RFP # C REQUEST FOR PROPOSAL. Acute Graft versus Host Disease Plasma Biomarker Analysis in Baseline and Post-Treatment Patient Samples

Transcription

1 RFP # C REQUEST FOR PROPOSAL Acute Graft versus Host Disease Plasma Biomarker Analysis in Baseline and Post-Treatment Patient Samples BMT CTN Protocol 0802 A Multi-Center, Randomized, Double Blind, Phase III Trial Evaluating Corticosteroids with Mycophenolate Mofetil vs. Corticosteroids with Placebo as Initial Systemic Treatment of Acute GVHD ISSUED BY: National Marrow Donor Program 3001 Broadway St. N.E. Broadway Ridge, Suite 100 Minneapolis, MN September 16, 2010 Proposal Must Be Returned By November 4, :00 p.m. Central Time Page 1 of 14

2 National Marrow Donor Program RFP # C Table of Contents Section I General Information Page 3 A. National Marrow Donor Program Contact B. Milestone Schedule Section II Background Page 4 A. Program Establishment B. Project Objectives Section III Scope of Work Page 5 A. Project Deliverables/Requirements Section IV Budget Page 10 A. Pricing and Reimbursement B. Best Value C. Office of Management and Budget Circulars D. Travel Section V Submission Procedure Page 11 A. Preparation of Formal Response B. Terms Section VI Evaluation for Award Page 14 A. Response Evaluation B. Award Attachments Attachment 1 Attachment 2 Attachment 3 Attachment 4 Attachment 5 Business Information Sheet Substitute W-9 and Business Classification Form Certifications Regarding Debarment & Lobbying Price per Sample Form Accrual Projections Page 2 of 14

3 SECTION I GENERAL INFORMATION A. National Marrow Donor Program (NMDP) Contact Questions concerning this solicitation should be submitted September 20 October 13, 2010 via to: Renẻe Carby Contracts Representative National Marrow Donor Program Coordinating Center 3001 Broadway Street N.E. Broadway Ridge, Suite 100 Minneapolis, MN Telephone: Fax: rcarby@nmdp.org B. Milestone Schedule Please note that a formal proposal, comprised of the Technical Response & Business Response, for the purpose of this RFP is due no later than November 4, 2:00 p.m. Central Time. Formal proposals must be delivered to the NMDP representative named in Section I A. Release of RFP & Network Announcement September 16, 2010 Submission of Written Questions September 20 October 13, 2010 Posting of Responses to Questions September 21 October 14, 2010 Formal Proposals Due by 2:00 p.m. Central Time November 4, 2010 Contractual Award TBD Responses to any questions shall be considered as part of the Statement of Work. Page 3 of 14

4 SECTION II BACKGROUND A. Program Establishment In October 2001, the National Institutes of Health (NIH), through the National Heart, Lung, and Blood Institute (NHLBI) and the National Cancer Institute (NCI) established the Blood and Marrow Transplant Clinical Trials Network (BMT CTN). The purpose of the BMT CTN is to conduct large multi-institutional clinical trials. These trials address important issues in hematopoietic stem cell transplantation (HSCT), thereby furthering understanding of the best possible treatment approaches and promoting the efficient comparison of novel treatment methods and management strategies of potential benefit to children and adults undergoing blood or marrow transplants. Participating BMT CTN investigators collaborate through an organization designed to maintain continuity of operations, to facilitate effective communication and cooperation among participating transplant centers and with collaborators at the National Institutes of Health, and to offer trials participation to patients in all regions of the U.S. The BMT CTN is committed to including widespread transplant community participation in these trials. This commitment extends also to the many research investigators that currently support the numerous clinical protocols and biomarker research studies associated with HSCT trials. The NIH awarded a grant to the Medical College of Wisconsin (MCW) for the operation of the BMT CTN Data and Coordinating Center (DCC) to oversee clinical trial operations for the BMT CTN. The DCC is comprised of the Statistical Office of the Center for International Blood and Marrow Transplant Research (CIBMTR ) at MCW, the National Marrow Donor Program (NMDP) and the EMMES Corporation. National Heart, Lung, and Blood Institute (NHLBI) is providing funding to the BMT CTN to conduct a Phase III, randomized double blind, placebo controlled trial evaluating the addition of MMF vs. placebo to systemic corticosteroids as initial therapy for acute GVHD. The primary endpoint will be GVHD free survival at Day 56 post randomization. The NMDP is committed to its global mission to extend and improve life through innovative stem cell therapies. The NMDP also provides resources for patients and physicians, and conducts research to improve the outcomes of stem cell transplantation. Among other activities, the NMDP is responsible to contract with laboratories, hospitals, suppliers and other organizations participating in BMT CTN projects. The NMDP, on behalf of the BMT CTN, NCI, NHLBI, and the protocol team led by Study Chairpersons, Javier Bolaños-Meade, MD of the Johns Hopkins School of Medicine, and J Vincent T. Ho, MD of the Dana Farber Cancer Institute, are collectively referred to as the Network for purpose of this RFP. The Network is requesting a firm proposal to fulfill the Scope of Work for this study. Page 4 of 14

