Attachment-1-SMARTT_Biologics_Additional_Information.pdf

NHLBI SMARTT Attachment 1 Biologics Production Facility

Attachment 1 Additional Information Specific to Solicitation NHLBI-HV-10-12

• Section B - Brief Description of Supplies or Services Page 2

• Section C - Statement of Work and Reporting Requirements Page 2

• Section F – Deliveries or Performance Page 5

• Section L - Additional technical proposal instructions Page 6

a. General Description of the Program and Desired Results

b. Background Information

c. SMARTT Committees

d. Estimated Level of Effort

e. Page and Formatting Limitations

f. Technical Proposal Table of Contents

g. Travel

h. Offerors Must Address

i. Constraints

• Section L - Additional business proposal instructions Page 12

a. Business Proposal Table of Contents

b. Cost Proposal Excel Workbook

c. Performance Based Acquisition

• Section M - Evaluation Factors for Award Page 12

• Packaging and Delivery of Proposal Page 15

• Proposal Intent Response Sheet Page 16

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The contractor will support the Science Moving towArds Research Translation and Therapy (SMARTT) program for the production and testing of novel therapeutics to treat heart, lung, and blood diseases. The Biologics Production Facility (PF) will support translational research and provide services as a US FDA-defined current good manufacturing practice (cGMP) production facility for biological therapy products. The Biologics PF will evaluate and prioritize requests for service based on their ability to fulfill the requests.

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall furnish the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Statement of Work below.

b. The Contractor shall deliver the items specified in the deliverables section to the destinations indicated.

c. The Program schedule is estimated to be as follows:

• Planning Phase for twelve (12) months beginning 2010

• Accepting service and manufacturing requests for fifty-six (56) months

• Closeout and termination of service agreements for four (4) months

Detailed Description of Duties for the Production Facility (PF) for Biologic Therapeutics

The Contractor shall serve as a Production Facility (PF) for the SMARTT Program. The PF shall perform the following specific tasks and activities working cooperatively with others to coordinate study activities among the other Facilities, the SMARTT CC, and NHLBI.

Phase I – 12 months

1. Participate as a member of the SMARTT Steering Committee (SC), and subcommittees as necessary, which will provide overall guidance for SMARTT to achieve program objectives. Attend SC meetings and participate in teleconferences as needed.

2. Contribute to the design and content of the CC’s manual of procedures (MOP) to describe the methodologies to be employed and new methodologies developed. The MOP shall conform to US FDA cGMP guidelines as well as Good Laboratory Practices (GLP) guidelines and include procedures for production of biological therapeutics.

Provide copies of the Biologics PF portion of the MOP, and any amendments thereto, as described in Article F.1.

3. Contribute to the design and content of the CC’s customer satisfaction survey for investigators to evaluate the quality, acceptability, and timeliness of the products and services provided.

4. Contribute to the design and content of the CC’s public and private websites and the electronic database of all orders for biologics production.

5. Work with the SC to develop procedures for evaluating, prioritizing and processing requests for service.

6. Contribute to the design and content of the CC’s marketing plan to advertise and promote the use of SMARTT program and services.

7. Work with NHLBI and the CC to develop Material Transfer Agreements (MTA) for use between the PF and the research investigator’s institution.

Phase II – 60 months

1. Provide services as a US FDA-defined current good manufacturing practice (cGMP) production facility for biological therapy products.

2. Process, analyze, store, and ship products produced.

3. Provide investigators with translational support or biological therapy products as requested.

4. Evaluate and report to the CC the feasibility of, and approximate time required to fulfill, each Request for Services Application (RSA) from investigators.

5. Work with the CC to implement procedures for evaluating, prioritizing and processing

RSAs.

6. Collaborate with the CC to contribute manufactured product data to its electronic databases and web sites. Submit data as defined and called for in the MOP.

7. Implement and maintain quality control and quality assurance plans for all biologics products requested.

8. Design and implement monitoring plans for products including production and compliance with regulatory requirements. Maintain and make available for review, as necessary, records of monitoring activities.

