December 2003| VOL. 12 | www.McGowan.pitt.edu

REUNION OF HEART AND LUNG TRANSPLANT RECIPIENTS BRINGS PATIENTS, RESEARCHERS AND THE MEDICAL CENTER TRANSPLANT TEAMS TOGETHER AGAIN!

Nearly 200 patients who have had heart, lung or heart/lung transplants at the University of Pittsburgh Medical Center (UPMC) returned to Pittsburgh - some for the first time - along with family members and friends for reunion activities planned by UPMC and the McGowan Institute for Regenerative Medicine.

The weekend of November 14, 15 and 16 was the second annual Patient Reunion Celebration. It is intended as a celebration… not only of life, but also of the hope that new technologies represent for patients requiring an organ transplant. For many patients, this reunion was the first opportunity they have had in a number of years to talk to the team of surgeons, physicians, nurses and other transplant support personnel who cared for them.

In the photograph above, Dr. Robert Kormos, medical director of the McGowan Institute and director of UPMC’s Artificial Heart Program and Thoracic Transplantation, addresses the crowd of nearly 350 patients, their families and other guests. “Many of the people who have had heart transplants at the University of Pittsburgh Medical Center also have been treated with a ventricular assist devices (VAD) that helped them to stay alive until a donor organ could be found,” said Robert Kormos, M.D. “It is good for scientists and physicians to be able to see that their work makes a real difference in people’s lives.”

“The mission of the McGowan Institute for Regenerative Medicine is to foster research in developing new therapies to restore tissue and organ function damaged by injury or disease,” said Alan J. Russell, Ph.D., director of the McGowan Institute. “The people gathering here are living examples of the value of this kind of research. It is only fitting for us to be involved in hosting such an event.”

Patient Weekend activities included a luncheon at the McGowan Institute, educational programs, tours of the McGowan Institute Laboratories and a gala celebration Saturday evening at the Senator John Heinz Pittsburgh Regional History Center. Dr. Brack Hattler, Dr. Robert Kormos, Dr. Kenneth McCurry, Dr. Srinivas Murali, and Dr. Aldo Iacono welcomed the patients and guests, as they shared their appreciation for patients' brave and pioneering spirit and their hope for the future. A non-denominational worship service was held Sunday morning at the Heinz Chapel.

Dr. Back Hattler stops to admire the quilt made by transplant patient families. Patients are given an opportunity to share a caring thought by designing their own square within the quilt.

More than 1,600 transplants of thoracic organs have been performed at the University of Pittsburgh since 1980. Last year, UPMC transplant surgeons performed 41 heart, two heart/lung and 58 lung transplants. In addition, there were 21 implants of heart assist devices.

“Any physician can tell you that it's always an uplifting experience to see people who were desperately ill resume normal lives,” said Kenneth R. McCurry, M.D. (Shown in the photo to the right), assistant professor of surgery and director of lung and heart/lung transplantation at UPMC. “This reunion is a wonderful opportunity for us to share good times in our patients' lives - after all, we've seen many of the worst times.”

Among those attending the patient reunion were:

• Hobert Corley, 52, of Elkins, W.Va., who underwent a heart transplantin 1999 after a 10-year-plus struggle against cardiomyopathy - a progressive weakening of the heart muscle. A former high school math teacher, Corley waited for three years on a transplant list before a suitable donor organ became available. “We had one air-conditioned bedroom, and I was so sick that I basically spent my days lying in bed watching television,” he said. “Now I am back at work teaching - this time in college.”

• Robert Danniballe, 70, of Steubenville, Ohio, who underwent a heart transplant in 1996. A businessman and active leader in Ohio politics, Danniballe had endured two heart attacks and coronary artery bypass surgery before weakening to the point where every day became a fight to live from one breath to the next. “I was so bad I couldn’t leave the hospital, but I was stubborn,” said Danniballe. “Now, I go 10 hours a day - I just got back from Florida last week. I’ve had the best six years of my life. I never thought I would see 70 years old.”

• William Settino, 61, of Shaler Township in Pittsburgh’s northern suburbs, who had a double-lung transplant in 1999. By the time Settino was diagnosed with the progressive disease scleroderma in 1991, damage to his lungs was too great to be helped by medication. Chronic lung disease aggravated by the condition took its toll, and by 1998, his lung capacity had been halved. “I am so lucky,” says Settino, who is an accountant. “I’m doing everything I did before - golfing, bowling, dancing - even riding the Phantom roller coaster at Kennywood with my kids and my grandchildren.”

• James Vance, 45, of Bainbridge, N.Y., who had a double-lung transplant in 1991 and a kidney transplant in 2001. Sickened from 16 years of working in a chemical plant, by 1985 Vance had dwindled from 145 pounds to 96 pounds. Massive amounts of oxygen were no longer effective and he prepared for death. “Now I’m a motivational speaker about organ donation and president of the Sidney (N.Y.) Rotary Club,” says Vance, whose wife donated one of her kidneys to him last year when subsequent health problems prompted complete renal failure. “I’m blessed,” he says.

• Joan Oliva, 50, of Buzzard’s Bay, Mass., whose congenital heart defect and consequent cardiopulmonary hypertension led her to a transplant of a new heart and two lungs in 1985. “I had excellent treatment in Pittsburgh,” says Oliva, who returned to the city yearly for follow-up exams for 10 years. Now checkups take place nearer to her Cape Cod home but she still maintains close contact with those who took part in her care in Pittsburgh. “I went back to work, and I can breathe now without being out of breath after 10 minutes,” she says. “I can go out in the cold without coughing my brains out.”

“Celebrate Life 2003” is a tribute to the brave patients and pioneering clinicians, scientists and engineers. While the accomplishments achieved to date are significant, the opportunities for the future are even more exciting. Through regenerative medicine therapies, such as artificial organs and medical devices, tissue engineering and cellular transplant, we look forward to the possibility of advancing the healing of damaged and diseased organs.

