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Programs & Resources

FAQs

Frequently Asked Questions
  1. Regarding programmatic issues, who should be contacted?
  2. What is DCIDE?
  3. Why is DCIDE needed?
  4. What can DCIDE do?
  5. What DCIDE is NOT
  6. Isn't DCIDE competing with private industry?
  7. Who can use DCIDE?
  8. Can companies use DCIDE?
  9. Does NCI acquire intellectual property through DCIDE?
  10. How is DCIDE new?
  11. Does DCIDE sponsor clinical trials?
  12. Describe the DCIDE process and review of requests for support
  13. What is the format of requests for support?
  14. What are the evaluation criteria?
  15. Who oversees the DCIDE program?
  16. Where can I find additional information?

1. Regarding programmatic issues, who should be contacted?
Barbara Y. Croft, Ph.D.
Cancer Imaging Program, NCI
6130 Executive Blvd., Suite 6000
Bethesda, MD 20892
Telephone: 301-496-9531
Fax: 301-480-3507
E-mail: bc129b@nih.gov

2. What is DCIDE?
DCIDE is a new program designed to expedite and facilitate both the development of promising imaging enhancers (contrast agents) or molecular probes and their translation from laboratory synthesis to IND application. Under this program, developers of a promising diagnostic agent or probe can apply to the National Cancer Institute (NCI) for assistance. NCI will make its pre-clinical development resources available to competitively-selected developers in order to remove the most common barriers between laboratory discoveries and IND status.

The DCIDE program is intended to supply or enable missing steps to those who lack development capacity or resources so that promising discoveries may eventually be translated to the clinical research environment. The DCIDE program will focus on promising diagnostic agents that are not otherwise likely to undergo adequate pre-clinical testing to warrant an IND application. The DCIDE program will not provide full-scale clinical development but will facilitate the performance of the pre-clinical studies necessary to bring an imaging agent to IND status. The NCI anticipates that, once a specific agent receives IND status, its clinical development will continue along established mechanisms under the sponsorship of either private companies or NCI. Upon filing of the IND, agents will be included in a Translational Probe Library managed by NCI to provide availability to other investigators by limited agreement.

The DCIDE program will consider the full range of diagnostic imaging agents, including contrast agents, biologic and molecular probes, and radiolabeled compounds as well as agents that may be an integral part of image-targeted therapy. The program will also include agents relevant to detection or monitoring of pre-cancerous lesions.

3. Why is DCIDE needed?
A significant number of promising diagnostic imaging agents at various stages of development are not being advanced into clinical trials. Many of these agents could enhance clinical medicine, either by providing a measure of response to chemopreventive interventions or therapy or by serving as surrogate endpoints to preventive measures or therapy. Advances in genomics and molecular biology have changed the nature of new diagnostic enhancers and molecular imaging probes. An emphasis on highly specific molecular targets and processes has led to products with increased complexity and higher costs of development but smaller market potential. This trend has effectively created a class of agents that investors consider too risky for commercial development but that have the potential to influence diagnosis and treatment significantly.

4. What can DCIDE do?
The DCIDE program can supply assistance in any or all of the following activities:

  • Steps in pre-clinical development that are necessary to convert a potential new agent into a diagnostic drug candidate suitable for early clinical testing (IND) and that are generally not otherwise available to the investigators. These steps may include pharmacokinetics, dosimetry, imaging feasibility, IND-directed toxicology, etc.
  • Regulatory affairs, so that requirements of the Food and Drug Administration may be satisfied by any investigator who seeks Investigational New Drug status
  • Access to probes for approved pre-clinical protocols (including animal models)

5. What DCIDE is NOT.
DCIDE is not a grant program. In other words, grant funds will NOT be given to the originating investigators to do these studies themselves. The work will be done under contract arrangements with companies, academic laboratories, or government-owned contractor-operated facilities. In exceptional cases, a contractual arrangement may be made with the originating investigator if it is not feasible to perform the studies by the above mechanisms.

