Sol_75N92021Q0123.pdf

75N92021Q0123

1. REQUEST NO.

5a. ISSUED BY

NAME

a. NAME

c. STREET ADDRESS

d. CITY

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON

OR BEFORE CLOSE OF BUSINESS (Date)

2. DATE ISSUED 3. REQUISITION/PURCHASE REQUEST NO. 4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG.1

RATING

6. DELIVERY BY (Date)

7. DELIVERY

9. DESTINATION

a. NAME OF CONSIGNEE

b. STREET ADDRESS

PAGE OF PAGES

5b. FOR INFORMATION CALL: (No collect calls)

TELEPHONE NUMBER

AREA CODE NUMBER

8. TO:

b. COMPANY

e. STATE f. ZIP CODE

c. CITY

d. STATE e. ZIP CODE

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it to the address in Block 5a. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services. Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

THIS RFQ

REQUEST FOR QUOTATION

(THIS IS NOT AN ORDER)

IS IS NOT A SMALL BUSINESS SET ASIDEX

06/14/2021 6027193

1 8

National Heart, Lung, and Blood Institutes Bethesda MD 20892-7511

National Institutes of Health 08/17/2022

BLDG 10, 1A, BETHMC

BLDG 10 - Clinical Center, 1st Floor, Wing A, 10 Center Drive N/A

Bethesda

MD 20814

301 827-3317Elizabeth Francois

06/22/2021 1200 ED

FOB DESTINATION

OTHER

(See Schedule)X

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS (%) b. 20 CALENDAR DAYS (%) c. 30 CALENDAR DAYS (%) d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations

13. NAME AND ADDRESS OF QUOTER

b. STREET ADDRESS

c. COUNTY

d. CITY e. STATE f. ZIP CODE

14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

16. SIGNER

a. NAME (Type or print)

c. TITLE (Type or print)

a. NAME OF QUOTER

AREA CODE

NUMBER

15. DATE OF QUOTATION

b. TELEPHONE are are not attached

AUTHORIZED FOR LOCAL REPRODUCTION

Previous edition not usable

STANDARD FORM 18 (REV. 6-95)

Prescribed by GSA - FAR (48 CFR) 53.215-1(a)

COMBINED SYNOPSIS / SOLICITATION

(1) Action Code: Combined Synopsis/Solicitation

(2) Date: 06/14/2021

(3) Year: 2021

(4) Contracting Office Zip Code: 20892

(5) Classification Code: R499

(6) Contracting Office Address:

6705 Rockledge Drive

RKL I

Bethesda, MD 20892

(7) Subject/Title: Laboratory Services for Adeno-Associated Virus Based Therapeutics Against SARS-CoV-2

(8) Proposed Solicitation Number: 75N92020Q0123

(9) Closing Response Date: 06/22/2021

(10) Contact Point(s): Elizabeth Francois, Contract Specialist

(11) Contract Award and Solicitation Number: TBD

(12) Contract Award Dollar Amount: TBD

(13) Contract Line Item Number(s): TBD

(14) Contractor Award Date: TBD

(15) Contractor Name: TBD

(16) Description: TBD

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a separate written solicitation will not be issued.

(ii) The solicitation number is 75N92020Q0123 and the solicitation is issued as a request for quotation (RFQ).

(iii) The solicitation document, the incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2021-05 effective 03/10/2021.

(iv) This requirement is set-aside for small business. The associated NAICS code is 541990, All Other Professional, Scientific and Technical Services, Small Business Size, $16.5M. The acquisition is being conducted in accordance with the procedures of FAR Part 12 and FAR Part 13.

(v) It is anticipated that there will be two (2) contract line items listing the required services.

(vi) The requested requirements are listed in the attached Statement of Work.

(viii) Provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Items, applies to this acquisition.

• The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors shall be used to evaluate offers:

o Offeror can provide all required services/deliverables as described in the Statement of Work.

o Quotes should include cost estimate, broken down into hourly compensation

(ix) The provision at FAR clause 52.212-2, Evaluation – Commercial Items, is applicable to this acquisition. The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous and best value to the Government, price and other factors considered.

The following factors shall be used to evaluate offers:

• Offeror must have a PhD in biomedical science, biology, or genetics and at least five (5) years post-doctoral research experience.

• Offeror must have publications in peer reviewed journal or documented research experience that are related to primary tissue culture, next generation sequencing technology, AAV biology , autoimmune disease, and vaccine development.

• Offeror must have within the last 10 years research experience in the area of gene expression analysis by microarray or RNA-seq, and histological analysis of bone or salivary glands as well as establishing short term cultures for AAV transduction.

• Offeror must have a background in the production of recombinant gene transfer vectors and assay development including LIPS assay.

