FLEXIBLE SYSTEM TO ADVANCE INNOVATIVE RESEARCH FOR CANCER DRUG DISCOVERY BY SMALL BUSINESSES Release Date: August 20, 1998 RFA: CA-98-022 P.T. National Cancer Institute Letter of Intent Receipt Dates: October 20, 1998 and June 22, 1999 Application Receipt Dates: November 17, 1998 and July 20, 1999 PURPOSE Discovery and development of new cancer therapeutics, including both drugs and vaccines, normally involve lengthy and costly projects. The multiple components of the overall process including discovery, efficacy testing, development of lead agents, toxicology and pharmacology, Investigational New Drug Application (IND) filing, and clinical evaluation, may require years and several million dollars. The small business community is an active participant in the cancer therapy discovery effort. The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have supported these efforts; however, the extent of such support has been limited by the traditional stringent guidelines of the Phase I and Phase II components. Recently the NIH has announced that applicants may request a larger budget and period of support if necessary for completion of the project (See NIH Guide for Grants and Contracts, February 13, 1998 (https://grants.nih.gov/grants/guide/notice-files/not98-014.html). This RFA provides a flexible system within the SBIR and STTR programs to accommodate the extensive needs and complex discovery and development process, at least partially, from basic discovery through proof of principle demonstration in clinical trials. HEALTHY PEOPLE 2000 The Public Health Service (PHS) is committed to achieving the health promotion and disease prevention objectives of "Healthy People 2000," a PHS-led national activity for setting priority areas. This RFA, Flexible System to Advance Innovative Research for Cancer Drug Discovery by Small Businesses, is related to the priority area of cancer. Potential applicants may obtain a copy of "Healthy People 2000" (Full Report: Stock No. 017-001-00474-0 or Summary Report: Stock No. 017-001-00473-1) through the Superintendent of Documents, Government Printing Office, Washington, DC 20402-9325 (telephone 202- 512-1800). ELIGIBILITY REQUIREMENTS Eligibility requirements are described in the OMNIBUS SOLICITATIONS. Any small business, independently owned and operated by United States citizens or permanent resident aliens may apply. It must be organized for-profit, cannot be dominant in its field of expertise, and must have its principal place of business in the United States. Including any affiliates, the company can be the employer of no more than 500 people. MECHANISM OF SUPPORT Support for the RFA is through the SBIR and STTR mechanisms, which are set- aside programs. This RFA is a one-time RFA, which may be reissued. Applications can be submitted for support as Phase I STTR (R41) or Phase I SBIR (R43) grants: Phase II STTR (R42) or Phase II SBIR (R44) grants; or under the SBIR/STTR FAST-TRACK option as described in the OMNIBUS SOLICITATIONS. Phase II applications in response to this RFA will only be accepted as competing continuations of previously funded NIH Phase I SBIR/STTR awards. The Phase II proposal must be a logical extension of the Phase I research. Information on the FAST-TRACK process and the OMNIBUS SOLICITATIONS are available at: https://grants.nih.gov/grants/funding/sbir.htm Except as otherwise stated in this RFA awards will be administered under PHS grants policy as stated in the Public Health Service Grants Policy Statement, DHHS Publication No. (OASH) 94-50,000 (Rev) April 1, 1994. FUNDS AVAILABLE It is expected that five awards will be made in FY99, and $1.8 million from the SBIR and STTR set-asides will be designated for this purpose. The number of awards will be dependent upon receipt of a sufficient number and diversity of applications with high scientific merit. RESEARCH OBJECTIVES Recent advances in all branches of medical sciences provide new insight into the underlying mechanisms in malignancy and suggest new targets and approaches for therapy. For example, key growth regulatory pathways are being delineated, genes mutated in cancer cells have been identified, array technology for expression of thousands of genes as well as computer-assisted evaluation of data are available, new technologies in chemistry allow facile synthesis of millions of new chemicals, and high resolution structures of important target proteins are becoming available. The application or translation of these new discoveries and innovations into clinical benefit for the cancer patient is essential; however, the process is lengthy and costly. Following initial discovery, efficacy testing, and optimization, lead compounds must undergo a series of rigorous evaluations culminating with the clinical