Somatic Cell Therapy Symposium
International Society for Cellular Therapy (ISCT)
with AABB and the FDA
Sept. 25-27
Bethesda, Maryland
International Society for Experimental Hematology (ISEH)
35th Annual Scientific Meeting
Sept. 27-30
Hyatt Regency
Minneapolis, Minnesota
10th Biennial National Symposium on Hematopoietic Cell
Transplantation
Stanford University School of Medicine
Sept. 28-30
Fairchild Auditorium
Stanford, California
• October
Tumor Immunology: An Integrated Perspective
American Society for Cancer Research (ASCR)
Oct. 4-8
InterContinental Miami
Miami, Florida
American Society for Human
Genetics (ASHG)
56th Annual Meeting
Oct. 9-13
Ernest N. Morial Convention Center
New Orleans, Louisiana
American Society for Histocompatibility and Immunogenetics (ASHI)
32th Annual Meeting
Oct. 16-20
San Diego, California
American Association of Blood Banks (AABB)
2006 Annual Meeting
Oct. 21-24
Miami Beach Convention Center
Miami Beach, Florida
Stem Cells in Cancer and Regenerative Medicine
University of Texas M.D. Anderson Cancer Center
Oct. 27-29
J.W. Marriott Hotel
Houston, Texas
• November
International Conference on Molecular Targets and Cancer
Therapeutics
American Society for Cancer Research (ASCR)
Nov. 7-10
Prague, Czech Republic
European Society of Gene Therapy (ESGT)
14th Annual Congress
Nov. 9-12
Athens, Greece
National Marrow Donor Program (NMDP)
19th Annual Council Meeting
Nov. 10-12
Hilton Minneapolis Hotel
Minneapolis, Minnesota
• December
American Society of Hematology (ASH)
48th Annual Meeting
Dec. 9-12
Orange County Convention Center
Orlando, Florida
American Society for Cell Biology (ASCB)
46th Annual Meeting
Dec. 9-13
San Diego, California
2007
BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 8-12
Keystone Conference Center
Keystone, Colorado
2008
BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 13-17
Manchester Grand Hyatt Hotel
San Diego, California
2009
BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 11-15
Tampa Convention Center
Tampa, Florida
2010
BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 4-8
Keystone Conference Center
Keystone, Colorado
2011
BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 17-21
Hawaii Convention Center
Honolulu, Hawaii
2012
BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 1-5
Manchester Grand Hyatt Hotel
San Diego, California
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Top
Stories |
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NIH says bill not needed to authorize embryonic stem cell
research
The National Institutes of Health says it does not need
legislation authorizing it to research means of creating
embryonic stem cells without destroying human embryos. NIH says
such research proposals would undergo the same review process
regardless of whether new legislation is enacted.
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Two private stem cell research facilities
established in New York
Two private facilities have been established in New York to
conduct stem cell experiments with human embryos and donor eggs.
These labs, which avoid federal limits on human embryo research,
will be used to investigate potential treatments for amyotrophic
lateral sclerosis and diabetes by developing human stem cells
tailored to each disease.
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Cancer vaccine developer to be sold
After its most promising cancer vaccine failed clinical
trials in 255 patients with advanced pancreatic cancer, the
German owner of Therion Biologics Corp. has decided to close the
company and sell off its assets. The company has been working
for 15 years to develop cancer vaccines.
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Functional stem cells obtained from liver of human fetus
Scientists at the University of Washington have obtained
functional stem cells from the liver of a human fetus. According
to a report published in the advanced online edition of the
Proceedings of the National Academy of Sciences, these cells
replaced damaged liver cell tissue in rodents.
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Formula helps predict inherited colon cancer mutations
A formula has been developed to help find colon cancer
patients who have inherited certain aberrant genes, according to
a report in the June 29 issue of the New England Journal of
Medicine. The formula combines such factors as a patient’s
age and sex with cancer characteristics such as the tumor’s
location and gives a score for the likelihood that inherited
mutations are responsible.
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Word from President
Robert Negrin, MD
Your stack of problems is probably weighty enough without
my adding to it. But here are a few more ounces … in
case you aren’t already aware.
A strict interpretation of the
FDA
Current Good Tissue Practice (cGTP) rule,
implemented in May last year, prohibits the release or
infusion of contaminated blood products.
That may not be a large problem in blood transfusions,
but it can present a real dilemma in the transplantation
of hematopoietic progenitor cells. When an HPC product
is a unique match and the patient has been prepared to
receive it, there’s little room for clinical choice. The
potential benefit of the transplant may far surpass the
risk to the patient or even the donor in the case of an
autologous transplant. A replacement product may be
difficult to obtain or may not even be feasible.
