NOT-DA-10-006: Request for Information (RFI): Identifying Organizations with the Appropriate Expertise to Participate in a Collaborative Drug Development Partnership

Request for Information (RFI): Identifying Organizations with the Appropriate Expertise to Participate in a Collaborative Drug Development Partnership

Notice Number: NOT-DA-10-006

Key Dates
Release Date: January 12, 2010

Issued by
National Institute on Drug Abuse (NIDA) (http://www.nida.nih.gov)

Purpose

This request for information (RFI) seeks to identify institutions with the appropriate expertise to participate in a collaborative drug development partnership with the National Institute on Drug Abuse (NIDA), a part of the National Institutes of Health (NIH). The mission of this product development partnership (PDP), to be achieved by 2020, is to develop, test, and facilitate domestic and global access to safe and effective medications for the treatment of tobacco dependence, including aids for smoking cessation. The partnership will achieve its mission through collaboration between public (government agencies and institutes), civil society (academia, NGOs, philanthropic institutions) and private sector entities. An ideal partner entity in this venture would be able to provide pharmaceutical project management and drug discovery expertise as well as pre-clinical and clinical capabilities. The partnering entity/ies would also be expected to raise funds in support of PDP’s mission, to contribute/administer financing for research projects carried out by the PDP and to manage various functions of the PDP such as award and grant making. Furthermore, the partner(s) would be expected to explore potential partnership opportunities to extend and enhance the work of the PDP, including collaborations with other organizations and/or groups that could advance the mission of the PDP. NIDA might obtain the full-range of needed expertise by engaging more than a single partner.

This RFI serves to notify the community that NIDA is considering to establish the PDP described above, and to provide all interested parties an opportunity to comment.

Background

With this RFI, NIDA expresses the interest in entering into a Product Development Partnership (PDP) to address a profound public need to eradicate tobacco dependence. This PDP is expected to function over a decade, starting in 2010, as a collaboration of stakeholders with the objective to support objective-driven research projects carried out jointly by the PDP partners to accelerate the drug discovery process and develop more effective and safe medications for the treatment of tobacco dependence. PDPs are examples of Private Public Partnerships (PPP), a means to accomplish NIH’s mission to improve the public health through biomedical research in a faster, more economical, and more effective way by leveraging its resources. PDPs benefit academia by increasing access to resources for research and training while extending the application of findings more directly into improvements in health. PDPs benefit the pharmaceutical industry by increasing the knowledge base and facilitating access to novel targets, new platform technologies, new chemistries, disease expertise, and biomarker development. Most critically, PDPs benefit patients by accelerating the expansion of a robust body of basic, translational and applied science to support regulatory decision-making, thereby facilitating the development of safe and effective medications. When the partnership includes expertise in public health, PDPs can also increase the access to new medications. Depending on the interest and response generated, NIDA may commit long-term financial support as well as “in kind” contributions to the PDP, such as subject matter scientific expertise and research facilities and infrastructure.

Information Requested

Interested parties should specifically address the drug discovery and development expertise they possess, relevant to nervous system diseases, and the ways in which this expertise would support the mission of the PDP. In addition, some organizations may have additional expertise that may be valuable to the venture, such as project management expertise, fundraising, lobbying and advisory capabilities; as noted below, these too should be precisely specified.
Entities responding to this RFI are requested to submit the following information:

description of the entity’s scientific interests and expertise in areas applicable to research in developing, testing, and facilitating access to safe and effective medications as aids to smoking cessation;
areas of scientific expertise of staff, and how any missing expertise required for this PDP would be obtained;
suggestions for ways and means by which this PDP might operate, including perception of roadblocks, identification of additional potential partners, and how public and private sector participation can be managed;
prior experience, if any, with PDP-type activities or collaborative drug discovery and development;
information on how the entity makes decisions regarding participation in projects such as PDPs, including veto processes, evaluation of the suitability of projects, partners, and overall internal decision-making structure;
information on how the entity functions with regard to direct solicitation of research applications, making funding decisions, and provision of administrative oversight to those projects;
experience in lobbying for support with federal or other levels of government;
fundraising experience;
description of the expertise in fiscal management that would occur, including management of the flow of funds between the partners;
experience in addressing public policy objectives.

Responses

Responses will be accepted through Monday, April 5, 2010. Please email your response to the above inquiries to: koustovae@nida.nih.gov

In your response, please also provide the following (and include the Notice number NOT-DA-10-006 in the subject line):

Name of the institution/site
Principal investigator(s) and full contact information

This RFI is for information and planning purposes only and should not be construed as a solicitation or as an obligation on the part of NIDA. NIDA does not intend to award a grant or contract to pay for the preparation of any information submitted or for NIDA’s use of such information. Acknowledgment of receipt of responses may not be made, nor will respondents be notified of NIDA’s evaluation of the information received. No basis for claims against NIDA shall arise as a result of a response to this request for information or NIDA’s use of such information as either part of our evaluation process or in developing specifications for any subsequent announcement. Responses will be held confidential. Any proprietary information should be so marked.

Inquiries

Elena Koustova, PhD, MBA
Program Director
Genetics and Molecular Neurobiology Research Branch
Division of Basic Neuroscience and Behavioral Research
6001 Executive Boulevard, Room 4257
Bethesda, MD 20892
Telephone: 301-496-8768
E-mail: koustovae@mail.nih.gov

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