Amendment 1 - TechEvalFactor_Biologics 10-29-2026.docx

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Senior Advisor 2 for Biological Therapeutics Development to act as External Oversight Committee (EOC) Subject Matter Expert (SME) Services.
Solicitation number
7571PSQ00013
Issued by
Not on record

About this file

This is an Amendment 1 evaluation factors document for a Request for Quote solicitation (7571PSQ00013) issued by the National Institute of Neurological Disorders and Stroke (NINDS) for Senior Advisor 2 subject matter expert (SME) services supporting the NIH Blueprint Neurotherapeutics Network for Biologics (BPN-Biologics) drug discovery and development programs. The position requires a highly experienced executive-level individual with extensive expertise in biologics drug discovery and development, particularly for nervous system conditions and opioid-related therapeutics under the NIH HEAL Initiative. This acquisition is set-aside for small business concerns.

The technical evaluation is structured as a single factor worth 100 points: Personnel Qualifications, evaluated without individual sub-factor point scoring. Quoters will be assessed on three sub-factors: (1) Professional Experience and Expertise in Biologics Drug Discovery and Development, including demonstrated leadership in executing and managing biologics development tasks (antibodies, proteins, peptides, large-molecule therapeutics), experience across the full discovery-to-clinical-trials process, successful IND applications, publications, patents, and regulatory expertise in chemistry, manufacturing, and controls (CMC) and immunogenicity assessment; (2) Educational Degrees and Certifications, including advanced degrees and board certifications in relevant areas such as protein engineering, immunology, bioprocess development, and toxicology; and (3) Collaborative Team Experience, including multi-disciplinary team leadership, consulting, and service on strategic and advisory boards. Price will be evaluated for reasonableness and risk but will not be point-scored. Past performance evaluation, limited to two relevant Federal Government or commercial references demonstrating similar complexity and magnitude, applies only to technically acceptable quotes and will assess interpersonal skills, attention to detail, computer literacy, and communication abilities. The Government reserves the right to conduct discussions, request revisions, evaluate without discussions, or make no award.

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EVALUATION FACTORS

Senior Advisor 2 for the Blueprint Neurotherapeutics Network (BPN) to Act as Subject Matter Expert (SME) with Biologics Drug Discovery and Development Expertise

All quotes from responsible Quoters will be evaluated according to the technical evaluation factors outlined below.

The Government will award a purchase order resulting from this solicitation to the respondent whose quote represents the best value, technical factors, price, and past performance considered. The tradeoff process may be used in making this determination.

The technical factors combined are considered significantly more important than price and past performance. Price and past performance will be considered in the evaluation process but will not be point scored. It is the Government’s intent to evaluate each quote using the selection factor listed below.

The Contract Specialist and Contracting Officer will review quotes for conformance to the solicitation instructions. The Government’s Technical Reviewer(s) will evaluate the quotes in accordance with the technical evaluation factor described below.

IMPORTANT:

The Government may elect to discuss or obtain additional information and/or request revisions from one or more respondents at any point during the evaluation and source selection process, in accordance with RFO FAR Part 12 procedures. The Government also reserves the right to evaluate quotes and award a purchase order(s) without discussions as well as the right to make no award at all.

Technical Evaluation Factor:

The technical reviewer(s) will evaluate the qualifications of proposed personnel to determine whether the personnel are capable of performing the work contemplated within the SOW. An overall score will be given for this factor; sub-factors will not be individually scored. This evaluation will be done in accordance with Factor 1: Personnel Qualifications and its sub- factors, which are described in Table A:

Table A: Evaluation Factor for Phase One Technical Factors Technical Factor 1: Personnel Qualifications – 100 points Qualifications of proposed personnel will be evaluated to determine to what extent the personnel are capable of performing the work contemplated within the SOW. These include documented experience with drug discovery and development programs in the area of biologics drug discovery and development, educational background, and training. Availability of proposed personnel and their designated responsibility on the project will also be evaluated, including letter(s) of commitment from proposed key personnel.

Considerations include the experience, executive-level competence, and time commitment of the proposed 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 the project. Basic credentials will be evaluated in the following areas, which are required to carry out the requirements described in the SOW:

Sub-factor 1: Professional Experience and Expertise in Biologics 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 biologics drug discovery and development.

Evaluations shall be based on demonstrated expertise and experience in executing and managing biologics development tasks (e.g., antibodies, proteins, peptides, and other large-molecule therapeutics), particularly for nervous system conditions. Broad experience across the entire biologics discovery and development process, from candidate discovery and optimization through cell line and process development, IND-enabling studies, and early-phase clinical trials, shall be considered favorably.

Professional experience of proposed personnel shall also be evaluated for preparation of successful investigational new drug applications, as well as publications, patents, and work on drugs brought to market. In addition, experience showing 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 efforts involving compliance as well as familiarity with regulatory procedures and guidelines relevant to biologics drug discovery and development, including chemistry, manufacturing, and controls (CMC) and immunogenicity assessment.

Sub-factor 2: Educational Degrees and Certifications 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 as well as other evidence of advanced training applicable to biologics drug discovery and development (e.g., protein engineering, immunology, bioprocess development, toxicology) 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 outside organizations and members at various management levels. Experiences such as team leadership, consulting, or service on strategic and advisory boards shall be considered favorably.

The Government will evaluate price for award purposes by adding the total price for all options to the total price for the basic requirement in accordance with FAR 52.217-5 Evaluation of Options (Nov 2025) (Deviation). 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 them. The evaluation factor for price and past performance are described in more detail in Table B:

Table B: Evaluation Factor for Non-Technical Factors

Price Evaluation:

Quoter’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. Quoter is expected to establish a reasonable price relationship between all price elements. An evaluation of the respondent’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.

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

Past Performance:

The Quoter shall identify up to two (2) awards with the Federal Government and/or commercial customers that demonstrate recent and relevant past performance.

Relevant is defined as work similar in complexity and magnitude to the work described in the SOW.

This evaluation will not be conducted, however, on any respondent whose quote is determined to be technically unacceptable or otherwise not considered for award.

Include the following information:

· Project title

· Description of the project

· Contract number

· Contract amount

· Government Agency/Organization

· Contracting Officer’s name, address, and phone number

· Contract and, if applicable, task order number

· Current status, e.g., completed and/or if in progress, start and estimated completion dates

· Dollar value and type of contract

· Name of company being referenced

· SOW paragraphs that the reference applies to

· Key personnel (please highlight those individuals who worked on the relevant project(s) and are also being proposed for this effort.)

· A brief narrative of why you deem the reference to be relevant to this effort

The Government may also consider information obtained through other sources. Past performance information will be used to determine the quality of the contractor’s past performance as it relates to the probability of success of the required effort.

Examples of relevant past performance that demonstrate customer satisfaction in the following areas shall be viewed favorably:

1) Interpersonal skills

2) Attention to detail

3) Computer and software literacy

4) Writing, Communication, and Presentation Skills

File details come from the government source that posted it. Updated .