Attachment 5 - Tech Eval Criteria.pdf

TECHNICAL EVALUATION CRITERIA

Solicitation Number: 75N95024Q00252

“Biological Therapeutics Product Development Subject Matter Expert Consulting Services”

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

This evaluation will proceed in two phases.

Depending on the quality of the responses submitted, the Government will award one purchase orders 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 during both Phases One and Two of the evaluation process but will not be point scored. It is the Government’s intent to evaluate each individual key personnel proposed under each quote using the selection criteria listed below. Phase One will be scored out of 100 possible points for Technical Factor #1. Phase Two will be scored out of 100 possible points for Technical Factors #1, #2 and #3.

Please note that during Phase Two of the evaluation process, the Government may revise any Quoter’s score for Technical Factor #1 and/or its evaluation of the Quoter’s price and past performance if merited by that Quoter’s oral presentation and Phase Two response.

Phase One Technical Evaluation Criteria:

During Phase One, the TEP will evaluate the quoter’s response and the qualifications of proposed personnel to determine whether the quoter and proposed 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: Quoter and Personnel Qualifications and its sub- factors, which are described in Table A.

Table A: Evaluation Criteria for Phase One Technical Factors

Technical Factor 1: Quoter and Personnel Qualifications – 100 points Qualifications of quoters and proposed personnel will be evaluated to determine to what extent they are capable of performing the work contemplated within the SOW. For the quoter, these qualifications include documented program management experience deploying SMEs for drug development programs. For the proposed personnel, these qualifications include documented experience with biologics development projects in the required SME areas, 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.

A program management plan that addresses all tasks described in the SOW will be considered. Considerations will also include the experience, executive-level competence, and time commitment of the proposed personnel.

Sufficiently detailed resumes should be submitted for the main areas listed in the SOW (chemistry, controls, and manufacturing (CMC), pharmacokinetics/pharmacodynamics (PK/PD), absorption, distribution, metabolism, and excretion (ADME), toxicology, bioassay development, regulatory affairs, medical writing, biostatistics, quality assurance, and first-in-human study planning and design) to demonstrate available personnel capable of fulfilling a wide range of requirements.

Sufficiently detailed resumes of proposed key personnel, consultants, and any subcontractors proposed for the Sample Task Orders will be evaluated for appropriateness of credentials, training, qualifications, experience, and competence to carry out the project.

Sub-factor 1: Program Management Experience for Drug Discovery and Development The quoter shall address their ability to provide program management support through a description of the subject matter experts (SMEs) available to support the program broadly, a description of their process for recommending and deploying SMEs for projects, and their experience managing multiple task orders across many projects. The SOW provides greater detail about the activities required for Program Management Support and what should be addressed in the proposal.

Sub-factor 2: Professional Experience and Expertise in Drug Discovery and Development Professional experience of the quoter and proposed personnel shall be evaluated for length and breadth of demonstrated leadership experience in biologics development projects related to the required subject matter expert (SME) areas.

Evaluations shall be based on demonstrated expertise and experience in executing and managing the drug development tasks described in the SOW. Broad experience across the entire drug discovery and development process from discovery to clinical trials shall be considered favorably.

Professional experience of quoter and 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 development and examples.

Sub-factor 3: 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 development shall be considered favorably.

Sub-factor 4: 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.

Total Possible Points: 100

During Phase One, 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 (JUL 1990). 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 criteria for price and past performance are described in more detail in Table B:

Table B: Evaluation Criteria for Phase One Non-Technical Factors

Price Evaluation:

Respondent’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. Quoters are 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:

Quoters 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.

Phase Two Technical Evaluation Criteria:

During Phase Two, respondents whose quotes received the highest ratings for Phase One will be given an opportunity to conduct oral presentations. These presentations will be conducted virtually in accordance with the “Phase Two Instructions” section of the solicitation.

The TEP will primarily use these presentations to evaluate a respondent’s proposed technical approach as well as the quality of its oral communication/presentation skills in accordance with Technical Factor 2: Understanding the Project and Technical Approach and Technical Factor 3: Communication and Oral Presentation Skills. The evaluation criteria for Technical Factors 2 and 3 are described in more detail in Table C:

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

Guiding Biotechnology and Biologic Discovery and Development Projects

1. Experience in providing expert advice for biotechnology and biologic discovery and development projects clients in the biopharmaceutical industry or academia.

2. Experience in CMC, In-vitro/Bioassay development, ADME/Pharmacokinetics, Toxicology, Regulatory Affairs/Operations, Medical Writing, Biostatistics, and/or Quality Assurance strategy development

3. Experience in providing guidance on strategy development, technical due diligence, and proposing related requirements to develop different biologic modalities in either manufacturing, nonclinical or clinical phase of development.

4. Experience with biotechnology products and biologic discovery for nervous system conditions

Regulatory Requirements of Nonclinical and Clinical CMC Development

1. Previous hands-on experience in the preparation and/or review of the CMC sections of pre-IND, IND and/or BLA for biologics.

2. Understanding of US regulatory requirements pertaining to nonclinical and clinical

CMC development of different biologic modalities

1. General Customer Service

1. Interpersonal skills

2. Attention to detail

3. Computer and software literacy

4. Writing, Communication, and Presentation Skills

Table C: Evaluation Criteria for Phase Two Technical Factors Technical Factor 1: Personnel Qualifications – 50 points Please see Table A.

Technical Factor 2: Understanding the Project and Technical Approach – 25 points The Government will evaluate the Quoter’s proposed technical approach and comprehensive understanding of the project’s goals, objectives, and specific requirements as described in the SOW, including their interrelation and complexity. The technical approach will also be evaluated for soundness, practicality, and feasibility for accomplishing these requirements.

This will include an evaluation of the Quoter’s understanding of the Sample Task Order requirements and the potential task orders to be issued under this contract. Additionally, the Government will evaluate the Quoter’s discussion of anticipated problems and constraints likely to be encountered in performing the work and potential plans and solutions for resolving them. Finally, in light of SME consultants’ anticipated roles on assigned projects, the Government will evaluate examples of how the Quoter has effectively trained/instructed other individuals in their discipline.

Technical Factor 3: Communication and Oral Presentation Skills – 25 points The Government will evaluate the effectiveness of Quoter’s interpersonal, written, and verbal communication skills as well as demonstration of its ability to successfully communicate with groups and actively participate in team meetings. Due to the frequency and importance of the Lead Development Team (LDT) meetings, which are described in Sample Task Order 1, the SMEs must be willing and capable of making positive and meaningful contributions to group discussions.

Since, as stated in the SOW, some members of the LDTs may lack drug discovery and development experience, the oral presentation must also establish that the SME is able to share its knowledge with fellow team members in a manner that is both informative and collegial. These qualities will be evaluated by the Quoter’s demonstrated ability to communicate its technical approach during its oral presentation, address any questions or issues raised by the evaluation panel members, and provide an overview of SME’s specific areas of expertise and experience.

Total Possible Points: 100

Evaluation Criteria for Phase Two Non-Technical Factors

Price Evaluation:

Please see Table B.

Past Performance:

Please see Table B.