This is a Sources Sought Notice is to seek contractors that can provide professional training and facilitation services necessary to conduct a “Pharmacokinetic (PK) & Pharmacodynamic Modeling (PD) training class for FDA employees. This notice is for planning purposes only, and does not constitute an invitation for Bids, Request for Proposal or Request for Quotation or an indication the Government will award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a small business set-aside is possible. Background OB requires professional services support to facilitate PK/PD customized five (5) day training course to ensure staff are well prepared to address mission critical modeling and simulation clinical objectives. The training course will include PK in the context of preclinical and clinical research and how PK can impact drug development and regulatory guidelines governing PK/PD studies. Using its specialized knowledge and skills, the contractor will facilitate five (5) day virtual course with recorded components. There live webinar sessions are designed for student/facilitator interaction. Scope of Work The purpose of this procurement is to seek the full professional training and facilitation services necessary to conduct the “Pharmacokinetic (PK) & Pharmacodynamic Modeling (PD)“to FDA employees. The five (5) day course on concepts and applications of PK/PD modeling will be presented to forty (40) FDA employees. The contractor shall provide the following: Provide a comprehensive overview of PK/PD. Provide a bridge between science and medicine in the development of a drug. Describes the role of in-vivo PK and PD studies in a drug development program, set out the uses to which the findings can be put, and discuss their implications for clinical development and application for marketing approval. Provide detail on a variety of aspects of such studies: design, sampling, data analysis, research in special populations, and bioequivalence testing. Describe PK/PD and disease progression relationship by investigating drug action, summarizing extensive data, building a knowledge repository, dosing regimens and predictions. Describe and predict the time of course of drug effects under various physiological and pathological conditions. The contractor shall have the necessary expertise, knowledge, and experience to successfully perform all the tasks identified in the task listed below. Refer to the Draft Statement of Work for specific details. Capability Statements Responses to this source sought notice shall unequivocally demonstrate the respondent’s capabilities to provide the services above as well in the draft statement of work. Though the target audience is small business, all interested parties may respond. Please include all the requested information using an excel spreadsheet. At a minimum, responses shall include the following: 1. Business name and bio, Unique Entity Identifier (UEI), business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm. A SAM.gov account and a UEI is required 2. Descriptive literature, brochures, marketing material, etc. detailing the nature of services the responding firm is regularly engaged in providing. (May use a PDF format) 3. Provide information that demonstrates the capabilities to provide the services in the draft statement of work. 4. Client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include DUNS number and size status) if not the respondent. 5. Market Research Pricing information shall include prices for performing the 5-day training that includes all necessary personnel, material and services. 6. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and Schedule Item Numbers (SIN)s that are applicable to this potential requirement are also requested. If a large business, clarify if subcontracting opportunities exist for small business concerns. The Government is not responsible for locating or securing any information, not identified in the response. Response Instructions Interested parties shall respond with capability statements using a excel spreadsheet when possible and send the reponses via e-mail before 9:00 AM Eastern Time on February 20, 2023, to
[email protected]. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in Government Point of entry. However, responses to this notice will not be considered adequate responses to a solicitation. Confidentiality: No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).