 

On-Line registration for the 2004 McGowan Institute Scientific Retreat is now available. Under the leadership of Cliff Brubaker, Dean of the School of Health and Rehabilitation Sciences, an exciting program has been developed; the Program Committee consists of Michael Chancellor, Ellen Cohn, Rory Cooper, Brad Keller, John Murphy, Bruno Peault, David Vorp, and Alan Wells.

The retreat will be held at Nemacolin Woodlands Resort from February 23-24, 2004. Accommodations are limited, so please register early.

[Registration Page]

 

NIH Grant to Develop an Antibody Filter: William Federspiel, Ph.D. has been awarded a $1.5 million NIH grant on developing an antibody filter. Co-Investigators and collaborators include Drs. Eric J. Beckman, Nicolai V. Bovin, William R. Wagner, and Stephen Badylak. The program includes a subcontract to the Shemyakin Institute of Bioorganic Chemistry, Russian Academy of Sciences in Moscow, Russia.

The focus is to develop and study specific antibody filters (SAFs) for extracorporeal capture of anti-A blood group antibodies (Abs) causing hyperacute organ rejection. The specific aims of the proposed research are to:

Synthesize trisaccharide and related tetrasaccharide A antigens. The synthesized products will be used to immobilize several synthetic Ag conjugates, and to test membranes and assess their Ab binding interactions and functional capacity as related to Ag type and composition.

• Synthesize trisaccharide and related tetrasaccharide A antigens. The synthesized products will be used to immobilize several synthetic Ag conjugates, and to test membranes and assess their Ab binding interactions and functional capacity as related to Ag type and composition.

• Evaluate the mass transfer characteristics of Ab capture in SAF modules using a bench-top perfusion loop.

• Design and fabricate SAF modules capable of reducing normal anti-A levels from whole body blood volumes down to the accepted clinical target for ABO-incompatible transplantation, and perform in-vitro evaluation of Ab capture from these "clinical" SAFs.

While anti-A removal is the subject of this grant, the proposed work will provide a scientific framework for the design and operation of effective SAF devices targeting other pathogenic Abs including anti-B blood group Abs, a less clinically significant but still important impediment to ABO-incompatible transplantation.

Mechanisms of ECM Scaffold Remodeling: Stephen F. Badylak, DVM, MD, PhD, has been awarded a grant in the amount of $1,339,395 from NIH for his proposal, “Mechanisms of ECM Scaffold Remodeling”. Collaborators include: Michael K. Chen, MD, University of Florida, Karen K. Hirschi, PhD, Baylor College of Medicine, Alan R. Spievack, MD, Alan R. Spievack, MD, and Mervin C. Yoder, MD, Indiana University.

This four year grant will investigate the mechanism by which bioscaffolds derived from naturally occurring extracellular matrix become vascularized to support a three dimensional structure. The study will investigate the ability of the scaffolds to recruit circulating progenitor cells as suggested by earlier work in Dr. Badylak’s laboratory and then investigate the ability of scaffolds seeded with vascular progenitor cells to rapidly develop a functional vasculature. Finally, a labeled scaffold will be used to determine the rate of scaffold degradation in vivo and follow the fate of the degradation products. Successful completion of these studies would provide a key step forward for the field of tissue engineering/regenerative medicine as it moves from tissue to organ engineering and from the laboratory to human patients.

Evaluation of Hemodynamic Performance and Basic Biocompatibility In Vivo: Harvey Borovetz, Ph.D. in collaboration with Levitronix will conduct three vivo experiments to evaluate hemodynamic performance and basic biocompatibility of the Levitronix blood pump under a NIH grant.

Evaluation of Hemodynamic Performance and Basic Biocompatibility In Vivo: Harvey Borovetz, Ph.D. in collaboration with Levitronix will conduct three vivo experiments to evaluate hemodynamic performance and basic biocompatibility of the Levitronix blood pump under a NIH grant.

London Daily Telegraph Highlights Gerlach Liver Research: The London Daily Telegraph recently reported on the pioneering research of Joerg Gerlach, PhD, MD toward the development of a bioartificial liver. Through clinical trials in Germany, Dr. Gerlach's bioartificial liver has been able to stabilize 14 patients until a liver transplant was available. In addition, an additional 6 patients were supported on the bioartificial liver for up to 7 days, permitting the patient's liver to regenerate and recover. In the later cases, because of the liver recovery, no transplant was necessary.

Dr. Gerlach and his colleagues are continuing their research in the McGowan Institute laboratories on the development of this promising new technology.

 

A sophisticated control system, developed by researchers at the McGowan Institute, senses when to increase or decrease the rate of blood flow, has been implanted for the first time in the United States by surgeons at the Texas Heart Institute in Houston. The HeartMate II, a new left ventricular assist system (LVAS) is unique as other approved and experimental devices require manual adjustments.

The implant launches a U.S. pilot trial to test the safety and potential effectiveness of the HeartMate II, a miniature rotary pump with axial flow bearings, for patients with end-stage heart failure. Made by Thoratec Corporation, the device is designed to eventually provide long-term cardiac support for patients who are in end-stage heart failure.

UPMC is one of four centers that will test the device in seven patients who are candidates for heart transplantation. The device will be evaluated initially for use as a bridge to heart transplantation.

 

Assistant Professor Tracy Cui received her BE in Polymer Materials and Chemical Engineering and her MS in Biophysics from Tsinghua University, Beijing, China. Her PhD research at the Macromolecular Science and Engineering Center, University of Michigan, Ann Arbor, was dedicated to developing biocompatible and electroactive coatings for neural microelectrode arrays. Prior to joining the University of Pittsburgh’s Bioengineering Department, she worked for Unilever Research as a research scientist and has been working on biomaterials and bio-tribology. Her main research interest is interfacing biological systems via electroactive conductive polymer. Focus areas will include: 1) Surface Modification and Characterization of Biosensors, BioMEMS and implantable medical devices; 2) Conducting Polymer Sensors and Actuators for Biomedical Application; and 3) Polymer Based Biomaterial and Tissue Engineering. In the future, Dr. Cui wants to see neural prosthetic devices developed for implantation to help recover lost brain function.

