SOLICITATION NOTICE
A -- Predictive Value of Systems Biology for Relatively Rare Cardiovascular Adverse Events: Prospective Evaluation
- Notice Date
- 8/31/2008
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 541711
— Research and Development in Biotechnology
- 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
- REQ1046089
- Point of Contact
- Monifa N Coleman, Phone: 301-827-7164
- E-Mail Address
-
monifa.coleman@fda.hhs.gov
- Small Business Set-Aside
- Total Small Business
- Description
- 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 541711, 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. This is a total small business set-aside. 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) for a firm-fixed price base year and one option year. The Food and Drug Administration (FDA) intends to award a purchase order for services for predictive value of systems biology for relatively rare cardiovascular adverse events: prospective evaluation. The Statement of Work is as follows: Background: The modern clinical trial is the international gold standard for evaluating the safety and efficacy of new therapies. While this evaluation tool provides the objective evidence upon which regulatory approval is based, practical limitations on the study size, duration and subject population leave uncertainties regarding safety that cannot be fully answered until a drug is in use by a large, heterogeneous population. Clinical trials are neither powered nor designed to detect rare serious adverse events. When planning the later phases of drug development (phase III and IV), having information that may be predictive of likely adverse events could be extremely valuable in guiding the design of clinical trials and post-market safety studies. Models that can simulate the effects of activating a drug target on the physiology and biochemistry of normal and diseased humans, while not providing information sufficient to make a regulatory decision, may provide information that is helpful in refining development and post-market surveillance plans on potential safety concerns. One area of science that has the potential to provide useful predictive value in drug evaluation is systems biology. Systems biology ideally seeks to understand complex biological systems in their entirety by integrating all levels of functional information into a cohesive model. Platforms are based on mathematical descriptions of known functions and behaviors of biological components linked into complex models that allow for the dynamic interaction of large numbers of variables. The science of systems biology has evolved rapidly in recent years, due in part to increasing computational power and the ease of amassing comprehensive information on an organism’s genes, proteins, metabolic pathways, transporters, and other components. Systems biology has matured to the point it is now being applied to simulations of clinical trials. By introducing the ability to alter physiological parameters to reflect values seen in disease states, it is possible to build dynamic large scale computer models of human disease. Further, by creating a large number of models with a range of parameters that reflect the heterogeneity of healthy and diseased individuals, it is possible to build a population of unique virtual subjects. Activating a drug target in this virtual population and following the temporal changes this induces in key variables allows for simulation of a clinical trail. Each trial can have a potentially unlimited number of subjects representing commonly encountered subpopulations (e.g. diabetics). While systems biology is a potentially useful tool in evaluating the safety and efficacy of drugs, the utility has not been evaluated in a regulatory context. This project would test the predictive value of a systems biology simulation of an ongoing outcomes clinical trial, using a virtual patient population that reflects the variation of the actual subject population. Objective: A.To develop a systems biology simulation of the effects of specific drugs within a predetermined class in order to model the safety and effectiveness of these drugs, as well as identify potential biomarkers predictive of responder/non-responder and adverse responder. B.To simulate the clinical efficacy-safety profile (efficacy endpoints, adverse events, incidence) in a selected organ system of a drug in development. The simulated subject population will approximate the variability in the actual clinical trial population. C.Evaluation of the validity of the modeling approach by comparing simulated efficacy and safety to the clinical trial results in terms of the population profiles and individual responses. Scope of Work: The FDA will select a drug class and a set of drugs within that class for which it has ongoing clinical trials. The contractor shall conduct a systems biology evaluation of the selected drugs to determine if the safety issues associated with each drug are compound-specific, or a class effect. The contractor shall model different scenarios/compounds with differing PK/PD and receptor binding characteristics providing a preliminary assessment of the safety & efficacy profiles of each drug. The contractor shall provide a simulated risk profile of the drugs. In addition, candidate biomarkers will be identified to differentiate patients who are likely to benefit from a drug (responders) from patients who do not respond, or who are exposed to a higher risk (adverse responders) due to specific drugs. In the second phase, the contractor shall construct a virtual clinical trial population based on a range of subject characteristics with variability specified by the FDA. This virtual population will be used to conduct virtual clinical trials with a trial design and characteristics specified by the FDA. The contractor shall provide the FDA with statistical summaries of the trial results, as well as individual virtual subject level data and will provide a prediction of rare and serious adverse events and identify biomarkers that may identify subjects who will benefit as well as those who may be at increased risk of an adverse event. Reporting Requirements and Deliverable Items SOW No.ActivityDeliverableTimeframe (work days) 1Comparative pharmacologic simulation of several investigational drugs from the same mechanistic classSimulation of the following variables at intended doses: Total cholesterol, HDL Cholesterol/LDL cholesterol (including particle size and distribution for both), triglycerides, and plaque volume and compositions. 