| |
|
January 2, 2007 |
| |
| If
you are unable to view these articles or access the links,
please visit the ASBMT Web Site at
www.asbmt.org to read this
issue. To be removed from this distribution list, please see
instructions at bottom. |
| |
 |
Top
Stories |
| |
|
|
|
Legislation and Regulation |
| |
|
|
|
Clinical
Research |
| |
|
|
|
Pharmaceutical News |
|
|
|
|
|
Association
News |
| |
|
|
|
Calendar |
| |
|
|
|
Job &
Fellowship Connections |
|
|
|
|
|
Monthly Journal |
|
|
|
|
|
eNews
Archives |
|
|
|
|
|
|
|
|
|
|
|
|
|
BMT Tandem
Meetings
Feb. 8-12, 2007
Keystone, Colorado |
|
|
|
|
|
|
|
Calendar |
|
• January
Stem Cell Transplantation in Children: Current Results and
Controversies - Meeting #9
Cincinnati Children's Hospital Medical Center
Jan. 16-18
Manchester Grand Hyatt
San Diego, California
In the Forefront of Basic and Translational Cancer Research
American Association for Cancer Research (AACR)
with Japanese Cancer Association (JCA)
Jan. 21-25
Hilton Waikoloa Village
Waikoloa, Hawaii
Phacilitate Cell & Gene Therapy Forum 2007
Jan. 22-24
Baltimore Marriott Waterfront Hotel
Baltimore, Maryland
Cell Death and Cancer: Opportunities for Intervention
Stanley J. Korsmeyer Symposium
Jan. 25-26
Conference Center at Harvard Medical School
Boston, Massachusetts
Oncogenomics 2007
American Association for Cancer Research (AACR)
Jan. 31-Feb. 4
Pointe Hilton Tapatio Cliffs
Phoenix, Arizona
• February
Chemistry in Cancer Research: A Vital Partnership
American Association for Cancer Research (AACR)
with the American Chemical Society (ACS)
Feb. 4-7
Sheraton San Diego Hotel and Marina
San Diego, California
BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 8-12
Keystone Conference Center
Keystone, Colorado
Making Rational Immunosuppression Decisions for the
Individual Patient
American Society of Transplantation (AST)
11th Annual Winter Symposium
Feb. 15-19
Wigwam Golf Resort & Spa
Phoenix, Arizona
Translational Research at the Aging and Cancer Interface
American Association for Cancer Research (AACR)
Feb. 20-23
Omni San Diego Hotel
San Diego, California
• March
4th International Conference on Tumor Microenvironment:
Progression, Therapy and Prevention
American Association for Cancer Research (AACR)
with the International Cancer Microenvironment Society (ICMS)
March 6-10
Pallazo dei Congressi
Florence, Italy
Euroconference on Biobanking
European School of Haematology (EHS)
and European Group for Blood and Marrow Transplantation (EBMT)
March 9-11
Quinta da Marinha Hotel
Cascais, Portugal
Hematopoietic Growth Factors: Use in Normal Blood and Stem
Cell Donors
University of Minnesota Biomedical Engineering Institute,
American Association of Blood Banks (AABB),
American Red Cross (ARC), and National Marrow Donor Program (NMDP)
March 15-16
Hyatt Regency Bethesda Hotel
Bethesda, Maryland
5th Conference on Mesenchymal and Tissue
Stem Cells
American Society for Blood and Marrow Transplantation (ASBMT),
with the International Society for Cellular Therapy (ISCT)
March 15-17
Wyndam Hotel
New Orleans, Louisiana
Canadian Society of Transplantation (CST)
Annual Scientific Meeting
March 15-18
Fairmont Banff Spring
Banff, Alberta, Canada
International Pediatric Transplant Association (IPTA)
4th World Congress
March 17-21
Gran Melia Cancun
Cancun, Mexico
Advances and Controversies in the Biology and Therapy of
Acute Myelogenous Leukemia and Myelodysplasia
Acute Leukemia Forum 2007
March 23
W Hotel
San Francisco, California
American Association of Blood Banks (AABB)
2007 Spring Conference
March 23-25
Hyatt Regency Albuquerque
Albuquerque, New Mexico
World Marrow Donor Association (WMDA)
Working Group Meetings
March 23-25
Lyon, France
Advances and Controversies in the Biology and Therapy of
Acute Myelogenous Leukemia and Myelodysplasia
Acute Leukemia Forum 2007
March 23
W Hotel
San Francisco, California
American Association of Blood Banks (AABB)
2007 Spring Conference
March 23-25
Hyatt Regency Albuquerque
Albuquerque, New Mexico
American Association of Tissue Banks
11th Annual Spring Meeting
