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June 1, 2005 |
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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
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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. 16-20, 2006
Honolulu, Hawaii |
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Are you finding it more or less difficult to participate in clinical
trials?
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Calendar |
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• June
3rd Annual International Umbilical Cord Blood Transplant
Symposium
California Blood Bank Society (CBBS), with the National Marrow
Donor Program (NMDP)
June 3-4
Hilton Los Angeles Airport
Los Angeles, California
Chronic GvHD: The Next Frontier in Transplantation Research
NIH Consensus Development Project on Criteria for Clinical
Trials in Chronic Graft-vs.-Host Disease
June 6
Marriott Bethesda North Conference Center
Bethesda, Maryland
International Society for Stem Cell Research (ISSCR)
3rd Annual Meeting
June 23-25
San Francisco Marriott
San Francisco, California
• July
Pan-Pacific Lymphoma Conference
University of Nebraska Medical Center
July 11-15
Hyatt Regency Kauai
Poipu, Hawaii
Society for Cryobiology
Cryo 2005, 42nd Meeting
July 24-27
University of Minnesota
Minneapolis, Minnesota
Aplastic Anemia & MDS International Foundation (AA&MDSIF)
Patient & Family Conference
July 28-30
Denver Airport Marriott
Aurora, Colorado
International Society for Experimental Hematology (ISEH)
34th Annual Scientific Meeting
July 30-Aug. 2
Glasgow, Scotland
• October
American Association of Blood Banks (AABB)
58th Annual Meeting
Oct. 15-18
Seattle Convention Center
Seattle, Washington
Aplastic Anemia & MDS International Foundation
with NCI and NIH Office of Rare Diseases
Bone Marrow Failure Scientific Symposium
Oct. 17-19
Loews L’Enfant Plaza Hotel
Washington, D.C.
American Society for Histocompatibility and Immunogenetics (ASHI)
31st Annual Meeting
Oct. 17-21
Hilton Washington Hotel
Washington, D.C.
International Society for Interferon and Cytokine Research (ISICR)
Annual Meeting
Oct. 20-24
Shanghai International Everbright Convention Center
Shanghai, China
International Cytokine Society (ICS)
Annual International Cytokine Conference
Oct. 27-31
Lotte Hotel Jamsil
Seoul, Korea
European Society of Gene Therapy (ESGT)
13th Annual Meeting
Oct. 29-Nov. 1
Hotel Hilton Prague
Prague, Czech Republic
• November
National Marrow Donor Program (NMDP)
18th Annual Council Meeting
Nov. 4-6
Hilton Minneapolis Hotel
Minneapolis, Minnesota
• December
American Society of Hematology (ASH)
76th Annual Meeting
Dec. 3-6
Ernest N. Morial Convention Center
New Orleans, Louisiana
American Society for Cell Biology (ASCB)
45th Annual Meeting
Dec. 10-14
Moscone Center
San Francisco, California
2006
BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 16-20
Hawaii Convention Center
Honolulu, Hawaii
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
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Top
Stories |
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Cord blood transplants enhance survival for babies with Krabbe
disease
Stem cell transplants from umbilical cord blood enhance
survival for babies born with Krabbe disease, according to a
study published in the May 19 issue of The New England
Journal of Medicine. Eleven newborns received transplants
from unrelated donors, as did 14 older infants who had begun to
show signs of the disease. All of the newborns are still alive,
with the oldest 6 ˝ years old.  |
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Trimodal therapy may be best cancer
treatment option
A treatment strategy that combines chemotherapy, radiation
and a protein kinase inhibitor is much more effective against
cancer than any combination of two treatment methods, according
to scientists at the German Cancer Research Center and
Heidelberg University Hospitals. In human skin cancer cells and
in mice injected with these cells, the trimodal therapy was more
effective in inhibiting the multiplication of cancer cells in
vitro and triggered the suicide program in more vessel lining
cells. |
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Guidelines for Human Embryonic Stem Cell Research released
Revised donor consent rules, prohibition on paying donors
and limits to mixing human and animal cells are among the
recommendations included in Guidelines for Human Embryonic
Stem Cell Research, a 131-page report that a joint committee
of the National Academies' Institute of Medicine and National
Research Council have released. Compliance with the guidelines
is voluntary, but the panel urged everyone involved in human
embryonic stem cell research to abide by them.
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Stem cell pioneer forms research company
Jamie Thomson, the scientist who first isolated human
embryonic stem cells, is forming Cellular Dynamics
International, a company that will test new drugs on heart cells
it plans to develop from stem cells. Cellular Dynamics will
first develop tests made from kidney cells tweaked to mimic
heart cells, a technique invented by company co-founder Craig
January.