Depending on the type of organism detected, the
clinician is likely to choose to proceed with the
infusion, taking all appropriate precautions with
respect to prophylactic antibiotics, informed consent,
notification of the primary-care physician and
investigation of the cause of the contamination.
The collection, processing and infusion of bone marrow
and peripheral blood stem cells is not a closed system.
There’s opportunity for bacterial contamination in the
donor, as well as in the various steps of collection,
processing, sampling and thawing, or even possibly in
the microbiology laboratory.
Studies have shown that about 1.5% to 3% of infused HPC
products are not sterile. Try as we may – no matter what
technology is used and how careful we are – no one has
been able to push the percentage much lower.
This dilemma posed by section 1271.265 of the cGTP rule
was explored in a meeting two weeks ago between FDA
representatives and leaders of cellular therapy
organizations, including ASBMT. Presented at the meeting
were data from a survey of members of the International
Society of Cellular Therapy (ISCT). The survey,
representing 177 facilities, found that:
• 67% had released products known before infusion to be
culture-positive
• 36% had infused products that became culture-positive
after infusion
Also presented were the results of a Mayo Clinic study
of 7,233 HPC products and 2,118 transplants, revealing
minimal acute toxicity or adverse reactions that could
be traced to the infusion of culture-positive autologous
or allogeneic peripheral blood cells or donor
lymphocytes, and no measurable effect on the patients’
short-term or long-term survival.
Over the past year, some centers have been reporting the
transplant of positive-culture products as a deviation
from the cGTP rule under the urgent medical need
exemption. The FDA, however, has maintained that
permitted deviations apply only to donor eligibility and
not to the transplant of manufactured products that have
failed a sterility test.
At last month’s meeting, the FDA representatives
acknowledged the apparent disparity between accepted
clinical practice and the regulation and said that the
information presented would be evaluated to determine
whether a guidance document or adjustment in the cGTP
rule may be needed.
In the meantime, it is important for each clinical
center and processing laboratory to have a policy on how
contaminated products are to be handled, patients and
physicians notified and reporting performed. It would
appear that no additional labeling of the product is
required. A new requirement expressed at this meeting
was that these situations should be reported to the FDA
as an infused contaminated product. If the contamination
is identified and the product is not infused, then no
reporting is required.
The FDA is aware that the use of culture-positive
products may be necessary under certain circumstances of
medical need and is working on how to handle the
exceptions. As we learn more, we will quickly pass the
information along to you.
– Rob |
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Legislation and Regulation |
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Investigation challenges validity of many solid organ
programs
About 20 percent of the federally funded solid organ
transplant programs fail to meet the government's minimum
standards for patient survival or perform too few operations to
ensure competency, according to a Los Angeles Times
investigation. The programs examined had 71 more patients die
than expected within a year of transplant.
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Clinical Research |
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Allogeneic stem cell transplants improve ALL survival
Use of allogeneic stem cell transplants as consolidation
therapy for people with acute lymphoblastic leukemia is
associated with a relatively low rate of relapse but a
relatively high rate of treatment-related deaths. According to a
report in the June 15 issue of the journal Cancer, using
this treatment in high-risk patients improved survival by 42
percent.
Molecule may be responsible for spread of renal cell carcinoma
Researchers have discovered that molecule B7-H4 helps renal
cell carcinoma grow and spread by blocking the immune system.
According to a report published in the advanced online edition
of the Proceedings of the National Academy of Science,
when this molecule is active, patients are three times more
likely to die from the disease.
Skin-derived stem cells can create neural cell types
Stem cells derived from adult skin can create neural cell
types that can be transplanted into and function in mouse models
of disease. According to a report in the June 14 issue of The
Journal of Neuroscience, these skin-derived precursors can
generate Schwann cells that myelinate axons in the peripheral
and central nervous systems of mice that lack myelin.
Protein that spreads cancer could help repair nerve damage
Id proteins, known to promote tumor growth and aid in the
spread of cancer, could be used to regrow axons that are damaged
in spinal cord injuries or neurological diseases, according to
research reported in the advance online edition of the journal
Nature. An enzyme in normal cells degrades Id proteins,
and re-introducing this enzyme into cancer cells could eliminate
the proteins.
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Pharmaceutical News |
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Revlimid approved for treating multiple myeloma
The anemia drug Revlimid (lenalidomide) manufactured by
Celegene Corp. has been approved by the FDA for a new use to
treat multiple myeloma.
