Attachment_10thru14_REVISED_0002.pdf

RFP

75N91023R00024

Attachments 10-14

Attachment Data Management and Sharing is removed and marked

RESERVED

Page 1 of 21 Attachment 10 – TORFP

#1 75N91023R00024

Task Order Request for Proposal – TORFP 1 Statement of Work: PREVENT Cancer Preclinical Drug Development Program

A. Task Order Title – “Contract Orientation and Kickoff Meeting”

B. Task Order Number – TORFP #1

C. Background and Task Order Statement of Work:

The purpose of this task order is to hold an orientation/ kickoff meeting to discuss Standard Operating Procedures (SOP) for all Contractors awarded an Indefinite Delivery, Indefinite Quantity (ID/IQ) contract for the Preclinical PREVENT Cancer Program.

The contractor shall budget for the Principal Investigator and one Business Representative, to travel from their current location to the National Cancer Institute (NCI) in Rockville, MD for a meeting on or about 11/15/2023. The meeting will begin at 9:30 a.m. and conclude at approximately 1:00 p.m. The government intends that this kick-off meeting will be virtual.

During the meeting, the NCI will present overarching goals of the contract, reporting requirements, invoicing requirements, scheduling, and future task orders. Contractors will be able to ask specific questions and discuss contracting procedures at this meeting.

No technical proposal is required for this task order; however, a detailed budget proposal indicating all costs associated with the subject task order must be submitted.

D. Reporting Requirements and Deliverables: NONE

E. Proposal Due Date: Proposals are due by 2:00 PM EDT on 2/21/2023 in an electronic format to the Contracting Officer, Mr. Rich Taylor at Rich.Taylor@nih.gov. See the eCPS attachment for contract proposal submittal.

The National Cancer Institute reserves the right to make a single award, multiple awards, or no award. In addition, changes might occur as a result of availability of funds. The Government reserves the right to award a task order without discussions if the Contracting Officer determines that the initial proposed cost/ price is fair and reasonable and that discussions are not necessary.

If a proposal is not received on the date and time specified herein, it will be considered late and handled in accordance with subparagraph (c)(3) of FAR Clause 52.215-1, “Instructions to Offerors – Competitive Acquisition” and HHSAR Clause 352.215-70, “Late Proposals and Revisions”.

F. Offerors Questions: Questions regarding this TORFP #1 must be submitted to the Contracting Officer by 2:00 PM EDT on 01/23/2023. Submit questions via email to the Contracting Officer (email address stated above). Responses to questions will be emailed as an amendment to the TORFP.

Attachment 10 75N91023R00024 2 of 21

G. Type of Task Order: Firm Fixed Price

H. Invoicing and Payment: See the base award for invoicing and payment instructions.

I. Anticipated Number of Task Order Awards: up to 25 (tentative)

J. Initial Task Order Period of Performance: 11/1/2023-12/15/2023

K. Technical Proposal Instructions: NONE L. Business Proposal Instructions:

1. Business Proposal COVER SHEET: Submit the following:

• Solicitation or contract number

• Task order number

• Name and telephone number of point of contact

• Name, address, UEID, and telephone number of contract administration office (if applicable)

• Date of submission

• Name, title, and signature of authorized representative

2. Budget: Provide a summary of proposed cost and/or price (Attachment 1); profit or fee (as applicable);

and total.

M. Evaluation Factors for Award

1. Cost/Price: Offerors’ cost/price proposal will be evaluated for 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. Normally, price reasonableness is established through adequate price competition, but may also be determined through price analysis techniques as described in FAR 15.404.

2. Understanding of the Requirement: Offer’s proposal will be evaluated for reasonableness of appropriate personnel and labor hours proposed.

3. Data Sharing Management: Offeror shall submit their management plan for data sharing as per RFP.

N. Attachments

Attachment 18: Breakdown of Proposed Estimated Cost and labor hours (see Section J of the RFP).

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ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

PREVENT Cancer Preclinical Drug Development Program: Preclinical Efficacy and Intermediate Endpoint Biomarkers

It is strongly recommended that Offerors use the following template as the Table of Contents for the Technical Proposal. All information presented in the Technical Proposal shall be presented in the order specified below.

These additional Technical Proposal instructions reflect the requirements of the Request For Proposal (RFP) and provide specific instructions and formatting for the Technical Proposal. While Section L.2.b. of the RFP provides a generic set of Technical Proposal instructions applicable to all NIH R&D solicitations, these additional Technical Proposal instructions are tailored to the specific requirements of the RFP. The information requested in these instructions shall be used, along with Section L, to format and prepare the Technical Proposal, and shall be used as a Table of Contents for your Technical Proposal.

Offerors are advised to give careful consideration to the Statement of Work (SOW) and attachments, Mandatory Qualification Criteria and Technical Evaluation Criteria in Section M, and the RFP as a whole in the development of their Technical Proposals.

Offerors shall submit a proposal that addresses the Mandatory Qualification Criteria and the Task Areas in the Statement of Work. If the proposed approach will involve a subcontracting arrangement, then the Offeror shall include a letter of commitment from the subcontractor(s), plus documentation of subcontractor’s expertise, qualifications and prior performance, as well as a narrative describing how the Offeror will manage the subcontractor(s).