9. Provide reports as described in Article C.2. Make available, for site visits, documents and data to support these reports, as requested by the CC.

10. Participate in yearly site visits to be conducted by the CC.

11. Maintain a laboratory that meets all requirements for the production of research grade and clinical grade reagents.

12. Comply with all relevant Office of Human Research Protections (OHRP) and Office of

Laboratory Animal Welfare (OLAW) regulations.

13. For each manufactured product, the PF shall:

I. Provide complete protocol information, including quality control and quality assurance procedures, in accordance with the MOP.

II. Prepare archival samples from each lot manufactured.

14. Establish and implement a plan to work with institutional technical transfer offices to facilitate the completion of material transfer agreements and contracts required to ship materials from one institution to another.

15. Participate as a member of the SMARTT SC and, as necessary, in teleconferences and meetings with investigators requesting services.

16. Provide the CC with updates to the Biologics PF portion of the MOP.

17. Work with the CC to advertise and promote the use of SMARTT program and services.

18. Establish and maintain working relationships with relevant NIH/NHLBI programs.

Collaborate with other NIH/NHLBI programs to provide tailored assistance to SMARTT investigators and investigators submitting applications to the NHLBI SMARTT program to assist with the development of a comprehensive strategy to develop their specific product or application.

19. Collaborate with other NIH and non-NIH groups to establish standardized terminology to document and report translational research on biological therapies produced by the SMARTT program and other NHLBI funded programs. The SMARTT program shall engage the services of Clinical and Translational Science Awards (CTSA) programs whenever possible. The CTSA programs are charged with reducing the time it takes for laboratory discoveries to become treatments for patients, engaging communities in clinical research efforts, and training the next generation of clinical and translational researchers. More information is available at http://www.ctsaweb.org/.

20. Work with the CC, NHLBI, and SMARTT investigators to achieve orderly closeout and termination of service agreements during the final months of the contract.

ARTICLE C.2. REPORTING REQUIREMENTS

In addition to those reports required by other terms of the contract, the contractor shall prepare and submit the following reports in the manner stated below and in accordance with ARTICLE F.1. DELIVERABLES of this contract. Unless otherwise specified all deliverables shall be provided on a CD and two paper copies.

a. Manual of Procedures: The Manual of Procedures is to include all elements identified in

ARTICLE C.1. Phase 1 above and all amendments thereto.

b. Semi-annual technical reports: The semi-annual technical reports, in a narrative form, shall be concise and informational. They shall include but not be limited to: a cover page which includes the contractor=s name and address, the contract number, the name of the Principal Investigator; a description of overall progress, current problems which may impede performance, and proposed corrective actions; and activities planned for the next reporting period. Specific biological production and translational service information shall be in tabular format and include the following: the name of the requesting investigator, the grant number (if applicable), the name of the project, the procedures adopted, information on quality control and quality assurance methods, lot numbers, and date of completed testing. The report shall also address administrative matters and staffing changes. A semi-annual technical report will not be due when the final report is due.

c. Final technical report: The final report shall identify all biological production and other activities conducted during the performance of the contract. The report shall include an integrated summary of completed services to support the safety of any proposed clinical investigation.

d. Biologics Production and Services Database: The contractor shall provide all relevant data and results generated for biologics therapeutics to a database maintained by the

CC.

SECTION F – DELIVERIES OR PEFORMANCE

ARTICLE F.1. DELIVERIES

Satisfactory performance of the contract shall be deemed to occur upon performance of the work described in ARTICLE C.1. and upon delivery and acceptance by the Contracting Officer, or the duly authorized representative, of the following items in accordance with the stated delivery schedule.

