Cell Therapy Stimulus Opportunities

There are some real, imminent stimulus funding opportunities related to cell therapy that offer up to $1 million in funding over 2 years for up to 200 projects all to be handed out quite quickly. If you're interested, here is some info.

To cut right to the chase here's the link:

Recovery Act Limited Competition: NIH Challenge Grants in Health and Science Research (RC1) — request for applications (RFA) number: RFA-OD-09-0003. Bethesda, MD: National Institutes of Health, March 4, 2009. (http://grants.nih.gov/grants/guide/rfa-files/RFA-OD-09-003.html)

The American Recovery and Reinvestment Act of 2009 (Recovery Act) (H.R. 1, S. 1 - PDF-1MB) is a Federal public law passed by the 111th United States Congress and signed into law by President Barack Obama on February 17, 2009.

As part of the Recovery Act, NIH has designated at least $200 million in FYs 2009 - 2010 for a new initiative called the NIH Challenge Grants in Health and Science Research, to fund 200 or more grants, contingent upon the submission of a sufficient number of scientifically meritorious applications.

The April 9 issue of NEJM (Volume 360:1479-1481) summarizes the program as follows:

The NIH also announced that it had designated "at least" $200 million of the stimulus money to fund 200 or more grants in specific challenge areas (comparative-effectiveness research, clinical research, genomics, information technology for processing health care data, regenerative medicine, stem-cell research, and nine others) that "focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds."

This program will support research on Challenge Topics which address specific scientific and health research challenges in biomedical and behavioral research that will benefit from significant 2-year jumpstart funds.

Challenge Areas, defined by the NIH, focus on specific knowledge gaps, scientific opportunities, new technologies, data generation, or research methods that would benefit from an influx of funds to quickly advance the area in significant ways. The research in these areas should have a high impact in biomedical or behavioral science and/or public health.

Links to high priority topics within the broad Challenge Areas that relate particularly to cell therapies include:

(06) Enabling Technologies
(07) Enhancing Clinical Trials
(11) Regenerative Medicine
(13) Smart Biomaterials – Theranostics
(14) Stem Cells
(15) Translational Science

I've scanned through and below are some of the funding high priority topics that I thought might be applicable and of interest here but it is certainly not exhaustive (in other words you should look for yourself):

06-DK-101* Development of cell-specific delivery systems for therapy and imaging. Develop non-viral strategies for cell-specific delivery of pathway-interactors and molecular probes. These new molecular complexes could allow delivery of cell-penetrating agents for the study of disease pathways, the imaging of tissue mass and disease progression, or the development of tissue-specific therapeutics. Contact: Dr. Olivier Blondel, 301-451-7334, blondelol@mail.nih.gov; NIAAA Contact: Dr. Samir Zakhari, 301-443-0799, szakhari@mail.nih.gov; Contact: Dr. Joan McGowan, 301-594-5055,
NIAMShelp-NIHChallengeGrants@mail.nih.gov

06-EB-102* Development of biomedical technologies and systems. Focus areas include: (1) providing immediate diagnostic information for multiple conditions at the point-of-care; (2) a robust, consistently accurate glucose sensor with extended functional lifetime, improved accuracy and low variability of readings; or (3) low cost diagnostic or therapeutic systems. Also, development of such devices engineered to work in low resource settings. Contact: Dr. William Heetderks, 301 451-6771, heetderw@mail.nih.gov

11-DC-101* Hair Cell Regeneration and Maintenance. One common cause of hearing impairment in humans is the progressive loss of the auditory transduction cells, or hair cells, in the inner ear. A similar loss of motion transduction cells in the vestibular organ is a probable cause of balance disorders. Once lost, these cells cannot be spontaneously regenerated in mammals. The Challenge is to develop and validate methods to regenerate and maintain hair cells in animal model systems with the eventual goal of successful translation to human treatments. Contact: Dr. Nancy Freeman, 301-402-3458, freemann@nidcd.nih.gov

11-EB-101* Vascular networks in engineered tissues. Research on the design, optimization, and formation of a complete vascular network capable of delivering oxygen and nutrients and removing waste products in engineered tissues (i.e., vascularization of engineered tissue constructs). Dr. Rosemarie Hunziker, 301-451-1609, hunzikerr@mail.nih.gov