Assistant Professor Nirmala Sundar Raj has been a faculty member in the Department of Ophthalmology since 1990. Dr. Sundar Raj’s research interests include: the mechanisms of the homeostasis of the corneal epithelium, a self-renewing tissue, and the activation of corneal stromal cells during wound healing.

Dr. Sundar Raj provided a variety of monoclonal antibodies developed to over 40 of investigators, both inside and outside the University of Pittsburgh. She currently serves as the coordinator for Integrity in Research, for the department of Ophthalmology and is a member of the Review Committee for the Competitive Medical Research Fund grants.

She volunteers her time with the UPMC Language Bank, helping break any language barriers by acting as an interpreter for visitors from India. An active community member, Dr. Sundar Raj has participated in Chatham College Women in Science Internship program, Trainee Susan Anderson. She also participates in the "Young Women in Science" day, organized by the School of Medicine.

Dr. Marc A. Simon, Fellow in Cardiovascular Disease at the Cardiovascular Institute of the University of Pittsburgh Medical Center, recently joined the McGowan Institute. His main research focus involves exercise physiology and outcomes in end-stage heart failure patients who are implanted with ventricular assist devices, and outcomes research in end-stage heart failure patients who are treated with cardiac resynchronization therapy. Dr. Simon employs a strong interest in developing mechanical circulatory support for end-stage heart failure patients, by combining engineering and clinical areas.

Dr. Simon received his medical degree from the University of Maryland and completed his residency at the University of Colorado School of Medicine and Affiliated Hospitals in Denver. In September 2001 he began his fellowship program at UPMC Presbyterian. While in Colorado in 1999, Dr. Simon developed and completed a retrospective analysis of heart patients chronically treated with beta blockers to evaluate the predictive utility maximal oxygen consumption.

Peter D. Wearden, M.D., Ph.D. Clinical Instructor- Cardiothoracic Surgery. Current responsibilities include the Director of Surgery of the Center for Preclinical Studies-McGowan Institute; Dr. Wearden joined the Department of Surgery in 2001 where he serves as Clinical Instructor- Cardiothoracic Surgery. He has served as a Resident in Cardiothoracic Surgery, responsible for cardiothoracic patients at UPMC Presbyterian and University Drive VA hospitals 2001-2003). Prior to joining the University of Pittsburgh, Dr. Wearden was the Chief Resident in Surgery (2000-2001) at Ruby Memorial Hospital; Senior Surgical Resident, Ruby Memorial Hospital and the LA Johnson VA Hospital (1998-2001). From 1993 to 1998, Dr. Wearden served as Intern and Junior Surgical Resident, and Research Associate in Surgery at the West Virginia University School of Medicine. Dr. Wearden received his Ph.D., Pharmacology and Toxicology, School of Medicine, West Virginia University (1999); M.D., School of Medicine, West Virginia University (1993).

Questions: Contact Jo-Anne Drabik at drabikj@upmc.edu or 412-235-5124 or Lindsay Rodzwicz at rodzwiczlj@upmc.edu or (412) 235 5157

 

Title: Progression of Cardiovascular Disease in Type 1 Diabetes

Release Date: December 4, 2003

RFA Number: RFA-HL-04-013

CFDA Numbers: 93.837, 93.847

URL: http://grants1.nih.gov/grants/guide/rfa-files/RFA-HL-04-013.html

Letter of Intent Receipt Date: February 24, 2004

Application Receipt Date: March 24, 2004

Purpose: The National Heart, Lung and Blood Institute (NHLBI) and the National Institute of Diabetes, Digestive and Kidney diseases (NIDDK) invite investigator initiated applications for basic and clinical studies to enhance our understanding of the onset and progression of cardiovascular disease (CVD) in patients with type 1 diabetes. Classic CVD risk factors such as hyperglycemia, hypertension, dyslipidemia, and central obesity increase the risk of CVD in patients with type 1 diabetes, but do not fully explain the significantly higher incidence of CVD in type 1 diabetes. Thus type 1 diabetes may lead to unique mechanisms for the onset and progression of CVD, as well as influencing mechanisms known for type 2 diabetes and the general population. Identification of the mechanisms that trigger early development of atherosclerosis in type 1 diabetes is important for development of interventions to prevent and treat CVD in this population. This Request for Applications (RFA) seeks basic and clinical studies that will enhance our understanding of the effects of type 1 diabetes and its metabolic complications on the early development and fast progression of cardiovascular disease in these patients.

 

Title: Research on Crystal Deposition Arthropathies

Release Date: December 5, 2003

RFA Number: RFA-AR-04-006

CFDA Numbers: 93.846 (NIAMS) and 93.866 (NIA)

URL: http://grants1.nih.gov/grants/guide/rfa-files/RFA-AR-04-006.html

Letter of Intent Receipt Date: July 19, 2004

Application Receipt Date: August 19, 2004

Purpose: The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) and the National Institute on Aging (NIA) invite applications for research on improved diagnosis and treatment of the major crystal deposition arthropathies including gout, calcium pyrophosphate dihydrate (CPPD) crystal deposition disease and hydroxyapatite crystal deposition disease (also known as basic calcium phosphate crystallopathy). The applications may be for individual research projects (R01) or for exploratory/developmental grants (R21). The crystal deposition arthropathies constitute significant public health problems. Theseproblems are anticipated to grow in scope in view of the increased number of elderly in our population, and the increasing numbers of people with osteoarthritis predisposing cartilage to calcification disorders. The Request for Applications (RFA) is based, in part, on the scientific opportunities identified in the NIAMS Roundtable held in 2003: "Opportunities for Translational Research on Articular Crystal Deposition Diseases: Gout, CPPD Crystal Deposition Disease, Hydroxyapatite Deposition Arthropathy."

