SOLICITATION NOTICE
B -- Noninvasive imaging studies of pharmacokinetics/pharmacodynamics as tools in medical product development and patient care
- Notice Date
- 8/23/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541690
— Other Scientific and Technical Consulting Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, Maryland, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- FDA-RFQ-1048361
- Archive Date
- 9/23/2008
- Point of Contact
- Lee Cohen,, Phone: 3018277046
- E-Mail Address
-
lee.cohen@fda.hhs.gov
- Small Business Set-Aside
- Service-Disabled Veteran-Owned
- Description
- Solicitation Number: FDA-RFQ-1048361 Title: Noninvasive imaging studies of pharmacokinetics/pharmacodynamics as tools in medical product development and patient care Notice Type: Combined Synopsis/Solicitation Synopsis: This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR 12.6, simplified acquisition procedures and the resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular 05-26. This announcement constitutes the only solicitation and a written solicitation will not be issued. This synopsis, NAICS code 541690, is to notify contractors that the government intends to issue a Purchase Order in accordance with FAR Part 13.106 for the following statement of work, under the simplified acquisition procedures. Prospective offerors are responsible for downloading the solicitation and any amendments. It is the offeror's responsibility to monitor the FedBizOpps website for the release of any amendments to this solicitation. The Government reserves the right to award a contract without discussions if the Contracting Officer determines that the initial offer(s) is/are providing the Best Value and discussions are not necessary. This solicitation is issued as a Request for Quote (RFQ) The Food and Drug Administration (FDA) intends to award a purchase order for professional services as described in the following Statement of Work: SCIENTIFIC SERVICES PROGRAM (SSP) STATEMENT OF WORK (SOW) 1.TITLE – Noninvasive imaging studies of pharmacokinetics/pharmacodynamics as tools in medical product development and patient care. 2. GENERAL – In FDA's view, the applied sciences needed for medical product development have not kept pace with the tremendous advances in the basic sciences. The new science is not being used to guide the technology development process in the same way that it is accelerating the technology discovery process. For medical technology, performance is measured in terms of product safety and effectiveness. Not enough applied scientific work has been done to create new tools to get fundamentally better answers about how the safety and effectiveness of new products can be demonstrated, in faster time frames, with more certainty, and at lower costs. In many cases, developers have no choice but to use the tools and concepts of the last century to assess this century's candidates. As a result, the vast majority of investigational products that enter clinical trials fail. Often, product development programs must be abandoned after extensive investment of time and resources. This high failure rate drives up costs, and developers are forced to use the profits from a decreasing number of successful products to subsidize a growing number of expensive failures. As such, the path to market even for successful candidates is long, costly, and inefficient, due in large part to the current reliance on cumbersome assessment methods. An area of science that has emerged alongside the pathway of medical product development is non-invasive imaging. Biological imaging, particularly medical imaging, has seen rapid advancement over the last few years and is now widely accepted as both a research tool and as an evaluative and predictive tool in facilitating clinical and reimbursement decisions. Pharmacokinetic/dynamic imaging is well accepted in the medical community to diagnose cancers, identify metabolic disorders and depict marginal perfusion to the brain and heart. The consensus of numerous experts in the field is that is that these tools are not yet well integrated into our current drug development paradigms. Current paradigms of drug development often fail to include, if even consider, modern testing methods such as imaging and pharmacokinetic (PK) and pharmacodynamic (PD) modeling. It is believed that the drug discovery / development process not sufficiently efficient (in cost and time) to adequately address society’s healthcare needs. Assuming that PK/PD imaging continues to demonstrate positive contributions to the medical product development pathway, there is general agreement that a need will exist to define some common standards: for processes/protocols, for measurements, for analysis methods and for regulatory compliance. Harmonized research protocols should allow pooling of data from multiple centers and studies. Commonly accepted and harmonized methods of measurement should similarly allow interoperable databases to be created and serve as a resource for retrospective data mining to inform future medical product development and also encourage more sharing of resources (data and biospecimens included) researchers in the process. Common methods of data analysis should allow researchers to review large databases with a consistent, high-quality toolset that would be readily acceptable to investigators and regulators. Despite some of the competitive rhetoric, the scientific and industrial communities are looking for constructive alliances where resources can be leveraged and data can be shared. Therefore, FDA seeks, under its Office of Scientific and Medical Programs, its public health mission, and its Critical Path Initiative, to grant an award for the development of a multidisciplinary collaborative infrastructure to sustain the aforementioned activities and to support the implementation and initial phases of some of the work described herein. This multidisciplinary collaborative effort is expected to advance the understanding of and development