March 25-27
Renaissance Hollywood Hotel
Hollywood, California
European Group for Blood and Marrow Transplantation (EBMT)
33rd Annual Meeting
March 25-28
Palais des Congrès of Lyon
Lyon, France
• April
Organ Transplantation: Ethical, Legal and Psychological
Aspects – Towards a Common European Policy
Dutch Transplant Foundation (DTF)
April 1-4
World Trade Center
Rotterdam, The Netherlands
American Association for Cancer Research (AACR)
98th Annual Meeting
April 14-18
Los Angeles Convention Center
Los Angeles, California
2nd Annual Wisconsin Stem Cell Symposium: Heart and Blood
University of Wisconsin-Madison
April 18
BioPharmacetuical Technology Center Institute
Madison, Wisconsin
American Society for Apheresis (ASFA)
28th Annual Meeting
April 18-21
Gaylord Opryland Resort and Convention Center
Nashville, Tennessee
• May
American Society of Pediatric Hematology/Oncology (ASPH/O)
20th Annual Meeting
May 3-6
Metro Toronto Convention Centre
Toronto, Canada
American Transplant Congress
American Society of Transplantation (AST)
May 5-9
San Francisco, California
5th Annual International Umbilical Cord Blood Transplantation
Symposium
California Blood Bank Society and Cord Blood Forum
May 11-12
Los Angeles Airport Marriott
Los Angeles, California
2008
BMT Tandem Meetings
(Combined ASBMT and CIBMTR annual meetings)
Feb. 13-17
Manchester Grand Hyatt Hotel
San Diego, California
|
|
|
|
|
|
|
| |
|
Top
Stories |
| |
Stem cell harvesting method fails to capture aggressive cells
The current method of harvesting CD34+ stem cells from
donated bone marrow fails to capture many of the cells that
might be more vigorous in reproducing and rebuilding the immune
system. According to a report in the online issue of the journal
Stem Cells, in mice most of these cells are especially
vigorous in multiplying and producing T lymphocytes.
 |
|
|
California set to begin awarding grants for stem cell research
The $3 billion investment by the state of California in stem
cell research is reaping dividends. Over the past two years,
grants and gifts from private sources to California researchers
have totaled more than $200 million, and the California
Institute for Regenerative Medicine is expected to begin
awarding its grants in just a few weeks.
|
|
|
Using printer turns stem cells into bone and
muscle
Researchers have used a custom-designed ink-jet printer to
direct adult stem cells from mice to develop into bone and
muscle cells. The scientists printed growth-factor solutions on
the same slide, or "paper," forming a scaffold onto which stem
cells can interact and differentiate into bone or muscle cells
side by side.
|
|
|
Stem cells act to repair damage in brain
In mice genetically engineered to have holes in an area of
their brains, stem cells moved in to repair the damage.
According to a report in the Dec. 15 issue of the journal
Cell, knocking out genes that help stem cells develop into
neurons resulted in replacement of the missing areas of the
brain with ependymal cells.
|
|
|
|
 A
Word from President
Robert Negrin, MD
Have you ever been moved to write a letter to the FDA
about a proposed rule? Have I got an opportunity for you.
The agency is proposing changes to its system of
National Drug Codes for labeling and bar codes for all
human drugs and therapeutic agents, including biologics.
Under the proposed system – clearly not written with
hematopoietic progenitor cell (HPC) products in mind – the
agency will issue an identifying number for every
therapeutic product. Are you ready to apply to the FDA for
an identifying number for each unit of stem cells
collected peripherally and from umbilical cords before it
is released?
The deadline for public comment is Jan. 26.
You can click here to
submit a comment online, or fax a letter to (301)
827-6870. If you send a fax, mention Docket No. 2005N-0403
and RIN 0910-AA49.
ASBMT is part of a coalition of health-care associations
that submitted testimony at an FDA hearing in December,
seeking exemption for HPC products. The FDA now needs to
hear from you.