 

Title: Interagency Registry of Mechanical Circulatory Support for End-Stage Heart Failure

Release Date: December 4, 2003

Notice: NOT-HL-04-103

Response Due Date: December 30, 2003

Purpose: The NHLBI plans to release a Request for Proposals for a Clinical and Data Coordinating Center to establish a patient and device data registry to track patients receiving mechanical circulatory support for end-stage heart failure. The registry will also establish a tissue and blood repository. The registry will benefit the research and practice communities as well as federal agencies concerned with patient safety and oversight.

The NHLBI would like information from academic institutions, professional groups and private industries that develop and apply mechanical circulatory support devices to identify optimum parameters to establishing a registry and ways to design and implement an effective program. Specifically, NHLBI seeks advice concerning core information to be collected, concerns and solutions to protect rights of patients, facilities, providers and support teams and manufacturers. Also important are independence of data analysis, access to data and data sharing, and potential strategies for the registry to become at least partially self-supporting. Ways to involve private industry without undermining the independence of the program governance are also sought.

Information Requested: NHLBI seeks comments and suggestions as requested below.

1. Patient outcomes are determined by patient characteristics, surgical provider and facilities support, and device performance. Please suggest data elements you consider essential for collection by the registry.

2. Abstracting hospital and out-patient data and checking accuracy of submitted data will be required. Please provide concerns you have about the registry collecting data on patients, devices, hospitals and medical providers. Please suggest ways the NHLBI can design registry protocols to minimize those concerns.

3. Please identify ways for NHLBI to encourage industry to participate and support the registry.

4. Please suggest ways to design the registry so that participants do not have duplicate reporting requirements.

5. Please provide methods to ensure accuracy and security of data in the registry.

6. Please suggest strategies for the registry to become at least partially self-supporting.

7. We would appreciate any additional views or opinions that you think would be useful to develop a registry that will improve outcomes for patients receiving mechanical circulatory support.

Response and Process: Responses in any of the areas are welcome; respondents should not feel compelled to address all items. Please respond no later than December 30, 2003. We look forward to your thoughts, opinions and suggestions and hope that you will share this document with your colleagues. All responses will be kept confidential.

To respond please link to the online form in the "What's New" section on the NHLBI home page ( http://www.nhlbi.nih.gov/new/whatsnew.htm ) or send a letter, fax or email to the following address:

Amanda Curto
Program Specialist
Clinical and Molecular Medicine Program
Division of Heart and Vascular Diseases
National Heart, Lung, and Blood Institute
National Institutes of Health
6701 Rockledge Drive, Rm. 9153, MSC-7940
Bethesda, MD 20892-7940 (Courier 20817)
Tel. 301-435-0515 / Fax. 301-480-1336
Email: curtoa@mail.nih.gov

 

Grand Challenges in Global Health

Solicitation for Letters of Intent (LOI)

Due Date: January 9, 2004

Purpose of this Announcement: The purpose of this announcement is to solicit Letters of Intent (LOIs) from investigators interested in applying for funding to address one of the grand challenges under the Grand Challenges in Global Health initiative. A LOI is a mandatory first step in the application process. Each LOI must address one, and only one, of the selected grand challenges described below. LOIs on other topics will not be considered.

The Grand Challenges in Global Health Initiative:  The Grand Challenges in Global Health initiative was established by the Bill & Melinda Gates Foundation, in collaboration with the National Institutes of Health and the Foundation for the National Institutes of Health, to support scientific and technological research that addresses critical scientific challenges in global health and increased research on diseases that cause millions of deaths in the developing world. The initiative, led by an international Scientific Board, seeks the participation of the global scientific community in addressing the "Grand Challenges" for scientific exploration, focusing attention on the most critical health problems in the developing world. Although there are enormous challenges that relate to poverty, access to health interventions, and delivery systems in developing countries, this initiative is focused on the grand scientific and technological research challenges in health.

Selection of the Grand Challenges: The Grand Challenges in Global Health initiative started with a worldwide call for ideas from the scientific community on what the grand scientific and technological challenges in global health should be. Over 1,000 submissions were received from 75 countries. These ideas have been sorted, analyzed and synthesized. From the analysis, a first set of 14 grand challenges has emerged that were judged to be the most compelling ideas with the greatest chance of making a dramatic difference. These challenges are the subject of this announcement. Additional challenges may be announced in the future.

Definition of a Grand Challenge: The grand challenges that have been chosen call for specific scientific or technological innovations that will remove a critical barrier to solving an important health problem in the developing world with a high likelihood of global impact and feasibility. They ask for innovative research that will break through the roadblock that stands between where we are now and where we would like to be.  Research that deals with the general topic of a grand challenge without focusing on solving the specified problem , will not be considered responsive, regardless of its merit.

List of Grand Challenges: Applicants may respond to one or more of the following grand challenges. However, each LOI must be confined to a single challenge.

Goal: To improve childhood vaccines:

GC #1 Create effective single-dose vaccines that can be used soon after birth .

GC #2 Prepare vaccines that do not require refrigeration .

GC #3  Develop needle-free delivery systems for vaccines .

Goal: To create new vaccines:

GC #4  Devise reliable tests in model systems to evaluate live attenuated vaccines .

GC #5  Solve how to design antigens for effective, protective immunity .

GC #6 Learn which immunological responses provide protective immunity .

Goal: To control insects that transmit agents of disease:

GC #7   Develop a genetic strategy to deplete or incapacitate a disease-transmitting  insect population .

GC #8   Develop a chemical strategy to deplete or incapacitate a disease-transmitting insect population .

Goal: To improve nutrition to promote health:

GC #9 Create a full range of optimal, bioavailable nutrients in a single staple plant species .