6. Isn't DCIDE competing with private industry?
No. In fact, NCI expects the DCIDE program to add value to discoveries in which companies initially showed little interest. The cost sharing for development enabled by the DCIDE program will make these discoveries more attractive licensing candidates for industry than they would have been otherwise. We do not expect the existence of a successful DCIDE program to deter investigators from licensing discoveries to interested companies. It does not seem likely that companies interested in licensing an academic discovery will wish to risk loss of the opportunity by allowing the compound to go through the DCIDE program process first.

7. Who can use DCIDE?
Anyone who has created an imaging drug or enhancer that is likely to improve diagnosis and treatment significantly but is unlikely to undergo further pre-clinical testing due to developmental and/or approval barriers may receive assistance under the DCIDE program.

8. Can companies use DCIDE?
Yes. Business as well as academia may face significant barriers that prevent development of promising agents. Therefore, companies as well as academic research institutions may use DCIDE.

9. Does NCI acquire intellectual property through DCIDE?
It is expected that originating parties will have acquired intellectual property protection prior to involvement of NCI. Normally, NCI will not acquire intellectual property rights to inventions made by its employees with Research Materials under DCIDE unless the originating investigator and NCI mutually agree that to do so would be in the best interest of the project. It the NCI does file a patent application, the originating investigator will be given the opportunity to negotiate for an exclusive license under procedures set forth in 37 CFR Part 404.

Many DCIDE tasks will be accomplished by the use of NCI's development contracts. Normally, an NCI contractor may elect to retain rights under the Bayh-Dole Act for any contributions it makes that rise to the level of invention. NCI contractors have, as a term of their funding, agreed to offer a first option to the originating investigator for license negotiations. Certain other contractors or subcontractors may be subject to a Determination of Exceptional Circumstances through which their rights in subject inventions made using Research Materials may be assigned to the originating investigator. Should an invention occur, the originating academic party will thereby have acquired a valuable potential ally in commercializing the subject of the research and may have acquired additional intellectual property if the invention was derived from collaborative research. DCIDE Material Transfer Agreements will form the basis for sharing Research Material and confidential information with NCI.

10. How is DCIDE new?
The NCI has had programs to facilitate the development of therapeutic drugs for several years but has had no similar program for imaging agents. Although investigators can apply for research grants for imaging agent development, such grants are usually awarded for novel investigatory work, not for routine studies, such as toxicity and biodistribution, that must be done prior to filing for IND status.

11. Does DCIDE sponsor clinical trials?
No. NIH has several mechanisms (e.g., research project grants, cooperative groups, and cooperative agreements) for funding clinical trials. DCIDE addresses the concern that promising imaging agents either do not undergo clinical trials or receive lower priority for funding because a pre-clinical component is missing. DCIDE will supply the pre-clinical necessities to allow development toward IND status, which must be achieved before clinical trials can begin. Investigators will use existing mechanisms to fund and conduct clinical trials. We anticipate that support by DCIDE for pre-clinical aspects of imaging agent development will increase enthusiasm for funding the clinical trial through existing pathways.

12. Describe the DCIDE process and review of requests for support
Initially, the NCI announced a call for requests for resources two times a year. The frequency of proposal and review cycles was re-evaluated after the first year of experience; requests for resources may now be made on the first of every month, after consultation with program staff.

Requests for resources will be competitively evaluated by a specially constituted DCIDE Evaluation Panel, consisting of non-NCI experts from academia and industry. This evaluation panel will provide individual opinions on the requests for resources. Requests for resources with sufficient scientific merit will then be evaluated by a committee of NCI staff members. NCI staff will select the requests for resources that are most consistent with the resources available and will commit them to development. The number of projects to be supported in any evaluation cycle will depend on both the level of merit and the availability of funds. The selected projects will receive the type of assistance requested to ensure the filing of an IND application at the earliest feasible date.