Square Peg for a Round Hole
The stated purpose of the changes in the National Drug
Code (NDC) system is to increase patient safety. The FDA
would assign NDC numbers for both domestic and imported
products. Here, as we view it, are a few of the problems:
• HPC products have variable active and inactive contents.
Each is uniquely tailored to a patient’s needs – not mass
produced like most commercial drugs. Each HPC product is a
lot unto itself and would require its own NDC number.
• Due to the biological nature of HPC products, which are
typically infused within hours of collection, there is no
reasonable opportunity for the collection facility or
processing lab to attain an identifier code within minutes
of collection 24 hours a day, seven days a week.
• The integrity of the HPC products can be compromised if
delayed to obtain an identifier. Particularly problematic
would be products imported to the United States, which, as
we all know, is very frequent.
• A useful database of HPC product information would be
impossible to create for searches before product use. The
HPC product would necessarily be infused before the NDC
number is populated in any federally maintained database.
• Adverse reactions that occur with a patient after
infusion already are required to be reported to the FDA.
• The process of obtaining an NDC number for bar coding
each product would impose an undue burden on the
manufacturer with no positive benefit for patient safety.
• Current cellular therapy processing and hospital
laboratory computer systems are not designed to
accommodate the reading and incorporation of NDC data. New
computer programs would be needed by manufacturers and
hospitals.
In summary, the effect of the proposed changes in the National Drug Code
system would detract from, rather than enhance, current
levels of patient safety in HPC transplants.
A Better, Round Peg
A much superior alternative already exists. The cellular
therapy community has spent much time and effort in recent
years to develop a system for accurate and complete
identification and tracking of HPC and other therapeutic
cell products. The ISBT 128 Standard was voluntarily
created to identify and track cells from the time of
collection through manufacturing, storage, transport and
ultimately patient infusion.
More comprehensive that the proposed NDC scheme, the ISBT
128 labeling system offers more information for better
tracking and tracing of products. The system is currently
recognized by the major standard-setting organizations for
cellular therapy, including ASBMT, EBMT, ISCT, NMDP, WMDA,
FACT, AABB and other national and international
organizations.
The creation of an inferior NDC system would be overly
burdensome and, more important, could adversely affect
patient safety by opening the manufacturing processes to
opportunities for error and by directing resources away
from processes and initiatives that can add to patient
safety.
Your Voice Is Needed
A provision in the proposed rule allows the FDA to grant
exemptions. You can help claim an exemption for HPC
products by your communication to the FDA.
Personalize your comments by explaining why, from your
perspective and experience, the proposed National Drug
Code system would be troublesome to your practice and
potentially harmful to your patients. Be constructive. The
agency is trying to enhance patient safety but needs to
understand the negative implications of the proposed
coding system for HPC products.
It will be gratifying to hear that the agency received a
cascade of e-mail and faxed letters from the blood and
marrow transplant community.
– Rob |
|
|
|
|
Legislation and Regulation |
|
|
Rule would require new codes on HPC products
The FDA is accepting public comments through Jan. 26 on a
proposed rule that would require a National Drug Code label on
all therapeutic products, including biologics such as
hematopoietic progenitor cells collected for transplant.
FDA proposes expanding access to experimental drugs
The FDA has proposed regulatory changes to expand access to
experimental drugs to individual patients, small patient groups
and larger populations under a treatment plan when there is no
satisfactory alternative therapy to diagnose, monitor or treat
the disease or condition. The proposed rules are open for
comment for 90 days.
|
|
|
|
Clinical Research |
| |
Gleevec
provides long-term survival for leukemia patients
Gleevec (imatinib) from Novartis AG continues to treat
chronic myeloid leukemia even after five years of use. A
long-term study found that 89 percent of more than 500
volunteers who started taking the drug beginning around June
2000 remained alive. The rate of deaths related to chronic
myeloid leukemia was 5 percent.
Stem
cell division slows in aging brains
Stem cells divide less frequently in aging brains, leading
to a dramatic drop in the number of new nerve cells being born
in the hippocampus. According to research published in the
advance online issue of the journal Neurobiology of Aging,
it may be possible to stimulate the brain's ability to produce
new brain nerve cells in order to treat neurodegenerative
diseases such as Alzheimer's, depression and dementia.
