BAA PreProposal Conference 1-11 -Amend 7

Narayan Iyer, PhD Acting Chief, Anthrax Vaccine

HHS/ASPR/BARDA/

CBRN MCM Development BAA 09-34 rPA Special Instructions

Pre-Proposal Conference January 11, 2009

Agenda

1. Welcome and Introductions

2. Overview of BAA Process/

Timeline

3. Answers to Questions submitted

4. Technical and Business

Proposal Expectations/Instructions

5. ARD Contract

Management/Expectations

6. Open discussion

BARDA manages advanced development and procurement programs for vaccines, drugs, therapeutics and diagnostics for CBRN threats and pandemic influenza

Programs are supported by:

Advanced Research and Development Appropriations Project BioShield Special Reserve Fund Pandemic Influenza appropriations

Biomedical Advanced Research and Development Authority (BARDA)

Purpose of the BAA

• Identify innovative and promising technologies for advanced development across CBRN Research Areas of Interest, focusing on Technology Readiness Levels 6 to 7 (Pre-IND-Phase 2) ─ Vaccines (rPA special instructions) ─ Antitoxins and Therapeutics ─ Antimicrobial Drugs ─ Radiological/Nuclear Threat Countermeasures ─ Chemical Threat Countermeasures ─ Clinical Diagnostic Tools

• Accelerate contract awards

• Build a sustainable advanced development program to meet PHEMCE implementation plan goals and mature MCMs for Project BioShield acquisition

BAA Process Flow Chart

Cat II Scientifically & technically sound proposals that may require further development. May be recommended for acceptance subject to funds availability.

Cat III Proposals not technically sound or do not meet agency needs.

Not acceptable for funding.

Cat I Well conceived scientifically & technically sound proposals important to program objectives. Recommended for approval subject to funds availability.

Within 90 days

Within 270 days

BAA Review Time

What is the timing and process for submitting a proposal under the BAA?

Please review Part IV: Proposal Preparation and Submission section on page 19 for further information on review time.

Within 180 days of Full Proposal receipt

Source Selection Notification (pending availability of funds)

Receipt confirmation within 1 week

Within 90 days of Invitation

Stage 2: Full Proposal

Receipt confirmation within 1 week.

Decision within 90 days

AnytimeStage 1: Quad Chart and White Paper

USG ResponseDeadline for Submission

Proposal Stage

Advantages of Submitting White Paper/Quad Chart

• Offerors will have an opportunity to receive valuable feedback from BARDA on their proposal plans & alignment with BARDA’s goals

• Mutual Benefit: Offerors save initial preparation time & develop focused full proposal and BARDA saves time during review cycle.

• The preparation time and cost associated with the submission of a white paper/quad chart are minimal compared to a full proposal.

• Offeror will have an opportunity to resubmit white paper/quad chart again or a proposal after incorporating suggested additional data during the BAA open period.

• Negotiation timeframes will be shortened because the full proposals will be in line with the BARDA mission, therefore, awards will be made sooner.

BAA Process

• Archive of Q&A from previous pre-proposal meetings are located on FedBizOpps (www.fbo.gov)

• Will I get a chance to clarify what was in my proposal?

─ Typically no ─ If invited back for negotiations: yes

• Will BARDA provide feedback on submission?

─ For this BAA, we will send out a letter of notification with

BARDA’s feedback on proposal’s strengths and weaknesses.

• How far should the development plan in the proposal go?

─ Offerors should focus their development plan on a base year with the possibility of continuing development up to 5 years pending availability of funds and achievement of milestones.

Questions and Answers

Responses to questions received on rPA Special Instructions Mod 6

Technical Questions and Answers (Qs&As)

• Question 1: Is it advisable for the Offerors to prepare a single full proposal covering both GUP (<5 doses) and PEP use (<3 doses) or to apply for each indication in separate full proposals? Should the Offerors submit separate pre-proposals?

─ For proposals under this BAA-09-34 special instructions a single proposal should be prepared. Please review the amendment 6 (rPA special instructions) and Part II of the BAA for the Research and Technical Objectives. The development path of candidate product should focus on Licensure first for GUP in adults and develop plans / execute work (if part of the approved SOW) towards pre-licensure utilization (EUA).

Qs&As Cont.,

• Question 2: Can the dosing schedule and / or strength be different for GUP (<5 doses) and PEP use (<3 doses)?