13. What is the format of requests for support?
Please use the PHS 398 form to request support. Send original and 4 copies to the contact person. Please observe the type size and line spacing requirements. In a document not to exceed 25 single-spaced pages, requestors are to supply the following information:

  • Face Page, AA: Complete relevant information. This is not a request for funding. No human subjects or vertebrate animals will be used.
  • Form Page 2, BB: Abstract: a summary of the project to fit into the box provided.
  • Form Page 3, CC: Table of Contents: Adapt to the information being supplied. Please number pages consecutively.
  • Form Page 6, FF: Biographical Sketch for the requestor.
  • Form Page 7, GG: Other Support: Use this format, with any expansion necessary, to describe all current and anticipated sources of support for the project. This includes a summary of the status of past, planned, or ongoing negotiations with companies relating to licensing or future development of the product, as well as reasons that negotiations to license have not been successful to date.
  • Research Plan Section: The following should be included in the Research Plan, substituting for the usual PHS 398 form information:
    • Background: a summary of the field from which the discovery has emerged that will allow evaluators to appreciate the scientific and medical importance of the imaging agent.
    • Hypothesis: a clear statement of the hypothesis (-ses) that will be tested and the model and/or methodology required for biochemical validation or certification of the probe/agent.
    • Request: a clear statement of specifically what is needed (and therefore requested from the National Cancer Institute) to bring the compound to IND status. Also, a clear statement about the anticipated role of the requestor or requestor institution in the development of the project once NCI becomes involved.
    • Justification: an explanation of why the imaging agent represents a particularly innovative or promising approach to the prevention, detection, diagnosis, or treatment of cancer.
    • Uniqueness: a discussion of related or similar molecules already under development by NCI or industrial (or other) sponsors and why this particular imaging agent should be given priority by the NCI in light of possible competition.
    • Contact with relevant FDA staff: a disclosure of the current stage of discussions with the relevant FDA staff about IND filings for the imaging agent.
  • Checklist, II: Complete the relevant information.
  • Appendix (not included in page limitation): background preprints and reprints.
  • Intellectual Property: Each DCIDE applicant must include a letter with his or her application from the appropriate authorized staff person overseeing intellectual property and/or technology transfer for his or her affiliated institution or company verifying that s/he has reviewed the DCIDE request and that application is or is not eligible for consideration by the DCIDE program. The letter should include a statement by the applicant disclosing any patents, issued or pending, and/or licenses, granted and/or pending, with respect to the product of the application as well as any know patents that block the development of the products of the application. In the event that an application requires the use of non-commercially available technology/material which is patented by a third party, applicant must provide documentation that the third party patent holder does not object to the applicant's use. If a technology/material is found not to be eligible for use in the DCIDE application and is central to the investigator's proposal, application to the DCIDE program is not encouraged

14. What are the evaluation criteria?

Stage I: Scientific Merit (non-NCI reviewers):

  • Strength of scientific evidence and hypothesis
  • Certification (biochemical or physiological validation)
  • Potential clinical impact
  • Novelty
  • Feasibility

Stage II: Operational Feasibility (NCI staff):

  • Resource availability
  • Potential impact on current or proposed clinical trials by NCI
  • Magnitude of pre-clinical studies required to address scientific/regulatory issues
  • Resource intensity, i.e., costs and benefits

15. Who oversees the DCIDE program?
The DCIDE program will be subject to oversight by a group of outside experts acting under the aegis of the NCI's Board of Scientific Advisors.

16. Where can I find additional information?

Developing Medical Imaging Drug and Biological Products

  • Part 1: Conducting Safety Assessments [Word] or [PDF] (Issued 6/17/2004, Posted 6/17/2004)
  • Part 2: Clinical Indications [Word] or [PDF] (Issued 6/17/2004, Posted 6/17/2004)
  • Part 3: Design, Analysis, and Interpretation of Clinical Studies [Word] or [PDF] (Issued 6/17/2004, Posted 6/17/2004)

Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs (PDF)

Center for Drug Evaluation and Research's Regulatory Information

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

Further Information

If you have questions about any aspect of the DCIDE program, please contact:
Barbara Y. Croft, Ph.D.
Cancer Imaging Program, NCI
6130 Executive Blvd., Suite 6000
Bethesda, MD 20892
Telephone: 301-496-9531
Fax: 301-480-3507
E-mail: bc129b@nih.gov