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Shira Aharoni Machluf Director, Business Development FreeMind Group Non-Dilutive Funding Opportunities for Cancer R&D FreeMindGroup @FreeMindGrp FreeMind Group

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Page 1: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

Shira Aharoni MachlufDirector, Business DevelopmentFreeMind Group

Non-Dilutive Funding Opportunities for Cancer R&D

FreeMindGroup

@FreeMindGrp

FreeMind Group

Page 2: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

April 5, 2017 2/32

FreeMind Group, LLC

FreeMind Group, LLC www.freemindconsultants.com

Est. 1999

60 Fulltime Employees

Diverse Client Base:

Academics, University Medical Centers, and Independent Research Institutes

Industry – Small Startups to Large Pharmaceutical Companies

450-500 Applications Annually

FreeMind Group

Page 3: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

Identify 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

A Tool to Maximize Your Funding Potential

FreeMindGroup, LLC

3/32FreeMind Group, LLC

www.freemindconsultants.com

Non-Dilutive Funding – A Strategic Financial Tool

April 5, 2017

Page 4: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

FreeMind Group, LLC 4/32

NIH 2017 Budget - $33.1B

Research Projects $17,820,973

55%

Research Centers $2,644,811

8%

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%

All others $733,9232%

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

~$27,000,000,000

April 5, 2017

Page 5: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

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National Cancer Institute -

Budget

NCI’s Pocket Of Money

NCI Budget

FreeMind Group, LLC www.freemindconsultants.com

4500

4700

4900

5100

5300

5500

5700

5900

FY 2013 Actual FY 2014 Actual FY 2015 Actual FY 2016Enacted

FY 2017Presidnt's

Budget

Mill

ion

s o

f D

olla

rs

NCI Budget

April 5, 2017

18.8% Increase!

Page 6: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

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National Healthcare

burden

Some Interesting Statistics

https://costprojections.cancer.gov/expenditures.html

FreeMind Group, LLC www.freemindconsultants.com

April 5, 2017

Page 7: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

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Some Interesting Statistics

FreeMind Group, LLC www.freemindconsultants.com

April 5, 2017

The cost of cancer care for 2020 is estimated to

be $157 billion (in 2010 dollars).

Growth and Aging of the U.S. population is the

primary cause

Page 8: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

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Some Interesting Statistics

FreeMind Group, LLC www.freemindconsultants.com

https://report.nih.gov/categorical_spending.aspx

Cancer Type

0

100

200

300

400

500

600

700

800

Mill

ion

s o

f D

olla

rs

FY 2017 Estimated Research Funding by Cancer Type

Long Tail…

April 5, 2017

Page 9: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

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Submission Types

FreeMind Group, LLC www.freemindconsultants.com

Routes

April 5, 2017

~65% of the awards are granted through the unsolicited mechanism

Funding Routes

1. Solicited – Address a specific area

of interest

2. Unsolicited – Investigator Initiated

R21, RO1, SBIR - Try to establish

interest prior to submitting

Page 10: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

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Funding Opportunities

NIH

Unsolicited Opportunities

FreeMind Group, LLC www.freemindconsultants.com

April 5, 2017

Page 11: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

April 5, 2017 FreeMind Group, LLC

NIH, FDA, CDC, ACF

PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for SBIR Grant Applications Parent (PA-16-302)

Funding: $225K for Phase I (total costs) and up to $1.5M (total costs) for 2 years for Phase II

Scope:

Eligible United States small business concerns (SBCs) only.

SBCs that have the research capabilities and technological expertise to contribute to the R&D mission(s) of the NIH, CDC, FDA or ACF awarding components identified in this FOA are encouraged to submit SBIR grant applications in response to identified topics.

The equivalent NIH’s STTR is PA-16-303.

Deadline:Today!

Upcoming deadline isexpected to be on Sep 5th.

11/32FreeMind Group, LLC

www.freemindconsultants.comApril 5, 2017

Page 12: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

FreeMind Group, LLC

NCI Funding: $275K (direct costs) for 2 years

Scope:

Development of new exploratory research in cancer diagnosis, treatment, imaging, symptom/toxicity, and prevention clinical trials.

Your project may involve considerable risk, but may lead to a breakthrough in a particular area, or to the development of novel techniques, agents, methodologies, models, or applications that could have a major impact on a field of cancer research.