Experience in bioinformatics is beneficial.

(x) Offerors to include a completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, with all offers.

An Offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

(xi) The FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

(xii) The FAR clause at 52.212-5, Contract Terms and Conditions Required to

Implement Statutes or Executive Orders – Commercial Items, applies to this acquisition.

• 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment. (AUG 2019) (Section 889(a)(1)(A) of Pub. L. 115-232).

• 52.217-9, Option to Extend the Term of the Contract (Mar 2000)

• 52.222-3, Convict Labor (June 2003) (E.O. 11755)

• 52.222-21, Prohibition of Segregated Facilities (APR 2015)

• 52.222-26, Equal Opportunity (APR 2015) (E.O. 11246)

• 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014)

(29 U.S.C. 793)

• 52.222-50, Combating Trafficking in Persons (MAR 2015). (22

U.S.C. chapter 78 and E.O. 13627)

• 52.222-53, Exemption from Application of the Service Contract Labor

Standards to Contracts for Certain Services-Requirements

• 52.223-18, Encouraging Contractor Policies to Ban Text

Messaging While Driving (AUG 2011) (E.O. 13513)

• 52.225-13, Restrictions on Certain Foreign Purchases (JUN 2008)

• 52.232-33, Payment by Electronic Funds Transfer—System for Award

Management (JUL 2013) (31 U.S.C. 3332)

(xiii) Additional contract requirement(s):

• Provide cost estimate, broken down into hourly compensation

• Provide most recent resume narrating capabilities to meet the additional requirements as stated

• Provide a CV stating the relatable experience and education background necessary to complete the tasks as stated under the statement of work.

(xiv) The Defense Priorities and Allocations System (DPAS) and assigned rating are not applicable.

(xv) Offers shall be submitted via the FedConnect web portal (www.fedconnect.net).

The due date for receipt of offers is 12:00 PM Eastern Time on 06/22/2021.

(xvi) Point of Contact:

Elizabeth Francois, Contract Specialist

Elizabeth.francois@nih.gov solicitation 75N92021Q0123

(17) Place of Contract Performance:

Adeno Associated Virus (AAV) biology section lab space

NIH/NIDCR

10 Center Drive Bethesda, MD 20892 http://www.fedconnect.net/ mailto:Elizabeth.francois@nih.gov

18) Period of Performance:

August 2021 - August 2022

(19) Set-aside Status: Small Business Set-aside

STATEMENT OF WORK

Program Office:

IC:NIDCR

Project Officer: John Chiorini, Ph.D.

Background:

The overall research goal of the Adeno-Associated Virus (AAV) Biology Unit is to define the interactions of adeno- associated virus (AAV) with its target cell. The hypothesis is that by understanding these interactions, and the biology of the virus, the unit can contribute to the use of AAV vectors for gene therapy. The AAV Biology section on gene transfer considers AAV vectors to be the most useful vector for clinical studies with this tissue. Current projects study the tropism and transduction pathways of different serotypes of AAV, the lifecycle of the virus, identifying and characterizing new isolates of AAV, and characterizing the interactions between novel cellular proteins and the AAV Rep proteins. Application of this technology include deliver of therapeutic genes for the treatment of disease with unmet clinical need. The outlined project, expands upon current on-going research conducted by the AAV Biology section of the (AAVBS), Division of Intramural Research (DIR), National Institutes of Dental and Craniofacial Research (NIDCR) in the area of gene therapy and is required to meet the unmet clinical need created by the current pandemic.

Purpose:

Emerging viruses such as SARS-CoV-2 represent a significant risk to the global security and public health. Although vaccine technology has advanced, the development of new approaches to combat viral infections are needed. In recent years, the use of broadly neutralizing antibodies or nanobodies to control virus infection has shown promise and even resulted in approved drugs. However, limitations to using these therapeutic vaccine technologies is the short half-life of these antibodies in vivo and the need for repeated injections of the neutralizing antibodies. Over the past 10 years, gene delivery technology based on adeno associated virus (AAV) has made rapid progress and has generated approved drugs for treating genetic diseases. The AAV gene delivery platform offers the possibility of employing a single application for potential life-long expression of a therapeutic protein.

Contractor Requirements (Scope of Work):

The contractor shall learn the techniques developed by the AAV Biology Section and the resources available to carry out the project. The Contractor shall develop research plans to:

1) Establish short term in vitro culture systems detection of AAV transduction and expression.

2) Prepare and analyze serum samples from experimentally treated animal models.

3) The Contractor shall attend AAV Biology Section group meetings, and related seminars at NIH as needed.

4) The services required involve advanced cell and molecular biological techniques, and the ability to create new methodologies for the advancement of the tasks. Tasks require extensive knowledge of AAV biology.

