REVISEDAdditionalTechnicalProposalInstructions.pdf

Additional Technical Proposal Instructions

“Re-Synthesis of Non-GMP Compounds for Screening”

A detailed work plan must be submitted indicating how each aspect of the Statement of Work is to be accomplished. Your technical approach should be in as much detail as you consider necessary to fully explain your proposed technical approach or method. The technical proposal should reflect a close understanding of the nature of the work being undertaken. The technical proposal must be comprehensive and include information on how the project is to be organized, staffed, and managed.

Information must be provided which will demonstrate your understanding and management of important events or tasks.

B. Mandatory Qualification Criteria

Offerors must include, in a separate section of the Technical Proposal, a discussion of how they meet the Mandatory Qualification Criteria required by Section M., Mandatory Qualification Criteria.

1. Technical Discussions

The technical discussions included in the technical proposal should respond to the items set forth below:

a) Personnel

Describe, in detail, the experience and qualifications of personnel who will be assigned for direct work on this project. Information is required which will show the composition of the work group, its general qualifications and recent experience with similar programs.

Special mention shall be made of direct technical supervisors and key personnel, and the percentage of their total time each will be available for this project. Contingency hires (i.e, employment offers that hinge on whether this contract is awarded) are not acceptable for this RFP.

Offeror’s should assure that the Principal Investigator, and all other personnel proposed shall not be committed on Federal grants and contracts for more than a total of 100% of their time. If the situation arises where it is determined that a proposed employee is committed for more than 100% of his or her time, the Government will require action on the part of the offeror to correct the time commitment.

1. Principal Investigator

The Principal Investigator, preferably a Ph.D or MS with at least 20 years of experience, will be responsible for the overall implementation of the contract and will be the institution’s key contact for technical aspects of the project. It is desirable that the Principal Investigator be assigned to this project a minimum of 15% of the time. If it anticipated that the Principal Investigator for this project will exceed 15% on this contract, it is expected that he/she will conduct hands-on chemical syntheses.

Even though there may be co-investigators, identifying the Principal Investigator who will be responsible for the overall implementation of any awarded contract is of paramount importance.

Discuss the qualifications, recent experience in chemical synthesis, and recent examples of successfully completed chemical syntheses by the Principal Investigator. State the estimated time to be spent on the project and the areas for which he/she will be responsible. Frequent communication between the NCI COTR and the Contractor is essential to maintain the effectiveness of the contract, address and remedy problems of synthesis, and potential/likely changes in the biological evaluation procedures and priorities which may impact the operations of the contract. Explain, in detail, how you will accomplish this.

2. Other Investigators

List all other investigators/professional personnel who will be participating in the project. All other technical support personnel should be trained chemists, preferably at the B.S. level or above, and should devote at least 50% and preferably 100% of their time to this project. Discuss their qualifications, experience and accomplishments in the area of chemical synthesis, giving examples. Sate the estimated time each will spend on the project and the areas or phases for which each will be responsible.

3. Additional Personnel

List the names and titles of additional personnel, if any, who will be required for fulltime employment.

4. Consultants

Consultants are not visualized as a part of this contract. If consultants are proposed, justification for their need shall be provided.

5. Resumes

Updated resumes of the Principal Investigator and of all other professional personnel assigned to this project must be provided, including, if proposed, consultants or subcontractors. Each should indicate educational background, recent experience related to chemical synthesis, and other related scientific or technical accomplishments. Designate those publications directly related to this project for each of the investigators names. Unrelated data or resumes of individuals not assigned to or involved with the proposed work group are neither necessary nor desired.

b) Technical Approach

Use as many subparagraphs, appropriately titled, as needed to clearly outline the general plan of work. Discuss how you would proceed with the preparation of the two compounds listed below as examples. Include literature examples where available and if more than one synthesis is available justify your choice of approach with detailed discussion. Address problems that may be encountered. Discuss your proposed solutions to such problems.

Describe in detail the approaches that you would use for synthesis, purification and characterization of examples 1 and 2 that are shown in Figure 2 (attached). Indicate the time required for completion of each synthesis and comprehensive cost analysis for each target.

Note: The compounds cited above are merely examples for the purpose of demonstrating your capabilities for this project and are not compounds you will be asked to prepare or modify.

c) Facilities and Equipment

Describe, in detail, the laboratory space to be used for this project. In situations where more than one building or institution is involved, a clear description should be given of the location of all sites, distance and travel time between them. While it is expected that most of the equipment will be under the direct control of the Principal Investigator, special mention should be made when this is not the case.

