SPECIAL NOTICE
B -- Economics of Vaccines - Tracking Vaccines under Development to Determine Cost Drivers of the Vaccine Development and Approval Process
- Notice Date
- 7/31/2009
- Notice Type
- Special Notice
- NAICS
- 611310
— Colleges, Universities, and Professional Schools
- Contracting Office
- Department of Health and Human Services, Centers for Disease Control and Prevention, Procurement and Grants Office (Atlanta), 2920 Brandywine Road, Room 3000, Atlanta, Georgia, 30341-4146
- ZIP Code
- 30341-4146
- Solicitation Number
- 2009-N-11508
- Archive Date
- 8/29/2009
- Point of Contact
- Russell T Oxford, Phone: 770-488-2082
- E-Mail Address
-
efn3@cdc.gov
(efn3@cdc.gov)
- Small Business Set-Aside
- N/A
- Description
- The Centers for Disease Control and Prevention (CDC), National Center for Immunization and Respiratory Diseases (NCIRD), Immunization Services Division (ISD) intends to award, on a sole source basis, a contract to the University of Michigan, 2901 Baxter Road, Ann Arbor, Michigan 48109-2150. By contractual agreement, The University of Michigan shall determine the relative technical and regulatory costs to develop and produce vaccines by utilizing economic analysis and data mining methods. The University of Michigan will submit a study design and a plan for completion of this project. Throughout the study, University of Michigan researchers will submit reports describing the data collected, interview progress, and preliminary analytic results. At the completion of data collection, the contractor will conduct a final economic analysis and submit a report detailing the analysis, and prepare a manuscript suitable for publication in a peer-reviewed journal. For further details, see the attached statement of work. The authority for this sole-source acquisition is FAR Subpart 6.302-1. Justification for other than full and open competition is considered due to the continued need to match existing services of on-going studies being conducted by the CDC. Regents of the University of Michigan, is believed to be the only source available that possesses the intellectual property rights to proprietary information of the vaccine pricing model developed for the CDC through a cooperative agreement, reference: FOA #IP06_010, Industrial Costs of Commercializing and Vaccines, and CFR 45 74.36. Further, University of Michigan researchers have made unique use of the Pharmaprojects database to develop a vaccine production pricing model that is both unique and rare to the vaccine manufacturing industry. Failure to acquire services from the University of Michigan, will preclude the use of such proprietary information, thus will result in significant project delays, skewed results from the pricing model, and ultimately create a substantial duplication of cost to the Government that is not expected to be recovered through competition. Firms that believe they can provide the services, as listed in the attached Statement of Work, are encouraged to identify themselves and give written notification to the Contracting Officer within 15 days of the publication date of this synopsis. Determination by the Government not to compete this proposed action based on responses to this notice is solely within the discretion of the U.S. Government. Respondents will assume all financial costs for preparing a response to this notice. The U.S. Government assumes no financial obligation for the preparation and distribution of prepared responses. Inquires may be sent to Russell T. Oxford by e-mail at roxford@CDC.gov or by fax to 770-488-2044 STATEMENT OF WORK Centers for Disease Control and Prevention (CDC) National Center for Immunization and Respiratory Diseases (NCIRD) Immunization Services Division (ISD) Solicitation Number: 2009-N-11508 Project Title: Economics of Vaccines - Tracking Vaccines under Development to Determine Cost Drivers of the Vaccine Development and Approval Process C.1 Background This special studies requirement will address several objectives of the U.S. National Vaccine Plan: 1) encourage the development of new and improved vaccines; 2) ensure the stable supply of vaccines; and 3) conduct research into the economics of vaccines [http://www.hhs.gov/nvpo/vacc_plan/vacc_planp25.pdf ]. Several times between 2000 and 2004, there were shortages of vaccines medically recommended for both children and adults in the US [Coleman, NVAC]. One of the concerns that arose out of the various stakeholder discussions regarding the reasons for the shortages was the increasing business-related costs of complying with FDA regulations in the development and production of vaccines [Coleman, IOM]. While it is true that regulatory costs of doing business have increased, there is also a potential argument to be made that the technical costs of developing and producing vaccines have also increased. Many of the vaccines that have been developed in recent years use expensive new technologies and adjuvant (to improve immune response). There is no research that separates development and production costs into regulatory and technical components. This research proposal will identify what portion of costs