5) The contractor shall perform the tasks in the laboratory or animal facility, or at a computer work station on-site.

Literature analyses, planning of experiments and data analyses will be done on- and off-site.

6) The contractor shall perform antibody profiling and histologic analysis.

7) The contractor shall insure that assay design and validation will include LIPS analysis of serum antibody formation, as well as elisa development for antigen detection and validation.

Additional Tasks:

Task 1

1) Establish short term in vitro culture systems detection of AAV transduction and expression. These cultures will enable the detection of recombinant protein expression from AAV vectors related to vaccine and passive genetic immunization.

a) Review literature for currently used methods to create short term primary cultures of human cells useful for

AAV transduction related to vaccine development and passive genetic immunization.

b) Develop new methodologies to assess stability of the cultures related to vaccine development and passive genetic immunization.

c) Test the efficacy of new methodologies in vitro.

d) Adjust methodology accordingly to improve survival of the cells.

2) Utilize the new cultures of human cells to study AAV transduction related to vaccine development and passive genetic immunization.

a) Review literature for previous studies utilizing similar approaches to understand antigen presentation

b) Identify critical adjuvent factors in AAV transduction related to vaccine development and passive genetic immunization.

c) Begin to test compounds/therapeutics that promote AAV transduction related to vaccine development and passive genetic immunization.

Task 2

1) Prepare and analyze serum samples from experimentally treated animal models. These plans will be submitted to the Project Officer (principle investigator of the AAV Biology Section), and the contractor will work with members of the section to carry out the planned experiments. The deliverables are the conduct of experiments animal models used for analysis of antigens related to COVID19.

a) Review the literature for currently used methods to monitor serum analytes related to vaccine development and passive genetic immunization

b) Develop new methods to assess function related to vaccination and passive genetic immunization.

2) Pre-clinical testing of cultures of animal models as a drug target.

a) Review the literature for currently used methods to assess vaccination and passive genetic immunization.

b) Perfect these models and use them as models of vaccine candidate evaluation.

c) The contractor shall insure that assay design and validation will include LIPS assay as well as elisa development for antigen detection and validation.

d) Review the literature for currently used methods to identify gene expression and analyte changes associated with antigen detection and vaccine validation.

e) Develop new methods to assess function related to vaccination and passive genetic immunization.

Task 3

1) Systematically store raw data (electronic Word files, Excel files, PowerPoint files, Photoshop files, output files from various pieces of equipment, other types of) on government owned computers and the section’s share drive.

a) Ensure that data maintains its integrity.

b) Ensure that data is backed up appropriately.

c) Ensure that data is available for viewing/analysis by members of the section.

2) Communicate results of experiments at meetings to be held at NIDCR, Bethesda, MD

a) Present data, as needed at group meetings held every Thursday

b) Present data as needed at other venues, Salivary gland Interest Group meetings held approximately every other

Tuesday.

c) NIDCR Data Sessions held weekly on Thursdays domestic and international meetings.

d) Write documents such as manuscripts when appropriate, abstracts, reports as needed, etc.

3) The contractor shall evaluate the tasks at hand on a weekly basis and will coordinate these tasks with appropriate

NIH staff.

4) The contractor will use equipment provided by the government Project Officer.

Personnel Preferred Qualifications:

1) The contractor is preferred to have a PhD in biomedical science, biology, or genetics and at least 5 years post-doctoral research experience.

2) The contractor is preferred to have publications in peer reviewed journal or documented research experience that are related to primary tissue culture, next generation sequencing technology, AAV biology , autoimmune disease, and vaccine development

3) The contractor is preferred to have within the last 10 years research experience in the area of gene expression analysis by microarray or RNA-seq, and histological analysis of bone or salivary glands as well as establishing short term cultures for AAV transduction.

4) The contractor is preferred to have a background in the production of recombinant gene transfer vectors and assay development including LIPS assay. Experience in bioinformatics is beneficial.

Deliverable Requirements:

1) The contractor’s work will be reviewed weekly for appropriate progress made in the form of research progress reports.

2) Research data, including results obtained through the process, as well as other relevant patient data, will be collected and maintained daily in the lab on-site in Building 10. The completed final summary must be submitted prior to the end of the contract period.

3) The contractor may be required to present findings at scientific meetings on behalf on the AAV biology section as required.

All reports may be submitted electronically to:

TBA

Place of Performance:

Adeno Associated Virus (AAV) biology section lab space

NIH/NIDCR

10 Center Dr.

Bethesda, MD 20892.

Period of Performance:

Base Year: 12 Months Option Year 1: 12 Months mailto:jchiorini@dir.nidcr.nih.gov