─ It is anticipated, but not required, that the vaccine candidate will have a different schedule for GUP and PEP (≤ 3 doses).

Please also review the ideal characteristics of desired rPA anthrax vaccine in special instructions.

• Question 3: Is it feasible to obtain confirmatory post-exposure efficacy data, from post-licensure use during an event on ethical ground?

─ Post-licensure efficacy studies are not part of this BAA.

• Question 4: Should use in pediatric and geriatric populations be planned as a post-licensure Label Indication Extension?

─ Post-licensure efficacy studies are not part of this BAA.

Qs&As Cont.,

• Question 5: Is it acceptable to demonstrate proof-of concept efficacy using anthrax spore aerosol challenge in relevant animal models after completing Phase I clinical trial(s) still rendering the Offeror eligible and being able to propose an SOW consistent with activities for vaccine candidate product development at TRL 6 or higher?

Qs&As Cont.,

• Answer to Question 5:

─ Offeror should submit sufficient data including proof-of-concept efficacy data as defined in the special instructions, amendment 6 to meet the evaluation criteria set forth in the BAA. Specifically relevant would be the statement ‘Ongoing or planned studies will be considered depending on the available information and supporting data’.

─ BARDA will evaluate and consider alternative approaches to demonstrate efficacy early in the program. BARDA would also consider efficacy data from studies conducted with preliminary formulations or purification processes.

Qs&As Cont.,

• Question 6: To what extent BARDA expects offeror to provide supporting information for the Proof of concept efficacy in the proposal in absence of challenge studies.

─ It is the responsibility of the offeror to demonstrate efficacy of their proposed vaccine candidate. Please see response to Qn 5 above.

Qs&As Cont.,

• Question 7: In view of the cancellation of BARDA-RFP due to inability of manufacturers meeting the BioShield statutory requirements of having the product ready for licensure within 8 years, what is the new time frame BARDA expects from the offerors to develop and seek license of the product so as to be eligible to enter BAA-BARDA-09- 34(Amendment 06)?] ─ There is no statutory requirement or restriction on the offeror’s to seek licensure within a timeframe to be eligible for BAA-BARDA-09-34 Amendment 06.

─ It is anticipated that contracts awarded under this BAA will be awarded as one-year base contracts with one-year options up to 5 years. Continuation of funding after the initial year is dependent upon availability of funds and achievement of milestones.

Qs&As Cont.,

• Question 8. In Amendment 1, Question 12, the contract period of performance is stipulated as 5 years total (1 year base and 4 one year options). However, the BAA also references selection of appropriate developmental milestones. Is it acceptable to extend the period-of-performance beyond 5 years to complete critical programmatic milestones?

─ It is anticipated that contracts awarded under this BAA will be awarded as one-year base contracts with one-year options up to 5 years. Continuation of funding after the initial year is dependent upon availability of funds and achievement of milestones.

Qs&As Cont.,

• Question 9. The initial solicitation and its Amendments do not provide any guidance on a contract start date. What should we use as a contract start date to design our development plan?

─ We anticipate a tentative contract award date by end of FY 2010 pending successful negotiations with offerors.

─ Development plans can use a reasonable start date which can be adjusted during negotiations, if a contract is awarded.

Qs&As Cont.,

• Question 10. In Section 4 A (page 21) of the BAA, it states that the technical proposal must not exceed 50 pages (unless otherwise specified in Part VI: Special Instructions) including figures, tables and graphs. If the proposal exceeds 50 pages, only the first 50 pages will be reviewed.

─ Feedback/guidance from BARDA will be provided when offerors submit a white paper/quad chart per the BAA requirements including the page limits.

─ If offerors choose to submit a full proposal, BARDA recommends that you review Part IV, Section 5 of BAA- BARDA-09-34, entitled Full Proposal Submission and put together a proposal within the page limit.

Technical and Business Proposal Expectations/Instructions

Technical Proposal Instructions

• Part IV, Section 5 of BAA-BARDA-09-34, entitled Full Proposal Submission.

• Volume I Technical Proposal – Must include a Statement of Work that clearly details the scope and objectives of the effort and the technical approach.

