Combined Synopsis Solicitation.pdf

COMBINED SYNOPSIS / SOLICITATION COMPETITIVE

NIH-NINDS-CSS-20-002609

TITLE: Medicinal Chemistry Consultant Support Services

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation;

proposals are being requested and a written solicitation will not be issued.

The solicitation number is NIH-NINDS-CSS-20-002609 and the solicitation is issued as a request for quotation (RFQ).

This acquisition is for a commercial item or service and is conducted under the authority of the FAR Part 13—Simplified Acquisition Procedures; FAR Subpart 13.5— Simplified Procedures for Certain Commercial Items; and FAR Part 12—Acquisition of Commercial Items, and is expected to exceed the simplified acquisition threshold.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-06, dated 05-06-2020.

The associated NAICS code is 541990 (All Other Professional, Scientific and Technical Services) and the small business size standard is $15.0 million.

This requirement is a 100% small business set-aside.

Statement of Need and Purpose: The purpose of this requirement is to procure consultant services to provide technical recommendations to the NIH Blueprint Neurotherapeutics Network drug discovery and development programs in the area of Medicinal Chemistry.

Background Information: The National Institutes of Health (NIH) is the nation’s leading medical research agency and the primary Federal agency whose mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability, conducting, supporting and making medical discoveries that improve people’s health and save lives.

The NIH Blueprint for Neuroscience Research, a consortium of 15 NIH Institutes and Centers that support neuroscience research, established the Blueprint Neurotherapeutics Network (BPN) as a pipeline between the typical endpoint of NIH-funded research and the beginning of industry drug development. The BPN provides neuroscience researchers with funding and access to a full range of industry-style drug development services and expertise. The program is intended for projects requiring medicinal chemistry optimization and contract research organization (CRO) support through Phase I clinical testing. Each project is directed by a Lead Development Team (LDT) composed of the principal investigator (PI), industry consultants hired by NIH, and NIH staff. This team maps out a research strategy, including milestones, and oversees implementation by CROs. Bioactivity and efficacy studies are funded through an award to the PI; other research services can be provided without cost to the PI through NIH contracts.

Project Requirements: Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the requirements in the Statement of Work below:

The Contractor shall provide this support while serving on NIH BPN Lead Development Teams (LDTs). LDTs meet for approximately two hours every one to two weeks via teleconference and each LDT project may require between three and ten hours weekly, inclusive of meeting and preparation time.

The Contractor is expected to provide support services in a collaborative way. LDTs that the Contractor is assigned to may work on several projects in the exploratory through preclinical safety stages. Some projects may proceed to investigational new drug (IND) and clinical trial stages.

Please refer to RFQ Attachment #1 - Statement of Work (SOW) for complete details and specifications.

Period of Performance: The anticipated period of performance is a one-year base period from the effective date of award and two (2) subsequent one-year option periods. The anticipated period of performance for the base period is June 20, 2020 through June 19, 2021.

Place of Performance: The primary place of performance shall be the Contractor site.

Conference calls and email shall be the primary mode of communication; however, the Contractor may be required to work at Government facilities in the continental United States, primarily Bethesda, MD, on an as needed basis.

Contract Type Contemplated: A Labor-Hour Purchase Order with Options to Extend the Term of the Contract and Options for Increased Quantity Separately Prices Line Item is contemplated.

RFQ Attachments:

Attachment #1 - Statement of Work (SOW) Attachment #2 – FAR 52.204-24 and 52.212-3 Certifications Attachment #3 - Terms and Conditions Attachment #4 - Invoice and Payment Instructions Attachment #5 - Electronic Invoicing Instructions for NIH Contractors/Vendors Attachment #6 - Information and/or Physical Access Security Requirements

The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

Evaluation Criteria:

All quotations from responsible Quoters will be evaluated by a Technical Evaluation Panel according to the technical evaluation factors outlined below.

The NIH may elect to discuss or obtain additional information and/or request revisions from only one Quoter or any number of Quoters in accordance with FAR Part 13 procedures. Quoter may be invited to give an Oral Presentation to present information to clarify or augment written information submitted. The Government reserves the right to evaluate quotations and award a contract/order without discussions. Additionally, the Government reserves the right to make no award at all.

