Attachment 5 - Additional Technical Proposal Instructions.pdf

ATTACHMENT 5: ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS,

FORMAT FOR TECHNICAL PROPOSAL, and TABLE OF CONTENTS

Interventional Agents Chemistry Services (IACS)

75N93024R00002

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 should be presented in the order specified below.

These additional Technical Proposal instructions reflect the requirements of the solicitation and provide specific instructions and formatting for the Technical Proposal. While Section L of the solicitation provides a generic set of Technical Proposal instructions applicable to all NIH R&D solicitations, these instructions are tailored to the specific requirements of the RFP.

The information requested in these instructions should be used to format and prepare the Technical Proposal, and should be used as a Table of Contents for your Technical Proposal.

Offerors should follow the instructions in Section L of the solicitation, and include the information requested here.

Offerors are advised to give careful consideration to the Statement of Work, all reference materials, and attachments, the Technical Evaluation Criteria in Section M, and the solicitation as a whole in the development of their Technical Proposals.

Offerors proposing subcontracts to perform portions of the Statement of Work should clearly identify the specific tasks for which they plan to utilize subcontractors, as well as the method and level of integration/coordination between the prime Contractor and all proposed subcontractors, and the expected advantages of such an approach.

Offerors must refer to the solicitation Attachment entitled “Packaging and Delivery of the Proposal,” which details strict guidelines, including page limitations, formatting and layout of proposals, and prohibits the offerors use of links to internet web site addresses (URLs) to direct readers to alternate sources of information.

TECHNICAL PROPOSAL – TABLE OF CONTENTS

Note: The Government has requirements in all Task Areas, however, Offerors are not required to propose to all Task Areas. All Offerors must propose to Task Area A and at least one Task Area from Task Areas B and C. Offerors must submit one proposal per task area proposed. If submitting to all three task areas, you are required to submit three proposals. Offerors should submit to Task Areas where they are capable to best meet the overall qualifications needed to fulfill the technical requirements of that Task Area.

Proposals responding to the minimum number of Task Areas is equally desirable by the Government as a proposal responding to all Task Areas. Each Technical Proposal shall address all elements of the proposed Task Area and detailed plans in response to the

Sample Task Order matching the proposed Task Area; and all General Task Order Requirements described in the parent contract statement of work. Proposals will be evaluated independently for each Task Area proposed. If an Offeror proposes to both Task Area B and C, award may occur for either B or C, or for both B and C, in addition to the possibility of no award.

Task Area A will not be peer reviewed.

SECTION 1:

1) PROPOSAL TITLE PAGE. Include RFP title and number, name of organization, UEI number, and identify if the proposal is an original or a copy. Offerors that include in their proposals data that they do not want disclosed to the public for any purpose, or used by the Government except for evaluation purposes, shall also include the legend regarding Restriction on Disclosure and Use of Data prescribed by FAR 52.215-1(e)]

2) TABLE OF CONTENTS. In SECTION 2 of the Table of Contents, include the Task Area you are proposing on.

SECTION 2: TECHNICAL PROPOSAL OVERVIEW (suggested 6-page maximum, which will be included in the overall page limit set in the RFP)

Provide a brief overview of the Technical Proposal, including:

1) A brief description of the activities in the Task Area proposed by the offeror and all proposed subcontractors, including identification of all proposed subcontractors and a list of key personnel for the offeror and the proposed subcontractors with degrees, titles and role in the project.

2) By area of expertise, provide the total number of staff, the number available to be assigned to the contract for the offeror and all proposed subcontractors, and total number of additional staff to be hired and trained.

3) A brief description of the facilities and equipment to be made available by the offeror and all proposed subcontractors.

a. If Task Area C is proposed, a brief description of all CGMP manufacturing facilities including support functions such as storage.

Table of Contents Page

1. SECTION 1 1

2. SECTION 2: TECHNICAL PROPOSAL OVERVIEW – TASK AREA B x

3. SECTION 3: TECHNICAL PLAN/APPROACH x

4. SECTION 4: SCIENTIFIC AND TECHNICAL PERSONNEL x

5. SECTION 5: FACILITIES, EQUIPMENT, AND OTHER RESOURCES x

6. SECTION 6: PROJECT MANAGEMENT x

7. SECTION 7: QUALITY SYSTEM x

8. SECTION 8: OTHER CONSIDERATIONS x https://www.acquisition.gov/far/current/html/52_215.html#wp1144408

SECTION 3: TECHNICAL PLAN/APPROACH FOR EACH TASK AREA

GENERAL NOTES

Describe, in detail for each Task Area proposed, overall technical capabilities, approaches, methodologies, plans and procedures for providing services for interventional agent development described in the SOW. Clearly specify the planned source (e.g. in-house, consortia partner, subcontract, etc.) for described technical capabilities. If technical capabilities are to be obtained from a subcontractor, identify the subcontractor, if already known.

Regarding responses to the Sample Task Orders matching the Task Areas, describe in detail the proposed approaches, methodologies, plans and procedures for completion of activities in the respective SOWs. Propose a timeline to complete the activities described in the Sample Task Order in the response and include a Gantt chart. Discuss relevant organizational experience, problems or obstacles encountered and approaches implemented to resolve or correct potential or identified problems.

