FreeMind Group, LLC

FreeMindGroup

@FreeMindGrp

FreeMind Group

Biodefense and Infectious Diseases Funding Opportunities

Jonathan Adalist

Senior Director, Business Development

FreeMind Group

FreeMind Group, LLC 2

FreeMind Group

FreeMind Group, LLC

Est. 1999

60 Fulltime Employees

Diverse Client Base:

• Academics, University Medical Centers, and Independent Research Institutes

• Industry – Small Startups to Large Pharmaceutical Companies

400-450 Applications Annually

March 1, 2017

FreeMind Group, LLC 3

A Tool to Maximize Your Funding Potential

FreeMind Group, LLC

Identify the most relevant funding opportunities

Strategize to maximize the application’s chance of success

Manage complex project production processes

Lead joint application writing

Support final contract negotiations

Non-Dilutive Funding – A Strategic Financial Tool

March 1, 2017

FreeMind Group, LLC 4

NIH 2016 Budget - $32.31B

Research Projects $17,820,973

55%

Other Research $2,010,924

6%

Training $830,430

3%

Research & Develop. Contracts $2,995,825

10%

Intramural Research $3,581,878

11%

Res. Management & Support 1,692,585

5%

Adapted from the NIH Data Book, www.report.nih.gov

~$27,000,000,000

March 1, 2017

FreeMind Group, LLC

4200

4250

4300

4350

4400

4450

4500

4550

4600

4650

4700

4750

FY 2014 Actual FY 2015 Actual FY2016 Enacted FY 2017 President's Budget

NIAID Budget (Dollars in Millions)

NIAID Budget (Dollars in Millions)

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Pocket of Money

NIAID Budget

March 1, 2017

FreeMind Group, LLC

• $5.25B in funding for Infectious diseases

• ~$1.9B in funding for Biodefense

• NIAID has one of the best success rates in the NIH with 24% success

in contrast to the 19.1% average for 2016.

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Pocket of Money

NIH Categorical Spending

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FreeMind Group, LLC 7

NIAID – Bugs of Interest

NIAID Newly appeared in a population or

Existed but rapidly increasing in incidence or geographic range, or

Are caused by one of the NIAID Category A, B, or C priority pathogens.

A

•Anthrax

•Botulism

•Dengue

•Plague

•Ebola

•Tularemia

•etc…

B

•Q Fever

•Brucellosis

•Salmonella

•Hepatitis A

•West Nile Virus

•etc…

C

•Yellow Fever

•Tuberculosis

• Influenza

•Rabies

•Chikungunya

•SARS

•etc…

https://www.niaid.nih.gov/research/emerging-infectious-diseases-

pathogens

March 1, 2017

FreeMind Group, LLC

Funding Routes

1. Solicited – Address a specific area of interest

2. Unsolicited – Investigator Initiated R21, RO1, SBIR - Try to

establish interest prior to submitting

3. Broad Agency Announcements (BAAs)

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Submission Types

Routes

March 1, 2017

FreeMind Group, LLC

NIH – Preclinical Funding

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NIH - Preclinical

NIH

March 1, 2017

FreeMind Group, LLC

Funding:• Direct costs of up to $750k per year over up to 5 years• Additional $300k for purchasing equipment.• Total award including overhead may be up to $5.25M

Scope:• Supports milestone-driven projects focused on developing and

utilizing novel predictive assays, models and/or research tools.• Must focus on one or more of the following: CRE, MDR

Acinetobacter or MDR Pseudomonas aeruginosa.• Projects must complete assay/tool/model development prior to

the end of the third year of the project period.

March 1, 2017 10

Partnerships for the Development of Tools to Advance Therapeutic Discovery for Select Antimicrobial-Resistant Gram-Negative Bacteria (R01)

NIAID – R01

Deadline:

May 17, 2017

RFA-AI-16-081

FreeMind Group, LLC

Funding:

• Direct costs of up to $300k per year over up to 3 years

• Total award including overhead may be up to $1.2M

Scope:

• CounterACT aims to develop new and improved therapeutics to treat and/or prevent injuries resulting from chemical threats.

