SOURCES SOUGHT
B -- Developmental Dosage Forms and Delivery Systems for Anti-tumor Agents
- Notice Date
- 12/13/2006
- Notice Type
- Sources Sought
- NAICS
- 541710
— Research and Development in the Physical, Engineering, and Life Sciences
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 6120 Executive Blvd. EPS Suite 600, Rockville, MD, 20852, UNITED STATES
- ZIP Code
- 00000
- Solicitation Number
- SS-NCI-TBS-2007-4
- Response Due
- 12/27/2006
- Archive Date
- 1/11/2007
- Description
- Sources Sought Notice No. SS-NCI-TSB-2007-4 Title: ?Analysis of Anti-Cancer Chemicals and Pharmaceutical Formulations? This Source Sought Notice (SS) is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Cancer Institute (NCI). The purpose of this SS is to identify qualified small businesses including 8(a), HUBZone, or Service-Disabled Veteran-owned business concerns that are interested in and capable of performing the work described herein. The NCI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this SS, the NCI may issue a Request for Proposal (RFP). THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NCI shall arise as a result of a response to this SS or the NCI?s use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement. It is anticipated that three (3) cost-reimbursement, completion type contracts would be awarded for a period of five (5) years with an option for yearly extensions up to two (2) additional years. The National Cancer Institute is seeking qualified small businesses including 8(a), HUBZone, or Service Disabled Veteran-owned business concerns to provide support to NCI?s Pharmaceutical Resources Branch (PRB), Development Therapeutics Program (DTP), Division of Cancer Treatment and Diagnosis (DCTD) in providing acquisition/ screening/support of novel anticancer agents from various initiatives such as Cooperative Research and Development Agreements with the extramural community and Rapid Access to Intervention Development (RAID) initiatives. These agents require dosage form development resulting in clinical products suitable for human Phase I clinical trials. The clinical agents are made widely available to the clinical research community through the Clinical Trials Evaluation Program (CTEP). Currently three contracts resulting in approximately 10 staff years are supported by this effort. (University of Arizona N02-CM-27142; University of Kenntucky N02-CM027142 and University of Kansas N02-CM-27004) Capability Statements for this requirement shall address the following six (6) areas: 1. Evidence that the proposed facility meets FDA standards for Laboratory Quality Unit in accordance with current Good Manufacturing Practice (cGMP) regulation, including compliance with all Occupational Safety and Health Act (OSHA) and United Stated Department of Transportation (DOT) regulations regarding the handling of chemicals. 2. Experience with contracts of a similar size and scope to this proposed project. Contract(s)/project(s) listed may include those entered into by the Federal Government, agencies of state or local governments, and commercial concerns. 3. A n Approach that demonstrates a clear understanding of the draft SOW. 4. Proposed Personnel demonstrate that your organization has the necessary expertise to perform the requirements of the project. A Principal Assistant (PA) must also be assigned to this project. For information purposes, it is estimated that about 4,160 direct labor hours of effort will be required on a yearly basis. 5.All necessary equipment and instrumentation for all aspects of the analytical assessment of bulk drug substances and formulated drug products is required. The Government will not be providing equipment for use on this project; therefore, the contractor shall provide evidence that the equipment and instrumentation identified in this draft SOW shall be accessible and available for immediate use on this project. 6. The Related Experience of the Company must address the capability of the organization to meet the above requirements. Interested qualified small business organizations should submit a capability statement for this requirement not to exceed twenty (20) single sided pages including all attachments, resumes, charts, etc. (single spaced, 12 point font minimum) that clearly details the ability to perform the aspects of the notice described above and in the draft SOW. All proprietary information should be marked as such. Responses will be reviewed only by NIH personnel and will be held in a confidential manner. In the event an RFP is issued, North American Industry Classification System (NAICS) code 541710 with a size standard of 500 employees is being contemplated. Capability statements are due no later than 3:00 p.m. eastern prevailing time on December 27, 2006. Please submit one (1) original and three (3) copies of your response to: Drake G. Russell, Contract Specialist, Treatment and Support Branch, Office of Acquisitions, National Cancer Institute at Frederick, P.O. Box B, 244 Miller Drive, Room 121, Fort Detrick, Frederick, Maryland 21702-1201. If courier service is used, the address is the same except delete P.O. Box B, 244 Miller Drive, Room 121 and replace with Building 244, Room 121. Facsimile responses will not be accepted. Electronic responses, via e-mail, may be sent to russeldr@mail.nih.gov. Electronic submissions must be in PDF, however WordPerfect or Microsoft Word will be