PreProposal Conference Thermal Burn BAA Spl Inst Presentation_23Feb2012 1 .pdf

Ron Manning, Ph.D., Chief, CRN Branch Narayan Iyer, Ph.D., Project Officer Tom Hu, Ph.D., Project Officer Brian Tse, Ph.D., Project Officer

CBRN MCM Development

BAA 11-100-SOL-00009

Special Instructions Thermal Burn Definitive Care Products

Pre-Proposal Conference February 23, 2012

Agenda

1. Welcome and Introductions

2. Understanding BAA - Overview BAA

Process/ Timeline

3. Thermal Burns – BAA Special Instructions

4. Technical and Business Proposal

Expectations/Instructions

5. ARD Contract Management/Expectations

6. Open Discussion / Response to FAQs

BARDA Mission

Ensuring the availability of countermeasures to address public health emergencies

• Three threat areas: Chem/Bio/Rad/Nuc, Pandemic Influenza, Emerging Infectious Diseases

• Comprehensive portfolio approach to development and acquisition of products

• Unique niche in USG biomedical R&D ─ Bridge the “Valley of Death” ─ Mid- to late-stage product development ─ Staff with experience in product development and manufacturing ─ Work with industry to progress product candidates through the pipeline

Legislation Governing BARDA

• Project BioShield Act ─ Special Reserve Fund ($5.6 B) ─ Emergency Use Authorization (FDA)

• Pandemic and All-Hazards Preparedness Act ─ Established ASPR and BARDA ─ Allowed for milestone payments ─ Authority to invest in advanced R&D ─ Yearly appropriations from Congress

• Federal Acquisition Regulation (FAR)

• Health and Human Services Acquisition Regulations

(HHSAR)

Understanding BAA:

Overview of the BAA Process and Timeline

Purpose of the BAA

• Identify innovative and promising technologies for advanced development across CBRN Research Areas of Interest ─ Vaccines ─ Antitoxins and Therapeutics ─ Antimicrobial Drugs ─ Radiological/Nuclear Threat Countermeasures ─ Chemical Threat Countermeasures Diagnostic

• Accelerate contract awards with a flexible solicitation

• Build a sustainable advanced development program to meet PHEMCE implementation plan goals and mature MCMs for eventual FDA approval and possible inclusion in the Strategic National Stockpile.

Purpose of the Special Instructions

• Focusing on specific area-

─ Thermal Burn Definitive Care Products

─ Area of Interest 4: Radiological /Nuclear Threat MCMs

─ TRL 3 and above https://www.medicalcountermeasures.gov/federal-initiatives/guidance/integrated-trls.aspx

• Accelerate contract awards

• Refer to Details ─ Solicitation Number: BARDA-CBRN-BAA-11-100-SOL-00009

─ Amendment 04

Special Instructions

• The last day for submission of proposals under this special instructions is Saturday, March 3, 2012 and coincides with the expiration date for this BAA.

• March 3 is a Saturday. However, your electronic submission will be considered timely if is submitted on or before that day.

• It is anticipated that these special instructions may be renewed if the current BAA is renewed.

• Renewed BAA would have a new reference number / expiration date/ updated submission guidelines

BAA Process Flow Chart

OTA

Coop Agreement

Grant

Publish BAA Or

Special Instructions

Receive Incoming

White Papers

Evaluate White

Papers

Review Panel

Regrets Notification

Not Acceptable

Acceptable

Full Proposal Invitation

Source Selection

Evaluation Board

Evaluate Proposal

Cat I Cat II Cat III

Contract Award

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 for further information on review time.

Proposal Stage Deadline for Submission

USG Response

Stage 1: Quad Chart and White Paper

March 03, 2012

5 PM US EST

(Coincides with expiration of this

BAA-11)

Receipt confirmation within 1 week.

Decision within 90 days

Stage 2: Full Proposal Within 75 days of Invitation

Receipt confirmation within 1 week

Source Selection Notification (pending availability of funds)

Within 180 days of Full Proposal receipt

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.

• The submission of White Papers is strongly recommended. The success rate of winning an award is higher when a White Paper is submitted

BAA Process - FAQ

• Is there an archive of these slides and Q&A for this and previous pre-proposal meetings ─ Yes, It is located on FedBizOpps (www.fbo.gov)

• If I am invited for a full proposal and have questions, will I get a chance to talk before I submit my proposal?

─ Yes. You are allowed discussion via the CO

• If not invited for a full proposal, will I get a chance to clarify about my White paper?

─ Typically no; You will receive a letter with explanation

BAA Process - FAQ

• Will BARDA provide feedback on my full proposal submission?

─ For this BAA, we will send out a letter of notification with BARDA’s feedback on proposal’s strengths and weaknesses.

• Will I get a chance to clarify or revise my full proposal?