• Supported activities: confirmation of molecular targets, demonstration of in vitro activity, preliminary in vivo efficacy, preliminary ADME/Tox evaluations and PK/PD data.

March 1, 2017 11

Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01)

NIH – U01

Deadline:

September 12, 2017

PAR-16-330

FreeMind Group, LLC

Funding:

• Budgets are not capped, funding for up to 5 years.

• We recommend not asking for more than $2.5M without pre-approval.

Scope:

• Supported activities: GLP IND-enabling safety studies and pivotal efficacy studies in animals, cGMP production, and human safety clinical trials.

• Viewed by BARDA as a stepping stone towards receiving BARDA support.

March 1, 2017 12

Countermeasures Against Chemical Threats (CounterACT): Optimization of Therapeutic Lead Compounds (U01)

NIH – U01

Deadline:

September 12, 2017

PAR-16-331

FreeMind Group, LLC

NIH – Clinical Funding

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NIH - Preclinical

NIH

March 1, 2017

FreeMind Group, LLC

Funding:

• Up to ~$200k total award

Scope:

• Fundable activities include establishing the team, site & collaborator identification, study design, protocol development and various other activities.

March 1, 2017 14

NIAID Clinical Trial Planning Grant (R34)

NIAID – R34

Deadline:

May 12, 2017

PAR-16-272

FreeMind Group, LLC

Funding:

• Up to $1.5M for Phase II, $1.7M for Fast Track.

• Cap may be exceeded for research on specific topics, one of these is “Discovery & development of therapeutics for infectious diseases.”

Scope:

• Support for hypothesis-driven, milestone-driven clinical trials.

• Commercialization Plan must be included NIAID can decide if IND / IDE is required

March 1, 2017 15

NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)

NIAID – U44

Deadline:

May 12, 2017

PAR-16-271

FreeMind Group, LLC

Funding:

• No budget cap, up to 5 years of funding.

Scope:

• Will accept applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials.

• Has R01 equivalent for “Low-risk” trials.

March 1, 2017 16

NIAID Clinical Trial Implementation Cooperative Agreement (U01)

NIAID – U01

Deadline:

May 12, 2017

PAR-16-270

FreeMind Group, LLC

Biomedical Advanced Research and Development Authority

(BARDA)

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BARDA

BARDA

March 1, 2017

FreeMind Group, LLC

The mission of BARDA is to develop and procure medical countermeasures that address chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.

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BARDA

BARDA

DiscoveryPreclinical

DevelopmentPhase I Phase II Phase III Licensure

Production and DeliveryPHASES

IND NDA/BLA

Licensed Product

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

PROBABILITY OF SUCCESS TO LICENSURE

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

PipelinePhase Cost

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

March 1, 2017

FreeMind Group, LLC

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

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

• Carefully craft your whitepaper ensuring your science is well presented and represented and meets the guidelines and specification of the solicitation.

• Very short documents, must be coherent & concise.

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BARDA

Stage 1Pre-Application

REVIEW

Stage 2Full Application

Technical Review

AWARD $$$

Stage 3Contract

Negotiations

March 1, 2017

FreeMind Group, LLC

Funding:

• No budget cap

• Extremely high funding levels possible

Scope:

• Clinical development of Vaccines, Antitoxins and Therapeutic Proteins, Antimicrobial Therapeutics, Radiological / Nuclear Threat Medical Countermeasures, Chemical Threat Medical Countermeasures & Clinical Diagnostics.

March 1, 2017 20

Broad Agency Announcement (BAA) for the Advanced Research and Development of Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures for BARDA

BARDA – BAA

Deadline:

Rolling

BAA-16-100-SOL-00001

FreeMind Group, LLC

CARB-X

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CARB-X

CARB-X

March 1, 2017

FreeMind Group, LLC

• Global public-private partnership focused on antibacterial development.

• Funded by BARDA, NIAID, Wellcome Trust, AMR Center, CLSI & MassBio.

• Accelerator that provides funding, business services and scientific services.

• $350M in funding made available over the next 5 years.

• Next cycle expected in September.