may be attributable to regulatory requirements, and what are attributable to technical requirements. Since 2006, the University of Michigan has been funded by the CDC Immunization Services Division to develop a proprietary pricing model for new vaccines that is now the intellectual property of the University of Michigan, with rights of use granted to the CDC. With appropriated grants funding, the University of Michigan purchased the use of a proprietary database called Pharmaprojects. This database tracks the movement of vaccine products from their inception through licensure, through all clinical trial phases. University researchers have gained a significant amount of expertise at data mining in Pharmaprojects, a skill which took quite a bit of time as the data collection systems of Pharmaprojects are idiosyncratic The uniqueness of the University of Michigan use of the Pharmacoprojects database was to mine data for microeconomic analysis of specific vaccine and biologics products that have not been previously analyzed either in business or university research. In addition, researchers at the University of Michigan have developed other project-specific skills: extracting clinical trials data from FDA websites; interpreting FDA vaccine-specific data available from the agency; and building relationships with business and technical personnel working in vaccine-originating businesses or vaccine policy arenas (e.g., pharmaceutical consultants, biotechnology firms, pharmaceutical firms, and policy makers). In addition to becoming expert at extracting original data for microeconomic analysis of vaccines and biologics, the University of Michigan researchers have developed intellectual property in the form of a unique pricing model that incorporates: the time it takes vaccine products to work through all phases of development and post-licensure production; risk of vaccine product failures; and pricing options. This model provides a clear picture of the overall net return to businesses that invest in vaccine development and sales. It is anticipated that this CDC project will take advantage of the intellectual property and project-specific data collection and analytic skills and professional contacts of researchers at the University of Michigan. C.2. Purpose 1) Understand how the regulatory process affects the decision to engage in the development of new vaccines; and 2) Understand which costs are necessitated by the technical process of vaccine development and which costs are necessitated by the government regulatory process. The CDC requires this information because : 1. Understanding the interaction of regulation and the decision to produce vaccines will allow the government to create policies that retain current vaccine manufacturers in the business and attract potential new entrants to the market 2. Understanding the division of costs between regulation and technical processes will allow government to: a. Streamline regulatory processes if they are found to be unnecessarily burdensome b. Determine potential financial incentives to vaccine developers that might reduce prices of new vaccines which, in turn, would decrease vaccine program purchase costs c. Hold data-informed discussions in venues where the U.S. Government is chastised for driving up research, development and manufacturing costs through unnecessary regulations. C.3 Objectives Specific objectives are to: 1. Update existing, proprietary pricing model that is the intellectual property of the Regents of the University of Michigan developed at the behest of CDC through a cooperative agreement with the Regents of the University of Michigan. 2. Follow a cohort of ~150 to 200 new vaccine products in Pharmaprojects, a proprietary database that tracks the time needed for new vaccine products to progress from inception to licensure, 3. Interview the vaccine originators of each product, using the contacts developed by Dr. Davis and his group at the University of Michigan, and, where there is more than one originator (e.g., where a manufacturer buys the rights to a product developed by a biotechnology firm), then interview all involved, 4. Track time and regulatory activity through requests to the Food and Drug Administration (FDA) and through web sites run by the FDA, and 5. Model and analyze the data to apportion costs between regulatory and technical requirements. Through the use of quality health economic analysis and prevention effectiveness research, these data will be used to support the implementation of effective and sustainable immunization policies that ensure the supply of current and potential future vaccines. C.4 Requesting Agency Centers for Disease Control and Prevention (CDC) National Center for Immunization and Respiratory Diseases (NCIRD) 1600 Clifton Road, Mailstop E-52 Atlanta, GA 30333 C.5 Scope The contractor will submit a study design and a plan for completion of the work. Throughout the study, the contractor will submit reports describing the data collected, interviews progress, and preliminary analytic results. At the completion of data collection, the contractor will conduct a final economic