Deadline:June 19, 2017

12/32FreeMind Group, LLC

www.freemindconsultants.comApril 5, 2017

NCI Clinical and Translational Exploratory/Developmental Studies (R21) (PA-16-176)

Page 13: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

FreeMind Group, LLC

NIH Funding: Application budgets are not limited but need to reflect the actual needs of the proposed project

Scope:

The NIH Research Project Grant supports a discrete, specified, circumscribed project in areas representing the specific interests and competencies of the investigator(s).

Deadline:June 5, 2017

13/32FreeMind Group, LLC

www.freemindconsultants.comApril 5, 2017

NIH Research Project Grant (Parent R01) (PA-16-160)

Page 14: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

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Funding Opportunities

NIH

Solicited Opportunities

FreeMind Group, LLC www.freemindconsultants.com

April 5, 2017

Page 15: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

FreeMind Group, LLC

NCI, NIBIB Funding: $275K (direct costs) for 2 years.

Scope:

Encourage submission of applications which establish the feasibility of technologies, techniques or methods that:

1. explore a new multidisciplinary approach to a biomedical challenge;

2. are high-risk but have high impact

3. develop data that may lead to significant future research

The equivalent R01 is PA-16-242-the budget is up to $2.5M.

Deadline:R21- June 16th

R01-June 5th

15/32FreeMind Group, LLC

www.freemindconsultants.comApril 5, 2017

Exploratory/Developmental Bioengineering Research Grants (R21) (PA-16-040)

Page 16: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

FreeMind Group, LLC

NIHFunding: $275K (direct costs) for 2 years.

Scope:

High throughput screens for targets that address unmet needs in cancer prevention, treatment or diagnosis are encouraged.

This program intends to support mainly the following two stages of discovery research:

1. HTS assay implementation and

2. Hit validation

The equivalent R01 is PAR-14-284- no budget limitation.

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High Through Put Screening (HTS) to Discover Chemical Probes (R21) (PAR-14-283)

FreeMind Group, LLC www.freemindconsultants.com

Deadline:R21- June 16R01- June 5

April 5, 2017

Page 17: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

FreeMind Group, LLC

NCIFunding: Up to $500K/year (direct costs) for up to 5 years= up to $2.5M.

Scope:

Translation of scientific discoveries and engineering developments in imaging or spectroscopic technologies into methods or tools that address problems in cancer biology, risk of cancer development, diagnosis,

treatment, and/or disease status.

A distinguishing feature of each application will be formation of an academic-industrial partnership.

Deadlines:June 7, 2017

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Academic-Industrial Partnerships to Translate and Validate In-Vivo Cancer Imaging Systems (R01) (PAR-17-093)

FreeMind Group, LLC www.freemindconsultants.com

April 5, 2017

Page 18: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

FreeMind Group, LLC

NIBIBFunding: Up to $500K/year (direct costs) for up to 5 years= up to $2.5M.

Scope:

The purpose of this funding opportunity announcement is to encourage collaborations between the life and physical sciences that:

1. Apply a multidisciplinary bioengineering approach to the solution of a biomedical problem.

2. Integrate, optimize, validate, translate or otherwise accelerate the adoption of promising tools, methods and techniques for a specific research or clinical problem in basic.

Deadlines:June 5, 2017

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Academic-Industrial Partnerships for Translation of Technologies for Cancer Diagnosis and Treatment (R01) (PAR-15-075)

FreeMind Group, LLC www.freemindconsultants.com

April 5, 2017

Page 19: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

FreeMind Group, LLC

NIHFunding: Up to $500K/year (direct costs) for up to 3 years= up to $1.5M.

Scope:

It is expected that applicants will have in hand the starting compounds (“validated hits”) for chemical optimization and bioassays for testing new analog compounds.

The NCI is particularly interested in validated hits for targets that address unmet needs in the prevention, treatment, or diagnosis of cancer. Strategies that include testing of in vivo chemical probe activity in primary human tumor cells are encouraged.

Deadlines:June 5 2017

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Discovery of in vivo Chemical Probes (R01) (PAR-14-279)

FreeMind Group, LLC www.freemindconsultants.com

April 5, 2017

Page 20: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

FreeMind Group, LLC

NCIFunding: Up to $500K/year (direct costs) for up to 3 years= up to $1.5M.