Goal: To improve drug treatment of infectious diseases:

GC #10 Discover drugs and delivery systems that minimize the likelihood  of drug resistant  micro-organisms .

Goal: To cure latent and chronic infections:

GC #11 Create therapies that can cure latent infections .

GC #12 Create immunological methods that can cure chronic  infections .

Goal: To measure disease and health status accurately and economically in developing countries :

GC#13 Develop technologies that permit quantitative assessment of  population health status .

GC#14 Develop technologies that allow assessment of individuals for multiple conditions or pathogens at point-of-care .

Program Information: The Bill & Melinda Gates Foundation has provided a $200 million gift for this initiative.  Distribution of the funds among the challenges will be determined by the merit of the applications received.

Applicants responding to this announcement must address the chosen grand challenge in a focused and comprehensive approach that has a high probability of solving the stated problem. Collaborative approaches are encouraged. Projects involving multiple investigators or organizations must be submitted as a single LOI with a principal investigator who will lead the project.

Collaborations with scientists from the underdeveloped world are strongly encouraged, and are mandatory where the scientific goals demand it. Plans for such collaborations must be addressed in the application and any collaborators listed.

The application process involves two stages. The first stage in the application process is the Letter of Intent (LOI). This step is mandatory.

 
CLICK HERE to obtain a printed copy of the LOI and instructions.

In step two, an invitation to submit a formal application will be issued only to those applicants who present the most promising research approaches, based on the LOIs. Small planning grants may be offered to assist with the preparation of full applications involving multiple institutions to help defray costs of travel.

Applicants may request a project period of up to five years and a budget totaling up to $20 million over the life of the grant.  However, the size and duration of the request should be commensurate with the nature of the research. It is expected that many awards will be well below the budget limit. Renewals of grand challenges in global health grants will not be entertained.  Allowable direct costs include salaries, equipment, supplies, consultant costs, travel, and subcontracts for collaborative projects. All costs that can be directly attributed to the project may be requested as direct costs.

Administrative costs (indirect costs) will be reimbursed at 15 percent of modified direct cost (excluding equipment and subcontracts).

While not required in the LOI, all full applications will be required to present an intellectual property plan that addresses how any intellectual property used or discovered under the grant will be managed so as to assure that benefits accrue to the developing world where they are most needed.

The full application will also require a sharing plan, describing how data and materials produced by the grant will be shared with the community. Publication in open access journals will be encouraged.  See Sharing Terms and Conditions.

In the full application, applicants will be asked to describe how they will address any ethical, legal or social concerns raised by the research they propose. See Ethical, Social, Cultural Terms and Conditions.

Eligibility: For-profit, non-profit, academic, domestic and foreign institutions may submit LOIs. Individuals not affiliated with an institution are not eligible to submit an LOI.

Review Process for Letters of Intent : LOIs will be screened for eligibility and to determine how well they meet the requirements of the grand challenge they are proposing to address. Once the screening process is completed, an invitation to submit a full application will be sent to those respondents judged to have presented the most compelling ideas with the greatest impact on the developing world. Respondents who are not selected will be notified, but it will not be possible to provide feedback on the reasons for non-selection. No information will be provided until the selection process has been completed.

The following criteria will be used in screening LOIs:

•  Likelihood of solving the grand challenge

•  Degree of innovation and novelty

•  Potential for implementation of the proposed solution in the developing world

•  Qualifications of the investigators

•  Nature and appropriateness of any collaborative efforts

•  Budgetary considerations

Receipt and Review Schedule:

LOI Receipt Date: January 9, 2004

LOI Screening Completed:late February, 2004

Letter of Invitation to Applicants to submit complete applications: early March, 2004

Tentative Receipt date for applications: June 2004

Tentative announcement of awards: October 2004

This schedule may be adjusted, depending on the volume of applications received.

CONTACT INFORMATION

Questions related to the program may be addressed to: Grants@GrandChallengesGH.org

The Foundation for the National Institutes of Health (FNIH) is a non-profit corporation authorized by and established at the direction of the United States Congress to build and foster collaborative relationships with philanthropy, industry and academia to support the mission of the National Institutes of Health – improving health through scientific discovery.

More information about the Foundation for the National Institutes of Health is available at: http://www.fnih.org

 

Program Title: Grants for the Department-Level Reform of Undergraduate Engineering Education (DLR)

Program Solicitation Number: NSF 04-523 Replaces Document NSF 03-562

CFDA Numbers: 47.076, Education and Human Resources; 47.041, Engineering

Limit on Number of Proposals: 1 - Institutions can submit a maximum of one planning grant proposal and one implementation grant proposal.

Estimated Number of Awards: 26 - An extimated 20 planning and 6 implementation awards are expected to be made.

Anticipated Funding Amount: $8,000,000 per year for an estimated 20 planning grants of up to $100,000 each, and 6 implementation grants of up to $1,000,000 each, subject to the availability of funds and the quality of proposals received.

URL: http://www.nsf.gov/pubs/2004/nsf04523/nsf04523.htm

Full Proposal Deadline (due by 5 p.m. proposer's local time): March 12, 2004

Synopsis of Program: The Grants for the Department-Level Reform of Undergraduate Engineering Education solicitation provides an opportunity for institutions to compete for planning and implementation grants to assist departmental and larger units in:

Engaging faculty in the scholarship of learning and teaching on a department wide basis,

Developing, implementing, assessing and disseminating comprehensive plans to reformulate, streamline and update engineering degree programs,                

Developing, implementing, assessing department wide transformational change of student learning experiences,

Incorporating Service Learning opportunities into engineering programs,

Meeting the emerging workforce and educational needs of U.S. industry, and

Incorporating methods for integration of research and teaching. 

This solicitation is a collaborative effort between the Directorate for Engineering (ENG) and the Directorate for Education and Human Resources (EHR).