A detailed work plan shall be submitted indicating how each aspect of the Statement of Work is to be accomplished. Your technical proposal shall be in as much detail as you consider necessary to explain fully your proposed methods and rationale for their selection and shall reflect a clear understanding of the nature of the work being undertaken. The technical proposal must also include information on how the project is to be organized, staffed, and managed. Information shall be provided which will demonstrate your understanding of management of timeframes for planning and accomplishing the work to be performed.

The Offeror shall record and discuss specific factors not included elsewhere, which support your proposal. Using specifically titled subparagraphs, items may include unique arrangements, equipment, etc., which none or very few organizations are likely to have and is advantageous for effective implementation of this project.

The Offeror must adhere to a 150-page limit. Pages in excess of this limitation will be removed from the proposal and will not be provided to the reviewers to be read or evaluated. The 150-page limit excludes the cover sheet, resumes, and all appendices or attachments. The 150-page limit also excludes the proposals for each of the Sample Task Order responses and for Task Order #1, Contract Orientation and Kick-Off Meeting. Please refer to the Sample Task Orders and Task Order #1 for specific proposal submission instructions.

Pages shall be of standard size (8.5x11) with a font size of 10 points or larger. Proposal pages shall be numbered “Page 1 of 150”, “Page 2 of 150” and so on.

SECTION 1: COVER PAGES AND TABLE OF CONTENTS

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A. PROPOSAL TITLE PAGE. Include RFP title and number, name of organization, Unique Entity Identifier (UEI) which replaced the DUNS, proposal part, and identify if the proposal is an original or a copy;

B. PROJECT OBJECTIVES;

C. GOVERNMENT NOTICE FOR HANDLING PROPOSALS;

D. PROPOSAL SUMMARY AND DATA RECORD (NIH-2043);

E. TABLE OF CONTENTS. Include a Table of Contents with indicated pages of proposal sections that at a minimum uses the underlined Headings and Subheadings that appear below. Additional subheadings may be entered at the Offeror’s discretion.

SECTION 2: MANDATORY QUALIFICATION CRITERIA

The Offeror shall include all information which documents and/or support the mandatory qualification criteria in one clearly marked section of its technical proposal. This section related to the Mandatory Qualification Criteria must be listed in the Table of Contents with a page reference.

MQC for Efficacy Pool consist of:

1. Demonstration of an Approved Animal Welfare Assurance from the Office of Extramural Research (OER), Office of Laboratory Animal Welfare (OLAW), Office of the Director, NIH.

https://www.nal.usda.gov/legacy/awic/final-rules-animal-welfare-9-cfr-parts-1-2-and-3

2. Current Accreditation by the Association for Assessment and Accreditation of Laboratory Animal Care (AAALAC) (or equivalent) https://www.ncbi.nlm.nih.gov/books/NBK54050/; and

3. Documented participation of an American College of Laboratory Animal Medicine (ACLAM) certified veterinarian on their staff. Alternatively, the ACLAM veterinarian may have an established relationship as a contracted on-call consultant.

https://olaw.nih.gov/policies-laws/phs-policy.htm

If the American College of Laboratory Animal Medicine (ACLAM) veterinarian is not an employee of the Offeror or the proposed subcontractor, the Offeror must include a letter of commitment from the proposed veterinarian.

SECTION 3: TECHNICAL DISCUSSIONS

A. Personnel

The Technical Proposal shall include all information relevant to document individual training, education, experience, qualifications and expertise necessary for the successful completion of all contract requirements.

Clearly identify in a list or table showing the name, highest degree, organizational affiliation (employer), role on the project and percentage of effort to be committed to the project for all Personnel including any Subcontract Personnel.

Include for each named person an NIH Bio sketch or a Curricula Vitae (CV), that is limited to 5 pages, and which provides selected references for publications relevant to the scope of the RFP, and include experience with projects of similar scope, size and complexity carried out by the Offeror and any proposed subcontractors over the past five (5) years.

1. Principal Investigator:

a. Describe the education, training, experience, expertise, qualifications, and percentage of effort of the proposed Principal Investigator to lead and direct the activities to be carried out under this contract, including managing an interdisciplinary team in the conduct of pharmacologic efficacy https://www.ncbi.nlm.nih.gov/books/NBK54050/ https://olaw.nih.gov/policies-laws/phs-policy.htm

75N91023R00024 5 of 21 and biomarker studies employing rodent animal models. The Principal Investigator shall have a Ph.D., D.V.M. or M.D. or equivalent degree. The qualifications and experience of the Principal Investigator shall be discussed in terms of how they are appropriate to the management of any planned subcontract(s).

b. Discuss how the technical and scientific planning and implementation of Task Orders will be managed by the Principal Investigator.