March 1, 2017 22

The CARB-X Initiative

CARB-X

FreeMind Group, LLC

Department of Defense

(DoD)

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Department of Defense

DoD

FreeMind Group, LLC 24

Department of Defense

DTRA, USAMRMC, DARPA

DTRA: “Safeguard the United States and its allies from Weapons of Mass Destruction”

DARPA:“to maintain the technological superiority of the U.S. military…. by sponsoring revolutionary, high-payoff research that bridges the gap between fundamental discoveries and their military use.”

USAMRMC: “provide solutions to medical problems of importance to the American warfighter at home and abroad”.

March 1, 2017

FreeMind Group, LLC

Defense Threat Reduction Agency

(DTRA)

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Defense Threat Reduction Agency

DTRA

FreeMind Group, LLC

Funding:

• No budget cap

• You must justify what you ask for

Scope:

• Detection - Chemical and Biological

• Information Systems Capability Development

• Protection - Individual and Collective

• Hazard Mitigation

• Threat Agent Science

• Medical Pretreatments

• Medical Diagnostics

• Medical Therapeutics

• Threat Surveillance - Chemical and Biological.

March 1, 2017 26

Chemical/Biological Technologies FY2017 Program Build DTRA BAA

DTRA – BAA

Deadline:

Rolling

HDTRA1-17-S-0001

FreeMind Group, LLC

US Army

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The US Army

USAMRMC

March 1, 2017

FreeMind Group, LLC

Funding:

• No budget cap

• You must justify what you ask for

Scope:

• Aims provide solutions to medical problems of importance to the American war fighter.

• Military Infectious Diseases, Combat Casualty Care, Military Operational Medicine, Clinical and Rehabilitative Medicine, Military Biological Defense, Medical Chemical Defense, Medical Simulation & Information Sciences.

March 1, 2017 28

United States Army Medical Research and Materiel Command (USAMRMC) BAA for Extramural Medical Research

USAMRMC – BAA

Deadline:

Rolling

W81XWH-17-R-BAA1

FreeMind Group, LLC

Defense Advanced Research Projects Agency

(DARPA)

March 1, 2017 29

Defense Advanced Research Projects Agency

DARPA

FreeMind Group, LLC

Funding:• Up to $750kScope:• Aim to leverage biology as a technology to solve intractable

problems• Seeks to leverage advances in engineering and computer

science to drive and reshape biotechnology for national security

• Interested in a range of emerging technical areas ,including human-machine interfaces, human performance, infectious disease, and synthetic biology.

• Goal: to develop, demonstrate & transition biologically based technologies as part of the national security toolkit

March 1, 2017 30

DARPA Biological Technologies EZ BAA

DARPA

Deadline:

Rolling

HR001117S0005

FreeMind Group, LLC 31

NIH Review Process

Risk Management

Scientific Approach

Leadership

Environment

Significance

Innovation

Risk

Strength

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FreeMind Group, LLC 32

Maximizing Your Chances

Key Issues

Know the interests of the Agency

Present a complete, focused project

Ask for what is necessary

Leverage on research collaborations

Systematic Approach

March 1, 2017

FreeMind Group, LLC 33

Maximizing Your Chances

Key Issues

Different “pockets of money”

Different size of award/success rates

Conduct a thorough strategic assessment

Multi-Submission Granting Strategy

Target the Right Mechanism

March 1, 2017

FreeMind Group, LLC 34

FreeMind Group Professional Process

Core Service 1- Strategic Assessment

Long term Strategic approach Outline projects Tasks to be completed Link with existing pockets of money Solicited vs. Unsolicited Map of relevant funding opportunities

Core Service 2- Project Production Process

Project Management - coordinating Comprehensive templates Ongoing feedback and edits Budgets Converge information Final outcome – single coherent presentation

March 1, 2017

FreeMind Group, LLC 35

Thank you!

Contact Us!

Watch past presentations and webinars online on our YouTube Channel

Join our LinkedIn network and follow us on Twitter for updates and announcements relating to non-dilutive funding

www.freemindconsultants.com

FreeMindGroup

@FreeMindGrp

FreeMind Group

Jonathan AdalistSenior Director, Business Development

jonathan@freemindconsultants.com

+1 (617) 648-0340 ext 285

March 1, 2017