The Government will award a purchase order resulting from this solicitation to the quotation that represents the best value – technical factors, price, and past performance considered. The tradeoff process may be used in making this determination. Technical factors together shall be considered significantly more important than price and past performance. These factors will be evaluated using adjectival ratings and no numeric point system will be used. Price and past performance will be considered in the evaluation and source selection but will not be point scored. It is the NIH's intent to evaluate each written quotation using the Technical Evaluation Factors listed in Table A in descending order of importance.

Options. The Government will evaluate quotations for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that a quotation is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

A written notice of award or acceptance of a quotation, mailed or otherwise furnished to the successful quoter within the time for acceptance specified in the quotation, shall result in a binding contract without further action by either party. Before the quotation’s specified expiration time, the Government may accept a quotation (or part of a quotation), regardless of whether there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

A. Technical Evaluation Criteria

Technical Evaluation Factors

Factor 1: Personnel Qualifications

The qualifications of proposed personnel will be evaluated for capability in performing the work contemplated within the Statement of Work including documented experience with drug discovery and development programs in the area of Medicinal Chemistry, educational background, and training. Availability of proposed personnel and their designated responsibility on the project will be evaluated. This includes the experience, executive-level competence and time commitment of the 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 the project. Basic credentials for proposed personnel will be evaluated in the following areas, which are required to carry out the requirements delineated in the SOW and as follows:

Key Personnel Professional Experience in Drug Discovery and Development

Key personnel proposed shall be evaluated for length and breadth of demonstrated leadership experience in drug discovery and development projects related to medicinal chemistry.

Hands-on and leadership and management experience in drug discovery and development tasks, particularly for nervous system conditions, shall be evaluated.

Broad experience across the entire drug discovery and development process from discovery to clinical trials shall be considered favorably.

Key personnel’s professional experience 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, 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.

Finally, key personnel’s professional experience shall be evaluated for efforts involving compliance and familiarity with regulatory procedures and guidelines relevant to small molecule drug discovery development.

Key Personnel Education and Certifications Key personnel proposed shall be evaluated for conformance to the key personnel qualifications identified in the statement of work as well as for additional education and certifications related to the statement of work requirements. Advanced education and board certifications, as well as other evidence of advanced expertise applicable to drug metabolism and pharmacokinetics shall be considered favorably.

Key Personnel Collaborative Team Experience Key personnel proposed 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.

Factor 2: Understanding the Project and Technical Approach

Quoter’s technical approach will be evaluated for soundness, practicality, and feasibility to accomplish the requirements of the Statement of Work (SOW). NIH will also evaluate your technical response based on how well it shows your comprehensive understanding of the project’s goals, objectives, and specific requirements for Medicinal Chemistry Consultant Support Services as called for in the SOW. This includes an evaluation of the thoroughness of your background discussion of the work contemplated under this project. Furthermore, we will evaluate your understanding of the requirements/tasks to be performed, their interrelation and complexity, as well as your discussion of anticipated problems and constraints likely to be encountered in performing the work, and your plans, solutions, and approaches to resolving them.

Other considerations when evaluating your technical response include letter(s) of commitment from proposed key personnel stating they will be or are employee(s) of the proposed Quoter and examples of how the Quoter trains other project staff or clients in their discipline effectively.

Quoter’s technical approach will be evaluated for soundness, practicality, and feasibility to accomplish the tasks and requirements of the SOW. More specifically, we will evaluate for efficacy: ability to accomplish and meet all SOW requirements.

B. Cost/Price Evaluation

Quoter(s) Business Proposal will be evaluated for cost/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 cost/price elements. An evaluation of the Quoter’s price proposals will be made to determine if they reflect a clear understanding of the requirements and are consistent with the Technical Proposal.

Cost/Price Risk: Risk refers to any aspect of the Quoter’s proposals that could have significant negative cost consequences for the Government. Proposals will be assessed to identify potential risks.

C. 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 Statement of Work.

However, this evaluation will not be conducted on any Quoter hose proposal is determined to be technically unacceptable.

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 utilized to determine the quality of the contractor’s past performance as it relates to the probability of success of the required effort.