2. Other Scientific and Technical Personnel:

a. Describe the education, training, experience, expertise, qualifications, role in the project, and percentage of effort for all proposed scientific and technical personnel of the Offeror and all proposed subcontractors.

b. Document relevant qualifications for: animal testing, chemical analysis, veterinary and pathology support, examination of potential biomarkers/signaling pathways (genomics, epigenomics, proteomics and/or metabolomics, cell biology, miRNA and ncRNA biology, exosomes, PK/PD, immune response profiling, immunogenomics, etc.), and evaluation of statistical relevance.

B. Technical Approach

Offerors shall submit a proposal that addresses the Task Areas in the Statement of Work. If the proposed approach will involve a subcontracting arrangement, then the Offeror shall include a letter of commitment from each proposed subcontractor as well as documentation of the subcontractor’s expertise, qualifications and prior performance, and a narrative describing how the Offeror will manage the subcontractor(s).

1. Describe the procedures to be used for carrying out the types of preclinical efficacy and intermediate endpoint studies conforming to the Task Areas proposed in the Offeror’s proposal, including, but not limited to, criteria for animal model selection; animal handling; administering chemopreventive agents, vaccines or other immunopreventive agents, and control agents or adjuvant(s); moribund sacrifice;

method and equipment to be used for euthanasia; collection, handling and storage of biospecimens (e.g.

tissue, serum, urine, and other body fluids) from animals; necropsy and histopathology procedures;

immunological characterization; and analytical chemistry procedures.

2. Describe the capabilities of project management, including developing a project management plan;

monitoring and controlling project progress in a milestone format; tracking and controlling project expenditures; and monitoring and ensuring on-time delivery of deliverables.

3. Describe the features and capabilities of data management, including software programs currently in use, as well as proposed plans for oversight of data management functions, including protection of intellectual property and confidentiality of data of chemopreventive or immunopreventive agent(s).

4. Describe how quality assurance will be addressed within your organization concerning auditing of critical study events, raw data, and study reports.

5. Indicate when these audits are estimated to occur in relation to the generation of data and reports.

6. Safety and Health for Personnel - The Offeror shall provide a Safety and Health Plan

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a. The Offeror’s Safety and Health Plan shall include recent and ongoing experience in each task area in the Statement of Work (SOW).

b. Describe procedures and controls to be employed during tests included in the Statement of Work to ensure that the work is conducted in a safe and healthful manner. All pertinent chemical and/or biological hazards shall be addressed, from receipt of test agents to ultimate disposal of contaminated waste. Details of appropriate administrative and emergency controls, personnel training, protective equipment and work practices shall be addressed. All work shall comply with applicable local, State and Federal statutes relating to occupational safety and health, transportation and handling, and environmental protection.

c. Discuss equipment and unusual operating procedures established to protect personnel from hazards associated with this project and other factors you feel are important and support your proposed approach.

7. Describe proposed methods of statistical analysis for data and underlying distributions being compared.

8. Subcontracts - Describe any previous working relationship with proposed subcontractors.

The Offeror shall also address how they will handle privity of contract issues, i.e., the explain how it is anticipated information will flow between the National Cancer Institute (NCI), the Offeror, and any subcontractors since the prime contractor’s presence is required for any discussions.

C. Sample Task Order

Offerors shall respond to both Sample Task Order 1 and Sample Task Order 2 , and clearly label each proposal.

The response to the Sample Task Orders shall be included as a separate section (appropriately marked) in the Technical Proposal. The page limit for each Sample Task Order proposal is 12 pages. The Sample Task Order 12-page limit excludes the cover sheet, resumes, and all appendices or attachments. The Sample Task Order response does not count towards the technical proposal 150-page limit. The Offeror’s response to the Sample Task Order shall include discussion of technical approach, personnel proposed, and facilities and equipment.

See Section J – Attachments 2(a) and 2(b) for Sample Task Orders #1 and #2 Statement of Work 1a for Efficacy Pool

D. Facilities and Equipment

1. Facilities – The Offeror shall have an operating laboratory that is suitable to carry out technical tasks in the Task Areas outlined in the Offeror’s proposal, including but not limited to cell culture, biochemical and molecular assays, and laboratory animal studies using hazardous and/or carcinogenic test materials.

The laboratory shall be capable of handling hazardous chemicals safely and shall be able to provide appropriate facilities for housing animals required in the study. The laboratory and animal care must be sanitary and properly maintained in accordance with the criteria set forth by the animal accreditation organizations (see Mandatory Qualification Criteria in Section M).

Floor plan(s), drawn to scale, shall be included for all space that is to be used for this project. The diagram of each floor plan shall be adequately labeled to identify the space for its purpose, the scale that is used, and the items of equipment or other that are portrayed.

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Discuss operation, procedures, and administration of the cell culture and animal facility. In addition, indicate the location (with distance) for any facilities, which are not contiguous.

The Offeror shall describe the facilities and equipment that belong to subcontractors. Where facilities of the Offeror are not contiguous and for any non-co-localized subcontractors, the Offeror must describe logistical plans for the transfer of materials and/or data.