analysis and submit a report detailing the analysis, and prepare a manuscript suitable for publication in a peer-reviewed journal. C.6 Place of Performance All work, to exclude breifings or presentation of findings, will take place at the Contractors place of business. Briefings will take place at the Requesting Agency (See C.4) C.7 Period of Performance The period of performance is 24 months from the date of award. The project will be funded in two (2) 12 month increments, to include one base year and one option year. Determination to continue the second 12 month increment (exercise the option year) will be made prior to the end of the intial 12-month period, and is dependent on contractor performance within the base period. C.8 Continuity of Services. The Contractor recognizes that the services under this contract are considered vital to the U.S. Government and must be continued without interruption and that, upon contract expiration, a successor, either the U.S. Government or another contractor, may continue these services. The contractor agrees to (1) furnish phase-in knowledge transfer and (2) exercise its best efforts and cooperation to effect an orderly and efficient transition to a successor. C.9 Technical Services Required: Use economic analysis and data mining methods to estimate the relative technical and regulatory costs to develop and produce vaccines, and report results of findings. C.10 Tasks: The contractor shall: Task 1 Study design development Within two weeks of award, the Contractor's Principal Investigator and Project Manager will, in person or by teleconference, confer with and receive advice from CDC Project Staff. Items to be discussed will include, but not be limited to, numbers of products to be followed in the cohort of vaccines, data mining methods, time table for key informant interviews, collection of secondary data from FDA and FDA websites, refinement of pricing model, and potential estimation techniques. After this meeting the contractor will incorporate the advice of the CDC Project Staff into a study work plan. This task is to receive 5% of total project effort. Task 2 Submission of work plan Within three weeks of receipt of the statement of work, the Contractor shall forward to the Project Officer the project work plan. The work plan shall include the Contractor's proposed methods to perform task order requirements within the stated time frames, management and staffing plan, and a budget reflecting estimated costs to accomplish the requirements. This task is to receive 5% of total project effort. Task 3 Develop vaccine cohort and report initial results Within three months of award of the task order, the Contractor will identify and collect information on ~150-200 unique vaccine products (actual number to be determined in discussion). The data mining results will be compiled, including identification of all of the vaccine originators, and a report submitted. This report will be distributed to CDC Project Staff for review at a meeting convened by the Contractor either in Atlanta or by teleconference. At this meeting the views of the CDC Project Staff will be obtained on how to proceed with interviewing key personnel at each vaccine originator and identifying all of the costs, regulatory and technical, associated with each product. It is anticipated that there will be fewer vaccine originators than unique products on the assumption that the same originators will have multiple products in development. At this time, the number of originators to be interviewed will be decided in discussion between CDC Project Staff and the Contractor Research Staff. This task is to receive 15% of total project effort. Task 4 Interview of vaccine originators and collection of secondary data During the following 12 months, the Contractor shall interview the vaccine originators agreed upon to collect cost information. In addition, secondary data collection shall proceed for the vaccine product cohort. Secondary data collection shall include, but not be limited to, FOIA requests to the FDA and use of FDA-sponsored web sites. It is understood that some of the collection of secondary data may take longer than 12 months because much of this data collection is subject to the response times of the FDA, which are out of the Contractor's control. At the end of the 12 month period, the Contractor shall host a second meeting (by teleconference, in Atlanta, or at the University of Michigan) and distribute a report of the initial findings synthesizing original Pharmaprojects data, secondary data, and key informant interviews. Discussion between the Contractor and CDC Project Staff will occur regarding the final task of the project. This task is to receive 55% of the total project effort. Task 5 Final economic analysis report submission Within 18 months of award of the task order, the Contractor will conduct economic analyses using the final data set and submit a report outlining the methods, assumptions, and final results. The economic analysis will include an update of the original pricing model, and specific analysis of 3 to 5 unique products. This report will be