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Word from President Nelson Chao, M.D.
If you’re like me, you always have to pause for a moment
or two before writing the phrase principal investigator.
It’s a moment that averts the common mistake of “al”
versus “le.” I know it’s common because a Google search
for “principle investigator” finds more than 119,000
published pages -- all with the misspelling, unless you’re
confident that some of those pages are about investigating
behavioral or moral principles.
There’s ample reason for concern these days about
principal investigators, but it’s not all related to
spelling. After steady growth throughout the 1990s, the
number of PIs conducting clinical studies in the United
States has declined 11 percent since 2001. The drop
reflects a similar decline in the number of active
clinical trials and the value of study grants for those
trials.
These data come from the Tufts Center for the Study of
Drug Development, which analyzed a database of more than
100,000 PIs who registered with the FDA to conduct
clinical trials of investigational drugs between 1977 and
2004.
They found that turnover rates among PIs have nearly
doubled in the short time since 2001, and that only 3
percent of all board-certified physicians are PIs.
Furthermore, the proportion of female PIs to male PIs has
been steadily decreasing and is significantly below the
ratio of female-to-male board-certified physicians.
Incidentally, all of this is occurring while the number of
investigators abroad has increased by 8 percent.
The capacity of our medical research community to conduct
clinical trials is eroding at an especially inopportune
time. "Baby Boomers" are aging, entering a period of life
when the incidence curve for cancer and other chronic
diseases bends sharply upward. Ironically, the number of
new drugs and other therapies for cancer is increasing, as
we better understand the biology of the disease. But each
of these therapies requires well-thought-out clinical
trials led by experienced investigators. There also is a
great need for translational researchers, those who can
help bridge the laboratory bench to the bedside.
The amount of oversight needed for clinical trails is
enormous -- and rightfully so -- but the paperwork, the
bureaucratic hoops and the “hassle factor” are surely a
disincentive to investigators.
What can be done?
• Increase the number of mentored awards for clinical
research from the NIH.
• Increase the incentives, both tangible and intangible,
for leading clinical trials.
• Design and conduct courses on how to lead a clinical
trial. (Maybe this is something ASBMT can do for
hematopoietic stem cell transplantation and related
fields.)
• Establish new fellowships for translational research.
The downward trajectory for clinical research projects and
study grants is a genuine cause for alarm.
This is a ship that is not easily turned. It will take a
culmination of forces to steer the vessel -- spelled with
an “el” -- to a more favorable heading.
– Nelson |
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Legislation and Regulation |
Connecticut Senate approves stem cell research spending
The Connecticut Senate has approved spending $100 million
over 10 years to fund stem cell research, including human
embryonic stem cells. The bill, which would create an advisory
board and peer review board to advance and oversee research, now
goes to the House, where experts predict a longer debate.
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Clinical
Research |
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Statins may reduce risk of colorectal cancer
Statins, commonly used to control cholesterol and heart
disease, appear to reduce the risk of colorectal cancer,
according to a report in the May 26 issue of The New England
Journal of Medicine. Researchers at the University of
Michigan found that two statins, Zocor and Pravachol, reduced
the incidence of colorectal cancer by 47 percent in Israeli
patients.
Protein initiates cellular DNA repair, may help prevent
cancer
The protein ATF2 helps initiate cellular DNA repair, which
prevents the formation of genetic mutations, including those
that cause cancer. According to a report published in the May 27
issue of the journal Molecular Cell, a protein kinase
called ATM activates the protein.
Revlimid shows promise in treating myelodysplastic syndrome
In tests of 115 people with myelodysplastic syndrome who
were given Revlimid, 66 percent no longer needed blood
transfusions about six months into the study, and three-fourths
of them still don’t need transfusions a year later. Even more
promising, signs of the genetic mutation that fuels the disease
had diminished in 81 patients and disappeared in 51, according
to a presentation given at the recent meeting of the American
Society of Clinical Oncology.
Early environmental experiences can predispose to cancer
development
In rats with a genetic defect similar to uterine leiomyoma
and treated with diethylstilbestrol (DES) three to five days
after birth, nearly every rat developed tumors by adulthood. The
study, reported in the journal Proceedings of the National
Academy of Sciences, researchers found that rats exposed to
DES had more and larger tumors than unexposed rats that had the
genetic defect, and rats without the genetic defect that were
exposed to DES did not develop tumors.