Discussion shall include, as appropriate, but not be limited to:

• available room capacities;

• temperature controlled CO2 incubators, sterile laminar flow hoods;

• sterile tissue culture materials and techniques;

• cryopreservation capability, microscopy capability;

• climate controls and alarm systems;

• caging and exercise;

• diet and compound storage and preparation areas;

• water systems;

• cage washing areas;

• data collection and computer systems;

• animal treatment laboratories (cardiology, ophthalmology, phlebotomy, necropsy);

• clinical and anatomic pathology laboratories and established quality control practices;

• electrical and environmental back up provisions for critical components e.g. animal rooms, chemical test article and biological samples, etc.;

• data back-up systems.

2. Equipment - The Offeror shall have all the equipment necessary to accomplish the proposed studies including but not limited to incubators, microscopes, centrifuges, animal racks and caging, hazardous chemical storage cabinets, refrigerators and freezers to store samples at the appropriate temperature (4 degrees, -20 degrees, -80 degrees, or liquid nitrogen), pathology equipment such as microtomes, immunology equipment, laboratory, and analytical chemistry equipment. The laboratory shall have the necessary equipment to perform the intermediate biomarker studies. The laboratory shall have or have access to appropriate terminal and computer facilities and equipment for data collection and storage.

E. Organizational Background and Experience

The Offeror shall include an organizational chart that describes reporting structure of the organization.

Discuss prior experience with similar tasks and provide documentation of completed studies.

Provide documentation of abilities to interact with industrial collaborators and academic researchers. Discuss the organization’s experience and ability to collaborate with other individuals and organizations. In addition, describe the organization’s experience in appropriate use of subcontractors to supplement areas of expertise.

Discuss how the infrastructures composed of one or more collaborating institutions will be managed.

Describe organizational experience in data collection and processing capabilities (IT systems), including statistical analysis, and quality management. Provide documentation of validation studies undertaken by the organization to assure the accuracy of transmitted data for the version(s) of software shall be described.

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ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

PREVENT Cancer Preclinical Drug Development Program: Preclinical Services for CGMP Biopharmaceutical Product Development and Manufacturing

It is strongly recommended that Offerors use the following template as the Table of Contents for the Technical Proposal. All information presented in the Technical Proposal shall be presented in the order specified below.

These additional Technical Proposal Instructions reflect the requirements of the RFP and provide specific instructions and formatting for the Technical Proposal. While Section L.2.b. of the RFP provides a generic set of Technical Proposal Instructions applicable to all NIH Research & Development (R&D) solicitations, these additional Technical Proposal Instructions are tailored to the specific requirements of the RFP. The information requested in these instructions shall be used, along with Section L to format and prepare the Technical Proposal, and shall be used as a Table of Contents for your Technical Proposal.

Offerors are advised to give careful consideration to the Statement of Work (SOW), Technical Evaluation Criteria in Section M, and the RFP as a whole in the development of their Technical Proposals.

Offerors shall submit a proposal that addresses how each aspect of the SOW is to be accomplished. The technical proposal shall reflect a clear understanding of the nature of the work being undertaken and management of important events or tasks. The technical proposal must include information on how the project is to be organized, staffed, and managed. If the proposed approach will involve a subcontracting arrangement, then the Offeror shall include a letter of commitment from the Subcontractor(s), plus documentation of Subcontractor’s expertise, qualifications and prior performance, as well as a narrative describing how the Offeror will manage the Subcontractor.

Record and discuss specific factors not included elsewhere, which support your proposal. Using specifically titled subparagraphs, items may include unique arrangements, equipment, etc., which none or very few organizations are likely to have, and is advantageous for effective implementation of this project.

The Offeror must adhere to a 150-page limit. Pages in excess of this limitation will be removed from the proposal and will not be provided to the reviewers to be read or evaluated. The 150-page limit excludes the cover sheet, resumes, and all appendices or attachments. The 150-page limit also excludes the proposals for the Sample Task Order and Task Order #1- Contract Orientation and Kickoff Meeting.

Pages shall be of standard size (8.5x11) with a font size of 10 to 12 points, single spaced. Proposal pages shall be numbered “Page 1 of 150”, “Page 2 of 150” and so on.

SECTION 1: COVER PAGES AND TABLE OF CONTENTS

F. PROPOSAL TITLE PAGE. Include RFP title and number, date of the proposal, name of organization, UEID number, proposal part, and identify if the proposal is original or copy;

G. PROJECT OBJECTIVES;

H. GOVERNMENT NOTICE FOR HANDLING PROPOSALS;

I. PROPOSAL SUMMARY AND DATA RECORD (NIH-2043);

J. TABLE OF CONTENTS. Include a Table of Contents with indicated pages of proposal sections that at a minimum uses the underlined Headings and Subheadings that appear below. Additional subheadings may be entered at the Offeror’s discretion.

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SECTION 2: MANDATORY QUALIFICATION CRITERIA

Not Applicable.

SECTION 3: TECHNICAL DISCUSSIONS

The Technical Discussion included in the Technical Proposal shall respond to the items set forth below.

1. General Requirements

a. Personnel, Organizational Capabilities, and Project Management a-i) The Technical Proposal shall include all information relevant to document individual training, education, experience, qualifications and expertise necessary for the successful completion of all contract requirements. The Offeror shall provide an organizational chart that describes reporting structure of the organization.