of tools in the fields of non-invasive medical imaging and PK/PD. 3. OBJECTIVES – The goal of this contract is to address some of the hurdles translating promising new medical products (drugs, biologics and medical devices) from pre-clinical phases through clinical phases of development and then to patients. Safety data acquired in animal studies often fail to translate well into and often time, fall short of predicting responses in first in human studies. It is expected that this award will help to address, and/or pave the way to effectively address, the extent to which noninvasive imaging studies may be effective in accessing response to therapies in humans: whether through imaging tools to access biodistribution and uptake of the drug follows the same pattern as it does in the animal models, or through PK/PD data that can determine the effect of a therapeutic on a target in humans, whether predictable from the preclinical animal model or not. The studies to be developed will include measurements of drug PK/PD and toxicokinetics/ toxicodynamics. 4. SPECIFIC TASKS – 1.Develop a strategic plan and the key administrative elements for establishment of a scientific collaborative infrastructure to support a series of interdisciplinary projects aligned with FDA’s public health mission 2.To convene a scientific workshop of experts in the field: to include individuals from academia, industry and government with knowledge in imaging, in the pharmacological and toxicological aspects of drug development, and in pharmacokinetics and toxicokinetics, the overall objectives of such workshop to be co-developed with FDA 3.To complete a thorough literature review and assessment of the current state of knowledge and evaluative tools in assessing and predicting toxicity in drug development, using commonly used imaging modalities (anatomical and functional) and PK/PD assessment tools 4.To review the current state of knowledge and available evaluative tools in estimating drug toxicokinetics/toxicodynamics at target organs 5.To review the current state of knowledge and evaluative tools in estimating the relation between drug pharmacokinetics and drug toxicokinetics at target organs 6.To identify the key areas in PK/PD imaging where support is most urgently required. Examples of key topics include: i.Imaging agent development and for correlative imaging studies in therapeutic trials ii.High sensitivity, high specificity imaging probes with the goal toward clinical applications iii.Radiopharmaceutical and other tracer development for the diagnosis and treatment of human disease in clinical practice and research trials iv.Computational models based on systems approaches 7.To identify, assemble and solicit input from a team of investigators, regarding 1-6 above 8.To develop proposal(s) that includes quantitative predictive models, for addressing the scientific gaps indentified in 6 above, such proposals to include action items in addressing said gaps and resources to support the implementation of such action items 9.Develop standard operating procedures for collection and analysis of PK/PD imaging data. 10.To publish the findings of activities under 1-7 above, and funded through this SOW, in peer-reviewed scientific journals or other publication to ensure that all findings under this SOW are shared in the public domain (where collaborations exist, authorship shall include all collaborators, including FDA personnel, who were directly involved in the prosecution of the science) 5. REPORTING REQUIREMENTS – The contractor will need to make an oral report to the Project Officer and other designated staff at FDA. The PIs will also need to produce a quarterly update, in electronic format as well as a final report of all the key findings of the study, in electronic format. The format, length and other specifications of the final report shall be determined by the Project Officer and communicated, in writing, to contractor, such report to contain, at a minimum: (1) a summary of all work conducted; (2) the results and conclusions derived from the study/ies; (3) the next steps (if the study is not completed). The final report shall be submitted in both electronically and in hard copy to the Project Officer within thirty (30) days after the end of the contract period of performance. As requested by the Project Officer, the contractor, or his/her designate, shall be required to present and/or co-present at designated scientific meetings and conferences, with FDA staff, the findings of the study in an agreed-upon format. The CONTRACTORs shall be required to co-author, with FDA, as designated by the Project Officer, scientific writings in scientific and/or peer-reviewed journals to ensure that the findings of the study/ies, are widely communicated in the public domain for the benefit of the scientific community, clinicians and patients. The aforementioned reports and publications may be used by FDA in its normal business in informing regulatory review and in the conduct of additional studies. Implementation Plan The contractor shall submit an award implementation plan within 30 days of contract award. This report shall consist of a detailed plan for achieving contract deliverables and a timeline for implementation. Quarterly Progress Report The Contractor shall submit a quarterly evaluation report that assesses progress toward achieving defined deliverables. The report shall be submitted no later than 30 days following the close of every third month from the contract award date. The report shall be narrative in form and shall include a summary of progress toward completion of any work in progress, problems encountered to date, and the Contractor’s assessment of the impact of such problems on estimated costs and schedule. The report shall clearly separate the progress for any subtasks within the report. Quarterly reports shall not be required for periods that require annual or final reports. Annual Report The Contractor shall submit an annual evaluation report that