A. The items specified below, as described in SECTION C, ARTICLE C.2., will be required to be delivered F.O.B. Destination as set forth in FAR 52.247-35, F.O.B. Destination, within Consignees Premises (APRIL 1984), and in accordance with and by the date(s) specified below:

Item Description Quantity Delivery Schedule A. Manual of Procedures 1 to Coordinating Center

1 to Steering Committee Members 1 to Project Officer 1 to Contracting Officer

Within six months of contract award

B. Production Facility Data in accordance with Item #13 of SOW

1 to Coordinating Center 1 to Project Officer

In accordance with MOP

C. Semi-Annual Technical Progress Reports

1 to Contracting Officer 1 to Project Officer

Semi-Annually beginning at 6 months after award of the contract

D. Biologic Product or Associated Service

Research Investigators In accordance with MOP

E. Final Technical Report 1 to Project Officer 1 to Contracting Officer

On or before contract expiration

F. Annual Invention Report 1 to Contracting Officer In accordance with Article C.3.

G. Information Security Reporting 1 to Contracting Officer In accordance with Article C.2.

H. Multiple Principle Investigators Leadership Plan

1 to Project Officer 1 to Contracting Officer

In accordance with Article C.2.

Copies of deliverables shall be sent to the following addresses:

Addressee: Item Quantity Project Officer National Heart, Lung, and Blood Institute A-C 1 Division of Blood Diseases and Resources E 1 Rockledge 2 Building, Room 9030 H 1 6701 Rockledge Drive, MSC 7950 Bethesda, MD 20892-7950

Contracting Officer National Heart, Lung, and Blood Institute A 1 Office of Acquisitions C 1 Rockledge 2 Building, Room 6016 E-H 1 6701 Rockledge Drive, MSC 7902 Bethesda, MD 20892-7902

Coordinating Center A-B 1 (To be identified)

Research Investigators D 1 (To be identified)

Steering Committee Members A 1 (To be identified)

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

ADDITIONAL TECHNICAL PROPOSAL INSTRUCTIONS

a. General Description of the Program and Desired Results

The National Heart, Lung, and Blood Institute (NHLBI) is planning to support a Science Moving towArds Research Translation and Therapy (SMARTT) program for the production and testing of novel therapeutics to treat heart, lung, and blood diseases. This program will serve NHLBI investigators and will consist of: 1) a Production Facility (PF) for biologics; 2) a PF for non-biologics and small molecules; 3) a Pharmacology & Toxicology Center (PTC); and 4) a Coordinating Center (CC). SMARTT will provide consulting, manufacturing, pharmacology and toxicology testing, preclinical and early phase clinical study design support, and administrative and regulatory expertise. The CC will be the monitor and coordinator for organizational and regulatory aspects of the SMARTT Program. The PTC will be established to conduct pharmacology and toxicology testing of potential biologic, non-biologic, and small molecule therapeutics. The PFs will support translational research. These PFs will evaluate and prioritize requests for service based on their ability to fulfill the request. The biologic, non-biologic and small molecule products are primarily intended for clinical use within the United States. Products may be released by the PF for clinical use only under an Investigational New Drug (IND) issued by the US Food and Drug Administration (FDA).

Note: Production Facility (PF) and Facility are used interchangeably throughout the Statement of Work.

b. Background Information

The SMARTT program is designed to assist translation to the clinic of novel synthetic, natural, or biologic therapeutic interventions arising in the scientific community for the treatment of heart, lung, and blood diseases.

There are novel ideas and candidate molecules in the scientific community that deserve clinical testing. SMARTT will help Institutions bridge the gap between discovery and clinical testing, so that efficient translation of promising discoveries may take place. The major goal of SMARTT is to facilitate the movement of novel molecules and concepts from the laboratory to the clinic for proof-of principle clinical trials.