The Offeror shall clearly identify in a list or table showing name, highest degree, organizational affiliation (employer), role on the project and percentage of effort to be committed to the project for all Personnel, including any Subcontractor Personnel. Include for each named person an NIH Bio sketch or a Curricula Vitae (CV), that is limited to five (5) pages and which provides selected references for publications relevant to the scope of the RFP, and include experience with projects of similar scope, size and complexity carried out by the Offeror and any proposed subcontractors over the past five (5) years.

3. Principal Investigator: Describe the education, training, experience, expertise, qualifications, and percentage of effort of the proposed Principal Investigator to lead and direct the activities to be carried out under the Statement of Work. The qualifications and experience of the Principal Investigator shall also be discussed in terms of how they are appropriate to the management of any planned subcontract(s) if applicable. Discuss how the technical and scientific planning and implementation of Task Orders will be managed by the Principal Investigator.

4. Project Manager(s): Describe the education, training, experience, expertise, qualifications, and percentage of effort of the proposed Project Manager(s) to oversee, coordinate, integrate and manage all tasks/activities proposed. The qualifications and experience of the Project Manager(s) shall also be discussed in terms of how they are appropriate to the management of any planned subcontract(s) if applicable. Discuss how the planning and implementation of Task Orders will be managed by the Project Manager(s).

5. Other Key Scientific and Technical Personnel: a-i) Describe the education, training, experience, expertise, qualifications, role in the project, and percentage of effort for all proposed scientific and technical personnel of the Offeror and all proposed subcontractors. At minimum, include the following personnel: lead scientific, technical, and regulatory personnel.

a-ii) The Offeror shall also provide information related to Project Management as specified in the SOW, specifically:

• Describe the Project Management approach, including but not limited to staffing, organization, responsibilities, leadership, and lines of authority;

taylorr4 Highlight

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• Describe the systems for tracking project activities and monitoring progress, timelines and budgets;

• Describe the communication approach between the PI and the Government, and between all performance sites and activities, including Subcontractors;

• Address how privity of contract issues will be handled, and explain how information will flow between the National Cancer Institute (NCI), the Offeror, and any Subcontractors since the Prime Contractor’s presence is required for any discussions; and

• Describe plans for managing transitions as outlined in section 2.5 of the Statement of Work for cGMP.

a-iii) The Offeror shall provide documentation of abilities to interact with industrial collaborators and academic researchers and shall discuss the organization’s experience and ability to collaborate with other individuals and organizations.

• The Offeror shall describe the organization’s experience in appropriate use of Subcontractors to supplement areas of expertise and shall discuss how the infrastructures composed of one or more collaborating institutions will be managed as applicable.

• The Offeror shall describe organizational experience in data collection and processing capabilities (IT systems), including quality management.

b. Quality Management

The Technical Proposal shall document a Quality Management Plan (QMP) that includes management responsibilities, resources, training programs, oversight of all subcontracted manufacturing operations (if applicable), and communication processes, including timelines. The QMP outlines the procedures the Contractor shall follow to ensure that products generated under this contract, as specified in the SOW, adhere to the Current Good Manufacturing Practice (CGMP) quality standards.

The Offeror shall describe their Quality Control (QC)/Quality Assurance (QA) program required for compliance with all CGMP regulations and guidelines, and for implementation and completion of the Task Areas and other activities described in the SOW. The description of the Quality Management System(s) shall include, but is not limited to, a description of the personnel, resources and lines of authority for a Quality Assurance Unit (QAU);

the model, governing policies and standard operating procedures of the QAU; a description of the Quality System including QA and QC responsibilities; and a description of the process to ensure the commitment of senior management support for the Quality Management System(s). In addition, the Offeror shall also describe the management of Quality System activities at the proposed Subcontractor’s site, if proposed, that is appropriate for the phase of product development and within all applicable Regulatory regulations. Furthermore, the Offeror shall also describe any relevant organizational experience, problems or obstacles encountered with Subcontractor performance and approaches implemented to identify, resolve, remediate or correct identified problems.

c. Facilities, Equipment and Other Resources

The Technical Proposal shall document and provide evidence that the Offeror has access to a fully CGMP-compliant facility by submitting a copy of a current Food and Drug Administration (FDA) Establishment Inspection Report (EIR) obtained in the last 2 years with No Action Indicated (NAI) or Voluntary Action Indicated (VAI) classification, and/or detailed descriptions of facilities, equipment, space and other resources that are available for the Offeror to carry out each of the proposed Task Areas and other activities in a CGMP-compliant manner as outlined in the SOW. The Technical Proposal shall also document the capacity of the proposed CGMP-compliant facilities, equipment, and resources to

75N91023R00024 11 of 21 perform the proposed tasks as described in the SOW in a timely and efficient manner.

In addition, the Offeror shall provide information on the following:

• Location, space, and features of facilities including floor plan(s), drawn to scale, and a list of equipment and resources dedicated to the project for the Prime Contractor and any proposed Subcontractors.

• Lease or ownership information for proposed facilities.