Centers for Disease Control and Prevention

Title: Grant for Injury Control Research Center

Announcement Type: New

Funding Opportunity Number: 04057

CFDA Number: 93.136

URL: http://www.cdc.gov/od/pgo/funding/04057.htm

Letter of Intent Deadline:  December 26, 2003

Application Deadline: February 23, 2004

Funding Opportunity Description

Authority: This program is authorized under sections 301(a) and 391(a) (1) of the Public Health Service Act, [42 U.S.C. sections 241(a) 280b(a) (1)], as amended.

Purpose: The Centers for Disease Control and Prevention (CDC) announces the availability of fiscal year (FY) 2004 funds for a grant for an Injury Control Research Center (ICRC). This program addresses the "Healthy People 2010" focus area of Injury and Violence Prevention. A copy of "Healthy People 2010" is available at the following Internet address: http://www.health.gov/healthypeople .

The purposes of this program are:

1. To support an ICRC in a state predominately comprised of economically depressed rural communities where a relatively large portion of the work force is engaged in underground mining, family farming, and other rural occupations.

2. To support injury prevention and control research on priority issues as delineated in: "Healthy People 2010"; "Reducing the Burden of Injury: Advancing Prevention and Treatment"; and the research priorities published in the CDC Injury Research Agenda, located at http://www.cdc.gov/ncipc .

3. To integrate, in the context of a national program, the disciplines of epidemiology, medicine, biomechanics and other engineering, biostatistics, public health, law and criminal justice, and behavioral and social sciences in order to prevent and control injuries more effectively.

4. To define the injury problem; identify risk and protective factors; develop and evaluate prevention and control interventions and strategies; and ensure widespread adoption of effective interventions and strategies.

5. To provide technical assistance to injury prevention and control programs within a geographic region.

Measurable outcomes of the program will be in alignment with the following performance goal for the National Center for Injury Prevention and Control (NCIPC):

Conduct a targeted program of research to reduce injury-related death and disability .

Research Objectives: Center funding is to be designated for two types of activities. One type of activity is considered core and includes administration, management, general support services (e.g., statistical, library, media relations, and advocacy for injury prevention and control) as well as activities associated with research development, technical assistance, and education (e.g., seed projects, training activities, and collaborative and technical assistance activities with other groups). Funds may be allocated for trainee stipends, tuition remission, and trainee travel in accordance with the current rates for the United States Public Health Service agencies. Indirect costs for these trainee-related activities are limited to eight percent.

Defined research projects constitute the second type of activity, and ICRCs are encouraged to work toward addressing the breadth of the field. Core activities and defined research projects may each constitute between 25 percent and 75 percent of the operating budget, and should be balanced in such a way that the ICRC demonstrates productivity in research as well as teaching and service. Applicants with less demonstrated expertise in research are encouraged to devote a larger percentage of funds to defined research projects in order to establish their capability as research centers of excellence.

At least 80 percent of the costs (total direct and indirect costs) of the approved small and large research projects must be in alignment with the "CDC Injury Research Agenda," http://www.cdc.gov/ncipc .

Eligible applicants may enter into contracts, including consortia agreements, as necessary to meet the requirements of the program and strengthen the overall application.

 

Title: Grants for Traumatic Injury Biomechanics Research

Announcement Type: New

Funding Opportunity Number: 04047

CFDA Number: 93.136

URL: http://www.cdc.gov/od/pgo/funding/04047.htm

Letter of Intent Deadline: December 22, 2003

Application Deadline: February 19, 2004

Funding Opportunity Description

Authority: This program is authorized under section 301 (a) [42 U.S.C. 241(a)] of the Public Health Service Act, and section 391 (a)[42 U.S.C. 280 b(a)] of the Public Service Health Act, as amended.

Purpose: The purposes of the program are to:

1. Solicit research applications that address the priorities reflected under the heading, "Research Objectives."

2. Build the scientific base for the prevention and control of injuries, disabilities and deaths.

3. Encourage professionals from a wide spectrum of disciplines of engineering, epidemiology, medicine, biostatistics, public health, law and criminal justice, behavioral and social sciences to perform research in order to prevent and control injuries more effectively.

4. Encourage investigators to propose research that involves intervention development and testing as well as research on methods; to encourage individuals, organizations, or communities to adopt and maintain effective intervention strategies.

This program addresses the "Healthy People 2010" focus area of Injury and Violence Prevention. Measurable outcomes of the program will be in alignment with one (or more) of the following performance goals for the National Center for Injury Prevention and Control (NCIPC):

1. Increase the capacity of injury prevention and control programs to address the prevention of injuries and violence.

2. Monitor and detect fatal and non-fatal injuries.

3. Conduct a targeted program of research to reduce injury-related death and disability.

Research Objectives:

NCIPC is soliciting investigator-initiated research that will help expand and advance our understanding of nonoccupational unintentional and violence-related injuries, and to minimize the consequences of injuries when they do occur. NCIPC's public health approach draws on biomechanics in seven topic areas:

1. Preventing Injuries at Home and in the Community.

2. Preventing Injuries in Sports, Recreation, and Exercise.

3. Preventing Transportation Injuries.

4. Preventing Intimate Partner Violence, Sexual Violence, and Child Maltreatment.

5. Preventing Suicidal Behavior.

6. Preventing Youth Violence.

7. Acute Care, Disability, and Rehabilitation.

The following research themes are the focus of this solicitation:

High Priority

1. Use biomechanics research and the knowledge of injury tolerance and injury mechanisms to develop and/or evaluate interventions that address the following specific injury prevention and control problems:

a. Falls that occur among older, community dwelling

adults (e.g. hip pads).

b. Injuries in mass trauma events.

c. Severe and disabling falls among children.

d. Sports, recreation, and exercise-related injuries (e.g. playground and other play environments, safety gear).