Tykerb shows promise with early-stage breast cancer
Tykerb (lapatinib), an experimental cancer drug from
GlaxoSmithKline that treats late-stage breast cancer, shows
promise in treating early stages of the disease. Clinical trials
of the drug in combination with Xeloda from Roche significantly
slowed the progression of breast cancer and reduced the chances
of death, compared to patients who took Xeloda alone.
Two
mutations improve recovery from AML
Patients suffering from acute myeloid leukemia who had a
specific combination of two common genetic mutations are more
likely to achieve complete remission after chemotherapy.
According to findings presented at the American Society of
Hematology annual meeting in December, the success of stem cell
transplantation appeared to hinge on the status of combined
NPM1-positive and FLT3-ITD negative mutations.
|
| |
|
Association
News |
| |
|
Review addresses transplants for AML in children
A comprehensive evidence-based review of blood and marrow
transplantation for acute myeloid leukemia in children appears
in the January issue of Biology of Blood and Marrow
Transplantation. The review, supported by a grant from the
National Marrow Donor Program, is the latest in the ASBMT series
of evidence-based reviews of hematopoietic stem cell
transplantation for specific diseases.
Schedule is online for BMT Tandem Meetings
Final preparations are being made for the BMT Tandem Meeting
Feb. 8-12 in Keystone, Colo. The scientific program includes
plenary sessions on marrow vs. peripheral blood vs. cord blood
transplants, new biotechnologies and imaging, chronic GvHD,
mesenchymal stem cells, regulatory T-cells, and cancer and
embryonic stem cells.
Sessions will examine mandatory outcomes reporting
Two sessions at the BMT Tandem Meetings will take up issues
related to new federal requirements to report outcomes of
allogeneic hematopoietic stem cell transplants. An NMDP workshop
on “Measurement and Reporting Treatment Outcomes” will be at
10:30 a.m. on Thursday, Feb. 8, and an update on quality
outcomes reporting will be presented at the Medical Directors
Conference at 1:30 p.m. Sunday, Feb. 11.
Travel grants awarded to 40 young investigators
The ASBMT Board of Directors has announced 40 travel grants for
young clinicians and investigators who will be traveling to
Keystone in February for the BMT Tandem Meetings. Grants of
$1,000 each are being awarded to all young investigators who are
presenting oral abstracts at the meetings.
Faculty selected for clinical research training course
The faculty for the first ASBMT Transplant Clinical Research
Training Course has been announced. Tuition, travel, housing and
meal expenses will be paid for six competitively selected
fellows-in-training and four junior faculty. The course will be
July 18-23 in Keystone, Colo.
2007 version of RFI forms released
The 2007 update of the ASBMT Standardized Request for
Information (RFI) has been released, and the interactive forms
are available online. The RFI is used for submitting transplant
program data and information to third-party payers when they
request it.
Membership grows 5% to record 1,434
ASBMT membership climbed nearly 5% during 2006. Increases
occurred in all categories: Member, Associate Member, Affiliate
Member and In-Training Member. Health professionals outside of
the United States and Canada comprise 13% of ASBMT members.
Eleven new editorial appointments for BBMT
The ASBMT Board of Directors has appointed a new associate
editor and 10 new members to the Editorial Board for Biology
of Blood and Marrow Transplantation. Announcing the new
appointments was Editor-in-Chief Robert Korngold, Ph.D.
Mesenchyal conference will convene in March in New Orleans
The 5th national Conference on Mesenchymal and Tissue Stem Cells
will be March 15-17 in New Orleans. The conference on
mesenchymal stem cell biology, stem cell plasticity and cell
therapy is co-sponsored by ASBMT, the International Society for
Cellular Therapy and the Center for Gene Therapy of the Tulane
University Health Sciences Center.
150 transplant facilities now FACT accredited
Three blood and marrow transplant facilities achieved
accreditation and another earned accreditation renewal during
the fourth quarter of last year, as reported by the Foundation
for the Accreditation of Cellular Therapy (FACT). A total of 150
transplant centers are now FACT accredited.
Ballots for officers, directors are in the mail
The ballots for the annual election of ASBMT officers and
directors were mailed last Friday. Completed ballots must be
returned by Tuesday, Jan. 23.
|
|
