BARDA Funding Opportunities for Life Science Organizations...webinar. Syllabus: 1.SBIR/STTR 2.Details of a Detailed Budget 3.Joint webinar with the Michael J. Fox Foundation on Parkinson’s

FreeMind Group Webinar

Ayal RonenJuly 31th, 2012

BARDA Funding Opportunities for Life Science Organizations

August 1, 2012 FreeMind Group, LLC 2/34

FreeMind Summer SchoolFreeMind Summer School

FreeMind Group, LLC

FreeMind Group, LLC

Join us every Tuesday at Noon EDT for

the weekly FreeMind educational webinar.

Syllabus:1.SBIR/STTR2.Details of a Detailed Budget

3.Joint webinar with the Michael J. Fox Foundation on Parkinson’s and other Neurological disorders4.BARDA – mission and current funding opportunities5.Medical Devices funding opportunities6.Oncology

7.DOD – DARPA, DTRA, US Army, etc.8.Industry Academic Partnership programs

9.Bio Imaging and Bio engineering10.Biodefense and infectious diseases, NIAID

Webinar program is subject to change


� Est. 1999

� 25 Fulltime Employees

� Academia & Industry Clientele

� Extensive experience in submitting and winning large scale applications

� Over $1.5B in cumulative awards

The Global NonThe Global Non--Dilutive Funding Leader Dilutive Funding Leader

FreeMind Group, LLC

FreeMind Group, LLC


� Identifying most relevant funding opportunities

� Strategize to max. application’s chances

� Manage complex project production processes

� Lead joint application writing

� Supports final contract negotiations

A Tool to Max. Your Funding PotentialA Tool to Max. Your Funding Potential

FreeMind Group, LLC

FreeMind Group, LLC


Vision and Mission

Vision and Mission

Biomedical Advanced Research and Development Authority (BARDA)Biomedical Advanced Research and Development Authority (BARDA)

Vision:

“To enhance the capability of the U.S. Government to respond quickly to both known and emerging threats by supporting the development of a comprehensive portfolio of medical countermeasures, needed manufacturing infrastructure, and countermeasure production platforms.”

Mission:

“To develop and procure medical countermeasures that address the public health and medical consequences of chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.”

Adapted from the BARDA Strategic Plan 2011-2016


Three Pronged Approach

Three Pronged Approach

BARDA BARDA –– ManMan--made and Natural Threats made and Natural Threats

• CBRN Threats

• Chemical Nerve Agents and Cyanide

• Radiological and Nuclear Agents

• Biothreats (Anthrax, Smallpox etc.)

• Pandemic Influenza

• Emerging Infectious diseases

Adapted from The BARDA Multi-Broad Agency Announcement Pre-Proposal Conference 2012


BARDA Approach

BARDA Approach

BARDA BARDA –– Medical CountermeasuresMedical Countermeasures


BARDA BARDA –– Medical CountermeasuresMedical Countermeasures

PHASES

IND NDA/BLA

Licensed

Product

Licensed

Product

1-3% 10-25% 1-3% 18-35% 45-70% 90%

PROBABILITY OF SUCCESS TO LICENSURE

PR

OD

UC

T P

IPE

LIN

E

NIH ($11.8B)

BARDA ($540M)

Project BioShield ($5.6M)

Valley of Death

3- 7 yr 0.5 - 2 yr 1 - 2 yr 2 – 3.5 yr 2.5 – 4 yr 1 - 2 yrTime

Pipeline Phase Cost

$100M – 130M $60M – 70M $70M – 100M $130M – 160M $190M – 220M $18M – 20M



5 Principles5 Principles

BARDA BARDA –– Strategic Plan 2011 Strategic Plan 2011 -- 20162016

BARDA Guiding Principles

1.Collaborating in public- private partnerships2.Promoting Platform Technologies3.Prioritizing multipurpose products 4.Using case management and a matrixed organizational structure5.Ensuring an integrated portfolio with DOD


Read it!


5 Goals5 Goals


Goal 1

An advanced development pipeline replete with medical countermeasures and platforms to address unmet public health needs, emphasizing innovation, flexibility, multi-purpose and broad spectrum application, and long-term sustainability.

Goal 2

A capability base to provide enabling core services to medical countermeasure innovators.



5 Goals5 Goals


Goal 3

Agile, robust and sustainable U.S. manufacturing infrastructure capable of rapidly producing vaccines and other biologics against pandemic influenza and other emerging threats

Goal 4

Responsive and nimble programs and capabilities to address novel and emerging threats

Goal 5

A ready capability to develop, manufacture and facilitate distribution of medical countermeasures during public health emergencies



Key PointsKey Points

BARDA SummaryBARDA Summary

BARDA is committed to developing and providing MCMs for civilian preparedness & response to CBRN, pandemic influenza, and emerging infectious threats

BARDA utilizes public-private partnerships with industry

to achieve these goals by providing funding support and critical core services to its partners

BARDA maintains a balanced portfolio for specific and multiple threats and places a high priority on sustainable life cycle management


Interesting StatisticsInteresting Statistics

Industry vs. Academics

Industry vs. Academics

www.medicalcountermeasures.gov/barda/cbrn/cbrn-funding-activities.aspx




Total Awards Per Year

Total Awards Per Year

*Awards made in 2009 – 2011 did not have a corresponding dollar value, and as such are not displayed

*



Awards by FieldAwards by Field


*Many awards did not have a corresponding dollar value, and as such were not figured into the above

*


Typical BARDA Submission ProcessTypical BARDA Submission Process

• Whitepaper submission is the first and one of the most crucial steps for award.