 

Title: Metabolomics Technology Development

Release Date: September 29, 2003

RFA Number: RFA-RM-04-002 (formerly RFA-DK-04-001, see NOT-OD-04-008 )

CFDA Number: 93.847

URL: http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-04-002.html

This RFA is developed as a roadmap initiative. All NIH Institutes and Centers participate in roadmap initiatives.

Letter of Intent Receipt Date: February 24, 2004

Application Receipt Date: March 24, 2004

Purpose: The Institutes and Centers of the National Institutes of Health invite applications for development and application of new technologies in metabolomics to enable research aimed at elucidating biological pathways and networks. The purpose of this initiative is to encourage the development of highly innovative and sensitive tools for identifying and quantifying cellular metabolites and their fluxes at high anatomical, spatial, and temporal resolution.

The general aim of metabolomics is to identify, measure and interpret the complex time-related concentration, activity and flux of endogenous metabolites in cells, tissues, and other biosamples such as blood, urine, and saliva. For the purposes of this solicitation, metabolites include small molecules that are the products and intermediates of metabolism, but also carbohydrates, peptides, and lipids. The need for innovative technologies for measuring and quantifying metabolites involved in cellular pathways and networks was articulated in the 2003 NIH Roadmapping Initiative. It is expected that the technologies developed under this initiative will play a major role in transferring capabilities to laboratories and research institutes that are investigating the underlying pathways involved in cellular homeostasis, perturbation, development, and aging.

Many ongoing research programs focus on development of new genomics and proteomics tools and utilization of those approaches for studying cellular function. In contrast, relatively few research programs focus on metabolomics technology development and application. This initiative is to encourage the development of highly innovative and sensitive tools for identifying and quantifying cellular metabolites and their fluxes at high anatomical resolution---extending to subcellular--- and at a temporal resolution that would be appropriate to understanding cellular processes at biologically relevant timescales. The scope of projects that would be appropriate ranges from techniques for improving and refining the process of sample separation and processing; to new methods, reagents or instrumentation for identifying and measuring metabolites and their fluxes; to the development and utilization of data reduction, management, and analysis tools needed to establish proof of principle for the technology. New technologies that, if successful, have the potential to be scalable, either as high-

throughput applications or as advances that would be used in a large number of laboratories, are especially encouraged. While it is also important to develop data storage, data mining, and pathway modeling capabilities for metabolomics, these issues are explicitly not included in this particular solicitation.

 

Title: NIAMS Participation in Novel Approaches to Enhance Animal Stem Cell Research (PA-02-147)

Release Date: December 10, 2003

Notice: NOT-AR-03-005

URL: http://grants1.nih.gov/grants/guide/notice-files/NOT-AR-03-005.html

The National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) will participate in Program Announcement (PA-02-147) “Novel Approaches to Enhance Animal Stem Cell Research” which was released in the NIH Guide for Grants and Contracts August 9, 2002 ( http://grants.nih.gov/grants/guide/pa-files/PA-02-147.html ).

The NIAMS seeks studies to advance understanding of the biology of stem cells, the molecular mechanisms that govern formation of skin and musculoskeletal tissues, and the pathogenesis and treatment of arthritis and musculoskeletal and skin diseases.

Direct your questions about scientific/research issues to:

Bernadette Tyree, Ph.D.
Rheumatic Diseases Branch, Extramural Program
National Institute of Arthritis and Musculoskeletal and Skin Diseases
Bethesda, MD 20892
Telephone: (301) 594-5032
Email: tyreeb@mail.nih.gov

Direct your questions about financial or grants management matters to:
Melinda Nelson
Grants Management Branch

National Institute of Arthritis and Musculoskeletal and Skin Diseases
Bethesda, MD 20892
Telephone: (301) 594-3535
Email: nelsonm@mail.nih.gov

 

Title: Rapid Access to Intervention Development (RAID)

Release Date: December 12, 2003

Notice: NOT-CA-04-003

URL: http://grants1.nih.gov/grants/guide/notice-files/NOT-CA-04-003.html

The NATIONAL CANCER INSTITUTE (NCI) is requesting applications for the following initiative: Rapid Access to Intervention Development (RAID). RAID will make available to academic investigators, on a competitive basis, the preclinical development contract resources of NCI's Developmental Therapeutics Program (DTP). RAID is not a grant program. Approved applications to RAID instead gain access to the drug development contract resources of the Developmental Therapeutics Program. The goal of RAID is the rapid movement of novel molecules and concepts from the laboratory to the clinic for proof-of-principle clinical trials. RAID will assist investigators who submit successful applications by providing any (or all) of the preclinical development steps that may be obstacles to clinical translation. Possible tasks may include production, bulk supply, good manufacturing process (GMP) manufacturing, formulation, and toxicology. Suitable agents for RAID will include small molecules, biologics, or vaccines.

There are two receipt dates, February 1 and August 1, for requests for RAID support per year. Current requests must be received by February 1, 2004, with all materials submitted directly to the office listed below.

For information on the procedure for requesting RAID resources, visit the DTP web site http://dtp.nci.nih.gov/ . Inquiries are encouraged and DTP staff welcome opportunities to clarify issues or answer questions about the RAID program. Academic investigators may have collaborations with small-business partners and still qualify for RAID funding. Non-profit organizations other than universities may also submit RAID applications. Please note that a maximum of two distinct requests for support per investigator can be submitted for each receipt date.