1) Task Area B: Non-GMP Chemistry

The Offeor shall describe the demonstrated performance, usage, or implementation of 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 synthesizing parent compounds and related analogues.

b. Describe technical capabilities, processes and procedures to perform optimization of synthetic routes to improve yield, avoid costly or dangerous reagents, or support diversification from a late stage common intermediate.

c. 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.

The Offeror shall describe proposed plans, processes and procedures for the implementation and performance of the scope of activities described in Sample Task Order B-01 (Attachment 4).

2) Task Area C: GMP Manufacturing, Formulation, Fill, and Finish

The Offeror shall 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.

b. Describe plans, processes and procedures for cGMP-compliant synthesis of API and manufacturing processes and procedures.

c. Describe technical capabilities, processes and procedures for the development and performance of formulation studies for in vivo studies.

d. Describe technical capabilities, processes and procedures for the performance and/or support of stability assays and release testing required for clinical use and to provide a Certificate of Analysis.

e. Describe technical capabilities, processes and methods to manufacture drug product materials in compliance with cGMP regulations in amounts sufficient for pre-clinical/non-clinical evaluation and Phase I/II clinical trials.

f. Describe technical capabilities, processes, procedures and approach to develop and perform analytical methods to characterize interventional agents in various carriers in support of: product characterization, product release, in vivo safety, pharmacokinetic studies, and other pre-clinical evaluations.

g. Describe procedures for maintaining and providing all data, information and records required for the writing and submission of the Chemistry, Manufacturing and Controls (CMC) Information, Master File, and all other documents related to IND or NDA submission.

The Offeror shall describe proposed plans, processes and procedures for the implementation and performance of the scope of activities described in Sample Task Order C-01 (Attachment 5).

SECTION 4: SCIENTIFIC AND TECHNICAL PERSONNEL

The Offeror shall provide information relevant to document individual training, experience, qualifications and expertise necessary for the successful completion of the proposed Task Area and Sample Task Order requirements. Limit Biosketch to 2 pages and provide selected references for publications relevant to the scope of the Task Order.

Principal Investigator (PI): Describe the experience, training, expertise, and qualifications, and level of effort of the proposed Principal Investigator to lead and direct the activities to be carried out under the Statement of Work.

Other Key Scientific and Technical Personnel: Describe the experience, training, expertise and qualifications, as well as the level of effort, for all proposed key scientific, technical, and regulatory where appropriate (Task Areas B and C) personnel.

Include the following:

• Project Manager and

• Lead Scientific, Technical or Regulatory Personnel

SECTION 5: FACILITIES, EQUIPMENT, AND OTHER RESOURCES

The Offeror shall document availability and adequacy of facilities, equipment, space and other resources necessary to carry out the proposed Task Area and Sample Task Order requirements, including:

1) Provide location and features of facilities including a floor plan and a list of equipment and resources dedicated to the project for the prime contractor and any proposed subcontractors (lease or ownership information should be provided).

2) Identify and describe ALL support resources (including training programs, and computer and Information Technology systems) that will be required to effectively complete the functions specified in the Statement of Work

a. Provide information on facility and equipment validation.

b. Provide the history and details of facility audits and/or inspections where applicable, and any relevant Master File information.

c. Describe plans and procedures to be utilized for compliance with all safety regulations and guidelines including training and monitoring of personnel for exposure to hazardous materials.

d. Describe proposed plans and procedures for the receipt, storage, retrieval, packaging, and shipping of products, materials and reagents from domestic and international locations.

SECTION 6: PROJECT MANAGEMENT

1. The Offeror shall describe the Project Management approach for the overall project organization that addresses the planning, initiation, implementation, conduct, monitoring and completion of proposed tasks identified in the Statement of Work. If consultants and/or subcontractors are proposed, include the approach to solicit, select, award and manage the work performed by consultants and/or subcontractor(s).

2. The Offeror shall provide a Staffing Plan that describes roles, responsibilities, and level of effort for all scientific and technical personnel, including all proposed subcontractors and consultants. Provide an administrative and technical framework indicating clear lines of authority and responsibility for all proposed personnel. Include a chart of the proposed organizational/management structure for the project.

3. The Offeror shall describe the project management systems that will be used to track activities and to keep multiple activities on time and budget. The plan must include a description of the quality control methods that will be used to ensure the effective and efficient initiation, implementation, management, and oversight of contract requirements.

4. The Offeror shall outline how the PI and the Project Manager will communicate with the

Contracting Officer’s Representative and Contracting Officer and how the PI and Project Manager will communicate, monitor, and manage the project both internally and externally (at subcontractor facilities).

SECTION 7: QUALITY SYSTEM

The Offeror shall describe your current model and operating procedures for implementing a QC/QA program for completion of the proposed Task Area and Sample Task Order requirements.

As appropriate, include the following:

1. Complete description of the Quality System including QA and QC responsibilities

2. Description of process to ensure the commitment of the offeror’s senior management support for the Quality Systems

3. Quality System management of activities at subcontractor’s site that is appropriate for the phase of product development and within all applicable Regulatory regulations

4. Relevant organizational experience, problems or obstacles encountered and approaches implemented to resolve or correct identified problems.

SECTION 8: OTHER CONSIDERATIONS

This section of the Technical Proposal should document other resources not covered in Sections 1 through 7 above necessary to carry out the Task Order Statement of Work.