5 B. Project Objectives 1. Background and Rationale: A major barrier to graft versus host disease (GVHD) research and treatment is that the prognosis of GVHD relies almost entirely on clinical symptoms (maximum grade). No simple test for response to treatment of acute GVHD exists. A recent study performed discovery and validation experiments to identify a panel of informative biomarkers with diagnostic and prognostic value for GVHD has been performed (Paczesny, 2009; Blood 113: ). This study has been among the first to apply proteomic technology to identify biomarkers for GVHD, yet blood tests are still not yet able to predict a patient s response to treatment. Furthermore, the four-biomarker panel has not yet been validated in samples from different institutions. This proposal addresses the use (at minimum) of this four-biomarker panel (interleukin-2-receptor-alpha, tumornecrosis-factor-receptor-1, interleukin-8, and hepatocyte growth factor) and a newly identified skin-specific marker, elafin (Paczesny, 2010; Sci Transl Med. Jan 6;2(13):13ra2) for association with therapeutic responses. Upon completion, these studies will likely result in novel biomarker panels that may facilitate the therapeutic decision making process for allogeneic HCT patients. 2. Study Design and Objectives: For these studies, plasma samples collected on Day 0 and Day 28 post-treatment will be shipped from the BMT CTN Repository to the project laboratory and analyzed for a 5- protein biomarker panel. The results from previous discovery and validation studies suggested that the panel of four biomarkers can confirm the diagnosis of agvhd in patients at onset of clinical symptoms of agvhd and provide prognostic information independent of agvhd severity. The plasma protein biomarker panel will include at minimum: interleukin-2-receptor-alpha, tumor-necrosis-factor-receptor-1, interleukin- 8, hepatocyte growth factor and elafin. SECTION III SCOPE OF WORK A. Project Deliverables/Requirements: 1. Experience, Accreditation and Participation in Proficiency Testing Programs Laboratory must be able to document expertise, relevant experience and contributions of the Principal Investigator and supporting laboratory staff in performing standard plate-based ELISA or multiplexed assays on pre-hsct and post-hsct patient samples. Laboratory is asked to list any relevant laboratory certifications, accreditations and any federal, state or local licenses, and will provide evidence of participation in any laboratory proficiency programs related to the scope of work of this study. Page 5 of 14

6 2. Facilities and Resources The Laboratory shall have an established facility and the resources necessary to receive, process and store incoming samples, and, then to accommodate the testing of samples. The purchase of equipment will not be reimbursed as a separate element under this Agreement. 3. Records and Audit The Laboratory shall maintain such records, and establish and adhere to such procedures as may reasonably be required to document its performance under this project. The Laboratory shall maintain all records associated with performance of its obligations under this project for the term of this project and for no less than five years thereafter. For the duration of the period during which those records are maintained, the NMDP and its duly authorized agents, agents of the state or federal government, shall have access to all information, records and copies of records regarding the Laboratory s performance during the Laboratory s regular business hours upon reasonable notice and demand. During the period of performance of Services, the DCC will have the right, at reasonable times, and upon reasonable written notice, to perform at the DCC s expense: (i) on-site quality assurance audits of the Services performed by the Laboratory and (ii) on-site inspections of the documentation, record keeping and Standard Operating Procedures, records and facilities of the Laboratory which are specific to the Services being provided by the Laboratory. The purpose of an audit or inspections is to ensure the adequacy of the performance records, and that the activities are being performed are in accordance with the Laboratory s responsibilities. 4. Sample Shipments and Sample Accessioning Laboratory will receive yearly shipments of frozen baseline and post-treatment patient plasma samples from the BMT CTN Repository via priority overnight Fed Ex service. Except for designated holidays, Laboratory must be available to accept and analyze samples during normal business hours Tuesday through Friday, 52 weeks per year. The Laboratory shall ensure prompt accessioning of the received samples into inventory using an electronic inventory database. Samples shall be processed within time frames required for sample integrity and quality for all testing procedures. The Laboratory shall accurately identify and track all samples through the stages of receipt, storage, and reporting of results. The Network will provide necessary supplies for the collection, identification, packaging and shipping of all patient samples to the Laboratory. The Network uses a specimen tracking system called Global Trace, developed and maintained by The EMMES Corporation. Each plasma sample aliquot will be labeled with a unique 12- Page 6 of 14