SMARTT is not a grant mechanism. Approved applications to SMARTT gain access to the drug development contract resources of the NHLBI. The output of these resources is provided to the originating investigator, and may include Good Manufacturing Practices (GMP) synthesized material, formulation research, pharmacological methods, or IND-directed toxicology, for support of an investigator-held IND application and clinical trials. SMARTT does not sponsor clinical trials.

c. SMARTT Committees

SMARTT Steering Committee (SC) will guide the development and oversee the operations of the SMARTT program. The SC Chair will be an investigator that is not directly associated with any of the SMARTT contracts. Each of the four SMARTT contracts, Coordinating Center, Biologics Production Facility, Non-biologics Production Facility, and Pharmacology and Toxicology Center, will have 3 representatives on the SC. The committee will consist of 13 members plus representatives from NHLBI. The SC will meet three times in year one and twice per year in years 2 to 6. The CC will provide administrative and logistics support for the SC meetings and the CC will prepare meeting minutes. The CC will arrange and coordinate SC teleconferences, which will be held as needed and average less than four per month. Travel costs should be included in each budget for the SC meetings.

SMARTT Program Evaluation Panel (PEP) The NHLBI will establish a five member external Program Evaluation Panel to evaluate the goals and progress of the SMARTT program. The overall objective of the PEP will be to determine if the SMARTT program is meeting the needs of the scientific community and if so, how effectively. The CC will assist the NHLBI Project Officers with the selection and invitation of the PEP. The PEP will meet once a year in Bethesda, MD. The CC will develop metrics in collaboration with the PEP, SC and NHLBI to track and monitor program progress including, but not limited to, the timeliness and quality of services and success in meeting program goals. The CC will prepare potential metrics for discussion at the first steering committee meeting and shall collaborate with the Steering Committee to finalize the metrics within 6 months of contract initiation. The metrics will be included in the MOP and revised as needed throughout the contract period. The CC Principal Investigator will be required to attend one PEP meeting per year. The CC will provide administrative and logistic support for the PEP meetings. The CC will prepare minutes from open sessions and coordinate and pay for PEP members travel and an honorarium of $200 per day for each PEP members’ attendance.

SMARTT Scientific Review Board (SRB) The NHLBI will identify scientists who will be able to provide a merit evaluation of the Requests for Services Applications (RSA). These scientists will form the SRB from which 3 members will be selected to submit an electronic review for each

RSA. The CC will prepare and send the invitations to SRB members. The CC will develop the RSA review process which will include the electronic distribution of applications and evaluations.

The CC will coordinate and conduct all interactions with the SRB regarding the review of RSAs and provide an honorarium of $200 per day to each reviewer. Approximately 70 RSAs will be reviewed during the 6 year program.

d. Estimated Level of Effort

Principal Investigator 25% effort Co-Investigators (up to 4) 40% effort total Project Director 100% Technologists (up to 4) 120% effort total (includes QA/QC personnel) Regulatory Staff 15% Contract/Material Transfer Expert 10% Administrative Assistant 40%

PI and Project Director are key personnel. Project Director should have technical and administrative knowledge and will be the primary liaison between the PF and the CC.

e. Page and Formatting Limitations

The Technical Plan (objectives, approach, methods and schedule) of the technical proposal shall not exceed 30 single-sided pages or 15 double-sided pages. This page limitation does not include the cover sheet, abstract, table of contents, personnel, facilities, equipment and resources, other considerations, schedule, other support, cost information, and literature cited.

Appendices shall not exceed a total of 50 single-sided pages or 25 double-sided pages. Pages in excess of the limitation will be deleted and will be neither read nor evaluated. Each page of the technical proposal must be numbered sequentially. Offerors are encouraged to limit the overall size of the technical proposal, inclusive of appendices, attachments, etc. Although no page limit has been placed on the business proposal, offerors are encouraged to limit its content to only those documents necessary to provide adequate support for the proposed costs.

Type density and size must be 10 to 12 points. If constant spacing is used, 15 cpi (characters per inch) or fewer shall be used, whereas proportional spacing should provide an average of no more than 15 cpi. There must be no more than six lines of text within a vertical inch. Margins must be no less than ½ inch around, exclusive of headers and footers.

f. Technical Proposal Table of Contents

Sample Technical Proposal Table of Contents

1. Cover Page Page 1 Cover page should include: RFP Title and Number, Name of Organization, Name of Principal Investigator, Address, and Telephone Number.