trial. The actual procedures for these evaluations vary somewhat with each agent to be tested, and, with innovative approaches often required for new agents, an extensive research effort may be necessary for successful development and eventual commercialization. The objective of this RFA is to support the research activities required to enable small businesses to bring their research efforts for drug discovery and development to clinical evaluation. INCLUSION OF WOMEN AND MINORITIES IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of the NIH that women and members of minority groups and their sub-populations must be included in all NIH supported biomedical and behavioral research projects involving human subjects, unless a clear and compelling rationale and justification is provided that inclusion is inappropriate with respect to the health of the subjects or the purpose of the research. This policy results from the NIH Revitalization Act of 1993 (Section 492B of Public Law 103-43). All investigators proposing research involving human subjects should read the "NIH Guidelines For Inclusion of Women and Minorities as Subjects in Clinical Research," which have been published in the Federal Register of March 20, 1994 (FR 59 14508-14513) and in the NIH Guide for Grants and Contracts, Volume 23, Number 11, March 18, 1994. Investigators also may obtain copies of the policy from the program staff listed under INQUIRIES. Program staff may also provide additional relevant information concerning the policy. NIH POLICY AND GUIDELINES ON THE INCLUSION OF CHILDREN AS PARTICIPANTS IN RESEARCH INVOLVING HUMAN SUBJECTS It is the policy of NIH that children (i.e., individuals under the age of 21) must be included in all human subjects research, conducted or supported by the NIH, unless there are clear and compelling scientific and ethical reasons not to include them. This policy applies to all initial (Type 1) applications submitted for receipt dates after October 1, 1998. All investigators proposing research involving human subjects should read the "NIH Policy and Guidelines on the Inclusion of Children as Participants in Research Involving Human Subjects" that was published in the NIH Guide for Grants and Contracts, March 6, 1998, and is available at the following URL address: https://grants.nih.gov/grants/guide/notice-files/not98-024.html LETTER OF INTENT Prospective applicants are asked to submit, by the receipt dates listed at the beginning of this RFA, a letter of intent that includes a descriptive title of the proposed research, the name, address, and telephone number of the Principal Investigator, the identities of other key personnel and participating institutions, and the number and title of the RFA in response to which the application may be submitted. Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NCI staff to estimate the potential review workload and avoid conflict of interest in the review. The letter of intent is to be sent to Dr. George S. Johnson, NCI, at the address listed under INQUIRIES. APPLICATION PROCEDURES This RFA must be read in conjunction with the OMNIBUS SOLICITATION OF THE PUBLIC HEALTH SERVICE FOR SMALL BUSINESS INNOVATION RESEARCH GRANT (SBIR) APPLICATIONS (PHS 98-2) and the OMNIBUS SOLICITATION OF THE NATIONAL INSTITUTES OF HEALTH FOR SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) GRANT APPLICATIONS (PHS 98-3). All of the instructions within the omnibus solicitation apply with the following exceptions: -Special receipt dates -Initial review convened by the NCI Division of Extramural Activities -Additional review considerations. -More flexible time and budget specifications Applications received in response to this RFA are to be prepared as described in the OMNIBUS SOLICITATIONS for the SBIR and STTR programs. OMNIBUS SOLICITATIONS are available electronically through the NIH, Office of Extramural Research "Small Business Funding Opportunities" website: https://grants.nih.gov/grants/funding/sbir.htm. Hard copies, subject to availability, may be obtained from the PHS SBIR/STTR Solicitation Office, phone (301) 206-9385; FAX (301) 206-9722; email a2y@cu.nih.gov. Helpful information in preparation of the application can be obtained: https://grants.nih.gov/grants/funding/sbirgrantsmanship.pdf Applications in response to this RFA are to be submitted on the applicable grant application forms as follows: SBIR Phase I - PHS 6246-1 (1/98) https://grants.nih.gov/grants/funding/sbir1/sbir.htm STTR Phase I - PHS 6246-3 (1/98) https://grants.nih.gov/grants/funding/sbirsttr1/index.htm SBIR Phase II - PHS 6246-2 (1/98) https://grants.nih.gov/grants/funding/sbir2/index.htm STTR Phase II - PHS 6246-4 (1/98) https://grants.nih.gov/grants/funding/sttr2/index.html The application forms are also located