─ Yes. If invited back for negotiations (Cat I) or revision via a Cat-II letter

─ No, if rated Category III

Understanding Thermal Burns

BAA Special Instructions

Timeline Post-Detonation

Burn Wound Treatments

1. Anti-microbial barrier burn bandages

72 hrs - Beyond

• Conclusive burn wound care

• Functional recovery

• Provide fluids & nutrition

0 - 72 hrs

Key Complementary Products A. Oral rehydration therapy sachets B. Point-of-care airway management C. Analgesics (oral/intramuscular) D. Nutritional supplies (oral)

Burn Wound Treatments

2. Autologous-based treatment products

3. Natural biological products

4. Manufactured biological products

5. Anti-microbial burn dressings

Key Complementary Products E. Burn care surgical equipment F. Rehydration fluids (oral/intravenous) G. Nutritional supplies (oral/nasogastric) H. Pharmaceuticals (analgesics, sedatives, systemic antibiotics)

GOALS GOALS

• Administer fluids

• Secure airway

• Manage pain

• Provide early nutrition

• Prevent wound infection

Phase I Products Phase II Products Point-of-Care Definitive Care

Timeline Post-Detonation

Burn Wound Treatments

1. Anti-microbial barrier burn bandages

72 hrs - Beyond

• Conclusive burn wound care

• Functional recovery

• Provide fluids & nutrition

0 - 72 hrs

Key Complementary Products A. Oral rehydration therapy sachets B. Point-of-care airway management C. Analgesics (oral/intramuscular) D. Nutritional supplies (oral)

Burn Wound Treatments

2. Autologous-based treatment products

3. Natural biological products

4. Manufactured biological products

5. Anti-microbial burn dressings

Key Complementary Products E. Burn care surgical equipment F. Rehydration fluids (oral/intravenous) G. Nutritional supplies (oral/nasogastric) H. Pharmaceuticals (analgesics, sedatives, systemic antibiotics)

GOALS GOALS

• Administer fluids

• Secure airway

• Manage pain

• Provide early nutrition

• Prevent wound infection

Phase I Products Phase II Products Point-of-Care Definitive Care

Description of Primary Product Categories Supported Under BAA-Special Instructions

Product Categories Description

Autologous- Based Treatment Products

• Products that utilize a patient’s own skin cells to form a skin substitute or replacement.

Natural Biological Products

• Derived directly (or modified) from allogeneic or xenogeneic skin sources to provide a temporary skin substitute or skin replacement.

Manufactured Biological Products

• Derived from manufactured biomaterials or bioengineered cell lines, biological substitutes (allogeneic) to form a temporary skin substitute or skin replacement.

Other Products Potential to enhance the use or functionality of products in the three primary categories

Associated Products

• Can directly enhance functionality

• Innovative, stand-alone products

• Hypothetical example- debridement products which allow less labor-intensive wound preparation

Combination Products

• Combinations of 2 or more products/ technologies together has enhanced attributes

• A better, creative solution than either product alone

• Hypothetical example- a manufactured bioengineered cell line product providing a dermal base that allows efficient proliferation, smaller autograft donor site;

leading to increased coverage of graft area, lower pain, quicker recovery, shorter hospital stay, less-intense and shorter duration professional attendance

Description of Other Product Categories Supported Under BAA-Special Instructions

1. Dual-use (conventional and mass-casualty): Foster the development of products that will be market competitive and improve the standard-of-care for conventional burn injuries. These improved products would eventually integrate sustainably into routine clinical use while simultaneously improving the quality of mass-casualty care.

2. Surge capacity: Increase market acceptance and the potential for manufacturing surge capacity thereby improving availability of the products for national emergency preparedness.

Definitive Care Product Goals

• Cost competitive ─ Total cost-of-care

• Usable by a wider group of medical professionals ─ CONOPS-friendly

• Maximize health care benefit ─ Fewer clinical procedures (e.g., repeat grafting) ─ Shorter hospital stay ─ Reduce need for complementary medical supplies (e.g., analgesics)

• Amenability to stockpile or managed inventory solutions ─ Storage conditions ─ Shelf-life (expiry)

• Acquisition Approaches ─ Surge capacity / warm base

Definitive Care Product Attributes

Proposals can cover:

• Advanced development of any of the three primary product categories ─ Autologous- Based Treatment Products ─ Natural Biological Products ─ Manufactured Biological Products

• Exclusively focus on associated products with a potential to enhance the use or functionality of products ─ Example, debridement methods that reduce the need for surgical care or enhance the ease of adequate wound preparation or the ease of use

• Combinations of products and technologies that provide enhanced attributes that are not readily available using only one.

