ASBMT eNews

Attempt begins
to regrow
soldier’s finger

FDA to issue guidance
on clinical trial
adverse events

June 2, 2008

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

Biopharmaceutical News

Association News

Calendar

Job & Fellowship Connections

Monthly Journal

eNews Archives

BMT Tandem Meetings
Feb. 11-15, 2009
Tampa, Florida

NIH Grant Reviewers

Would you be interested in serving as a reviewer for NIH grant applications?

Calendar

• June
FOCIS 2008
Federation of Clinical Immunology Societies (FOCIS)
June 5-9
Boston Marriott Copley Place
Boston, Massachusetts

7th Annual International Umbilical Cord Blood Transplantation Symposium
California Blood Bank Society and Cord Blood Forum
June 6-7
Los Angeles Airport Marriott
Los Angeles, California

International Society for Stem Cell Research (ISSCR)
6th Annual Meeting
June 11-14
Pennsylvania Convention Center
Philadelphia, Pennsylvania

European Hematology Association (EHA)
13th Congress
June 12-15
Bella Center
Copenhagen, Denmark

• July
International Society for Experimental Hematology (ISEH)
37th Annual Scientific Meeting
July 9-12
Renaissance Boston Waterfront Hotel
Boston, Massachusetts

Molecular Biology in Clinical Oncology
American Association for Cancer Research (AACR)
July 11-18
Given Institute of the University of Colorado
Aspen, Colorado

Cancer Biostatistics Workshop
American Association for Cancer Research (AACR)
July 13-19
The Lodge at Sonoma
Sonoma, California

Advances in Long-Term Management of Adult Patients Undergoing Hematopoietic Stem Cell Transplantation
Fred Hutchinson Cancer Research Center
July 18-20
Hilton Union Square
San Francisco, California

Cryo 2008
Society for Cryobiology
45th Annual Meeting
July 20-23
Charlotte, North Carolina

• September
10th International Conference on Chronic Myeloid Leukemia: Biological Basis of Therapy
European School of Haematology
Sept. 5-7
Boston Sheraton Hotel
Boston, Massachusetts

American Association of Tissue Banks (AATB)
32nd Annual Meeting
Sept. 6-9
Marriott Chicago Magnificent Mile
Chicago, Illinois

11th Biennial National Symposium on Hematopoietic Cell Transplantation
Stanford University School of Medicine BMT Program
September 12-13
Frances C. Arrillaga Alumni Center
Stanford, California

European Society for Medical Oncology (ESMO)
Annual Meeting
Sept. 12-16
Stockholm International Fair
Stockholm, Sweden

ISCT Europe Regional Meeting
International Society for Cellular Therapy (ISCT)
Sept. 14-16
Cultural Conference Center Elzenveld
Antwerp, Belgium

American Society of Multicultural Health and Transplant Professionals (ASMHTP)
16th Annual Meeting
Sept. 17-19
Radisson Plaza Hotel
Minneapolis, Minnesota

25th National Oncology Economics Conference
Association of Community Cancer Centers (ACCC)
Sept. 17-20
Hyatt Regency San Francisco
San Francisco, California

8th Annual Somatic Cell Therapy Symposium
International Society for Cellular Therapy (ISCT)
Sept. 22-24
Hyatt Regency Bethesda
Bethesda, Maryland

• October
American Association of Blood Banks (AABB)
2008 Annual Meeting
Oct. 4-7
Palais des Congrès de Montréal
Montreal, Canada

Targeted and Tailored Therapies in Hematology/Oncology
Loyola University Chicago Stritch School of Medicine
Oct. 11
McDonald’s Hamburger University
Oak Brook, Illinois

Cytokines 2008: Cytokines in Cancer & Infectious Diseases
International Cytokine Society (ICS)
Oct. 12-16
Fairmont Queen Elizabeth Hotel
Montreal, Canada

International Congress on Hematologic Malignancies: Lymphoma and Myeloma
Imedex
Oct. 16-18
Waldorf-Astoria Hotel
New York, New York

International Society of Hematology (ISH)
32nd World Congress
October 19-23
Bangkok Convention Centre at CentralWorld
Bangkok, Thailand

Top Stories

California awards $271 million for stem cell research centers
The state of California has awarded $271 million in grants to build 12 stem-cell research centers, the largest amount of money awarded at one time in the state’s taxpayer-backed stem cell program. The universities and research institutes that are receiving the money have said they would spend an additional $560 million on construction of laboratories.