When equipment is only available on a shared basis some evidence should be provided as to who is responsible for controlling access and how determination of priority of usage will be made (letter of commitment from department head, etc.).

The proposal should address the following:

3. The offeror shall have available a fully operational facility, including all necessary equipment for organic and inorganic synthesis. Provide floor plans with dimensions to describe location and relationships of facilities directly involved. Indicate the extent of dedication to this project.

4. The offeror should have immediate and preferably hands-on access to the following equipment: infrared spectrometer, UV-VIS spectrometer, readily available access to multi-nuclear NMR, and analytical HPLC. Ready availability of preparative scale HPLC will be helpful. List available equipment, including brand names and model numbers; proximity to the project work area; and provisions for access to team members.

5. The offer should have available on short turnaround high resolution mass spectroscopy and high field proton (200-500 mHz) and 13C NMR service capable of providing multiple irradiation data. Combustion analysis may be available in-house or from a commercial laboratory. Describe equipment in this category available to you including the location of equipment, arrangements for obtaining such data in the form of a letter of commitment from the provider and the expected turnaround time.

6. Describe the library resources available to you. Note the extent of the collection of major chemical journals and the accessibility to computer online literature search capability. Describe the proximity of the library to the project work area.

d) Organization’s Capability and Experience

Describe the organization’s experience in supporting synthetic organic chemistry groups by addressing the following:

(a) The relationship of the proposed project team within the offeror’s organizational structure should be explained, as well as how this relationship will facilitate the studies.

(b) Provide an organizational chart showing lines of responsibility and authority as they relate to this project.

(c) Review of pertinent work performed by your organization which is relevant to this project and your proposed approach.

Please note that organizational experience is defined as the accomplishment of work, either past or ongoing, which is comparable or related to the effort required by this RFP.

This includes overall offeror or corporate experience, but not the experience and/or past performance of individuals who are proposed as personnel involved with the Statement of Work in this RFP.

Substances under study should be considered to be toxic agents and, thus, shall be handled carefully. The offeror shall comply with all pertinent local, state and federal government safety regulations such as those required by the DBA and OSHA. Describe the organization’s general safety program in case of fire, acid spills, explosions, etc., as well as your proposed approach for the handling of toxic agents, and the protection of laboratory personnel. Provide four copies of your organization’s safety manual.

e) Supplies

For proposal purposes, direct materials, supplies, analyses, and cost of packaging and distribution of the materials for this project should be estimated at $40,000 for Contract Year 01. Justification shall be provided if this estimate is exceeded. Direct cost budgets for the subsequent option years, if exercised, will be increased in accordance with proposed and subsequently negotiated escalation factors.

2. Technical Evaluation

Proposals will be technically evaluated in accordance with the factors, weights, and order of relative importance as described in the Technical Evaluation Criteria (Section M., hereof).

3. Additional Technical Proposal Information

a) Proposals which merely offer to conduct a program in accordance with the requirements of the Government’s scope of work will not be eligible for award. The offeror must submit an explanation of the proposed technical approach in conjunction with the tasks to be performed in achieving the project objectives.

b) The technical evaluation is conducted in accordance with the weighted technical evaluation criteria by an initial review panel. This evaluation produces a numerical score (points) which is based upon the information contained in the offeror’s proposal only.

4. Other Considerations

Record and discuss specific factors not included elsewhere which support your proposal. Using specifically titled subparagraphs, items may include:

a) Any agreements and/or arrangements with subcontractors. Provide as much detail as necessary to explain how the statement of work will be accomplished within this working relationship.

b) Unique arrangements, equipment, etc., which none or very few organizations are likely to have which is advantageous for effective implementation of this project.

c) Equipment and unusual operating procedures established to protect personnel from hazards associate with this project.

d) Other factors you feel are important and support your proposed research.

e) Recommendations for changing reporting requirements if such changes would be more compatible with the offeror’s proposed schedules.

Figure 2: Part of Attachment 15

Note: The compounds cited below are only examples for the purpose of demonstrating your capabilities for this contract, and are not compounds that you will synthesize or modify.

Describe in detail the synthetic approaches that your organization would use for the preparation of the following two examples shown below:

Describe synthesis of the above structure and give a complete cost estimate and time frame of completion for the synthesis of 500 mg of [1].

CbzH N N

H

H N

H

O O

O

O

[2]

Describe synthesis of the above structure and give a complete cost estimate and time frame of completion for the synthesis of 10 grams of [2].