in the back pages of the OMNIBUS SOLICITATIONS. Applications will be accepted on November 17, 1998, and July 20, 1999. The RFA title and number must be typed in line 2 on the face page of the application form. If an application is received after the application receipt dates, it will be returned to the applicant without review. The Center for Scientific Review (CSR) will not accept any application in response to this RFA that is essentially the same as one currently pending review, unless the applicant withdraws the pending application. This does not preclude the submission of substantial revisions of applications already reviewed, but such applications must include an introduction addressing the previous critique. SBIR/STTR projects submitted in response to this RFA must contain a Phase I feasibility segment that must be successful prior to a Phase II award. Applications can be submitted for Phase I or Phase II support, or as a combined Phase I and II (FAST TRACK). Phase II applications will only be accepted as continuations of previously funded Phase I grants. The Phase II proposal must be a logical extension of the Phase I research but not necessarily a Phase I supported in response to this RFA. Projects may be presented for SBIR/STTR support at all stages of the drug discovery and development process. Projects will be evaluated on overall innovation, strength of the drug discovery approach, and probability of clinical success, with less emphasis on the nature of the specific stage proposed in the application. This aspect is especially important if applications are focused on later stages of the drug discovery and evaluation process, which are generally more routine and often considered less innovative as stand alone projects. PHASE I: Demonstration of feasibility for the next step in the drug discovery and development process. It would be expected, but not required, that Phase I would support relatively early discovery and evaluation projects. Phase I projects should focus on research required to advance to the next stage in the development process and present a plan and time line outlining accomplishments and milestones to be achieved at each stage. Applicants should emphasize innovative aspects of the agent or project as well as the potential for clinical relevance. Applications should include a plan for the complete development of the agents and clearly state how the proposed Phase I fits into this plan. If the allowed 25 pages for Phase I projects i not sufficient, applicants should contact the Scientific Review Administrator (SRA) after receipt and assignment of the application to request approval for submission of supplementary information for review. For this RFA, projects normally would be supported in Phase I for up to 2 years with a budget of up to $300,000, total costs, per year. Larger budgets could be considered if required for conduct of the research and appropriately justified in the application. The second year of support will be contingent upon NCI programmatic evaluation to ensure that investigators are accomplishing milestones and time lines presented in the original application. PHASE II: Continuing support for development of preclinical activities and for establishment of proof of principle in clinical trials. Support can be requested for preclinical developmental activities including pharmacology, formulation and toxicology. Innovative aspects of the research necessary to complete the projects such as development of new in vivo evaluation models that may require "surrogate endpoints" should be clearly described. Support for clinical trial evaluation up to the point of establishing proof of principle can be requested to commence following completion of the pre- clinical activities and approval of the IND by the FDA. A brief plan for the clinical trial should be submitted with the application; however, a detailed clinical plan, including a budget, must be submitted and approved by NCI extramural staff prior to allocation of funds for this purpose. If a clinical evaluation is the direct object of the proposal, complete information should be provide within the application or as an attached Appendix. It is not possible for the SBIR/STTR program to provide full funding for the complete development process. Thus, a co-funding partner or other sources of support should be identified prior to Phase II award. The funds and/or resources to be dedicated to activities directly related to the SBIR/STTR project by the partner/company, including details of the commitment contingencies, must be clearly specified in the application. Appropriate documentation of the commitment must be provided. NCI contract-based resources through the Developmental Therapeutics Program (DTP), independent of the SBIR/STTR