11-HL-101* Develop cell-based therapies for cardiovascular, lung, and blood diseases. Cell-based therapies for cardiovascular, lung, and blood diseases offer a new paradigm for advancing and transforming patient care. Translational and early-phase clinical research has demonstrated that cell-based therapies may improve left ventricular function, reduce myocardial ischemia, and lead to improved lung function. Reconstitution of normal hematopoeisis using modified stem cell graft sources has great potential for treating specific genetic blood disorders. However, a number of significant challenges and barriers must be overcome to move the field forward toward broad clinical application. We encourage further research to determine the characteristics of the most promising target patient population, the best cell type and number of cells to use, the optimal methods and timing of delivery, and other preclinical parameters. Contact: Dr. Sonia Skarlatos, 301-435-0477, skarlats@nhlbi.nih.gov

14-EY-101* Development of stem cell treatment for degenerative diseases of the eye. The restorative properties of stem cells hold the promise in the treatment of degenerative eye diseases such as macular degeneration, diabetic retinopathy, retinitis pigmentosa and glaucoma, and diseases of the ocular surfaces. There is a need for the identification of biomarkers that can define stem cells and the end-stage cells, as well as reproducible protocols for the generation and purification of viable terminally differentiated cells. Contact: Dr. Grace Shen, 301-451-2020, sheng@mail.nih.gov

15-RR-101* Applied translational technology development. This program will support two-year applied translational projects to move advanced technologies from the prototype stage into the clinic. Novel, cost-effective tools for clinical care or clinical research will be modified, hardened, and tested. Interdisciplinary teams of technology developers, basic researchers and clinicians will address scientific and engineering problems associated with clinical applications of new technologies. Contact: Dr. Douglas Sheeley, 301-594-9762, sheeleyd@mail.nih.gov; NIDA Contact: Dr. Kris Bough, 301-443-9800, boughk@mail.nih.gov

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The broader Omnibus of Broad Challenge Areas and Specific Topics has many more challenge topics including the following I thought were potentially applicable:

06-EB-108 Imaging of Drug and Gene Delivery Systems. Three major challenges in the field of drug and gene delivery are: targeting of therapies to tissues, cells, and intracellular compartments; monitoring exactly where the therapies localize after administration; and determining if the agents delivered are doing what they were intended to do. We encourage proposals to develop multifunctional systems that: 1) are capable of targeted delivery of drugs, proteins, genes, or nucleic acids to specific cells, or compartments within cells in vivo; and 2) possess imaging capabilities to track delivery, assess function, and determine therapeutic efficacy. Contact: Dr. Lori Henderson, 301-451-4778, hendersonlori@mail.nih.gov

06-HL-103 Develop new imaging methodologies to track cells and measure accurately the chemical activities of enzymes and metabolites in intact cells, tissues, and organisms to improve basic understanding of cellular interactions, biological pathways, and their regulation. An improved ability to track cells in vivo will enhance our understanding of homing, engraftment, cell differentiation, and pathogenesis resulting from abnormal cells trafficking. Understanding the components and kinetics involved in biochemical reactions is key to evaluating and predicting the response of intact organisms to physiological and pathophysiological challenges and drug responses. Although our knowledge of the identity and quantity of proteins and complexes associated with reaction pathways in health and disease continues to advance, direct methods for imaging those reactions in intact systems are lacking. Development of appropriate tools to track cells, image the microvasculature, and image chemical activity in intact systems in real time will have broad applicability to many heart diseases, including myocardial ischemia and reperfusion injury, heart failure, and arrhythmias and lung diseases such as COPD, asthma, pulmonary hypertension, and sleep apnea. Similarly, new non-invasive cellular imaging modalities, capable of differentiating between normal and pathological states, would increase our understanding of the role of the microvasculature in sickle cell disease and thrombotic disorders. Contact: Dr. Lisa Schwartz Longacre, 301-402-5826, schwartzlongal@mail.nih.gov

11-DK-104 Use of Hematopoietic Stem Cells (HSC) to regenerate or repair mesenchymal tissues. Examples include: Develop and validate methods and reagents that induce HSCs to develop or trans-differentiate into different mesenchymal cell and tissue types; Develop and validate methods and reagents that allow HSCs to be propagated in vitro without loss of self-renewal potential. Contact: Dr. Terry Bishop, 301-594-7726, bishopt@mail.nih.gov