Pediatricians encourage public cord blood banking
The American Academy of Pediatrics has discouraged the use of private cord blood banks, except when a relative has a current need for a transplant. The AAP encourages parents to donate to public banks that make the cord blood available to patients with diseases such as leukemia, lymphoma, sickle cell anemia and thalassemia, as well as immune deficiencies and genetic diseases.

Microbes showing increasing resistance to antibiotics
Two recent developments have health authorities concerned about microbes that are resistant to antibiotics. First, some bacteria have developed the ability to “eat” the very drugs that are supposed to kill them. Second, cases of a lethal form of tuberculosis, XDR-TB, have exploded in Africa, Asia and Russia, with some cases reported in the United States.

Attempt begins to regrow soldier’s finger
In Texas, a wounded soldier was treated with a specially formulated powder, designed to help him regrow a finger that was lost during a bomb attack. This surgery is part of a study of regenerative medicine being pursued by the Pentagon and several top medical facilities, including the University of Pittsburgh Medical Center and the Cleveland Clinic. The drug, made from tissue extracted from pigs, tricks the patient’s body into regrowing tissue by attracting stem cells.

A Word from President Helen Heslop, MD

The odds today for winning research support from the NCI are less than one in five. With 14 percent being the current “payline” for grant applications, there’s ample reason for concern about investigators leaving academic research for other career opportunities.

Is it possible, in this time of austerity, that some investigators may have too much NIH funding? That’s one seemingly paradoxical conclusion of the report of an NIH peer review self-study of ways to improve the process for awarding grant support.

The study was prompted by several realities: stagnant NIH budgets, an increasing number of amended and resubmitted grant applications, and an ever-growing administrative burden on applicants and volunteer reviewers.

Possible solutions
Among the possible solutions recommended in the NIH self-study are:

Shortening the current 25-page RO1 grant application
Treating amended and resubmitted applications as if they are new requests
Funding more RO1 grants for early-stage investigators
Requiring investigators to devote at least 20% of their professional time to each grant

The latter recommendation – a 20 percent “minimum effort” – may seem odd when many investigators are struggling to get any funding, but the study found 783 investigators with four or more awards. That finding was amplified in a further analysis in a recent issue of Nature. It reported that 22 investigators had more than eight awards, but the analysis may be skewed because the NIH’s online database, Computer Retrieval of Information on Scientific Projects (CRISP), counts not just R01 awards, but all grants including components of program awards such as the PO1, the T32 training grants and supplements.

The American Society of Hematology has responded to the NIH self-study, agreeing with the goal of reducing administrative burdens on applicants and reviewers, but disagreeing on the elimination of amended grant requests – the A1 and A2 requests. ASH believes that critique, amendment and resubmission are key components of the peer review process that supports high-quality science.

ASH also argues that the 20 percent minimum effort could have a detrimental impact on multi-disciplinary, multi-investigator grants.

You can assist
The NIH self-study, nevertheless, is evidence that the agency recognizes shortcomings in the grant submission and review process and is seeking to repair them. Additional evidence is in a request that ASBMT received from the NIH last week, asking for nominations of qualified society members to serve on review panels.

“We would like this to be an ongoing process in which you send us names of volunteer reviewers to include in our registry of volunteer reviewers,” the agency said. The NIH is seeking nominations of experienced senior scientists who have received peer-review research support from the NIH or an equivalent agency.

If this sounds like you, and you would like to volunteer for an NIH study group that reviews grant applications, you can indicate your interest by clicking on this link and submitting your name, affiliation and e-mail address. It’s an opportunity for the BMT community to have more input to the process.

In the coming month, ASBMT will be preparing a list of qualified candidates to submit to the NIH.

– Helen

Legislation and Regulation

Senate gives nod to NIH supplemental appropriation
By a large margin of 75-22, the Senate has passed a supplemental appropriations bill that includes $400 million in additional funding for the National Institutes of Health and other science agencies. The similar version of the bill in the House of Representatives does not currently contain the NIH add-ons.

Oklahoma bill passes for public cord blood bank
Oklahoma soon will have a public cord blood bank, thanks to the governor’s signing of House Bill 3060. The bill directs the state Health Department to create the bank, subject to private and public funding. Oklahoma families can use the bank for free.