7 digit numeric/bar-coded label (ex: ) and will be scanned into the system and linked with patient and sample-related collection information. Sample shipments are put together in Global Trace and both electronic and hard-copy manifests are generated. The electronic sample manifests, including Fed Ex tracking information, will be sent via to the project laboratory on the day the sample is shipped. A printed manifest will be included with the samples shipped to a project laboratory. Project laboratory/laboratories will have access to Global Trace and will be required to make entries into Global Trace indicating the receipt of shipped patient samples. 5. Patient Accrual, Sample Type and Distribution for Testing It is estimated that approximately 372 patients will be enrolled in this study over an estimated 3 year accrual period. Anticipated patient accrual over the course of the study is shown in Attachment 5. Patient peripheral blood samples, collected in an EDTA containing Vacutainer tube, will be collected on Day 0 prior to initiation of agvhd treatment, and on Day 28 post-treatment initiation, and processed locally at each clinical site. The frozen EDTA plasma aliquots will be shipped yearly to the BMT CTN Repository for storage and laboratory distribution. On an approximately yearly basis, available frozen plasma samples will be shipped to the project laboratory for batched testing. Projected sample estimates used in this RFP are based upon 100% patient consenting and 100% sample collection at each time point. However, patient consenting historically is approximately 92%, and 100% sample collection at each time point can not always be achieved. Therefore, there will be no guarantees or minimum commitments to the total number of samples to be tested. Retesting, loss, or replacement of samples due to Laboratory s failure in its responsibilities or failure to follow laboratory procedures will be at the expense of the Laboratory. 6. Laboratory Testing Requirements The Laboratory will measure, at minimum, the following five biomarkers (IL2Ra, TNFR1, IL8, HGF, elafin) using standard plate ELISA or multiplex analysis format. Laboratory will batch the samples and run them simultaneously to maximize efficiency, cost and enhance inter-sample comparisons. The responding Laboratory may propose the use of additional biomarkers to be analyzed that they believe would provide extra value to the clinical questions being studied. Such procedural additions, additional associated costs, and the discussion of benefits will need to be supported by recent relevant data/publications from the submitting laboratory. 7. Laboratory Quality Control Program Laboratory will archive the results of all general instrument controls and quality control samples included in the same run as samples being tested in this project. The Page 7 of 14

8 QC reports should include the name and lot number of the control (if commercial), as well as the expected result range for each analyses performed on the control material. Laboratory will have existing Standard Operating Procedures (SOPs) and use appropriate quality control materials for all analytic procedures to be used for this study. Procedures must include the Laboratory s quality control program for the validation/qualification of all antibodies, reagents and instrumentation proposed for this study. Supporting staff must have validated training and experience with all instrumentation, QC and all analytical procedures. 8. Database Requirements and Report Submission Laboratory must have the capability to manage sample and analysis result data using a computer database. The Laboratory shall ensure that the database is secure with user identification and password protection. The database shall be routinely (at least weekly) backed up on disk or tape, and a copy must be stored off-site in a protected environment. The Laboratory must ensure that the back up procedures result in successful restoration of the database. The Laboratory agrees to provide to the NMDP upon request, a Disaster Recovery Plan to protect the database in the event of computer failure or corruption of files. The Laboratory shall protect against: a. Physical and electronic intruders from the outside. b. Unauthorized use of computers, data and other resources. c. Improper use of systems by authorized individuals. d. Computer viruses and willful destructive applications. e. Natural and man-made disasters. Laboratory will electronically submit completed results to BMT CTN in a report format that will be subject to approval by BMT CTN. This is typically done through electronic uploads to the BMT CTN web system. Laboratory shall also provide all other reports as reasonably requested by BMT CTN out of its database of study-specific information. Laboratories are asked to indicate in their RFP response if this type of data transfer is within the scope of the Laboratory s capabilities. And if not, the Laboratory is asked to propose an alternative electronic data transfer method. 9. Timelines for Reporting ELISA Results Laboratory will submit final, Principal Investigator approved testing results to EMMES once a year, or as directed by the designated representatives of the BMT CTN DCC. 10. Performance Criteria Laboratory performance for this project will be evaluated on the following: a. Receive and test samples according to SOW. b. Report verified final test results as instructed by the DCC. c. Met quality control standards. Page 8 of 14

