Notice Number: NOT-MH-12-034
Key Dates
Release Date: September 12, 2012
Response Date: October 31, 2012
Issued by
National Institute of Mental Health (NIMH)
Purpose
The National Institute of Mental Health (NIMH) seeks to facilitate the use of patient-derived reprogrammed cells (e.g., induced pluripotent stem cells or iPSCs, induced neuronal cells or iNCs) to study the molecular and cellular basis of mental illness, to identify potential targets for therapeutic intervention and to develop new diagnostic tools and/or interventions to reduce the burden of mental illness among the public. This Request for Information (RFI) solicits comments from all potentially interested parties in the academic, private and public sectors regarding their level and scope of interest in a collaborative public-private partnership, and where NIMH investment and/or coordination can help facilitate this research.
Background
Increasing efforts are being directed toward using iPSCs and iNCs to study molecular and cellular abnormalities underlying mental illness, including schizophrenia, bipolar disorder, autism spectrum disorders, attention deficit hyperactivity disorder and anxiety disorders. These technologies utilize (epi)genetic manipulation that reprogram adult somatic cells to stem cell or alternative cell fates, thereby generating an in vitro system with greater relevance to cellular pathophysiology. In April 2012, NIMH and the Foundation for the National Institutes of Health (FNIH) convened a meeting of scientists and representatives from academia, the biotechnology and pharmaceutical industry, government and the non-profit sector to discuss the latest technological advances in using patient-derived reprogrammed cells to identify molecular, cellular and developmental alterations relevant to mental illnesses. While the strategic goal is to use these cells for basic biological discovery and development of new candidate drugs, it was agreed that these studies are subject to similar needs and pitfalls as genetic or clinical studies. This includes the need for sufficiently powered sample sizes, cost reduction and greater efficiencies in reagent production, better validation of cell phenotypes, improved assays, a larger repertoire of tools for reporting and targeting, more emphasis on quality control and standardization, co-development of study designs and greater experimental rigor to facilitate replication. To meet these needs, participants recommended a more collaborative culture or consortium-like relationship among public and private partners.
Information Requested
In response to these recommendations, NIMH is soliciting detailed and specific feedback from potentially interested parties to gauge their level and scope of interest in a public-private partnership. The goal of this partnership is to bridge the gap between basic science and drug development, combining the unique skills of academic and industry researchers along with other stakeholders, to devise cell reprogramming-based assays that are highly replicable and can enable mechanistic studies of mental illness pathophysiology. NIMH is particularly interested in receiving feedback on the topics listed below, but feedback is not limited to these topics:
1. Parameters of interest in public-private partnership (examples may include, but are not limited to):
- Mental illness of primary and secondary interest to the potential partner.
- Nature and scope of interest in engagement in a public-private partnership with to-be-determined project groups, with substantive NIMH involvement and coordination.
- Nature and scope of contributions by the potential private partner; i.e., anticipated role and responsibilities in establishing, fostering and/or implementing the public-private partnership.
- Willingness to be listed as a potential partner on NIH postings, web sites or search engines, for the purpose of facilitating collaborations, as appropriate.
- Needs, concerns or recommended schemes related to the potential generation and use of new or shared intellectual property (IP), including Freedom To Operate without IP infringement and transparency in the sharing of data and resources.
2. Range of work best-suited for a public-private partnership, with specific feedback on stage of development. Among the goals may be: enhancement of statistical power, cost reduction, quality control, standardization, automation, robustness and greater experimental rigor to facilitate replication. Examples may include but are not limited to:
- Outreach to or recruitment of new patients, including those of ethnic diversity; generation of new cell lines.
- Technology development, including derivation, targeting/editing or reporting technologies specifically to facilitate patient versus control comparisons.
- Workflow optimization, standardization and quality control, including sample preservation/handling, neural differentiation protocols optimized for efficiency and correct specification/differentiation state, assay miniaturization and/or stabilization, lab to industrial scaling.
- Utilization of established platforms for high throughput small molecule screening, toxicity testing.
- Optimization of cellular/functional assays with relevance to disease pathophysiology.
- Dataset generation, including high content genomic and phenomic analysis for discovery or target validation.
- Comparative measures, including clinical phenotyping, drug response and genetic characterization of patients, post-mortem analysis, model organism studies, to validate pathophysiological relevance of reprogrammed cell-based phenotypes.
- Interdisciplinary training, such as across academic and industry research, methods dissemination, etc.
Additional Information
Interested parties are invited to respond. Responders are free to address any or all of the above items. Please note that the United States (U.S.) Government will not pay for response preparation or for the use of any information contained in the response. This RFI is for planning purposes only and is not a solicitation for applications or an obligation on the part of the U.S. Government to provide support for any ideas identified in response to it.
How to Submit a Response
Responses to this RFI will be accepted through October 31, 2012. Comments must be submitted electronically to [email protected]. Please include the Notice number in the subject line. All of the following additional information is helpful but optional:
- The nature of your interest in the area (i.e., biomedical researcher or other role in academia, industry, government agency, private foundation, advocacy or community group, other)
- Name of your organization
- Main area of research interest and/or disease focus
- Your name and contact information, including email address
You will see an electronic confirmation acknowledging receipt of your response, but will not receive individualized feedback on any suggestions. No basis for claims against the U.S. Government shall arise as a result of a response to this request for information or from the Government’s use of such information.
Inquiries
Inquiries regarding this Notice may be directed to:
David M. Panchision, Ph.D.
Division of Neuroscience and Basic Behavioral Science
National Institute of Mental Health
6001 Executive Boulevard, Room 7189, MSC 9641
Bethesda, MD 20852
Telephone: (301) 443-5288
FAX: (301) 443-5615
Email: [email protected]
and Human Services (HHS)