distributed to CDC Project Staff for review at a meeting convened by the Contractor in Atlanta or by teleconference. At this meeting the views of the CDC Project Staff will be obtained on the report regarding methods, assumptions, final results and suggestions for publication venue. This task is to receive 15% of total project effort. Task 6 Manuscript for publication Within 18 months of award of the task order the Contractor will deliver a manuscript suitable for publication in a peer-reviewed journal. The final version will be sent by the Contractor to the CDC Project Officer for CDC clearance and submission to a peer-reviewed journal for publication pending CDC clearance. This task is to receive 10% total effort. C.11 Deliverables: See section C.10 for further details. 1. A written project work plan (reports, diagrams, schematics) 2. Pharmaprojects data mining - electronic query reports and/or hard copy documentation 3. Development of vaccine product cohort - electronic and/or hard copy documented listings 4. Key informant interviews - documented interviews, to include audiovisual, electronic and/or written reports 5. Secondary source data collection - written reports 6. Update of intellectual property of the pricing model, and analysis of 3 to 5 specific products - written reports to include graphics, statistical analysis / modeling etc. 7. Economic analysis - written reports to include graphics, statistical analysis / modeling etc. 8. Preparation of interim reports and participation in regular teleconferences and/or meetings 9. Preparation of final written manuscript 10. The contractor shall bring problems or potential problems affecting performance to the attention of the appointed CDC Project Officer /Contracting Officer's Technical Representative (COTR) as soon as possible. Verbal reports will be followed up with written reports when directed by the CDC Project Officer/ COTR. C.12 Delivery Instructions: Deliverables shall be submitted by electronic format in Microsoft Word, Excel spreadsheets and/or Power Point presentations to the technical monitor and hard copy documents ( to include DVD, CD, and other audiovisual storage media) sent to the following address by FedEx, UPS or similar carrier. (U.S. postal service does not deliver to the address below) Economics Team ATTN: Dr. Margaret S. Coleman, PhD HSREB/ISD/NCIRD 4th Floor- M/S E-52 12 Corporate Square Atlanta, GA 30029 C.13 Acceptance of Deliverables: The CDC Project Officer / COTR will review the contractor deliverables in accordance with CDC policy. If deficiencies are discovered the Project Officer, he/she will provide a written description of all deficiencies to be corrected by the contractor. The corrected deliverables shall be re-submitted within 10 calendar days at no additional cost to the Government. C.14 Records/Data. All data and materials produced during the course of this contract are the property the (CDC) Centers for Disease Control and Prevention. C.15 Security and Privacy: Work on this project requires that personnel have access to Privacy Information. Personnel shall adhere to the Privacy Act, Title 5 of the U.S. Code, Section 552a and applicable agency rules and regulations, and shall agree to adhere to those privacy and security policies and procedures in place within the selected grantee's business environment. C.16 Government Furnished Items: The Government (CDC) will provide background documents and information necessary for contractor to begin the work. This will include access to NCIRD technical experts. C.17 Travel Requirements: The contractor will be required to travel to CDC to present final results. Additional travel may be necessary and is contingent on activities detailed in the final approved work plan. C.18 Key Personnel: The contractor shall identify key personnel in the technical proposal. Key personnel may not be removed from the task without express approval of the appointed U.S. Government Contraction Officer and the Contracting Officers Technical Representative (CDC Project Officer). C.19 Minimum Expertise Qualifications: The contractor is responsible for providing the expertise and technical and functional capabilities required to accomplish the task requirements and deliverables as stated in section 2.1 Tasks. At a minimum, the contractor must provide personnel with knowledge and expertise in the following areas: • The ability to perform data mining in Pharmaprojects, • The ability to engage in key informant interviews • The ability to collect secondary source information from the FDA • The ability to analyze data collected • The ability to perform economic modeling and interpret results • The ability to present findings in manuscript form
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/HHS/CDCP/PGOA/2009-N-11508/listing.html)
- Place of Performance
- Address: 300 North Ingalls, 6E05, Ann Arbor, Michigan, 48109-0456, United States
- Zip Code: 48109-0456
- Zip Code: 48109-0456
- Record
- SN01894627-W 20090802/090731235301-6d6e97864f1c3c637c24441c0e5248c8 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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