FFMN.PreProposal.Slides.pdf

ASPR: Resilient People. Healthy Communities. A Nation Prepared. 1

• Welcome

• Background

• Solicitation Overview

• Technical Overview

• RFP Key Sections and Elements

• Responses to Submitted Questions

• Solicitation Timeline/Next Steps

• Closing

Agenda

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HHS continues to make investments in vaccine technologies to reduce the time needed to create a vaccine.

However, the formulation, filling and finishing of bulk vaccine into final product for distribution remains a constraining step and response vulnerability.

The “difficulty […] filling and finishing enough vaccine that could be broadly available before the virus had spread widely is an important reminder of the unmet need for this capacity […]” *.

Lengthy delays could have had dire consequences during a more lethal event . The development of a FFMN forwards the BARDA mission of making countermeasures available for response to public health emergencies .

Background

* HHS/ASPR, “The Public Health Emergency Medical Countermeasures Enterprise Review”, August 2010.

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The August 2010 publication reported that “Current vaccine manufacturers lack the capacity to rapidly “fill and finish” sufficient quantities of pandemic vaccine for the Nation. HHS should immediately develop a network of existing facilities that are pre-qualified and under contract to fill and finish vaccine for U.S. Government-contracted vaccine manufacturers in a public health emergency.

This proposed additional infrastructure for influenza could also provide needed capacity for other MCM products.”

Background

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Background

The FFMN could support :

• Additional products being developed through the Centers of Innovation in Advanced Development and Manufacturing

(CIADM).

• Emerging influenza-focused or CBRN pharmaceutical companies who do not have fill finish capabilities already in-house

• Remediation of drug shortage situations of national consequence.

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• HHS/ASPR/BARDA is leading the initiative to establish the HHS-sponsored Fill Finish Manufacturing Network facilities

• Full and open competition

• Period of Performance = 10 years

• FFMN will be an Indefinite Delivery Indefinite Quantity (IDIQ) Contract with both Cost Reimbursable and Firm Fixed Price (FFP) CLINs.

• The USG shall provide 100% of the total funding for US directed activities except for CLIN 0001.

• USG may issue multiple awards.

• All updates, amendments, etc. will be available online at www.fedbizopps.gov.

FFMN Solicitation Key Elements

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Mandatory Criteria:

1. US Based filling facility

Demonstrate written evidence that the Offeror has unencumbered access to a US based filling facility which will be proposed for this solicitation and will be used for the duration of the contract.

2. Written evidence the Offeror has filled a FDA licensed /approved sterile product within the last two years at the facility being proposed:

Written evidence the Offeror has filled a FDA licensed/approved sterile product within the last two years at the facility being proposed;

or is a Bulk vaccine manufacturer who has manufactured an FDA licensed influenza vaccine, and has a partnership with a fill finish company who has filled an FDA licensed/approved sterile product within the last two years in the US-based facility being proposed for this solicitation (provide written evidence).

Fill Finish Manufacturing Network

(FFMN)

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Mandatory Criteria:

3. Written capability statement for pandemic influenza vaccine production. The Offeror shall provide a written capability statement for pandemic influenza vaccine fill and finishing.

The statement shall describe the current capacity and proposed additional capacity anticipated to be augmented, if resources are needed as part of this solicitation. The statement should include number of doses (10-dose multi dose vials), time frame required, and level of effort (additional resources) required to fulfill the additional doses. For the purposes of this solicitation, the maximum time frame to provide released doses is 12 weeks.

Fill Finish Manufacturing Network

(FFMN)

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• I: Augment Current US-based Fill and Finish Capacity ─ Fulfillment of this requirement may include:

• Purchasing of change parts, additional equipment, and minor renovations to supplement and/or re-qualify an existing fill finish facility.

• Purchase of equipment for a new line that includes equipment that is in contact with product is acceptable for this solicitation.

• Examples of acceptable activities may include upgrading and re-qualifying a previously obsolete filling line, replacing equipment such as a 5-head filler with a 10-head filler in order to increase throughput, adding automated inspection to replace a manual inspection process, and purchase of spare parts or dedicated parts in order to reduce changeover time between products.

• Construction of a new facility, a facility addition, or purchase and installation of new critical utilities systems is not within scope of this requirement. Requirement 1 will be fulfilled within the first 3 years of the contract.