9 11. Sample Storage and Disposal Laboratory acknowledges that its employees and representatives who will be working with the samples submitted for analysis could be exposed to HIV, hepatitis or other diseases. Laboratory will take all required and reasonable precautions to reduce the risk of exposure to such diseases. a. Laboratory will dispose of biohazardous waste according to local, state and federal regulations. b. Samples may only be utilized for the purposes of this project only, unless express written permission is granted by the DCC. Page 9 of 14

10 SECTION IV BUDGET A. Pricing and Reimbursement The Laboratory should submit a price per sample that will be sufficient to fulfill the requirements of Section IV of this RFP. Refer to Attachment 4, Price Schedule, for the format required for submitting pricing in response to this solicitation. Payment will be made for testing and reported on an annual basis upon satisfactory completion of each task. The Laboratory is encouraged to supply support of the prices in order to determine the reasonableness of the bid. Current published rates for the same, or similar, tests are one method of supplying such price support. The NMDP reserves the right to question, reject, or accept materials which might indicate the reasonableness of the offer. B. Best Value The NMDP standard for award is "Best Value (refer to Section VI Evaluation for Award ). Best value decisions are a combination of factors such as: technical excellence, price, quality, past performance, and other indicators. C. Office of Management and Budget (OMB) Circulars If applicable, the pricing supplied must comply with the appropriate OMB cost principles set forth in the following documents and are incorporated by reference in 45 CFR and 92.22: OMB Circular A-21 Cost Principles for Educational Institutions OMB Circular A-122 Cost Principles for Non-Profit Institutions 45 CFR Part 74, Appendix E Principles for Determining Costs Applicable to Research and Development under Grants and Contracts with Hospitals. D. Travel When necessary, the BMT CTN will provide for and schedule all travel arrangements. Travel costs should not be included in your bid. Page 10 of 14

11 SECTION V SUBMISSION PROCEDURE A. Preparation of Formal Response Please review requirements in this solicitation carefully. Instructions for preparing each section are provided below to assist in submitting a response. You must follow the instructions or delay may occur in the consideration of the proposal. Your response package must be received by the NMDP by the required date and time and to the attention of the individual cited on Section I. The Formal Response must contain the following information in writing: 1. Preparation of the Technical Response The Technical Response must contain the following information and shall not be more than 12 pages in length (any additional supporting information that is deemed by the Bidder as necessary, it may be included as an attachment). Should it be determined that further clarification and/or information is needed the Bidder will receive written notification of such request: a. Brief overview of your Laboratory s overall capabilities and the specific experience and capabilities to perform the technical requirements of this proposal. This should include a description of any unique capabilities, expertise or experiences that can be offered to the BMT CTN, including a list of any recent comparative contracts or grants. b. (Optional) The responding Laboratory may propose the use of additional biomarkers to be analyzed that they believe would provide extra value to the clinical questions being studied. Such procedural additions, additional associated costs, and the discussion of benefits will need to be supported by recent relevant data/publications from the submitting laboratory (any additional supporting information may be included as an attachment). c. Description of how your Laboratory will complete the Statement of Work, including: i. Name and title of the Principal Investigator to be listed on the potential subsequent agreement. Only one Principal Investigator may be named along with the percent of their effort for this program, as stated in available calendar months. Submit a brief Biographical Sketch as well as a description of the Principle Investigator s qualifications and direct experience with the assays and procedures related to the objectives of this project. The Principal Investigator named on the Business Information Sheet, Attachment 1, must be the same as identified in the Technical Response. Page 11 of 14