3 months 2Comparative clinical trial outcome simulation for several investigational drugs from the same mechanistic class1. Create virtual population for both efficacy and safety 2. Clinical trial simulation for primary outcome measurements (morbidity and mortality) and plaque stability9 months Period of Performance: September 22, 2008 through September 21, 2009 The period of performance for this contract shall be 12 months from the effective date of the award with a one-year option. 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: Table 1: Evaluation Factors Offerors will be evaluated: Area 1—Key Personnel (35 points) Factors to be considered include: Skills, qualifications, and experience of the proposed staff with respect to the tasks delineated in the Statement of Work, including: In depth working knowledge and understanding of systems biology as applied to the creation of integrated, dynamic large scale computer models of human disease and the creation of virtual populations In depth knowledge of human physiology In depth knowledge of systems engineering Demonstrated experience with clinical trial simulations based on virtual populations of subjects created on systems biology platforms which integrate multiple levels of biological information Availability of proposed resources to commit to the contract Area 2—Qualifications and Experience (35) The offerer will have the following systems biology models established and qualified: lipid metabolism, inflammation, plaque stability, and cardiovascular risk (e.g., myocardial infarction, stroke). Additionally, the offerer will have experience in using these and other systems biology (mechanistic) models in solving drug development and clinical trial issues. The offerer should have prior experience in using these tools and applications with prior pharmaceutical, biotechnology, or regulatory environments. An essential qualification for this project includes the ability of the Offerer to simulate clinical trials using a virtual trial population specifically created to have a pre-specified composition reflective of desired variability in disease state and pre-specified sub-populations (e.g. obese, diabetic). In addition, the Offeror shall describe their past performance in related clinical trial simulation efforts, identifying other organizations with which they have participated in similar efforts. Offerors shall submit a list of three (3) references that include the following: 1.Name of the contracting activity 2.Contract number 3.Contract type 4.Total contract value 5.Description of the work performed Name and on their performance under existing and prior contracts for similar services and products. Area 3—Management Plan and Approach (30 points) Factors to be considered in this area include the: •Degree to which the Offeror’s organization is able to support the efforts proposed •Planning, content, management, and delivery of the modeling and simulation services requested •Corporate approach to managing the project, including supervisory responsibility and accessibility to qualified staff Special Terms and Conditions: The Contractor selected must already have in place the infrastructure, expertise and capability to rapidly generate simulations of clinical trials based on the creation of virtual populations with pre-specified disease and physiologic characteristics. Core competencies need to exist in systems biology, clinical pharmacology, clinical trial design, and modeling and simulation. PAYMENT SCHEDULE: Payment will be made in monthly installments based on level of effort (hours worked). Below are possible labor categories to propose, but are not limited too: Labor Category (Loaded):Total Hours Hourly RateTotal Cost Senior Life Scientist$$ Senior Systems Engineer$$ Bioinformatics Specialist$$ Travel: Travel and Related expenses$ $ TOTAL$ $ FACILITIES: Contractor shall conduct research in space provided by FDA. FDA will also provide appropriate equipment. 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 Monifa.Coleman@fda.hhs.gov no later than September 5, 2008, 12:00pm EST. QUOTATIONS DUE: All quotations are due, via email to: Monifa.Coleman@fda.hhs.gov, no later than 12:00pm, EST on September 12, 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 52.217-9, 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 Monifa.Coleman@fda.hhs.gov. No phone calls will be accepted.
- Web Link
-
FedBizOpps Complete View
(https://www.fbo.gov/?s=opportunity&mode=form&id=fa4f446ebd3fbca6cd54ce4450551d69&tab=core&_cview=1)
- Place of Performance
- Address: 10903 New Hampshire Ave, Silver Spring, Maryland, 20993, United States
- Zip Code: 20993
- Zip Code: 20993
- Record
- SN01656413-W 20080902/080831213038-fa4f446ebd3fbca6cd54ce4450551d69 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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