NOTICE OF PROPOSED PROCUREMENT (NPP)

Solicitation #: 1000175432 Closing Date: November 30, 2015 Time: 2 p.m. EDT

This requirement is for the department of Health Canada.

Title:

In Vitro Pharmacokinetics for High Throughput Data Interpretation

Scope:

As part of a project funded by Canada’s Chemicals Management Plan (CMP) research fund, Health Canada research and regulatory scientists are developing tools and approaches to facilitate the use of in vitro studies and dosimetry to establish points of departure for risk assessment. The data generated through this contract will be used to assist in developing predictive tools and informing the utility of non-traditional toxicity data for regulatory use. Specifically, the development of tools to interpret and evaluate high-priority compounds that will assist evaluation programs within Health Canada in assessing the results of the high throughput data and contribute to informed screening and risk assessment of CMP chemicals.

The list of CMP cycle 3 substances included in the first experimental batch (See Table in RFP) represent substances that the Existing Substances Risk Assessment Bureau has identified as early data needs to support methods development and risk assessment activities. The pharmacokinetic parameters generated through this work fulfill a data-need priority for advancing our understanding for the integration of high throughput screening data into CMP. Specifically, the ethyl glycol ethers and hindered-substance groupings are currently being considered as an early assessment grouping under the upcoming phase of CMP cycle 3 assessment. Assessment-specific timelines will become available in winter 2015-16.

In addition to assessment activities, the substances are part of a larger research collaboration between the Environmental Health Science Research Bureau, Existing Substances Risk Assessment Bureau, and the US EPA National Center of Computational Toxicology. The in vitro pharmacokinetic parameters will be used to develop in vitro- to-in vivo extrapolation methods using pharmacokinetic models, high throughput data, chemo-informatics approaches, and available published health endpoints. An important deliverable of this collaboration is the development of a case study that will address several key elements, including uncovering the considerations of using high throughput data to develop categories and to evaluate the advantages and uncertainties associated with read-across.

Further substances comprising a second list will continue to be added for data generation as they are prioritized for assessment and/or are identified as being ideal candidates to support the development of predictive tools.

Objectives of the Requirement

The aim of this project is to conduct in vitro experiments to generate the pharmacokinetic parameters (microsomal metabolic stability and blood protein binding) for a series of chemicals identified by the Existing Substances Risk Assessment Bureau (ESRAB). Table 1 presents the first batch of chemical to be analyzed and a second batch of chemicals will be identified before the end of fiscal year 2015-2016. The resulting data will subsequently support the needed computational in vitro-to-in vivo extrapolation (IVIVE) methods which will then be used to estimate human equivalent doses. The data obtained from these pharmacokinetic evaluations will be used to facilitate the addition of a risk context to the high-throughput in vitro screening data.

Estimated Value:

The overall value of the requirement, including the cost of the professional services, equipment, miscellaneous costs, and any other costs which will be associated with the requirement is estimated at $85,000 in fiscal year 2015-16, with an option estimated at $55,000 in fiscal year 2016-17). The total estimated value of the requirement over 2 fiscal years is $140,000.

Ownership of Intellectual Property:

Canada will own the Intellectual Property.

Security Requirement:

There is no security requirement.

Mandatory Requirements:

M1. The bidder’s project team must have a team leader with PhD in a biomedical sciences field and analytical expert with a PhD relevant to the work described in the Statement of Work.

M2. The bidder’s project leader must demonstrate that within the last 5 years, they have undertaken projects to measure drug metabolism pharmacokinetic parameters using of in vitro analysis.

M3. The bidder must have at least 5 years of experience in conducting drug metabolism pharmacokinetics studies.

M4. The bidder must have at least 5 years of experience employing high end analytical techniques to assess in vitro experiments.

M5. The bidder must clearly outline the methods that will be employed to meet the technical requirements described in the Statement of Work. Proposed methods must be clearly described, consistent with the SOW’s requirements, and be sufficiently detailed so as to demonstrate the bidder’s overall competence, experience and grasp of the required services.

Selection Methodology

The contract will be awarded to the bidder with the highest technical score who stays within the budget of $85,000 for this fiscal year (FY2015-16) and $55,000 for the option year FY2016-17. The total budget for this requirement, including the option year, is $140,000.

Enquiries regarding this Request for Proposals are to be submitted in writing to:

Robert Merrick

Contracting Authority

E-mail: Robert.Merrick@hc-sc.gc.ca