12 ii. Names, qualifications, and direct experience with the assays and procedures related to the objectives of this project, for the key laboratory personnel who will be involved with the project. Please indicate the percentage of time each key person will dedicate to this project and how much of their time is dedicated to existing or proposed efforts. iii. Provide a brief description and listing of relevant publications from your laboratory that are related to the scope of work detailed in this RFP. iv. Describe the methodologies, testing procedures, reagents and instrumentation that will be used in this project to satisfy the study objectives and reporting requirements of this study. Describe sampling handling and data analysis workflow. Describe procedures to monitor, qualify and validate kits, the quality of the reagents and instrumentation used. Describe your Laboratory s current use of quality control materials and quality assurance measures related to the specific assays detailed in the scope of work for this study. v. While not a definitive requirement, please provide copies of any laboratory certifications, accreditations, and any federal, state or local licenses related to this scope of work. If available, provide evidence for participation in any laboratory proficiency programs related to the scope of work of this study. vi. Provide dates and description of the Laboratory s designated holiday schedule during the projected period of performance. 2. Preparation of the Business Response. The Business Response must contain the following information: a. Completed Business Information Sheet (Attachment 1): i. Only one Principal Investigator can be named. The Principal Investigator named will be the person cited in any resulting agreement. This person will have responsibility to fulfill the scope of work of the agreement. ii. The business contact is the person authorized to conduct negotiations and legally obligate the Laboratory, or to enter into discussions with the NMDP, pending authorization of the business officer, on behalf of the Laboratory. This person will be the NMDP s primary contact for any contractual or business matters regarding this RFP and any resultant agreement. iii. Indicate the authorized business officer who will sign any resultant agreement. This is the person authorized to obligate the Laboratory, usually someone in the Business, Finance, or Contracts office. Page 12 of 14

13 B. Terms b. Completed Price Sheet. The response must be in the format provided in Attachment 4. In addition, in reply to this RFP, the Laboratory may be required to supply additional supporting documentation for the prices submitted. If additional information is requested, the NMDP will specify the nature and the form of the supporting documentation. c. Alternative pricing may be considered, which the NMDP reserves the right to accept or reject, in whole or in part. d. Business documentation including: i. Completed and signed Substitute W-9 form and Business Classification form (Attachment 2) ii. Signed Certifications Regarding Debarment & Lobbying (Attachment 3) 3. Required Copies a. One (1) original of the entire proposal comprised of the Technical Response and Business Response, containing the forms indicated in IV.A.2.b. and d. above. (marked ORIGINAL) b. Two (2) complete copies of the Business Response, containing the forms indicated in IV.A.2.b. and d. above (marked COPY). c. Four (4) complete copies of the Technical Response (marked COPY). 4. Procurement Notices a. Any resultant award will be subject to the availability of funds within the Network. The final decision to fund this effort, in whole or in part, is solely that of the NMDP in conjunction with the Network. Any such decision is not subject to dispute. b. The term of the award shall commence approximately January 2011 and may continue and remain in effect for approximately 4 years, or upon notice of termination, whichever would be first. c. All responses must remain valid for at least one hundred eighty (180) days. This effort is part of a multi-center clinical trial consortium funded by the National Institutes of Health. Additional terms provided with the award reflect requirements of a multi-center clinical trial. By submitting this proposal the Laboratory agrees it will comply with the Publication language of the BMT CTN ( BMT CTN Administrative MOP, Chapter 8 ). Refer to for further information. Page 13 of 14

14 SECTION VI EVALUATION FOR AWARD A. Response Evaluation The NMDP will evaluate the Laboratory s ability to meet the specifications in described in Section III (Scope of Work). The NMDP, in collaboration with the Network, will: 1. Review the Formal Response to assess value to the Network, and determine the potential Laboratory s overall reliability and ability to perform the contemplated contract. 2. Seek clarifications or reject all or a portion of the proposal. 3. Issue an award to a Laboratory based on the criteria outlined in Sections III and IV. B. Award The NMDP may issue a contractual agreement without discussion to a Laboratory whose offer provides the best value to the Network technical, price and other factors considered. The NMDP may or may not provide you with an opportunity to revise or improve your offer or to provide a best and final offer prior to award of any Agreement. As such, your original proposal should present your best response to this request. As a condition of submission of a proposal, you agree to participate in such negotiations in good faith with the goal of entering into an agreement under terms and conditions conducive for the completion of the objectives, deliverables and requirements in this RFP as outlined herein. Page 14 of 14