Inquiries:

Inquiries regarding this notice may be directed to:

RAID
Office of Associate Director
Developmental Therapeutics Program
Division of Cancer Treatment and Diagnosis
National Cancer Institute
6130 Executive Blvd., EPN Suite 8022
Bethesda, MD 20892-7458 (U.S. mail)

Telephone: 301-496-8720
Fax: 301-402-0831
Email: raid@dtpax2.ncifcrf.gov

 

Title: Genomics of Transplantation Cooperative Research Program

Release Date: December 11, 2003

RFA Number: RFA-AI-04-002

CFDA Numbers: No. 93.855, Immunology, Allergy, and Transplantation Research No. 93.856, Microbiology and Infectious Diseases Research

URL: http://grants1.nih.gov/grants/guide/rfa-files/RFA-AI-04-002.html

Letter of Intent Receipt Date: February 16, 2004

Application Receipt Date: March 15, 2004

Purpose: The purpose of this RFA is to solicit applications from single institutions or consortia of institutions to establish cooperative interdisciplinary research programs for large-scale, broad-scope genomic studies in clinical transplantation, including solid organ, tissue, and cell transplantation. The goals of this program are to identify and characterize gene polymorphisms and gene expression patterns that: (1) correlate with and/or predict transplantation outcomes; (2) delineate immune responses relating to the onset and severity of acute and chronic graft rejection; (3) predict responses to immunosuppressive therapeutics to allow tailoring of therapy; and (4) elucidate the genetic basis of variability in graft survival between populations. The long-term goal of the program is to understand the genetic basis of immune-mediated graft rejection and differences in transplant outcomes, and thereby provide a rational basis for the development of more effective treatment and prevention strategies to improve long-term graft survival and provide a better quality-of-life for transplant recipients.

 

Title: Clinical Trials in Organ Transplantation

Release Date: December 9, 2003

RFA Number: RFA-AI-04-003

CFDA Numbers: No. 93.855, Immunology, Allergy, and Transplantation Research

No. 93.856, Microbiology and Infectious Diseases Research

No. 93.849, Kidney Diseases, Urology and Hematology Research

No. 93.837, Heart and Vascular Diseases Research

No. 93.838, Lung Diseases Research

No. 93.839, Blood Diseases and Resources Research

URL: http://grants1.nih.gov/grants/guide/rfa-files/RFA-AI-04-003.html

Letter of Intent Receipt Date: February 16, 2004

Application Receipt Date: March 15, 2004

Purpose: The Division of Allergy, Immunology, and Transplantation (DAIT) of the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH) invites applications from consortia of 2 or more institutions to participate in a clinical studies program of immune-mediated pathologic processes in organ transplantation. The purpose of this program is to support a cooperative, multi-site consortium for interventional or observational clinical studies, accompanied by mechanistic studies, to enhance our understanding of and ultimately reduce the immune-mediated morbidity and mortality of organ transplantation. These studies will be carried out in pediatric and adult candidates for and recipients of organ transplants as multi-center clinical trials that will (1) evaluate new therapeutic regimens to overcome immunologic barriers to graft acceptance and/or long-term graft and patient survival, (2) evaluate approaches to the treatment or prevention of immune-mediated complications of transplantation; (3) investigate the underlying mechanisms of action of the pathologic processes, agents or regimens under study; (4) develop diagnostic tests for and/or surrogate biomarkers that will facilitate routine surveillance, early diagnosis and ongoing monitoring of those processes that contribute to post-transplant morbidity and mortality. Studies of hematopoietic stem cell transplantation (HSCT) are excluded, unless HSCT is a component of a study of organ transplantation. Studies of islet transplantation for treatment of type I diabetes are also excluded.

 

Title: Ruth L. Kirschstein National Research Service Awards for Individual Predoctoral Fellows (F31)

Release Date: December 08, 2003

PA Number: PA-04-032

CFDA Numbers: 93.272 (NIAAA), 93.286, (NIBIB), 93.173 (NIDCD), 93.278 (NIDA), 93.282 (NIMH), and 93.853 (NINDS)

URL: http://grants1.nih.gov/grants/guide/pa-files/PA-04-032.html

Expiration Date: November 1, 2006

This program announcement supersedes PA-00-125

http://grants.nih.gov/grants/guide/pa-files/PA-00-125.html , which appeared in the NIH Guide on July 25, 2000.

Purpose: The National Institute on Alcohol Abuse and Alcoholism (NIAAA), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), the National Institute on Deafness and Other Communication Disorders (NIDCD), the National Institute on Drug Abuse (NIDA), the National Institute of Mental Health (NIMH), and the National Institute of Neurological Disorders and Stroke (NINDS) provide Ruth L. Kirschstein National Research Service Awards (Kirschstein-NRSA) to individuals for doctoral-level training. These Institutes award Kirschstein-NRSA individual predoctoral fellowships (F31) to promising applicants with the potential to become productive, independent investigators in their scientific mission areas.

Each Institute has a unique scientific purview and different program goals and initiatives that evolve over time. Therefore, it is critical that all applicants consult the appropriate Institute website and contact the appropriate Institute office, both listed under “Where to Send Inquiries,” prior to preparing an application to obtain current information about each Institute's program priorities and policies with regard to fellowships. This action is of utmost importance since applications with marginal or no relevance to NIAAA, NIBIB, NIDCD, NIDA, NIMH, or NINDS programs will not be accepted for review or funding by the participating Institutes.

 

Title: NHLBI Competitive Supplements for Human Embryonic Stem Cell Research

Release Date: December 12, 2003

PA Number: PAR-04-037

CFDA Numbers: 93.837, 93.838, 93.839

URL: http://grants1.nih.gov/grants/guide/pa-files/PAR-04-037.html

Expiration Date: February 13, 2004, unless reissued.

Letter of Intent Receipt Date: January 13, 2004

Application Receipt Date: February 13, 2004

Purpose: The purpose of these supplements is to enable NHLBI grantees with little or no prior experience working with human embryonic stem (ES) cell lines to conduct research with these cell lines that is directly related to the aims of an existing, funded NHLBI grant. The research proposed in the supplement should be within the scope of the existing NHLBI grant and may not expand the original scope of the parent grant. Only research using human ES cell lines listed in the NIH Human Embryonic Stem Cell Registry will be eligible for Federal funding (see http://escr.nih.gov/ ).

 

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