2. Table of Contents Page 2

3. Abstract/Project Objectives Page 3

4. Technical Plan/Statement of Work Page 4—#

The Technical Plan shall not exceed 30 single-sided pages or 15 double-sided pages. Pages in excess of the limitation will be deleted and will be neither read nor evaluated.

(1) Objectives – Goals and Specific Aims Page #

(2) Approach – Component Goals and Interactions Page #

(3) Methods – Technologies, Methodologies, Approaches, Applications Page #

(4) Schedule – Milestones and Benchmarks Page #

5. Personnel

(1) List of All Personnel in the Project Including Subcontractors, Consultants/ collaborators, by Name, Title, Department and Organization Page #

(2) Provide narrative for Principal Investigator/Project Director, Other Page #

Investigators and staff of expertise and qualifications

(3) Other Staff (Regulatory Staff, Technologist,…) Page # [Note: Include a resume/CV/biosketch for PI and co-investigators in the Appendices]

6. Facilities, Equipment, and Other Resources Page # Describe all facilities, equipment and other resources available for this project.

7. Summary of Related Activities Page #

8. Technical Proposal Cost Summary Page #

9. Animal Models Page #

See Instructions to Offerors, Technical Proposal Instructions.

10. Information Security Plan (if applicable) Page #

11. Appendices Page # Appendices shall not exceed a total of 50 single-sided pages or 25 double-sided pages.

g. Travel

The CC will plan, obtain meeting rooms, coordinate and make arrangements, and provide support for study meetings.

Steering Committee Meetings:

During Phase I, the Biologics PF Principal Investigator (PI), one Co-Investigator, and the Project Director will attend three meetings of the Steering Committee (SC). These meetings will take place in Bethesda, MD and each will last one day.

During Phase II, the Biologics PF PI, one Co-Investigator, and the Project Director will attend two SC meetings per year. These meetings will take place in Bethesda, MD and each will last one day.

Program Evaluation Panel (PEP) Meetings:

The PEP will meet one time per year in Bethesda, MD. The CC PI will attend each PEP meeting. The CC will be responsible for reimbursing the PEP members for travel expenses and an honorarium of $200 per day for each PEP meeting attended.

Site Visits:

The CC will conduct three site visits per year, one to each of the PFs and one to the PTC, to audit program and regulatory compliance. The PFs and the PTC should assume that two site visits per year to requesting investigator labs will be necessary for troubleshooting purposes.

For proposal purposes, assume that the site visits will be conducted in Chicago, IL.

h. Offerors Must Address:

1. Provide the names, degrees, training, qualifications, experience, role in project, and effort for each individual named in the offeror’s proposal and proposed subcontract(s).

2. Provide evidence of an established biologics production facility infrastructure, including types and quantities of products produced. Identify specific studies that have been performed, how quality control was ensured and monitored, and the costs associated with the performance of each study. Provide evidence of the performance of clinical studies performed under an IND issued by the US FDA. This information shall also be provided for all proposed subcontractor(s).

3. Provide evidence of previous translational study support for biological therapy products.

4. The SMARTT program will be customer-driven. Provide evidence of interactions with customers and satisfactory production of biologics for outside customers.

Note to Offeror: Since there is no way to determine the types of requests that the SMARTT program will receive, each PF must document its breadth of expertise in supporting biological therapy translational studies and in the manufacture and scale-up of biological therapy products. After an investigator’s request is deemed feasible, the SMARTT PF will work in close partnership with the investigator to complete the desired milestones. This will involve iteration of discussions and possible site visits to determine the course of work required for the specific biological therapy product. The PF must be willing to have frank discussions with requesting investigators to establish reasonable milestones and timelines and to determine when a project should be re-evaluated and ended.