• Pointers for ‘reviewer-friendly’ proposals:

─ Demarcate sections with Tabs- yearly activities, proposed milestones ─ Use WBS & Material Flow Guides; Provide a 5 Yr Integrated Overview ─ Maximize page usage by including data in graphs, tables, charts, and/or diagrams

• Gantt chart should include:

─ Adequate review times for all parties (e.g. BARDA, subcontractors, internal, etc).

─ Realistic timeline and appropriate linkage between interdependences.

Technical Proposal Instruction Proposed Work Breakdown Structure

1.2.2 Non-Clinical Development

1.2.3 Clinical

Development

1.2.3.1 Phase 2

1.2.3.2 Phase 3

1.2.2.3

PEP

1.2.2.4

GUP

1.2.3.1 Phase 1

1.0 ARD rPA Anthrax Vaccine

1.1 Program

Management

1.2 Development

1.2.1 Process

Development

1.4 Commercial Mfg

1.4.1 Bulk Drug Substance

1.4.2 Final Drug

Product

1.3 Regulatory

1.5 Storage & Delivery

1.3.1

IND

1.3.2

EUA

1.3.3

BLA

1.3.4 Post

Marketing

1.2.1.1 Assays

1.2.1.2 Bulk Drug Substance

1.2.1.3 Final Drug

Product

1.2.1.1.1 Stability

1.2.1.1.3 Assay

Development/ Validation

1.2.1.3.1

FDP

Manufacture

1.2.1.1.2 Potency

1.1.1

EVMS

1.2.1.3.2 Tech Transfer

(Template Available)

Example Schematic:

Studies and Material Usage

(Template Available)

Business Proposal Instruction

• Part IV, Section 5 of BAA-BARDA-09-34, entitled Full Proposal Submission.

• Volume II – Cost Proposal – Direct Labor, Indirect Costs, Travel, Subcontracts, Consultants, Other Direct Costs, Profit/Fee.

• Representation and Certifications:

• In accordance with FAR 4.1201 prospective Offerors shall complete the Online Representations and Certifications Application (ORCA) at http://orca.bpn.gov. Offerors should make mention of its ORCA completion in its proposal and provide its “Certification Validity” period.

• Security Plan - The work to be performed under this contract may involve access to sensitive BARDA program information.

Therefore, the Offeror(s) shall develop and submit a written Draft Security Plan that describes their procedures and policies to defend against theft, tampering, or destruction of product-related material, equipment, documents, information, and data.

• The Offeror is invited to submit a request for waiver if he or she believes the proposed work is exempt from some or all of the security requirements in the BAA or if the Offeror can demonstrate that commensurate protective measures have been applied that afford an equal level of protection. Requests for waivers should be submitted through the Contracting Officer to the Program Protection Office, BARDA.

• Small Business Subcontracting Plan - In negotiated acquisitions, each solicitation of offers to perform a contract or contract modification, that individually is expected to exceed $550,000 ($1,000,000 for construction) and that has subcontracting possibilities, shall require the apparently successful offeror to submit an acceptable subcontracting plan.

If the apparently successful offeror fails to negotiate a subcontracting plan acceptable to the contracting officer within the time limit prescribed by the contracting officer, the offeror will be ineligible for award.

• HHS current subcontracting goal is 39.9% for small business (hereafter referred to as SB), 5.00% for Small Disadvantaged Business, including Alaska Native Corporations (ANC) and Indian Tribes (hereafter referred to as SDB), 5.00% for women-owned business and economically disadvantaged women-owned business (hereafter referred to as WOSB), 3.00% HubZone business (HUBZone), and 3.00% service disabled veteran-owned small business (SDVOSB) and veteran-owned small business (VOSB) concerns.

ARD Contract Management/Expectations

Expectations and Understanding BARDA ARD Contract Management

• Expectations in Contract Management ─ Communication

• Frequent and open communication between PO and Program Manager

• Timely notification of issues and changes impacting day to day program

• Periodic on-site meetings

─ Audits, Site Visits and Meetings

• People in Plant during Mfg

• Periodic site visits at prime and subcontractors

• BARDA participation in regulatory meeting with FDA

─ Documentation Review and Approval

• Review of all draft and final Protocols, Standard Operating Procedures, Report

• Review of Timelines

• Review and approval of COAs

• Reporting Requirements and Deliverables (Please refer to Part III) ─ Technical Progress Reports ─ Meetings and Conferences ─ Regulatory and Quality Management

Open Discussion