FDA to issue guidance on clinical trial adverse events
The U.S. Food and Drug Administration soon will issue final guidance distinguishing between adverse events and unanticipated problems in clinical trials. The guidance also will clarify when adverse events must be reported to an institutional review board.

Clinical Research

Doctors expand natural killer cells to fight leukemia
Researchers have discovered a method for expanding the number of natural killer cells from cord blood while retaining the cells’ anti-leukemia effects. According to a report presented at the annual conference of the American Society of Pediatric Hematology/Oncology, use of this process generates more than 150 million natural killer cells from one cord blood unit. When given to mice with aggressive human leukemias, these cells reduced the circulating human acute lymphocytic leukemia and acute myelogenous leukemia cells by 60 to 85 percent.

Research lends new view to stem cell differentiation
Stem cells may differentiate through the collective behavior of multiple genes in a network that ultimately leads to just a few endpoints, according to a report in the May 22 issue of Nature. Researchers determined that cell populations maintain a built-in variability that can be harnessed for change under the right conditions. This indicates the conventional view that cells are instructed to progress along prescribed signaling pathways may be too simplistic.

Biopharmaceutical News

Prochymal cleared for expanded access treatment program
Osiris Therapeutics Inc. has received U.S. Food and Drug Administration clearance to initiate an expanded access treatment program for Prochymal. The drug is a formulation of adult mesenchymal stem cells that is administered through a standard intravenous line. This clearance makes the investigational product available to children with graft vs. host disease.

Advagraf not approved for liver transplants
The U.S. Food and Drug Administration has decided that it isn’t ready to approve Advagraf, a modified-release version of transplant drug Prograf, for liver transplants. Astellas Pharma of Japan says the drug, which already has been approved for this use in Europe, faces a delay of at least six months before receiving approval.

Association News

Society testifies before HRSA advisory council
ASBMT representatives testified on cord blood bank standards and accreditation, and on Medicare reimbursement for clinical trials and indications for transplant, at a hearing of the HRSA Advisory Council on Blood Stem Cell Transplantation.

Comment on cellular product labeling standards
Standards for uniform labeling of cellular therapy products have been developed and are posted online for public comment through Aug. 1. The draft U.S. Industry Consensus Standard for the Uniform Labeling of Cellular Therapy Products using ISBT 128, Version 1.0.0, is the result of collaborative efforts of ASBMT and six other cell therapy organizations.

New data for decision-making in MDS therapy
Recent advances in both drug and transplant therapies for myelodysplastic syndrome will be the topic of a live online CME program on July 21 and a subsequent CD. Produced by the National Marrow Donor Program, the program will feature Richard Stone, MD, discussing novel drug agents and potential applications, and Corey Cutler, MD, presenting advances in transplantation and outcomes. Interactive case histories will demonstrate collaborative approaches in determining treatment strategies.

Charter approved for reimbursement committee
A charter has been approved for a new ASBMT Committee on Reimbursement that consolidates several previous committees.

Scholars prepare for 2008 research training course
Sixteen young clinicians and investigators are preparing for the second annual ASBMT Transplant Clinical Research Training Course, to be held in early August in Park City, Utah.

Conference will celebrate cord blood anniversaries
An international conference on Biology and Clinical Application of Cord Blood Cells in October in Mandelieu, near Cannes, France, will celebrate the 20th anniversary of the first cord blood transplant and 10th anniversary of the International NetCord Foundation, the association of umbilical cord blood banks.

Murine models assess cell mobilization
The recent explosion in the understanding of the cellular and molecular mechanisms underlying hematopoietic stem and progenitor cell mobilization has led to novel therapeutic agents. Dr. Kirsten Herbert and colleagues in Australia review the challenges of designing relevant and efficient preclinical studies for testing these agents for mobilization efficacy in the current issue of Biology of Blood and Marrow Transplantation.

Copyright © 2008 American Society for Blood and Marrow Transplantation.
All rights reserved.
The editor for ASBMT eNews is Stephanie J. Lee, MD, MPH.
E-newsletter services provided by the medical editors at Ascend Media, LLC.

Do you have news, responses or opinions to share with us? Please e-mail the association office at enews@asbmt.org

Sponsored by an unrestricted educational grant from

ASBMT eNews is sent as a membership benefit of the American Society for Blood and Marrow Transplantation. If you would prefer not to receive future issues and want to remove your name from our mailing list, please reply with the word "REMOVE" in the subject line.