assesses progress toward achieving defined deliverables. The report shall be submitted no later than 30 days following the twelfth month from the contract award date. The report shall be narrative in form and shall include key scientific findings, a summary of progress toward completion of any work in progress, problems encountered to date, and the Contractor’s assessment of the impact of such problems on estimated schedule. The report shall clearly separate the progress for any subtasks within the report. Annual reports shall not be required for the period when the final report is due. In addition to the written annual report, the contractor shall prepare a report from the workshop identified above. This report shall contain key scientific findings, action plans and feedback from the workshop attendees. All slides, graphs, and other such material used in the presentation of this report shall be made available to FDA in electronic format readable by Microsoft PowerPoint® at the time of the presentation. Final Report The Contractor shall submit a final report of all the key findings of this award. The final report shall serve as the primary deliverable for each contract awarded. The final report shall contain detailed descriptions of: (1) a summary of all work conducted; (2) the scientific background, hypotheses/objectives, methods used, description and discussion of results, conclusions, and areas for future scientific studies. The length of the final report shall be no more than 25 pages. The final report shall be submitted within thirty (30) days after completion of contracted tasks as specified above. FDA will review the draft and will meet with the Contractor to provide feedback or changes within 15 days of receipt. No later than 15 business days after this meeting, the Contractor shall provide the final version of this report, as described above. As requested by the Project Officer, the Contractor, or his/her designate, shall be required to present and/or co-present with FDA staff the findings of the outcomes of this award at designated scientific meetings and/or conferences. The Contractors shall be required to co-author, with FDA, as designated by the Project Officer, manuscripts in scientific and/or peer-reviewed journals to ensure that the findings supported through this award, are widely communicated in the public domain for the benefit of the scientific community, clinicians, and patients. Type Report/DocumentDue Date Implementation Plan 30 days after contract award Quarterly reportWithin 30 days after the end of every third month after contract award. Annual Report (written document)Within 30 days after the end of the 12th month following the contract award Final Report (Draft)Within 30 days after the end of the 22nd month following the contract award Final Report15 days following 15-day FDA review of draft report Report Distribution: Five (5) paper copies and one electronic copy in Portable Document Format (PDF) shall be submitted to the Project officer. 6. QUALIFICATION REQUIREMENTS – The Contractor selected for the performance of this statement of work must have specific experience in the study of pharmacokinetics/pharmacodynamics of drugs using non-invasive imaging modalities such as positron emission tomography and magnetic resonance imaging and spectroscopy, as evidenced by publications in peer-reviewed journals. The Contractor shall have staff comprised of seasoned professionals in fields such as, but not limited to, pharmacology, nuclear medicine and bioengineering. The experts that will be participating in the performance of this statement of work must have knowledge in functional and molecular imaging modalities such as magnetic resonance imaging and spectroscopy, positron emission tomography, single photon emission computed tomography and optical imaging, in the pharmacological and toxicological aspects of drug development, and in pharmacokinetics and toxicokinetics, as evidenced by publications in peer-reviewed journals. 7. PLACE AND PERIOD OF PERFORMANCE, WORK DAYS, AND TRAVEL – a. Place of Performance. The place of performance will include any appropriate and necessary facilities necessary for the conduct of the scientific meeting. b. Period of Performance. The period of performance is not to exceed two calendar years from the date of award of the contract. Except for the travel listed in paragraph 7.c. below, all work will be at the performer’s location. c. Travel: Trips are contemplated as follows: 1 day trip to Washington, DC metro area by Senior Project Manager for scientific workshop. 8. EVALUATION CRITERIA– Contractor shall be evaluated on the following: •Contractor’s technical and functional understanding of the FDA and its mission. •Contractor’s knowledge and expertise in conducting non-invasive imaging methods to study pharmokinetics and pharmokodynamics of drugs. •Contractors experience in conducting scientific workshop(s) related to exploring current roadblocks in the use of imaging-based tools for target PK/PD and their role in drug development and in drug monitoring •Feasibility, practicability, innovativeness, and appropriateness of the Contractor’s approach in accomplishing all tasks and deliverables outlined in this SOW. 9. RESTRICTIONS & SPECIAL REQUIREMENTS – There are no known regulatory requirements that must be complied with during the performance of this work unless FDA submissions result from any of the work conducted. For any animal studies conducted, appropriate and necessary Institutional Animal Care and Use Committee (IUCAC) reviews and approvals shall be obtained and presented to the FDA. For any clinical studies involving human subjects and/or the use of patient records, necessary reviews and approvals shall be obtained from Institutional Review Boards (IRBs) and compliance with the Health Insurance Portability and Accountability (HIPAA) Act. 10. SECURITY – There is no security clearance required in the performance of these tasks: the effort is unclassified. 