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Pharmaceutical News |
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Spectrum granted Investigational New Drug application for
prostate cancer treatment
The U.S. Food and Drug Administration has granted an
Investigational New Drug application to Spectrum Pharmaceuticals
for its d-63153 hormone for prostate cancer treatment. The
approval allows Spectrum to conduct Phase I/II trials in the
United States. |
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Association
News |
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New definition for ‘stem cell transplantation’ proposed to
Medicare
ASBMT and the American Society for Hematology have jointly
submitted recommendations for a re-definition of stem cell
transplantation in Medicare’s coverage determination manual. The
Centers for Medicare and Medicaid Services (CMS) invited
recommendations on new wording that would recognize stem cell
transplant and high-dose chemotherapy as “both integral to the
course of treatment and covered as a single entity.”
Task force will study quality in stem cell therapy outcomes
An ad hoc committee has been appointed to study the
feasibility of transplant center-specific measures of quality in
hematopoietic stem cell therapy outcomes. Chairing the committee
is Dr. Roy Jones of M.D. Anderson Cancer Center.
Meeting with CBER will address cellular therapies
Representatives of ASBMT and other organizations in
allogeneic transplantation, gene therapy, tissue banking,
apheresis and biotechnology will meet with the FDA Center for
Biologics Evaluation and Research (CBER) on June 24. Part of an
ongoing series of twice-per-year meetings, recent sessions have
addressed regulatory strategy for biological combination
products and the regulatory distinction between and approaches
to homologous vs. non-homologous therapies.
Physician's handbook to cellular therapy published
The AABB has published Cellular Therapy: A Physician's
Handbook for medical professionals, attending physicians,
house officers, students, nurses, technologists and other
medical personnel. The handbook was developed with ASBMT, the
International Society for Cellular Therapy and the National
Marrow Donor Program. The editors are Drs. Edward Snyder and
Rebecca Haley.
Carreras leukemia foundation offers $50,000 fellowship
The Jose Carreras International Leukemia Foundation, jointly
with the Friends of the Jose Carreras International Leukemia
Foundation-U.S., is seeking applicants for its E.D. Thomas Post
Doctoral Fellowship. The fellowship provides $50,000 per year
and may be renewed for an additional two years. The deadline is
Nov. 2.
NMDP offers free subscriptions to ‘Advances’ e-newsletter
The National Marrow Donor Program is offering a free
subscription to Advances in Transplantation, a bi-monthly
e-newsletter highlighting selected journal articles from the
current and previous month. The subscription also includes three
special meeting editions, summarizing research presented at the
BMT Tandem Meetings, ASH and EBMT. Notices of upcoming NMDP
medical education programs and resources also are included in
the free subscription.
BBMT reviews reduced-intensity allogeneic transplants
Reduced-intensity allogeneic stem cell transplants have been
studied for more than 10 years in adults and children with
malignant and non-malignant diseases. Still needed are large
prospective randomized multicenter studies to define the
appropriate patient population, optimal conditioning regimens
and pre-transplantation immunosuppression, the role of donor
lymphocyte infusions, duration of hospitalization, overall
survival, differences in long-term effects and cost-benefit
ratio. Dr. Prakash Satwani and colleagues at Columbia
University’s Herbert Irving Comprehensive Cancer Center provide
a review of reduced-intensity allogeneic stem cell transplants
in this month’s issue of Biology of Blood and Marrow
Transplantation.
Authors of NIH-funded research may choose publication on PubMed
When authors submit manuscripts on NIH-funded research to
Biology of Blood and Marrow Transplantation, they will be
asked whether they want their published article forwarded to the
National Library of Medicine for free public access on PubMed
Central. With author agreement, articles will be forwarded 12
months after the publication date. Copyright of BBMT articles
will continue to be maintained by the journal and ASBMT. The new
policy responds to NIH concerns about free access to federally
funded research.
New BMT center in Russia appeals for equipment and support
Former Soviet President Mikhail Gorbachev next month will
dedicate a bone marrow transplant unit in St. Petersburg to his
wife, Raisa Maximovna, and in memory to Russian children
suffering leukemia. His wife succumbed to leukemia in 1999, but
not before raising substantial funds for children’s leukemia
hospitals. The new center is appealing for help from the
international BMT community for surplus equipment, “sister
hospital” programs and correspondence with the program director,
Prof. Lubov Fregatova.
Update on oral and gastrointestinal mucositis
Johns Hopkins University Medical School has published a CME
monograph "Beyond Quality of Life: Advances in the Understanding
and Treatment of Mucositis in Patients Undergoing Hematopoietic
Stem Cell Transplantation." Authored by Drs. Stephen Noga and
Jerry Spivak, the monograph is available online.
ASBMT members invited to participate in strategic plan
During June, ASBMT members will be invited to participate in
an online survey to provide input for a Board of Directors
strategic planning retreat. The brief survey will focus on the
society’s journal, annual meeting and current and future
programs. |
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