Att 5_Evaluation Criteria.docx

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Subject Matter Expert Consultant for Pharmaceutics / Formulation / Chemistry Manufacturing Control [CMC]
Solicitation number
75N95025Q00057
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This document is an Evaluation Criteria file for a Subject Matter Expert Consultant contract issued by the National Institute on Drug Abuse (NIH). The solicitation seeks a consultant for Pharmaceutics/Formulation/Chemistry Manufacturing Control services, with a total possible 50 points allocated to evaluating personnel qualifications. The technical evaluation will focus on three key sub-factors: professional experience in drug discovery and development, educational degrees and certifications, and collaborative team experience.

The government will award the contract on a best value basis, considering technical factors, price, and past performance, with technical factors weighted more heavily than price. Offerors will be evaluated on their personnel's expertise in drug discovery, particularly for nervous system and pain conditions, leadership experience in clinical trials, cross-functional team collaboration, and advanced degrees or certifications. The evaluation will also assess price reasonableness and potential price risks. Past performance will only be evaluated for technically acceptable quotes, and the government reserves the right to award without discussions or make no award at all.

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CSS_75N95025Q00057.docx DOCX document
Att 1_SOW.doc DOC document
Att 3_Invoice instruction.pdf PDF
Att 2_TC clauses.pdf PDF
Att 4 - Pricing template.xlsx XLSX spreadsheet

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EVALUATION CRITERIA

The Government will award a contract(s)/order(s) resulting from this requirement on the basis of best value, technical factors, price, and past performance considered. Technical factors together shall be considered more important than price and past performance. All technical evaluation factors are detailed below.

The Contract Specialist and Contracting Officer will review offers for conformance to the solicitation instructions. The Government’s Technical Evaluation Panel (TEP) will evaluate all offers based on the technical criteria described below.

TEP will evaluate the qualifications of proposed key personnel to determine capability of performing the consulting services described in this solicitation. The TEP will base its evaluation on Technical Factor 1: Personnel Qualifications and its sub-factors, which are described below in Table A. An overall score will be given for Technical Factor 1; sub-factors will not be individually scored.

IMPORTANT:

The Government may elect to conduct discussions, obtain additional information and/or request revisions from one or more Quoters at any point during the evaluation process, in accordance with FAR Part 13 procedures. The Government also reserves the right to evaluate quotes and award a purchase order without discussions as well as the right to make no award.

Table A. Technical Factors Evaluation Criteria Technical Factor 1: Personnel Qualifications – Total Possible Points: 50 Qualifications of proposed personnel will be evaluated to determine to what extent the personnel are capable of performing the work outlined in the SOW. This includes documented hands-on experience with drug discovery and development programs in the area of Pharmaceutics / Formulation/Chemistry Manufacturing Control, executive-level competence, educational background, and training.

The availability of proposed personnel and their designated responsibility in the project will also be evaluated, including letter(s) of commitment from proposed key personnel.

Resumes of proposed key personnel, consultants, and any subcontractors will be evaluated for appropriateness of credentials, training, qualifications, experience, and competence to carry out this requirement. Basic credentials will be evaluated in the following areas, designated as sub-factors of Technical Factor 1:

Title: Pharmaceutics Formulation/Chemistry Manufacturing and Controls Consulting Services Attachment 5 – Evaluation Criteria

· Sub-factor 1: Professional Experience and Expertise in Drug Discovery and Development Professional experience of proposed personnel shall be evaluated for length and breadth of demonstrated leadership experience in drug discovery and development projects related to the consulting services described in the SOW including hands-on leadership and management experience in Phase 1 in-house and outsourced trials, particularly for nervous system and pain conditions. Broad experience across the entire drug discovery and development process from discovery to clinical trials shall be considered favorably.

Professional experience of proposed personnel shall also be evaluated for experience in managing or leading drug discovery projects in biopharmaceutical industry, as well as publications, patents, and work on drugs brought to market. In addition, experience showing the use of expertise to identify or anticipate problems early on, overcome technical or regulatory difficulties, distill complex situations, or demonstrate strong risk-assessment ability to make wise use of limited resources, shall be considered favorably.

Professional experience of proposed personnel shall be further evaluated for experience involving cross-functional team efforts in drug development, as well as indications of strong interpersonal and organizational skills.

· Sub-factor 2: Educational Degrees and Certification Educational degrees and certifications of proposed personnel shall be evaluated for conformance to the required qualifications identified in the SOW; additional degrees and certifications related to the SOW requirements will also be evaluated. Advanced degrees and board certifications and other evidence of advanced training applicable to Pharmaceutics Formulation/CMC shall be considered favorably.

· Sub-factor 3: Collaborative Team Experience Qualifications of proposed personnel shall be evaluated for length and breadth of experience collaborating with multi-disciplinary teams, especially teams with members from external organizations and members at various management levels. Experience such as team leadership, consulting, or service on strategic and advisory boards shall be considered favorably.

In addition, the Government will, in accordance with FAR 52.217-5 Evaluation of Options, evaluate the proposed total price by adding the proposed prices for all options to the proposed price for the base requirement. The Government may determine that a quote is unacceptable if the option prices are significantly unbalanced. Evaluation of options does not obligate the Government to exercise said options. The non-technical factors of Price and Past Performance are described in more detail in Table B:

Table B. Non-technical Factors Evaluation Criteria Proposed Price Offeror’s total quoted price will be evaluated for price reasonableness. For a price to be reasonable, it must represent a price to the government that a prudent person would pay when consideration is given to prices in the market.

An evaluation of the offeror’s price quote will be performed to determine if it reflects a clear understanding of the requirements and is consistent with Quoter’s technical response.

If the Offeror proposes the involvement of any additional staff besides Key Personnel, it must clearly articulate how their role will be fulfilled and why it believes additional personnel are necessary. The Offeror must also specify how work time of additional staff will be charged (e.g. direct hourly rate or included within overhead cost). Finally, if Offer includes any Other Direct Costs (ODCs) besides travel in its Price Template, the Offeror must include its rationale for the other ODCs in the Offeror’s Price Narrative.

Price Risk: Refers to any aspect of Quoter’s quote that could have significant negative price consequences for the Government. Quotes will be assessed to identify potential risks.

Past Performance A past performance evaluation will be conducted only on Quoter’s whose quotes have been determined to be technically acceptable.

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