• The diagram of each floor plan shall be adequately labelled to identify the space for its purpose, the scale that is used, and the items of equipment or other that are portrayed.

• Indicate the location (with distance) for any facilities, which are not contiguous.

• The Offeror shall describe the facilities and equipment that belong to Subcontractors.

• Where facilities of the Offeror are not contiguous and for any non-co-localized

Subcontractors, the Offeror must describe logistical plans for the transfer of materials and/or data as applicable.

The Offeror shall also provide a copy of their Safety and Health Plan. Offerors shall describe procedures and controls to be employed to ensure that the work is conducted in a safe and healthful manner. All pertinent chemical and/or biological hazards shall be addressed, from receipt of agents to ultimate disposal. Details of appropriate administrative and emergency controls, personnel training, protective equipment and work practices shall be addressed. All work shall comply with applicable local, State and Federal statutes relating to occupational safety and health, transportation and handling, and environmental protection. Discuss equipment and operating procedures established to protect personnel from hazards associated with this project and other factors deemed important to support the proposed approach.

Discussion shall include, as appropriate, but not be limited to:

• Identification and description of all support resources, including information technology systems, which will be required to effectively complete the proposed Task Areas in the

SOW;

• Information on facility and equipment validation;

• History and details of facility audits and/or inspections, and any relevant Master File information;

• Experience, plans and procedures to be utilized for compliance with all safety regulations and guidelines in general, including but not limited to handling of potential biohazards, toxic chemicals, and radioisotopes as applicable, as well as training and monitoring of personnel for exposure to potentially infectious and other hazardous materials;

• Proposed plans and procedures for the receipt, storage, retrieval, packaging, labeling and shipping of products, materials and reagents from domestic and/or international locations;

and

• Available data back-up systems.

F. Technical Approach

Offerors shall address each of the proposed Task Areas in the Statement of Work. Offerors shall clearly specify their planned source for their planned technical capabilities (e.g. in-house, subcontract, etc.). If technical capabilities are to be obtained from a Subcontractor, identify the Subcontractor.

8. Task Area A, Product Development Planning and Evaluation (Parent Contract SOW section 3.1):

Describe the demonstrated performance, usage, or implementation of described technical capabilities, 75N91023R00024 12 of 21 processes and procedures to implement and perform the scope of activities described in Task Area A as follows:

a. Describe technical capabilities, processes, procedures, and methods for implementation and communication (i.e. reports) for assessing and advising on products for feasibility of design, development, manufacture, potency assay development, and stability testing for the development of Preclinical Investigational New Drug (IND)-enabling studies and Phase I - III clinical trial materials.

b. Describe technical capabilities, processes, procedures and methods for developing and writing Product Development Plans for specified products containing realistic timelines and deliverable-based product development plans.

c. Describe technical capabilities, processes, procedures and methods for conducting, reviewing and evaluating technical and facility audits, including those performed for potential vendors and/or Subcontractors. Provide auditing checklist or template for facility and/or technical audits of potential subcontractors if applicable.

d. Describe technical capabilities for all biopharmaceutical product classes and diagnostic reagents.

9. Task Area B, Analytical Assay Development and Product Characterization (Parent Contract SOW section 3.2): Describe the demonstrated performance, usage, or implementation of described technical capabilities, processes and procedures to implement and perform the scope of activities described in Task Area B as follows:

a. Describe technical capabilities, processes and procedures for designing, developing, qualifying and validating assays as needed for the characterization of a biopharmaceutical product or diagnostic agents as required for the successful performance of contract activities, such as to demonstrate safety, identity, potency, purity, and quality of the products. Safety assessment may include viral and non-viral adventitious agent detection in mammalian or other eukaryotic cells, as well as tumorigenicity and karyotyping assays.

b. Describe technical capabilities to prepare and document cell-line or clone history for master stocks, cell banks, and bacterial or viral clones applicable to the product, including CGMP-grade master stocks, cell banks, and bacterial/viral clones.

c. Describe technical capabilities, processes and procedures for designing and developing stability-indicating assays as needed for a biopharmaceutical product as required for the successful performance of contract activities, such as to demonstrate plasmid or host cell stability.

d. Describe proposed plans, processes and procedures for completing, directing and ensuring the successful technology transfer of all materials, assays, methods and procedures as required for the successful performance of contract activities.

10. Task Area C, Process Development and Related Activities (Parent Contract SOW section 3.3):

Describe the demonstrated performance, usage, or implementation of described technical capabilities, processes and procedures to implement and perform the scope of activities described in Task Area C as follows:

a. Describe any acquisition processes, procedures and anticipated timelines for obtaining any of the technical capabilities required to fulfill the SOW requirements for the following biopharmaceutical products including, but not limited to, recombinant proteins, peptides, nucleic acid based materials (such as RNAs and plasmids), vaccine adjuvant and delivery systems, and other biotechnology or cell-derived products.