5. Using the examples in item 6. below as appropriate, identify the types of biological production services and translational services that could be provided. Document previous experience providing similar services.

6. Using the examples below, provide approximate cost information, including shipping and handling in the cost of service estimates, for each type of translational service that could be offered (include the cost information in the business proposal). Provide projections for how many types of these services a PF would expect to receive for a five year period (include this information in the technical proposal).

Examples of translational services that may be requested of the SMARTT program are provided below. These examples are provided to illustrate the breadth of the required expertise for PFs and are not meant to be a comprehensive listing of the various requests SMARTT may receive.

• Acquisition of bulk substance (GMP and non-GMP)

• Scale-up production from lab-scale to clinical-trials lot scale

• Development of suitable formulations

• Development of analytical methods for bulk substances

• Production of dosage forms

• Stability assurance of dosage forms

• Quality control and quality assurance testing

• Screening of candidate molecules for performance characteristics

• Assay development

Note to Offeror: SMARTT PFs will not be expected to produce cells or gene therapy products as these are covered under other contracts. SMARTT PFs for biologics will not be expected to produce non biologics and small molecules that are covered under the contract for SMARTT PFs for non-biologics and small molecules (NHLBI-HV-10-13).

7. Document previous monitoring plans for products manufactured and demonstrate past interactions with the US FDA regarding biological therapy products.

8. Describe in detail the administrative structure of the proposed PF including the offeror and proposed subcontractor(s).

9. Propose detailed plans for the preparation and submission of reports about services performed. Describe computer system capabilities to interface with other databases.

10. Describe experience working with other organizations and the FDA. Describe plans to interact with the CC, NHLBI, the investigators, and the FDA.

11. Describe practices, equipment, and facilities that ensure safety of all personnel directly or indirectly involved in production of biologics.

12. Provide evidence of institutional commitment for this program.

13. Describe previous experience and plans to work with institutional technical transfer offices to facilitate the completion of material transfer agreements and contracts required to ship materials from one institution to another.

14. Provide any other information needed to allow reviewers to judge the capability of the offeror and proposed subcontractor to accomplish the Statement of Work.

Note to Offeror: Requests for SMARTT services and products will come from institutions across the US. An important legal and regulatory aspect of the SMARTT program is the transfer of a material from one institution to another. Liability and indemnification are concerns when a therapy is produced in one place and infused in another place. Academic institutions have varying levels of insurance; therefore, they are not able to provide complete liability to investigators who are manufacturing biological therapy products. The receiving institution must be informed of the nature of the product being transferred and be willing to accept the associated liability. The NHLBI and the SMARTT CC will work with the PF to write Material Transfer Agreements (MTAs) that will be acceptable to the offeror’s institution and the customer’s institution. However, it is essential that the offerors involve the appropriate institutional personnel in this process since each MTA will require signatures from institutional representatives.

i. Constraints

The risks in manufacturing therapeutic molecules as an IND governed by the US FDA are related to the uncertainty of the production process. Depending upon the availability and nature of the source material, there could be delays related to the consistency of lot-to-lot production.

There may also be delays related to the time it requires to answer concerns and questions from the FDA as the manufacturing and testing process is being finalized. The SMARTT program plans to minimize these potential delays and risks by placing timelines and milestones with decision points on each service request. If the pre-specified amount of progress has not occurred at each decision point, then the project will not proceed and resources will not be allocated.

ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS

a. Sample Business Proposal Table of Contents

1. Proposal Summary and Data Record, NIH-2043 ....................................Page 1

2. Offeror's Points of Contact ......................................................................Page 2

3. Breakdown of Proposed Estimated Costs (Excel Workbook) .................Page 3

4. A written justification of each cost element proposed ..........................Page #-#

5. Certificate of Current Cost or Pricing Data ……………………………...Page #-#

6. Disclosure of Lobbying Activities, OMB Form SF-LLL ..........................Page #-#

7. Qualifications of the Offeror..................................................................Page #-#

a. General Experience

b. Organizational Experience Related to the RFP

c. Performance History

d. Pertinent Contracts

e. Pertinent Grants

8. Extent of Small Disadvantaged Business Participation.........................Page #-# (See Instructions to Offerors, General Instructions)