11. HUMAN SUBJECTS & ANIMAL USE – No human subjects or animals will be used in the conduct of the work described herein. RESPONSES TO THIS RFQ shall include a technical and a firm fixed price cost proposal: The technical proposal shall not exceed 20 pages in length, not including resumes. The Font shall be not be smaller than 12 point. Proposals shall be singled-sided, doubled spaced pages. The firm fixed price cost proposal shall provide a breakdown of the labor costs, material costs and any other costs such as travel. EVALUATION FOR AWARD Basis for Award: a. Proposals received will first be evaluated from a technical standpoint without regard to proposed cost. Those proposals considered to be technically acceptable will then be evaluated from a financial and management standpoint. b. Technical factors are significantly more important than cost or price. It is pointed out, however, that should technical competence between offerors be considered approximately the same, then cost or price could become primary. c. FDA will base its award decision using a best value analysis that results in the most advantageous acquisition for the government. FDA’s acquisition strategy used to obtain best value may result in an award to other than the lowest priced, technically rated offeror. Best value analysis spans a continuum from the lowest priced, technically acceptable proposal to those proposals in which tradeoffs between price, past performance, and each offeror’s technical solution is evaluated. This tradeoff process (see FAR 15.101-1) depends on the government’s assessment of quality factors, including but not limited to past performance, compliance with solicitation requirements, technical excellence, management capability, personnel qualifications and prior experience, and price. TECHNICAL EVALUATION CRITERIA: Technical Evaluation Criteria WEIGHT 1.Technical Approach 45 Points The government will evaluate the offeror's technical approach to meet the needs, technical difficulties, challenges, and objectives of the Statement of Work(SOW). The government will consider the completeness, thoroughness, and soundness of the response to all functions and elements of the SOW. 2.Staffing/Management Approach (sub-criteria of equal importance) 25 Points •Evaluation of the offerors experience and capabilities for conducting scientific workshop(s) related to exploring current roadblocks in the use of imaging-based tools for target pharmacokinetics and pharmacodynamics and their role in drug development and in drug monitoring. •Evaluation of the individuals proposed as key personnel who will be responsible for fulfilling the requirements of this RFP will be based on their qualifications, education, background and previous experience in similar requirements. •Documented availability, qualifications, experience, education and competence of professional, technical and other personnel who will be assigned to work on this contract. •Managerial ability to achieve delivery or performance requirements as demonstrated by the proposed use of management and other personnel resources, and to successfully manage the project. •Evaluation of the project staffing strategy, a plan for the selection and use of expert consultants, estimated hours and labor mix, the experience, skills and qualifications of the proposed personnel to adequately minimize risk and successfully complete the requirements of this Contract. 3.Organizational & Personnel Experience and Resources 30 Points Experience is the opportunity to learn by doing similar work under similar contracts. The Contractor will be evaluated on the quality, applicability, and significance of relevant experience as it relates to the requirements of this SOW. Evaluation of the individuals proposed as key personnel who will be responsible for fulfilling the requirements of this RFP will be based on their education, background and previous experience in similar requirements. Additionally, the Contractor will be evaluated on the documented availability of adequate physical facilities, equipment, and other resources necessary to meet the requirements of this project. TOTAL: 100 Point PAYMENT SCHEDULE: Payment will be made as follows: Delivery and acceptance of 1st Quarterly Report - 25% of total award price Delivery and acceptance of Draft Final Report – 25% of total award price Delivery and acceptance of Final Report – 50% of total award price CCR: Vendors must be registered in the Central Contractor Register (CCR) prior to the award of a contract. You may register by going to www.ccr.gov. You will need your Dun & Bradstreet number and banking information. QUESTIONS DEADLINE: All questions are to be submitted via email to Lee.Cohen@fda.hhs.gov no later than Friday August 29, 2008, 2:00pm EST. QUOTATIONS DUE: All quotations are due, via email to: Lee.Cohen @fda.hhs.gov, no later than 12:00pm, EST on Monday, September 8, 2008. PROVISIONS and CLAUSES: The provision at FAR 52.212-1, Instructions to Offerors Commercial Items applies to this solicitation. The following agenda has been attached to this provision: None. Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications Commercial Items. The clause at FAR 52.212-4, Contract Terms and Conditions, Commercial Items applies to this acquisition. The following agenda has been attached to the clause: None. The clause at FAR 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders, Commercial Items applies to this acquisition. The following FAR clauses cited are applicable: FAR 52.217-8, FAR 52.222-26, FAR 52.222-35, FAR 52.222-36, and FAR 52.232-33. Clauses and provisions are incorporated by reference and apply to this acquisition. Responses to this notice must be sent via email to Lee.Cohen @fda.hhs.gov. Contracting Office Address: 5630 Fishers Lane, Room 2100 Rockville, Maryland 20852 Place of Performance: Contractor’s facility Primary Point of Contact.: Lee F. Cohen Lee.Cohen @fda.hhs.gov Phone: 301-827-7046 Fax: 301-827-7106
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