• Majority of applications do not make it past the whitepaper stage. To mean, if you are called to submit a full application your chances increase substantially.

• Carefully craft your whitepaper ensuring your science is well presented and represented and meets the guidelines and specification of the solicitation (TRL, Budget, Scope etc.)

• Correspondence via Amendments

Stage 1 Whitepaper

Stage 1 Whitepaper

REVIEWREVIEW

Stage 2Full Application

Stage 2Full Application

Technical ReviewTechnical Review

AWARD $$$AWARD $$$

Stage 3Cost Proposal

Negotiations

Stage 3Cost Proposal

Negotiations


Request a Tech Watch Meeting

Request a Tech Watch Meeting

www.medicalcountermeasures.gov/Requestwww.medicalcountermeasures.gov/Request--Meeting.aspxMeeting.aspx

Before Pre-application

submission!


Funding Opportunity #1Funding Opportunity #1

Advanced Research and Development of Chemical, Biological, Radiological, and Nuclear Medicine

Countermeasures

(BARDA-CBRN-BAA-12-100-SOL-00011)


BARDA BAABARDA BAA

Advanced Research and Development of Chemical, Biological, RadioAdvanced Research and Development of Chemical, Biological, Radiological, and Nuclear logical, and Nuclear Medicine Countermeasures (BARDAMedicine Countermeasures (BARDA--CBRNCBRN--BAABAA--1212--100100--SOLSOL--00011)00011)

CBRN BAA History

First BARDA Broad Agency Announcement was issued in 2009. Implemented as a ‘rolling’ BAA with renewals in 2010, 2011, and 2012.

Success

• 22 contracts have been awarded across all 6 CBRN areas of interest

• ~$375.7M has been awarded through June 2012

• ~1.37B assuming all base and contract options are exercised.

Deadlines:

Rolling BAA:

Pre-applications accepted on four

quarterly deadlines:

Sept 1, Dec 1, March

1, and June 7.

Invitation to submit

full application within

90 days.

Full application upon

invitation only, subject

Deadlines:

Rolling BAA:




1, and June 7.



90 days.





BARDA BAABARDA BAA

Advanced Research and Development of Chemical, Biological, RadioAdvanced Research and Development of Chemical, Biological, Radiological, and Nuclear logical, and Nuclear Medicine Countermeasures (BARDAMedicine Countermeasures (BARDA--CBRNCBRN--BAABAA--1212--100100--SOLSOL--00011)00011)

Funding: Budgets are not capped and must reflect the scope of the work. Funding can be requested for up to 5 years.

Scope:

• BARDA encourages the advanced research, development and acquisition of medical countermeasures such as vaccines, therapeutics, and diagnostics.Areas of interest1.Vaccines Development2.Antitoxins and Therapeutics3.Antimicrobials and Antivirals4.Radiological and Nuclear Agent Countermeasures5.Chemical Agent Countermeasures

6.Diagnostics

Deadlines:

Rolling BAA:




1, and June 7.



90 days.



Deadlines:

Rolling BAA:




1, and June 7.



90 days.





Science and Technology Platforms Applied to Medical Countermeasure (MCM) Development

(BARDA-SST-BAA-12-100-SOL-00013)


BARDA BAABARDA BAA

Science and Technology Platforms Applied to Medical CountermeasuScience and Technology Platforms Applied to Medical Countermeasure re (MCM) Development (BARDA(MCM) Development (BARDA--SSTSST--BAABAA--1212--100100--SOLSOL--00013)00013)

History:

Originally issued July 9, 2009 Reissued January 1, 2011 and June 20, 2012

Success:

Nine contracts have been awarded across all areas of interest

~$75,000,000 obligated to-date

Looking for new ideas that will improve BARDA’s capabilities to prepare for and respond to public health emergencies

focuses more on technologies and capabilities than

developing products for specific threats (CBRN and flu would focus on specific threats)

Deadlines:

Stay Tuned!

Deadlines:

Stay Tuned!

Deadlines:

Rolling BAA:

Pre-applications are accepted anytime.

Full applications:

Within 45 days from invitation to submit

Deadlines:

Rolling BAA:


Full applications:




BARDA BAABARDA BAA


Funding: Budgets are not capped and must reflect the scope of the work. We anticipate Funding can be requested for up to 5 years.

Scope:

• To address novel and emerging threats, as well as support the technological and scientific advancements of medical countermeasures for biodefense and pandemic influenza.

• Pipeline acceleration and evaluation of candidate vaccines and therapeutics.

• Product improvements to enhance safety, efficacy, ease of use, and manufacturability.