9. Other Administrative Data.....................................................................Page #-#

10. Representations & Certifications...........................................................Page #-#

11. Small Business Subcontracting….………………………………………..Page #-#

12. Annual Financial Report……………………………………...…………….Page #-#

13. Travel Policy…………………………………………………………………Page #-#

b. A detailed cost breakdown shall be submitted using the Excel workbook posted with this solicitation.

c. Performance-Based Acquisition - If it is determined during the negotiation process that objective, measurable performance requirements, performance standards, and quality assurance measures can be identified, then performance-based acquisition will be utilized.

If this is determined to be a performance-based acquisition, then offerors will be required to submit a quality assurance surveillance plan.

SECTION M - EVALUATION FACTORS FOR AWARD

GENERAL

Selection of a contractor for contract award will be based on evaluation of proposals against the following factors in order of importance: technical (which encompasses experience),cost, past performance), and Small Disadvantaged Business (SDB) participation. The technical proposal will receive paramount consideration in the selection of the contractor for this solicitation.

Evaluation of SDB participation will be performed only on those offers being considered for award. SDB participation will not be scored, but the Government’s conclusions about overall commitment and realism of the offeror’s SDB Participation Plan will be considered in determining the relative merits of the offeror’s proposal. All evaluation factors other than cost/price when combined are significantly more important than cost/price. The Government reserves the right to utilize the trade-off process described in FAR 15.101-1. This process permits tradeoffs among cost/price and non-cost factors and allows the Government to consider award to other than the lowest priced or highest technically rated proposal. In any event, the Government reserves the right to make an award to that offeror whose proposal provides the best value to the Government.

The evaluation will be based on the demonstrated capabilities of offerors in relation to the needs of the project as set forth in the RFP. The merits of each proposal will be evaluated carefully.

Each proposal must document the feasibility of successful implementation of the requirements of the RFP. Offerors must submit information sufficient to evaluate their proposals based on the detailed evaluation criteria/factors listed below.

TECHNICAL EVALUATION CRITERIA - Production Facility The evaluation criteria are used by the Technical Evaluation Panel when reviewing the technical proposals. The criteria below are listed in relative importance with weights assigned for evaluation purposes.

SCIENTIFIC AND TECHNICAL

APPROACH.........................................................................................40 Points A technical plan of merit within the context of the goals of the SMARTT program including documentation of the production of research and clinical grade biological products, the suitability of the quality control and quality assurance plans. Offerors’ previous experience in providing research and clinical grade biological products for specific requests from investigators and the performance of US FDA IND directed studies. Including how requests were evaluated, associated cost information, and information on shipping validation. Examples of translational services offered such as assistance with animal models or assay development.

PERSONNEL.......................................................................................20 Points Documented training, experience, expertise, and availability of the Principal Investigator for planning and directing the proposed production facility. Adequate plans describing the synergy of the proposed team. Documented training, experience, and availability of all personnel in conducting the proposed services.

SCIENTIFIC LEADERSHIP…………………………………………………20 Points Demonstrated experience in scientific leadership and collaboration necessary for the manufacture of biological products. Demonstrated ability to recruit and engage scientific expertise in the areas of heart, lung, and blood diseases as required by products or services requested. Evidence of successful participation in the provision of clinical grade biological products for Phase I/II clinical trials.

FACILITIES.......................................................................... .................20 Points Adequacy of the organizational structure of the production facility. Availability and adequacy of the facilities and resources necessary to meet the objective of the proposed biologics production facility, including institutional commitment to the SMARTT program. Adequacy of existing facility with regard to US FDA accreditation and certification as a cGMP production facility.