award, may be used to meet the co-funding requirement, but proper assurances from DTP/NCI must be provided prior to review. Conversion to a Cooperative Agreement (U44) may be advantageous if the NCI is to be an active partner in the development. A Cooperative Research and Development Agreement (CRADA) could also be considered to support some aspects of the development process; however, the CRADA should clearly state that the SBIR supported activities would be considered the responsibility of the small business and outside the terms of the CRADA. A CRADA Letter of Intent, if available, should be provided prior to review. If use of NCI contract resources, conversion to a cooperative agreement, or a CRADA are planned, the applicant should contact Dr. George S. Johnson at the address listed in INQUIRIES prior to submission of the application. Collaboration with NCI to conduct the clinical trial would be appropriate if agreed upon by the small business, the NCI, and all other involved participants and proper documentation is provided. Phase II awards can be for up to four years and $400,000, total costs, per year. As with Phase I, requests for larger budgets may be considered, and support for years two to four is dependent upon NCI Programmatic review of progress and achievement of proposed milestones and evaluation of additional information not required in the original application. FAST TRACK: Applications may be submitted for combined Phase I and Phase II, FAST TRACK consideration as described in the OMNIBUS SOLICITATIONS. However, due to the complex nature of the drug development process, it is recommended that only well defined and more advanced projects be proposed for support through this mechanism. Phase I, FAST TRACK applications must specify clear, measurable goals that should be achieved prior to Phase II funding. Failure to provide measurable goals in the Phase I application and/or sufficient detail in the Phase II application may be sufficient reason for the peer review committee to exclude the Phase II from consideration. If so, the applicant may apply later for Phase II support. Such applications will be reviewed by a standing Study Section of CSR or by a special review group convened in response to a re- issuance of this RFA, if applicable. Special provisions described in this RFA pertaining to Phase I and Phase II also apply to FAST TRACK applications. An additional requirement of the FAST TRACK mechanism is the commitment for funds and/or resources for commercialization of the product to ensure a rapid transition to the market. These funds are in addition to the funds required for research support in Phase II described above. A Commitment Appendix to the Phase II application must be included which specifies the amount of funds and/or nature of resources that will be dedicated to the SBIR/STTR project and must describe those activities. If such commitment is from an investor or partner organization, a copy of the agreement or a letter describing the details of the agreement must be provided. The small business concern must also submit a concise Product Development Plan (limited to five pages) as an Appendix to the Phase II application addressing the four areas described in the instructions for FAST TRACK applications in the OMNIBUS SOLICITATIONS. Potential applicants are encouraged to contact program staff for guidance and to read the advice and information on the web sites. However, responsibility for planning, direction, and execution of the proposed research will be solely that of the applicant. The completed original application and one legible copies must be sent or delivered to: Center for Scientific Review National Institutes of Health 6701 Rockledge Drive, Room 1040, MSC 7710 Bethesda, MD 20892-7710 Bethesda, MD 20817 (for express/courier service) One additional copies of the application must also be sent to: Ms. Toby Friedberg Referral Officer National Cancer Institute 6130 Executive Boulevard, Room 636a Bethesda, MD 20892-7405 Rockville, MD 20852 (for express/courier service) Telephone: (301) 496-3428 FAX: (301) 402-0275 REVIEW CONSIDERATIONS Upon receipt, applications will be reviewed by the CSR for completeness and by the NCI for responsiveness. Applications not adhering to application instructions described above and those applications that are incomplete or non-responsive will be returned to the applicant without review. Applications will be reviewed for scientific and technical merit and the documented ability of the investigators to meet the RESEARCH OBJECTIVES of this RFA by an initial review group convened by the NCI Division of Extramural Activities, in accordance with the standard NIH peer review procedures. As part of the initial merit review, all applications will receive a written critique and undergo a process in which only those applications deemed to have the highest scientific merit, generally the top half of the applications under review, will be discussed, assigned a priority score, and receive a second level review by the National Cancer Advisory Board. Review Criteria Review criteria are essentially as described in the OMNIBUS SOLICITATIONS with the additional considerations specified for this RFA. 1. The soundness and technical merit of the proposed approach. 