accepted. All responses, including electronic responses, must be received at NCI by the specified due date and time in order to be considered. The cut off date for questions regarding this Sources Sought is December 27, 2006 at 2:00 PM. All questions MUST be submitted in writing by 2:00 pm, December 20, 2006. Point of Contacts 1. Drake G. Russell, Contract Specialist, Phone (301) 228-4217, Email: russeldr@mail.nih.gov 2. MaryAnne Golling, Contracting Officer, Phone (301) 228-4215, Email: gollingm@mail.nih.govmailto:irvingr@mail.nih.gov. Development of Dosage Forms and Delivery Systems for Anticancer Agents DRAFT Statement of Work The Contractor shall furnish services, qualified personnel, material, equipment, and facilities not otherwise provided by the Government under the terms of this contract as needed to perform the work described below: 1. Determine the solubility profile of the supplied bulk drug substance in various physiologically acceptable aqueous and certain water miscible and least-toxic organic solvents. 2. Carryout physicochemical studies to characterize molecules including but not limited to solubility and stability profiles of the supplied bulk drug substance. 3. Develop approaches for intravenous delivery of drugs exhibiting inadequate solubility and/or stability in aqueous solutions depending on the need of the Program in collaboration with the PO. 4. Develop if necessary suitable stability-indicating assays to detect the active drug substance subject to a variety of experimental conditions including the formulation per se, heat, light, oxygen, and other parameters. 5. Prepare kinetic profiles to predict the stability of the drug substance in various physiologically acceptable aqueous vehicles and certain organic solvents as determined by NCI. Determination of pKa and partition coefficient of drug substance may be required. 6. Apply the solubility and stability enhancement approaches when needed to prepare experimental dosage formulations on small scale for subsequent therapeutic and toxicological evaluation by NCI in animals. Pack, label, and ship the experimental products according to instructions provided by the Government. 7. Evaluate the experimental dosage form under simulated use conditions, i.e., completeness and clarity of the constituted solution after freeze drying, stability of this solution per se and after dilution with intravenous fluids in glass bottles and in polyvinyl chloride (pvc) bags and other suitable containers or bags for intravenous administration. 8. The Contractor may also be asked by PO to develop other dosage forms like controlled release or targeted delivery system as well as dosage forms for different route of administration other than parenteral. 9. Carry out a short-term stability study of the finished dosage form under accelerated stability condition at 50OC, 37 OC, 25 OC, and under refrigeration condition as needed and directed by the Government in collaboration with PO per Program needs. 10. Depending on the Program needs and/or agent under investigation, it may be necessary to study and develop different types of dosage forms such as controlled release or targeted delivery systems as well as dosage forms for different routes of administrations. If the expertise or capabilities are not available to the offeror, they shall acquire the cooperation of experts or consultants with approval by the Project Officer. Development of Dosage Forms and Delivery Systems for Anticaner Agents DRAFT TECHNICAL EVALUATION CRITERIA TECHNICAL EVALUATION FACTORS The evaluation criteria are used by the technical evaluation committee when reviewing the technical proposals. The criteria below are listed in the order of relative importance with weights assigned for evaluation purposes. 1. Personnel Weight 35% a. The quality and extent of the Principal Investigator's recent experience, scientific accomplishments, and qualifications for leading the project. b. The extent and suitability of qualifications, experience and accomplishments of the project team with: 1) Development of parenteral dosage forms for intravenous use; 2) Development of stability indicating methodology; 3) Methods to improve drug solubility; 4) Development of other dosage forms or delivery systems; 5) Freeze drying of pharmaceutical products. c. Availability of all personnel for assignment to this project. 2. Understanding the Problem and Technical Approach Weight 35% The quality of the proposed technical approach, including: a. Scientific rationale, ingenuity, and thoroughness of the proposed approach; b. Suitability of the proposed formulation approaches for intravenous administration; c. Scientific rationale, ingenuity and thoroughness of work recently completed or currently in progress. 3. Facilities and Equipment Weight 20% a. Quality and suitability of the facility; b. Availability of the equipment for the performance of this work; c. Suitability of the laboratory layout for the efficient development and production of experimental dosage units. 4. Organizational Support and Experience Weight 10% a. Adequacy of organization's experience in the development of pharmaceutical dosage forms; b. Quality and suitability of the general safety program; c. Evidence for organizational support of this project; d. Adequacy of program for disposal of chemical and hazardous waste. Total 100%
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