• Product repurposing to treat novel and emerging pathogens.

• In vitro diagnostic platforms for the rapid diagnosis of human infection.

Deadlines:

Stay Tuned!

Deadlines:

Stay Tuned!

Deadlines:

Rolling BAA:


Full applications:


Deadlines:

Rolling BAA:


Full applications:



BARDA BAABARDA BAA


Areas of interest:

•Technologies to accelerate evaluation of candidate vaccines and therapeutics •Formulation, delivery, and manufacturing improvements •Therapeutics to treat novel and emerging pathogens •Methods and technologies to advance development of tests for rapid diagnosis of human injury and infection•Note: Individual proposals may address any Area of

Interest but not multiple areas. Submit a separate

proposal for each Area of Interest.

Deadlines:

Stay Tuned!

Deadlines:

Stay Tuned!

Deadlines:

Rolling BAA:


Full applications:


Deadlines:

Rolling BAA:


Full applications:




Advanced Development of Medical Countermeasures for Pandemic Influenza

(BARDA-FLU-BAA-12-100-00018)


BARDA BAABARDA BAA

Advanced Development of Medical Countermeasures for Advanced Development of Medical Countermeasures for Pandemic Influenza (BARDAPandemic Influenza (BARDA--FLUFLU--BAABAA--1212--100100--00018)00018)

Overall BARDA Influenza Program:

Vaccines:

Aim to stockpile pre-pandemic influenza vaccines to cover 20 million persons in the critical workforce

Aim for manufacturing capacity to produce pandemic vaccine

for U.S. population of 300 million within 6m of pandemic onset.

Awarded $1.5B in contracts in 2005-2007 to accelerate development and production of influenza vaccine

Antiviral:

Stockpiles to treat 25% of the U.S. population during a pandemic

Awarded a $102.6M contract for a new influenza antiviral

Diagnostics:Aim for 30 minute detection in clinical setting; awarded$17.7M and $13M, in 2006 and 2008, respectively

Deadlines:

Rolling BAA:




1, and June 7.



90 days.



Deadlines:

Rolling BAA:




1, and June 7.



90 days.




BARDA BAABARDA BAA

Advanced Development of Medical Countermeasures for Advanced Development of Medical Countermeasures for Pandemic Influenza (BARDAPandemic Influenza (BARDA--FLUFLU--BAABAA--1212--100100--00018)00018)

Funding: Budgets are not capped and must reflect the scope of the work. We anticipate Funding can be requested for up to 5 years.

Scope:

• Advanced development activities to improve candidate products and diagnostic tools and incorporate considerations of the challenging lifecycle requirements of these products before and during a pandemic.Areas of interest•Vaccines•Antiviral Therapeutics for Treatment and/or Prophylaxis•Mitigation of Severe Respiratory Disease Resulting from Influenza Infection

•Clinical Influenza Test Systems and Diagnostic Tools

Deadlines:

Rolling BAA:




1, and June 7.



90 days.



Deadlines:

Rolling BAA:




1, and June 7.



90 days.




Major ChallengesMajor Challenges

• Whitepaper submission

� Are you responsive? Maturity assessment, Justify TLR

rating

� Adhere to the guidelines! Different solicitations have

different stipulations

� Is your scientific story compelling – Innovative, Strong Leadership, well outlined? Clear Project Plan, with key

activities and milestones, Significant outcome?

• Unique sections – Statement of Work, Deliverables,

Project Management etc.

• Project Management and coordination

• Short timeline and time consuming!

Turning out a winning proposal

Turning out a winning proposal


Key IssuesKey Issues

Maximizing Your ChancesMaximizing Your Chances

• Know the interests of the Agency

• Read the BAA, Request a meeting with BARDA, and/or email the CO prior to sending the Pre-application

• Focus your project application

• Ask for what is necessary

• Present a complete project

• Leverage on research collaborations

Systematic Approach


Key IssuesKey Issues

Maximizing Your ChancesMaximizing Your Chances

• Different “pockets of money”

• Different size of award/success rates

• Some projects will not have the right target within BARDA (TRL). Perhaps NIH or DOD will!

• Conduct a thorough strategic assessment

Target the Right Mechanism


The Professional

Team

The Professional

Team

FreeMindFreeMind’’s NIH Teams NIH Team

� 25 full time employees

�Analysts

�Managers/Writers

� Dr. Merav Geva, FreeMind’s Director of the

Professional Department & Chief Analyst


Strategic

Assessment

Strategic

Assessment

FMG Professional ProcessFMG Professional Process


Specific ProjectSpecific Project

FMG Professional ProcessFMG Professional Process


Contact Us!Contact Us!

Thank you!Thank you!

Ayal Ronen

Vice [email protected]

(617) 648 0340

www.freemindconsultants.com

Ayal Ronen Ayal Ronen

Vice [email protected]

(617) 648 0340

www.freemindconsultants.com

Documents

BARDA Funding Opportunities for Life Science Organizations...webinar. Syllabus: 1.SBIR/STTR 2.Details of a Detailed Budget 3.Joint webinar with the Michael J. Fox Foundation on Parkinson’s