─ Example, collaborations among product manufacturers that together provide unique or comprehensive solution

Definitive Care Products- Scope

• Proposals for developing enhancements to products that already are approved by the FDA for treating thermal burns, to increase and/or demonstrate suitability for mass-casualty care

• Safe and effective medical products that can be used to treat full-skin-thickness burn injuries or deep partial-skin-thickness burn injuries with potential to convert to full-thickness injuries

• Preliminary data on key product attributes of existing current-generation products

• Comprehensive solutions (combinations of products and technologies) as feasible, useful, through collaborations or partnerships

Definitive Care Products- Priority

Technical and Business Proposal Expectations/Instructions

Proposal Instructions

• The ASPR website contains several links to pages with information to assist you in the preparation of your proposal.

http://www.phe.gov/about/amcg/toolkit/Pages/d efault.aspx http://www.phe.gov/about/amcg/toolkit/Pages/default.aspx�

Click on Getting Started http://www.phe.gov/about/amcg/Pages/ gettingstarted.aspx and AMCG Business Tool Kit http://www.phe.gov/about/amcg/toolkit/ Pages/default.aspx

Proposal Instructions http://www.phe.gov/about/amcg/Pages/gettingstarted.aspx� http://www.phe.gov/about/amcg/Pages/gettingstarted.aspx� http://www.phe.gov/about/amcg/toolkit/Pages/default.aspx� http://www.phe.gov/about/amcg/Pages/gettingstarted.aspx�

• In addition, you will receive detailed instructions about how to submit a proposal in your invitation letter.

• You may also contact the Contracting Officer or Contract Specialist assigned to your proposal.

Proposal Instructions

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

Response to Frequently Asked Questions

Technical Questions and Answers (Q&A)

• Question 1: Why are only 3 of the product categories listed in the previous Sources Sought Notice covered under these Special Instructions?

─ These special instructions focus on Definitive Care products.

The SSN sought information on the entire spectrum of products required for burn care including the Field Care.

─ Hence, the only primary product categories from SSN that are relevant for Definitive Care are:

# 2: Autologous –Based Treatment Products # 3: Natural Biological Products # 4: Manufactured Biological Products

─ Please see the description summary provided in the BAA and in this presentation.

Technical Q & A (Continued)

• Question 2: What do Associated Products and Combination Products mean, which are also covered under these Special Instructions?

─ Associated Products are those that do not by themselves fit into the primary categories but have a potential to enhance the use or functionality of products in the primary category

• An example is debridement agents which could enhance the grafting efficacy (or lower the rejection) of a graft ─ Combination Products are those that together provide a better creative solution than either product alone

• A hypothetical example- a manufactured bioengineered cell line product providing a base that allows efficient proliferation and a smaller autograft. donor site, leading to increased coverage area, lower pain, quicker recovery, shorter hospital stay, less-intense and shorter duration professional attendance

• A generic example is Shampoo + Conditioner

• Question 3: Please explain ‘Cost-sharing in development of dual-use technology’ referred on page 5 section 5B. What is the rationale?

─ In this instance ‘dual use’ refers to technology that can be commercially marketed and would be suitable for mass-casualty care, the area primarily of interest to USG.

─ ‘Cost-sharing’ refers to an approach in which an Offeror proposes to cover some cost of development based on its own commercial interest for the product, and requests financial support under a BARDA contract only for a part of the product development.

─ Work proposed under contract specifically covers objectives and goals outlined in the BAA-Special Instructions.

─ Allows judicious use of tax dollars

• Question 4: What guidance do you have about white papers and proposals?

─ Be clear and concise, use charts and tables for data ─ Do not repeat text or data in several places; Use the allowed pages wisely; Don’t feel obliged to use all the allowed pages ─ Tell the best story possible, sell the strong points as they align to the goals; Don’t over or under emphasize.

─ Know your limitations, don’t conceal the weak points ─ Be realistic about product development (& avoid looking naïve) ─ Have a management plan for your work and for subcontractors’ ─ Include document review in timelines ─ Include risk plan Schedule a Tech Watch meeting before submitting the white paper

• Question 5: The time to develop a WP between the pre-proposal conference and the expiration date is about 10days.

A. If a WP is submitted under BAA-11, special Instruction before 03March2012 and then, the special instruction is renewed under BAA-12, is it possible to retract the old submission and take additional time to submit a better WP under BAA-12?

─ Proposals can be retracted as long as they have not been reviewed.

• Question 5: The time to develop a WP between the pre-proposal conference and the expiration date is about 10days.

B. If the BAA-11 WP cannot be retracted, can one submit another WP under BAA-12 taking advantage of the longer time available to develop a better WP?

─ Offerors can submit any number of White Papers under the new BAA (or the old one, for that matter). It just depends upon whether they wish to begin work now on a White paper in response to the new BAA that will be a better submission.

─ It is anticipated that a new BAA-12 will be issued to replace the current BAA, and that Thermal Burn instructions will be included. To emphasize, this is our anticipation, not an assurance.