OTHER EVALUATION CRITERIA

Cost – An analysis of the offeror’s cost proposal will be conducted as part of the evaluation to determine whether costs are realistic, complete and reasonable.

Past Performance – Past performance will be evaluated based on one or more sources of information including but not limited to information contained in various Government databases or other sources. The evaluation will be performed only on those offerors being considered for award and will consider the extent of the offeror’s ability to meet project quality, performance, and schedule, and will consider noted concerns and areas of improvement.

SDB - Offerors will be required to submit a Small Disadvantaged Business (SDB) Participation Plan as part of their business proposal. Evaluation of the SDB Plan will be performed by the Contracting Officer only on those offerors being considered for award. The evaluation will be made based on a consideration of all relevant facts and circumstances. It will not be based on absolute standards of acceptable performance.

Evaluation of SDB participation will be assessed based on consideration of the information presented in the offeror's proposal. The Government is seeking to determine whether the offeror has demonstrated a commitment to use SDB concerns for the work that it intends to perform.

Offers will be evaluated on the following sub-factors:

a. Extent to which SDB concerns are specifically identified

b. Extent of commitment to use SDB concerns

c. Complexity and variety of the work SDB concerns are to perform

d. Realism of the proposal

e. Past performance of offerors in complying with subcontracting plan goals for SDB concerns and monetary targets for SDB participation

f. Extent of participation of SDB concerns in terms of the value of the total acquisition.

ADDITIONAL PROPOSAL INSTRUCTIONS

Packaging and Delivery of Proposal:

DUE DATE: 4:00 p.m. local time on November 6, 2009

Proposals not received at the place and time specified in the solicitation will be considered late and will be handled in accordance with HHSAR clause 352.215-70. Your proposal shall be organized as specified in Section L.2., "Instructions to Offerors".

Shipment and marking shall be as indicated below.

EXTERNAL PACKAGE MARKING: In addition to the address cited below, mark each package as follows:

"RFP NO. NHLBI-HV-10-12, NHLBI SMARTT Biologics Production Facility, TO BE

OPENED BY AUTHORIZED GOVERNMENT PERSONNEL ONLY"

NUMBER OF COPIES:

Technical Proposal: Original and Thirty-Five (35) Copies Business Proposal: Original and Five (5) Copies Technical & Business Proposal: Two (2) electronic copies as a text-readable PDF file on CD

IF HAND-DELIVERED:

Review Branch, Division of Extramural Research Activities National Heart, Lung, and Blood Institute Rockledge 2, Room 7195

6701 ROCKLEDGE DR MSC 7924

BETHESDA, MD 20817

IF USING U.S. POSTAL SERVICE:

Review Branch, Division of Extramural Research Activities National Heart, Lung, and Blood Institute Rockledge 2, Room 7195

6701 ROCKLEDGE DR MSC 7924

BETHESDA, MD 20892-7924

*THE ORIGINALS MUST BE READILY ACCESSIBLE FOR DATE STAMPING PURPOSES.

PROPOSAL INTENT RESPONSE SHEET

RFP No.: NHLBI-HV-10-12

TITLE OF RFP: NHLBI SMARTT Biologics Production Facility

If you intend to submit a proposal, please furnish the information requested below and return this page by October 12, 2009. Your expression of intent is not binding but will assist us in planning for proposal evaluation.

COMPANY/INSTITUTION NAME:

ADDRESS:

TELEPHONE NUMBER:

E-MAIL ADDRESS:

PROPOSED STAFF

Please provide the following for each proposed key personnel for the project:

Name (Last, First, MI)

Title Proposed Role on the Project

COLLABORATING INSTITUTIONS AND INVESTIGATORS:

Please provide the following for each proposed subcontractor or consultant:

Name (Last, First, MI)

Title Institution Name Proposed Role on the Project

Please fax or mail to:

Review Branch National Institutes of Health, NHLBI Attention: Valerie Prenger 6701 Rockledge Drive, MSC 7924 Bethesda, MD 20892-7924

FAX (301) 480-0730