11-EB-105 Advanced Imaging Systems for Tissue Engineering. The ability to monitor complex cell-cell and cell-matrix interactions in engineered tissues in vitro and in vivo is critically important. The imaging needs to be functional—able to assess meaningful changes non-destructively and non-invasively; intrinsic—using inherent signatures of normal biological processes (e.g. intermediates of energy metabolism, conformationally-based changes in light scattering); and dynamic—monitoring events as they are occurring. Proposals to develop tools for characterizing engineered tissues in vitro and in vivo are encouraged. Contact: Dr. Rosemarie Hunziker, 301-451-1609, hunzikerr@mail.nih.gov

11-EB-106 Technologies for Expanding Stem Cells and Producing Engineered Tissue. Tissue engineering and regenerative medicine is a rapidly evolving field, but current production and manufacturing technologies are confined to the laboratory scale and grossly inadequate to ensure sufficient quantity and quality on an industrial scale. New measurement tools, and engineering methods and design principles that can model, monitor, and influence the interaction of cells and their environment at the molecular and organelle level are urgently needed. Projects are sought to develop scaleable bioreactors to precisely control the chemical and mechanical environment for functional 3D tissue growth or for rapidly expanding stem cells; quantitative, non-invasive tools to monitor structure, composition, quorum sensing, and function of heterogeneous tissues in real time; and technologies for preservation, sterilization, packaging, transport, and ensuring cell and tissue health and phenotypic stability. Contact: Dr. Albert Lee, 301-451-4781, alee@mail.nih.gov

11-GM-101 Establishment of regenerative capabilities. Development of approaches and technologies to establish regenerative capabilities in adult cells to repair or replace damaged tissues and organs in situ and to improve wound healing and reduce scarring in human and animal models. Contacts: Dr. Susan Haynes, 301-594-0943, hayness@nigms.nih.gov, Dr. Richard Ikeda, 301-594-3827, ikedar@nigms.nih.gov

13-DK-104 Islet encapsulation. Development of novel islet encapsulation technologies/biomaterials for the optimization of a bioartificial pancreas. Contact: Dr. Guillermo Arreaza, 301-594-4724, arreazag@mail.nih.gov.

13-EB-102 Non-viral Gene Delivery Systems. The major barrier to success of gene therapy in the clinic is the lack of safe and efficient DNA delivery methods. Although viral delivery systems allow efficient and long-term gene expression, they generally do not permit targeted delivery to particular cells and tissues and pose problems with regard to immune response. Proposals are invited to develop novel, safe, and targeted, synthetic or viral mimetic vectors for gene delivery including quantitative studies that relate their structure and properties to function. Contact: Dr. Lori Henderson, 301-451-4778, hendersonlori@mail.nih.gov

14-DE-103 Enhancing Human Embryonic Stem (ES) Cell Culture Systems. Cell differentiation and tissue morphogenesis during normal development is guided by the highly orchestrated temporal, spatial and combinatorial action of multiple of ligands, signaling pathways, transcription factors, and extracellular matrices. In light of this tremendous complexity, the existing human ES cell in vitro culture systems lack appropriate sophistication thus necessitating the need for strategies to better mimic normal developmental processes. Recent progress in the fields of bioengineering, nanotechnology, biomaterials and bioimaging offer a wealth of tools that can lend tight control of the multiple parameters needed to improve the existing human ES culture systems. Goal: Integration of engineering disciplines with developmental biology and with ES cell technology for deriving a new generation of human ES cell culture protocols that will facilitate the application of ES cell-based therapies for the treatment of a multitude of human tissue degenerative diseases and trauma, including those of oral and craniofacial complex. Contact: Dr. Nadya Lumelsky, 301-594-7703, Nadya.Lumelsky@nih.gov

Finally, here is some other key data and links.

Challenge Award Resources

• 2009 Funding Opportunity Announcement (RFA-0D-09-003)
• NIH Institute & Center (IC) Web Sites
• Frequently Asked Questions - NIH Challenge Grants
• Challenge Awards Review Timeline

Some key timeline dates:
Application Due Date(s): April 27, 2009
Peer Review Date(s): June/July 2009
Council Review Date(s): August 2009
Earliest Anticipated Start Date(s): September 30, 2009

Budget requests should be commensurate with project needs up to a two-year project period. The requested budget may not exceed $500,000 total costs per year for a maximum of $1,000,000 total costs over a two-year project period.


Thanks to Bob Speziale from Invetech to pointing this out to me and thus...to you. Good luck to you all.