Mayne Pharma acquires rights to Nipent, SurfaceSafe
Mayne Pharma Limited and SuperGen Inc. have signed an
agreement allowing Mayne Pharma to acquire the North American
rights to Nipent and SurfaceSafe. Nipent has been approved to
treat patients with hairy cell leukemia, and SurfaceSafe is a
system to decontaminate surfaces where chemotherapy is mixed or
administered.
Panitumumab granted priority review by the FDA
The U.S. Food and Drug Administration has accepted Amgen’s
biologic license application for panitumumab, an investigational
fully human monoclonal antibody that targets the epidermal
growth factor receptor (EGFr), and has granted priority review.
The application was submitted for the treatment of patients with
metastatic colorectal cancer who have failed prior chemotherapy.
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Association
News |
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Meeting with payers will address reimbursement issues
An ASBMT delegation will meet this month with
representatives of third-party payers to discuss the measurement
of clinical outcomes, evidence-based reviews, transplant center
accreditation, standardized requests for information and cord
blood transplantation. The meeting is being organized by the
United Network for Organ Sharing (UNOS) and will include
representatives of companies such as Aetna, Allianz LifeTrac,
Blue Quality Centers for Transplant, Cigna LifeSource,
Interlink, Allianz LifeTrac, MultiPlan, PacificCare, United
Resource Networks and Wellpoint.
FDA asked to reconsider rule on contaminated products
The rare but occasional infusion of a contaminated cellular
product was the topic of a meeting last month between FDA
representatives and leaders of cellular therapy organizations,
including ASBMT. According to a strict interpretation of the
Current Good Tissue Practice (cGTP) rule, the release or
transplantation of a blood product with a positive microbial
culture is a reportable violation.
FACT announces new accreditations
Seven blood and marrow transplant facilities achieved
accreditation and 18 others earned accreditation renewals during
the first half of 2006, according to the Foundation for the
Accreditation of Cellular Therapy (FACT). In addition, two cord
blood banks were granted NetCord/FACT accreditation. The total
number of FACT-accredited facilities is now 145.
Topics, speakers scheduled for 2007 BMT Tandem Meetings
A preliminary agenda of topics and speakers has been
announced for plenary and concurrent scientific sessions and
workshops for the 2007 BMT Tandem Meetings, to be held Feb. 8-12
at the Keystone Conference Center in Keystone, Colo. Online
registration and abstract submission will open in August.
BMT Tandem Meetings will return to Honolulu in 2011
The ASBMT Board of Directors and the CIBMTR Executive
Committee have both voted to take the BMT Tandem Meetings back
to Hawaii in 2011. This year’s meeting in Honolulu was the sixth
consecutive year for record-setting attendance and abstracts:
2,030 registrants from 43 countries (an increase of 25%) and 510
accepted abstracts (an increase of 46%).
Journal gets new ‘impact factor’
Biology of Blood and Marrow Transplantation has earned an ISI Impact Factor of 3.561 – its highest since the journal was
founded in 1995. BBMT is ranked 4th among 20 transplant
journals.
Radioimmunotherapy and non-myeloablative therapy for lymphoma
The rationale for radioimmunotherapy in reduced-intensity
allogeneic transplantation for non-Hodgkin lymphoma is presented
in a review published in the July issue of Biology of Blood
and Marrow Transplantation. Dr. Ajay Gopal and colleagues at
the University of Washington and Fred Hutchinson Cancer Research
Center provide the evidence for radioimmunotherapy as an
attractive, minimally toxic modality for safely preventing early
progression of B-cell lymphomas and inducing remissions without
incurring the risks of traditional intensive therapy.
New therapies for myelodysplastic syndrome
New therapies for myelodysplastic syndrome is the topic for
the current issue of Blood and Marrow Transplant Reviews,
now in the mail to ASBMT members and about 10,000
hematologists/oncologists and other referring clinicians and
investigators. “Management of myelodysplastic syndrome has been
disappointing for years,” said John Wingard, MD, editor, in his
introduction to the issue. “True progress has been small to
date, but with the number of new therapies and new classes of
agents undergoing study, the future is hopeful.”
Clinical immunologists given update on targeting and GvHD
ASBMT sponsored and conducted a symposium on cellular and
molecular targeting of graft-versus-host disease at the 6th
Annual Conference of the Federation of Clinical Immunology
Societies (FOCIS) in June. FOCIS is a federation of 19
associations in the field of clinical immunology.
Looking to fill a staff position or expand your career?
ASBMT offers both a “Job Connection” and a “Fellowship
Connection” – online services for those seeking and offering BMT
employment and training opportunities. Much like classified want
ads in a newspaper or journal, the employment listings can be
searched free of charge by job seekers, and there is a nominal
fee for those announcing positions to fill.
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