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b. Describe technical capabilities, processes and procedures for the development and performance of scalable production processes and suitable for use in subsequent CGMP operations for the listed biopharmaceutical product classes, including establishment of master and working cell/viral banks.

c. Describe technical capabilities to produce biopharmaceutical products and diagnostic reagents suitable for IND-enabling safety and activity testing, and performance of the necessary characterization tests required for product release.

d. Describe technical capabilities, processes and procedures for the development and performance of formulation studies.

e. Describe technical capabilities, processes and procedures for the performance and/or support of stability indicating assays.

11. Task Area D, CGMP Manufacture, Related Activities and Documentation (Parent Contract SOW section 3.4): Describe demonstrated performance, usage, or implementation of described technical capabilities, processes and procedures to implement and perform the scope of activities described in Task Area D as follows:

a. Describe any acquisition processes, procedures and anticipated timelines for obtaining any of the technical capabilities required to fulfill the SOW requirements for the following biopharmaceutical products, including but not limited to recombinant proteins, peptides, nucleic acid based materials (such as RNAs and plasmids), vaccine adjuvant and delivery systems, and other biotechnology or cell-derived products.

b. Describe technical capabilities, processes, procedures and approach to scale-up and subsequent production of CGMP biopharmaceuticals suitable for Preclinical IND-enabling studies, as well as Phase I to III clinical trials. Include fermentation/cell culture platforms and purification capabilities.

c. Describe proposed plans, processes and procedures for the performance and documentation of CGMP-related activities for manufactured products intended for human clinical use.

d. Describe proposed plans, timelines, process, and procedures for fill-finish and labeling activities.

e. Describe plans to characterize, release and store CGMP-grade Final Drug Product for use in clinical studies.

f. Describe plans for the implementation and oversight of suitable product stability programs as required for the successful performance of contract activities.

g. Describe plans, processes and procedures for completing, directing and ensuring the successful delivery to the Government of all products as specified in the individual Task Orders (e.g. bulk product substance, intermediate and final products), all data obtained from in-process and release tests, stability programs and accurate and updated information regarding design, development and production of the biopharmaceutical product, including pertinent Contractor activities, computerized data files, original data and any related information such as Chemistry, Manufacturing and Controls (CMC).

h. Describe capabilities, processes, procedures and methods for obtaining and compiling regulatory documentation for submission to the Food and Drug Administration (FDA) (for Biologic License Application [BLA] or Investigational New Drug [IND] applications), or non-domestic regulatory authorities.

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i. Describe experience with the management of meetings and interactions with FDA or other regulatory agencies

G. Relevant Experience

The Offeror shall discuss prior experience with similar tasks proposed, and provide documentation of completed studies. For example:

• A list of CGMP manufacturing and related activities from the past five (5) years, including information on the type of agent, production platform, and other pertinent information, but devoid of any proprietary information;

• Relevant organizational experience with CGMP compliance and interactions with Regulatory Agencies;

• Experience with and plans for completion of in-process and release tests for clinical grade materials suitable for Phase I to III clinical studies;

• Experience with the implementation, oversight and execution of appropriate stability testing programs;

• Successful planning and implementation of procedures utilized to ensure compliance with all CGMP regulations and guidelines, including personnel training and monitoring program.

H. Sample Task Order

Provide a response to the Sample Task Order Statement of Work in accordance with these Additional Technical Proposal Instructions, addressing ALL Technical Tasks.

The response to the Sample Task Order shall be included as a separate section (appropriately marked) in the Technical Proposal. The page limit for the Sample Task Order proposal is 15 pages. The Sample Task Order 15-page limit excludes the cover sheet, resumes, and all appendices or attachments. The Sample Task Order response does not count towards the technical proposal 150-page limit. The Offeror’s response to the Sample Task Order shall include discussion of technical approach, including quality management; personnel, organizational capabilities and project management; facilities, equipment, and other resources; and relevant experience. The response to the Sample Task Order shall include a proposed work breakdown structure (WBS) and Gantt charts.

See Section J- Attachments for the Sample Task Order #2(c) for CGMP with Statement of Work 1b for CGMP Pool.

taylorr4 Highlight

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ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

PREVENT Cancer Preclinical Drug Development Program: Toxicology and Pharmacology Testing

It is strongly recommended that Offerors use the following template as the Table of Contents for the Technical Proposal. All information presented in the Technical Proposal shall be presented in the order specified below.

These additional Technical Proposal instructions reflect the requirements of the Request for Proposal (RFP) and provide specific instructions and formatting for the Technical Proposal. While Section L.2.b.

of the RFP provides a generic set of Technical Proposal instructions applicable to all NIH Research & Development (R&D) solicitations, these additional Technical Proposal instructions are tailored to the specific requirements of the RFP. The information requested in these instructions shall be used, along with Section L, to format and prepare the Technical Proposal and shall be used as a Table of Contents for your Technical Proposal.

Offerors are advised to give careful consideration to the Statement of Work (SOW) and attachments, Mandatory Qualification Criteria and Technical Evaluation Criteria in Section M, and the RFP as a whole in the development of their Technical Proposals.

Offerors shall submit a proposal that addresses the Mandatory Qualification Criteria and the Task Areas in the Statement of Work. If the proposed approach will involve a subcontracting arrangement, then the Offeror shall include a letter of commitment from the subcontractor(s), plus documentation of subcontractor's expertise, qualifications and prior performance, as well as a narrative describing how the Offeror will manage the subcontractor.

