BAA Pre-Proposal Slides.pdf

AMENDMENT TO BARDA BROAD AGENCY ANNOUNCEMENT

ADVANCED RESEARCH AND DEVELOPMENT OF CHEMICAL, BIOLOGICAL,

RADIOLOGICAL, AND NUCLEAR MEDICAL COUNTERMEASURES

Broad Agency Announcement Number: BARDA-CBRN-BAA-10-100-SOL-00012

Amendment Number: Two (2)

Amendment Posting Date: April 30, 2010

Issued By: Biomedical Advanced Research and

Development Authority (BARDA) 330 Independence Ave., SW, Room G640 Washington, D.C. 20201

Points of Contact: Primary: Glynis Fisher, Contract Officer glynis.fisher@hhs.gov

Alternate: Jeannett Jackman, Contract Specialist jeannett.jackman@hhs.gov

SUMMARY OF CHANGES

A. PURPOSE: The purpose of this amendment is to post the slides from Pre-proposal Conference #1, March 26, 2010.

B. The closing date for research areas 1 through 6 is hereby changed from March 1, 2011 to March 3, 2011.

C. Except as provided herein, all terms and conditions of the BAA remain unchanged.

mailto:glynis.fisher@hhs.gov mailto:jeannett.jackman@hhs.gov

CBRN MCM Development “Rolling” BAA BARDA 10-100-SOL- 00012

Pre-Proposal Conference

26 MAR 2010

Eric M. Espeland, PhD Project Officer, Division of CBRN Countermeasures

2:05 pm Welcome and Introductions 2:10 pm Overview of BAA Process/Changes 2:30 pm Technology Readiness Level (TRLs) 2:40 pm Open Discussion/Questions 3:00 pm Break (5-10 minutes) 3:10 pm Chemical MCM Special Instructions 3:30 pm Open Discussion/Questions 3:45 pm Adjourn

Agenda

CBRN BAA Team

Dr. Eric Espeland – Project Officer

Glynis Fisher – Contracting Officer

Ethan Mueller – Contracting Officer

Michael Younkins – Contracting Officer

Carl Newman – Contracting Officer

Jeannett Jackman – Contracting Specialist

Technical Points of Contact

Dr. Narayan Iyer – Vaccines

Dr. Stephen Morris – Antitoxins and Therapeutics

Dr. Joe Larsen – Antimicrobial drugs

Dr. Ron Manning – Rad/Nuc MCM

Dr. Ed Wakayama – Chemical MCM

Mr. Rodney Wallace – Diagnostics

CBRN Broad Agency Announcement Process Overview

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

Antitoxins and Therapeutics

Antimicrobial Drugs

Radiological/Nuclear Threat Countermeasures

Chemical Threat Countermeasures

Diagnostic (TRL 4 or greater)

Accelerate contract awards with a flexible solicitation

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

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

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 180 days

Publish BAA Receive

Incoming White Papers

Evaluate White

Papers

Peer Review Panel

Regrets Notification

Not Acceptable

Acceptable

Full Proposal Invitation

Source Selection

Evaluation Board

Evaluate Proposal

Cat I Cat II Cat III

Contract Award

CBRN Broad Agency Announcement Changes to 2009 BAA 09-34

2010 BAA will be open for 12 months (4 March 2010 – 3 March 2011).

Page limitation on white papers changed to 10 pages for all Areas of Interest.

Full Proposal Length will now be specified in the full proposal invitation letter.

Updates have been made under each Area of Interest.

TRL guidance for Diagnostics has moved from TRL 5-6 to TRL 4 or greater (see attachment 1)

Guidance is provided on the information that is required in the white paper submission.

Submission Deadlines

Security waiver language has been included to allow request for exemption from some or all security requirements.

Special Instructions for Chemical Countermeasures for treating Nerve Agents, Cyanide, and Pulmonary Agents

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

Proposal Stage Deadline for Submission USG Response

Stage 1: Quad Chart and White Paper

Dec. 1, March 1, June 1 and September 1 for Areas 1, 2, 3;

Anytime for Areas 4, 5, 6

Receipt confirmation within 1 week; Decision within 90 days

Revised TRL language for Diagnostics. TRLs for Biologics, etc are the same and are available on www.medicalcountermeasures.gov

Additional BARDA requirements language has been added (see attachment 8) http://www.medicalcountermeasures.gov/

Rating your Technology Readiness Level

Detailed TRL criteria are located in Attachment 1 (Diagnostic Devices) & www.medicalcountermeasures.gov

(biologics and drugs)

Key to rating your TRL:

When using these criteria, a medical countermeasure product should be rated at a particular level only after the sponsor has completed all activities listed in that level (e.g., a product is rated at TRL 4 once it completes all of the activities listed in TRL 4).

Example for Biologics and Drugs per Example for Biologics and Drugs per www.medicalcountermeasures.govwww.medicalcountermeasures.gov

QUESTIONS??

BREAK

10 minutes

CBRN MCM Development “Rolling” BAA BARDA 10-100-SOL- 00012

Special Instructions - Cyanide, Nerve, and Pulmonary Agents (phosgene, chlorine, ammonia, and diphosgene)

Pre-Proposal Conference

26 MAR 2010

Ed Wakayama, Ph.D., BCLD (ABB) Project Officer, Division of CBRN Countermeasures

Published as special Instruction to BAA-BARDA-10-

100-SOL-00012

Posting Date (4 MAR 2010)

Pre-Proposal Date (26 MAR 2010)

White Paper/Quad Chart submission/closing Date (1 MAY 2010)

Purpose: To specifically solicit solutions in a chemical threat medical countermeasure area

Goals:

Mitigate/treat mass casualties (Therapeutic rather than pre-treatment)

Develop easily administered and rapidly efficacious medical countermeasures against chemical agents

First-responders

Self-administered

May be used by untrained personnel (including personnel decontamination)

Objective: to focus on advanced development of medical countermeasures (TRL-5 or higher) that mitigate and treat chemical threat agents:

Nerve agents

Cyanide

Pulmonary agents (phosgene, diphosgene, chlorine and ammonia)

Timeline for contract award is ~12 months from date of white paper submission

At Risk Populations:

Pediatric

Pregnant women

Geriatric

Immuno-compromised

Treatment window may be very short: min. to hrs

IM Autoinjector is acceptable

Intranasal, inhalational, and oral administration with rapid bioavailability

Broad spectrum MCM for pulmonary agents

Require biomarkers for phosgene and diphosgene

QUESTIONS??