Program Requirements (Section C-3)

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• I: Augment Current US-based Fill and Finish Capacity

─ Technology transfer of influenza vaccine candidate into this facility

• Including complete qualification (IQ, OQ, PQ)

• License requirements

• Contractor may pursue their own pandemic influenza candidate partner, or USG may assist with introducing a candidate to the contractor to initiate the agreement process

Program Requirements (Section C-3)

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• II: Provide Filling and Finishing Services Non-Surge ─ Analytical development, scale-up, formulation, filling, finishing, technology transfer from 3rd party biopharmaceutical company(s), process optimization, process validation, labeling, packaging and distribution

─ Both Commercial and Clinical Trial scale lots ─ 2nd influenza vaccine candidate or other MCM products ─ Will be satisfied by USG issued T/DORs.

• III: Provide biopharmaceutical production surge capacity ─ Once a public health emergency has been declared, the Offerors shall provide X number of doses (multi-dose vials) within twelve

(12) weeks of receiving the bulk, based on a USG task order.

Program General Tasks (Section C-3) (cont)

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Delineated Contractor Tasks (Section C-4)

CLIN 0001 - Establish Agreements with License Holder/

Sponsor of influenza vaccine CLIN 0002 - Product Technology Transfer CLIN 0003 - Tech Transfer Reimbursement to the License

Holder/ Sponsor CLIN 0004 - Maintaining a State of Readiness (if applicable) CLIN 0005 - Fill Finish Services CLIN 0006 - Tech Transfer of Alternate Configuration CLIN 0007 - Contract Management CLIN 0008 - Shipping, Distribution and Storage

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• Be certain to read the entire RFP.

• Ask questions on anything that is unclear or requires further clarification.

• Direct written questions to the appropriate individuals.

─ Contracting Officer (CO) and Contract Specialist (CS).

• Three (3) separate required volumes.

─ Mandatory Criteria ─ Technical Proposal ─ Business Proposal

Requests for Proposals Introduction

United States Department of

Health & Human Services Office of the Assistant Secretary for Preparedness and Response

Government RFP’s are “just another Civil Service Test”

Key RFP Sections and Elements

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• Section A ─ Sign your name.

─ Must be signed at completion of “test.” Remember this is an optional test and instructions should be read prior to taking.

• Section B ─ Cost/Price schedule is an important part of the “Business Test.”

─ Refer to Section L for instructions on how to develop these prices and cost.

• Section C ─ Technical “text book” reading.

─ Information, technically, that you will need to read and meet to take and pass the technical test.

Request for Proposals

13-100-SOL-00004

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• Section F ─ Delivery schedule in Section F corresponds to deliverables listed in your “text book” reading courtesy of Section C and price/cost schedule in Section B.

• Section G ─ Instructors.

─ Contracting Officer (CO), Contract Specialist (CS), and

Contracting Officer Representative (COR).

─ Listing of students. (Offeror Key Personnel)

• Section H ─ Advanced and additional readings.

─ Needed to fully understand the context and requirements of the test.

Request for Proposals

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• Section I ─ Legal reading that must be complied with.

• Section J and Section K ─ Objective quizzes that must be completed.

─ Ensure you complete what you need to meet and fulfill the requirements of the “test.”

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• Section L ─ Instructions for the mandatory, technical, oral presentations, past performance, and business portions of the test.

─ It is very important that these instructions are followed.

• Section M ─ The test.

─ Make sure all questions are answered thoroughly, clearly, and unambiguously in a manner that the evaluation team can understand.

United States Department of

Health & Human Services Office of the Assistant Secretary for Preparedness and Response

Except, its open book, so please ask questions!

Remember, this is “just another Civil Service Test”

Questions to RFP due by March 15, 2013

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• RFP issued 2/8/2013

• Pre-Proposal Conference 2/28/2013

• Amendments (potential Q&A’s/RFP changes) various dates

• Final Questions Due 3/15/2013

• Final Q&A Amendment no later than 3/22/2013

• Proposals Due 4/5/2013

Solicitation Timeline: Pre-Submission

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• Oral Presentations/Mandatory Criteria Evaluation

• Technical and Business Evaluation Panels

• Contracting Officer Competitive Range Determination

• Pre-award Debriefing for Offerors not in the competitive range

• Discussions/Negotiations (if necessary)

• Site Visits (if necessary)

• Request and Receive Final Proposal Revisions

• Evaluation of Final Proposal Revisions

• Brief Source Selection Authority

• Award Determination

• Draft Contracts

• Contract Award

• Post-Award Debriefing

Post-Submission Activities

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Closing Remarks