A detailed work plan shall be submitted indicating how each aspect of the Statement of Work is to be accomplished. Your technical proposal shall be in as much detail as you consider necessary to explain fully your proposed methods and rationale for their selection and shall reflect a clear understanding of the nature of the work being undertaken. The technical proposal must also include information on how the project is to be organized, staffed, and managed. Information shall be provided which will demonstrate your understanding of management of timeframes for planning and accomplishing the work to be performed.

Record and discuss specific factors not included elsewhere which support your proposal. Using specifically titled subparagraphs, items may include: Unique arrangements, equipment, etc., which none or very few organizations are likely to have which is advantageous for effective implementation of this project.

The Offeror must adhere to a 150-page limit. Pages in excess of this limitation will be removed from the proposal and will not be provided to the reviewers to be read or evaluated. The 150-page limit excludes the cover sheet, resumes, and all appendices or attachments. The 150-page limit also excludes the 15 pages for the Sample Task Order response and for Task Order #1, Contract

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Orientation and Kick-Off Meeting. Please refer to the Sample Task Order and Task Order #1 for specific proposal submission instructions.

Pages shall be of standard size (8.5x11) with a font size of 10 to 12 points. Proposal pages shall be numbered "Page 1 of 150", "Page 2 of 150" and so on.

TECHNICAL PROPOSAL-TABLE OF CONTENTS

General Instructions:

SECTION 1

A. PROPOSAL TITLE PAGE. Include RFP title and number, name of organization, Unique Entity

Identifier (UEI) which replaced the DUNS number, proposal part, and identify if the proposal is an original or a copy.

B. PROJECT OBJECTIVES (NIH FORM 1688-1)

C. GOVERNMENT NOTICE FOR HANDLING PROPOSALS

D. PROPOSAL SUMMARY AND DATA RECORD (NIH-2043)

E. TABLE OF CONTENTS Include a Table of Contents with indicated pages of proposal sections that at a minimum uses the underlined Headings and Subheadings that appear below. Additional subheadings may be entered at the Offeror’s discretion .

SECTION 2: MANDATORY QUALIFICATION CRITERIA

The offeror shall include all information which documents and/or supports the mandatory qualification criteria in one clearly marked section of its technical proposal. At a minimum, the two most recent Food and Drug (FDA) Good Laboratory Practice (GLP) inspection reports shall be included in the proposal.

Offerors shall have on their staff a Doctor of Veterinarian Medicine (DVM) who is Board Certified in Laboratory Animal Medicine (ACLAM). Alternatively, the ACLAM veterinarian may have an established relationship as a contracted on-call consultant. Continuous veterinary care shall be assured.

In addition, provide documentation for Nuclear Regulatory Commission Licensure and current AAALAC accreditation.

SECTION 3: TECHNICAL DISCUSSIONS

A. PERSONNEL

Describe the experience, qualifications and training of personnel who will be assigned for direct work on this program. Information is required which will show the composition of the task or work group, its general qualifications, and recent experience with similar equipment or programs. Special mention shall be made of direct technical supervisors and key technical personnel, and the approximate percentage of the total time each will be available for this program.

CVs for all personnel shall be submitted. Each shall indicate educational background, recent

75N91023R00024 17 of 21 experience, specific or technical accomplishments, and a listing of relevant publications and technical reports. Limit CVs to 5 pages and provide selected references for publications relevant to the scope of the RFP, and include experience with projects of similar scope, size and complexity carried out over the past five (5) years.

1. Principal Investigator/Project Director

Describe the education, training, expertise, qualifications, experience, and accomplishments of the Principal Investigator. The Principal Investigator shall have a Ph.D., D.V.M., or M.D. degree or equivalent experience. The Principal Investigator shall have experience in managing an interdisciplinary team in the conduct of toxicological and pharmacological assessments to qualify potential cancer preventive or other pharmacological, hormonal, or nutritional agents for further testing and clinical development according to Food and Drug Administration (FDA) requirements; and adherence to FDA and International Conference on Harmonization (ICH) guidelines for toxicity and safety studies of compounds. State the percentage of effort for the Principal Investigator to be spent on the project.

2. Other Scientific and Technical Personnel

The Offeror shall list all other investigators/professional personnel who will be participating in the project. Describe the education, training, experience, expertise, qualifications, role in the project, and percentage of effort for all proposed key scientific and technical personnel of the Offeror and all proposed subcontractors. Document relevant qualifications for: pathology (specifically necropsy of animals and microscopic evaluation of blood and tissues), clinical pathology, statistics, veterinary medicine, laboratory animal care, analytical chemistry, pharmacokinetics and quality assurances.

3. Additional Personnel

• Offerors staff shall include an experienced DVM pathologist with an American College of Veterinary Pathology (ACVP) diplomate to be present at and oversee all scheduled necropsies and conduct histopathological evaluations. If the offeror does not have a DVM pathologist with the above credentials, the Offeror) may propose a subcontractor or consultant.

• Offerors shall…