2. The qualifications of the proposed principal investigator, supporting staff, and consultants. 3. The scientific, technical, or technological innovation of the proposed research. 4. The potential of the proposed research for commercial application. 5. The appropriateness of the budget requested. 6. The adequacy and suitability of the facilities and research environment. 7. Where appropriate, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects and/or (b) protecting against or minimizing any adverse effect on the environment. 8. Innovative aspects of the overall drug discovery and development plan. 9. Potential clinical relevance of the research and agent proposed. The Phase I application should specify clear, measurable goals (milestones) that should be achieved prior to initiating Phase II. Failure to provide clear, measurable goals may be sufficient reason for the initial review group to judge the application non-competitive. The initial review group will also examine the adequacy of plans to include both genders and minorities and their subgroups as appropriate for the scientific goals of the research, plans for the recruitment and retention of subjects; the adequacy of plans for including children as appropriate for the scientific goals of the research, or justification for exclusion; the provisions for the protection of human and animal subjects and the safety of the research environment. AWARD CRITERIA Funding decisions for Phase I or Phase II applications will be based on quality of the proposed project as determined by peer review, program priority, potential for clinical success, and availability of funds.. FAST TRACK, Phase II applications may be funded following submission of the Phase I progress report and other documents necessary for continuation. Phase II applications will be selected for funding based on the initial priority score, NCI's assessment of the Phase I progress and determination that Phase I goals were achieved, the project's potential for commercial success, and the availability of funds. Schedule Letter of Intent Receipt Date: Oct 20, 1998 Jun 22, 1999 Application Receipt Date: Nov 17,1998 Jul 20, 1999 National Cancer Advisory Board Review: Jan 1999 Oct 1999 Anticipated Award Date: Mar/Apr 1999 Jan 2000 INQUIRIES Inquiries concerning this RFA are encouraged. The opportunity to clarify any issues or questions from potential applicants is welcome. Direct inquiries regarding programmatic issues to: George S. Johnson, Ph.D. Division of Cancer Treatment and Diagnosis National Cancer Institute 6130 Executive Boulevard, Room 841 Bethesda, MD 20892-7456 Telephone: (301) 496-8783 FAX: (301) 402-5200 Email: gj16m@nih.gov Direct inquiries regarding fiscal matters to: Ms. Kathleen Shino National Cancer Institute 6120 Executive Boulevard, Room 243 Bethesda, MD 20892-7150 Telephone: (301) 496-7800, ext. 248 FAX: (301) 496-8601 Email: shinok@gab.nci.nih.gov Direct inquiries regarding review matters to: Ms. Toby Friedberg Division of Extramural Activities National Cancer Institute 6130 Executive Boulevard, Room 636 - MSC 7407 Bethesda, MD 20892 Rockville, MD 20852-7407 (for express/courier service) Telephone: (301) 496 -3428 FAX: (301) 402-0275 Email: tf12w@nih.gov AUTHORITY AND REGULATIONS This program is described in the Catalog of Federal Domestic Assistance No. 93.395. Awards are made under authorization of the Public Health Service Act, Title IV, Part A (Public Law 78-410, as amended by Public Law 99-158, 42 USC 241 and 285) and administered under PHS grants policies and Federal Regulations 42 CFR 52 and 45 CFR Part 74 and part 92. This program is not subject to the intergovernmental review requirements of Executive Order 12372 or Health Systems Agency review. The PHS strongly encourages all grant and contract recipients to provide a smoke-free workplace and promote the non-use of all tobacco products. In addition, Public Law 103-227, the Pro- Children Act of 1994, prohibits smoking in certain facilities (or in some cases, any portion of a facility) in which regular or routine education, library, day care, health care or early childhood development services are provided to children. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people.
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