N02CM37002-05_Technical_Proposal_Instructions.pdf

RFP: N02CM37002-05

Shelf Life Evaluation of Investigational Dosage Forms

TECHNICAL PROPOSAL INSTRUCTIONS

The offeror shall give a detailed work plan indicating the method of accomplishing each aspect of the statement of work. Your technical approach should be in as much detail as you consider necessary to explain your proposed technical approach or method. Your technical proposal should reflect your clear understanding of the nature of the work being undertaken. The technical proposal must include information on how the project is to be organized, staffed, and managed.

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

Recommended Technical Proposal Format - The following format is recommended for the submission of technical proposals:

I. COVER PAGE (TITLE PAGE)

II. TABLES OF CONTENTS (with page numbers)

III. TECHNICAL

Prepare a technical proposal in response to the instructions below. The Technical Evaluation Criteria will be used to evaluate the scientific aspects of the proposal.

1. Technical Discussion

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

a. Personnel

Describe the experience and qualifications 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.

OFFERORS 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.

To assist you in the preparation of your proposal, the Government considers the effort to be approximately 3.0 staff annually. This information is furnished for the offeror's information only and is not to be considered restrictive for proposal purposes.

(1) The Principal Investigator (PI) should be thoroughly familiar with analysis and evaluation of finished clinical dosage forms and should have at least three years of pharmaceutical experience in this area.

The PI should also possess a Ph.D. degree in either chemistry or pharmaceutics analysis along with experience that would qualify him/her to lead this project. The PI should devote at least 25% of his/her time to this contract effort.

Identify the Principal Investigator (by name) and describe the background, training, experience, and accomplishments that qualifies him/her to lead this project. Include the PI's updated curriculum vitae. Indicate the individual's availability and proposed level of effort.

(2) The PI's Principal Assistant who will be responsible for the day-to-day operation of this contract effort should also be thoroughly familiar with the analysis and evaluation of finished clinical dosage forms and should have at least three years of experience in the area of pharmaceutical dosage form analysis. The Principal Assistant should possess training and background in all aspect(s) of chemical or pharmaceutical analysis which would qualify her/him to direct the day-to-day operation of this project. It is recommended that the Principal Assistant devote 100% of her/his time to this contract effort.

Identify the Principal Assistant (by name) and describe the background, training, experience, and accomplishments that justifies him/her to direct the day-to-day operation of this project.

Also include the Principal Assistant's curriculum vitae. Indicate this individual's availability and proposed level of effort.

(3) Additional personnel should possess suitable technical experience and training to ensure satisfactory performance of all phases of work under their purview, including shelf life evaluation of clinical drug products, performance of other evaluations, and meeting the reporting requirements. Describe the background, training, experience, and accomplishments that qualifies each individual to perform in their area of responsibility. Also, include each individual's updated curriculum vitae. Indicate each individual's availability and proposed level of effort. If new staff are to be hired, describe the qualifications sought for these individuals.

b. Facilities and Equipment

The offeror should have adequate facilities and equipment as outlined in the Statement of Work to accomplish the goals and objectives of this contract.

The antineoplastic substances under study should be considered to be very toxic agents. Describe in detail your proposed approach for the handling and disposal of toxic substances.

(1) The Contractor shall provide at a minimum the controlled temperature storage capabilities stated in the following Table:

Storage Condition Approximate

Capacity

(sq. ft.)

Elevated Temperature

(40EC, 75%RH)

Controlled Room Temperature (22-25EC)

Refrigeration (2-8EC) 200

Freezer (-10 to -20EC) 30

Deep Freeze (-70 to -80EC) if needed

(2) The Contractor should dedicate two (2) four high performance liquid chromatographic (HPLC) systems equipped with auto-samplers, variable wavelength detectors, data acquisition system, and other ancillary equipment for exclusive use on this contract to accomplish the work. A third HPLC should be available for use during peak periods of analysis.

(3) Describe in detail the facility that will be directly utilized and available for this project, and provide a detailed floor plan of the proposed facility. Such description and floor plan with dimensions must be in sufficient detail to allow for proper evaluation of the proposed facility.

(4) Discuss in detail the compliance of your facilities with FDA promulgated cGMPs and how these impact upon this contract work.

Further, discuss your approach to assure compliance with all cGMP requirements.

(5) Describe security arrangements available to safeguard Government owned materials to prevent theft, misuse, or damage.

(6) Note the exact location of the facility proposed for this contract.

(7) Describe in detail the equipment, facilities, and analytical instrumentation including make and model number to perform the shelf life evaluation of oral and injectable clinical drug products.

Note the availability of the equipment and analytical instruments for this project. Indicate which equipment will be dedicated for use on this contract. If any facility, laboratory, equipment, or apparatus are not under the complete control of the P.I., describe the arrangement you have that assures the availability of this equipment when needed.

(8) Describe facilities for holding shelf life samples at low, ambient, and elevated temperatures, and proper humidity. Include a statement of the storage capacities.

(9) Describe the monitoring of the storage conditions to guarantee and document continuous proper storage. Indicate whether such equipment will be shared with other projects.

(10) Describe the procedures for routine maintenance and repairs of equipment and analytical instruments.

(11) Describe your dissolution equipment available for this project.

c. Understanding of the Project and Proposed Approach

(1) As of January, 2012, about 20 lots of NCI drug products were undergoing shelf life evaluation. These will require approximately 20-25 separate evaluations per year. It is anticipated that there will be 10 to 15 new lots (2-3 new chemical entities) each year requiring analytical method qualification and shelf life protocol preparation.

An equal number of stability lots will be >expired= per year from the shelf-life evaluation. The Contractor shall store and properly evaluate each of these insuring that no scheduled time points are missed or overlooked batches (See Statement of Work, Section C, Tasks). A complete schedule of these ongoing lots, and all of the analytical methods and protocols for these items will be available for review through the contracting officer.

(2) Indicate the systems and procedures to be used to insure that various activities will be scheduled so that all are performed at proper times.

(3) Describe your awareness and understanding of problems associated with shelf life evaluation of finished clinical drug products.

Discuss proposed approaches to the resolution of such problems.

(4) Discuss in detail your approach to the transportation of the test samples from their current location in Kansas City, MO, to the new site in a manner to insure the safe, intact, and timely arrival of the samples while maintaining and documenting an adequate controlled temperature required for all samples. The plan shall include, but should not be limited to providing guidelines for prevention of loss of the collection during shipment, freezer preparations(s), insurance and how broken bottles will be handled. Additionally, identify any potential problems associated with the move. Please provide a cost estimate for this move. Consideration should be given to how the Government provided equipment will be moved, protection against loss of temperature condition, the desirability of multiple shipments, and any other considerations that the Offeror feels are pertinent.

Provide an estimated timetable for performing and cost associated with the transition. Moreover, the cost for transition and move shall be provided as a separate budget as well as a category in the total estimated budget.

(5) Describe your general safety program in case of fire, acid spills, explosions, etc. Provide a copy of your organization's safety manual, if available.

d. Organizational Support and Experience

(1) Describe overall organizational experience in the analysis and evaluation of clinical pharmaceuticals that qualifies you to respond to this project.

(2) Describe in detail organizational activities currently ongoing or recently completed that would indicate satisfactory experience and capabilities in the analysis and evaluation of finished clinical drug products.

(3) Discuss your organization's overall ability to respond to work requirements. Describe possible interfering commitments which might cause delays in completion of the effort required. Indicate the priority to be placed on this effort as compared to other existing commitments.

(4) Indicate by chart and/or descriptive form how the various activities will be coordinated so as to demonstrate an awareness of organizational influences on project implementation and control.