Additional Terms and Conditions

The Quoter is to include a completed copy of the FAR provisions 52.204-24, Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment, and 52.212-3, Offeror Representations and Certifications—Commercial Items, with its quote. Both provisions are included in Attachment #2.

The FAR clauses 52.212-4, Contract Terms and Conditions – Commercial Items, Alternate I (JAN 2017) and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (MAR 2020), apply to this acquisition. These clauses and additional contract requirement(s) and terms and conditions applicable to this acquisition are listed in Attachment #3.

The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.

Additional Technical and Price Quotation Instructions

Responses to this solicitation must include clear and convincing evidence of the Quoter’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The price proposal must include the labor categories, the Government’s estimated amount of hours for each labor category, fully loaded fixed hourly rates for each labor category, breakdown and rationale for other direct costs or materials, and the total amount. Additional instructions include the following:

Responses to this solicitation must include clear and convincing evidence of the Quoter’s capability of fulfilling the requirement as it relates to the technical evaluation criteria. The Quoter must submit 1) a technical response and 2) a separate price quotation.

Technical Response:

The technical response should be prepared in reference to the evaluation criteria identified in this solicitation and may be up to thirty (30) single-sided pages.

The technical response shall include resumes of proposed key personnel, consultants, and any subcontractors, as well as a letter of commitment from proposed key personnel stating they will be or are an employee of the proposed Quoter.

Quoter shall include in the technical response examples of how they train effectively other project staff or clients in their discipline.

Price Quotation:

The price quotation must include an hourly rate as well as extended pricing for the full level of effort of each contract period. Options for increased quantity must also be detailed. The total contract price should all options be exercised must also be clearly indicated.

Since this requirement anticipates annual funding in the estimated amount of 20 hours for consultant support and includes an estimated annual not to exceed amount of 800 optional hours (for a total annual ceiling of 820 hours\) – pricing must be provided in sufficient detail.

See suggested format below:

Base Period:

Hourly rate = $__/hour Hourly rate x 20 hours = $_____ Option Item: Hourly rate x 800 hours = $______ Option Item: Travel NTE ‐ $1,200 Estimated Total (820 hours and travel) ‐ $____

Option Period 1:

Hourly rate = $__/hour Hourly rate x 20 hours = $_____ Option Item: Hourly rate x 800 hours = $______ Option Item: Travel NTE ‐ $1,200 Estimated Total (820 hours and travel) ‐ $____

Option Period 2:

Hourly rate =$__/hour Hourly rate x 20 hours = $_____ Option Item: Hourly rate x 800 hours = $______ Option Item: Travel NTE ‐ $1,200 Estimated Total (820 hours and travel) ‐ $____

Estimated Total (Base Period and Option Periods 1 & 2): $_____

Quoter should include the following statement within its price quotation:

“It is anticipated that the Government will fund an estimated amount of 20 hours and that a maximum of 800 additional hours may be funded and exercised during each contract period. It is also understood that a not‐to‐exceed travel amount of $1,200 may be funded and exercised during each contract period and may only be used with advance approval.”

Quoter’s Price Quotation shall clearly indicate the Level of Effort (LOE) for the proposed key personnel (e.g. consultant) but if the Quoter proposes hours for other Key Personnel, it must clearly articulate in its technical response how the role will be fulfilled and the rationale for why additional personnel are necessary. The Quoter must also specify a separate hourly rate in its price quotation.

Additional Solicitation Information

In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response.

All Quoters must have an active registration in the System for Award Management (SAM) www.sam.gov.

DATE QUESTIONS DUE: Any questions regarding this solicitation must be submitted electronically to the listed point of contact by 5:00 PM Eastern Standard Time on June 05, 2020.

Fax responses will NOT be accepted.

DATE QUOTATIONS DUE: All responses must be received by 5:00 PM Eastern Standard Time on June 12, 2020, and reference number NIH-NINDS-CSS-20-002609. Responses may be submitted electronically to Evan Feely, Contract Specialist, at evan.feely@nih.gov. Fax responses will not be accepted.

The name and telephone number of the individual to contact for information regarding the solicitation: Evan Feely, (301) 827-5301.

http://www.sam.gov/