Scope:

The purpose of this opportunity is to:

1. Invite researchers to submit collaborative research project applications to improve cancer screening, early detection of aggressive cancer and more.

2. Establish a Consortium for Imaging and Biomarkers (CIB) to perform collaborative studies.

Deadlines:July 10, 2017

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Imaging and Biomarkers for Early Detection of Aggressive Cancer (U01) (PAR-16-051)

FreeMind Group, LLC www.freemindconsultants.com

April 5, 2017

Page 21: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

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Funding Opportunities

NSF – SBIR/STTRs

FreeMind Group, LLC www.freemindconsultants.com

April 5, 2017

Page 22: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

April 5, 2017 FreeMind Group, LLC

NSF

NSF SBIR/STTR

Funding: Phase I up to $225,000 for up to 1 year.Phase II up to $750,000 for a period of up to 2 years.

Scope:

Eligible United States small business concerns (SBCs) only.

NSF supports startups to develop innovative, disruptive technologies, getting discoveries out of the lab and into the market.

Nanotechnology, advanced materials and manufacturing.

Biomedical technologies: Diagnostic assays & platforms and Drug delivery.

Deadline:June 14, 2017

22/32FreeMind Group, LLC

www.freemindconsultants.comApril 5, 2017

Page 23: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

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Funding Opportunities

FDA

FreeMind Group, LLC www.freemindconsultants.com

April 5, 2017

Page 24: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

FreeMind Group, LLC

Clinical studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

FDAFunding: Phase I up to $250K /year for up to 3 years. Phase II and III up to $500K /year for up to 4

years.

Scope:

FDA supports the clinical development of products for use in rare diseases or conditions.

FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products.

Deadline:Feb 7, 2018

24/32FreeMind Group, LLC

www.freemindconsultants.comApril 5, 2017

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Funding Opportunities

DOD – CDMRPs

FreeMind Group, LLC www.freemindconsultants.com

April 5, 2017

Page 26: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

FreeMind Group, LLC

Congressionally Directed Medical Research Programs (CDMRP)

Funding (for 2016): $1.065B across programs.

Awards up to $5,000,000

Some programs cover clinical trials.

Budget:

Breast Cancer Research Program - $120M

Lung Cancer Research Program - $12M

Ovarian Cancer Research Program - $20M

Prostate- $80M

Peer Reviewed Cancer Research Program - $50M

Deadline:Will be announced later this month!

Stage 1 Whitepaper

REVIEW

Stage 2Full Application

REVIEW

AWARD $$$

Submission Process

Issued annually by the DOD, typically around April.

Follow: www.cdmrp.org

26/32FreeMind Group, LLC

www.freemindconsultants.comApril 5, 2017

Page 27: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

FreeMind Group, LLC www.freemindconsultants.com

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CDMRP

CDMRP Breast Cancer Research Program-Breakthrough Award Level 4

Funding: Budgets up to $10M up to 4 years.

Scope :

BCRP seeks to accelerate high-impact research with clinical relevance, encourage innovation and stimulate creativity, and facilitate productive collaborations in the field of breast cancer.

This program provides funding for advanced translational studies that have potential for near-term clinical investigation and also small-scale clinical trials.

Deadlines:Will be

announced soon!

April 5, 2017

Page 28: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

Risk Management

NIH Review Process

Scientific Approach

Leadership

Environment

Significance

Innovation

Risk

Strength

28/32FreeMind Group, LLC

www.freemindconsultants.comApril 5, 2017

Page 29: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

Key Issues

Maximizing your Chances

Different “pockets of money”

Different sizes of awards/success rates

Conduct a thorough strategic assessment

Target the Right Mechanism

FreeMind Group, LLC www.freemindconsultants.com

29/32April 5, 2017

NDF

Page 30: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

April 5, 2017 FreeMind Group, LLC 30/32

Strategic Approach

Maximize your Chances

Seek insight into the interests and goals of the funding agencies

Correlate the granting strategy with your long term R&D plan

Identify ALL relevant funding opportunities

Plan and execute on a long-term Multi-Submission Granting Strategy

NDF

Page 31: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

April 5, 2017 FreeMind Group, LLC 31/32

Maximize Funding Potential

FreeMind Group, LLC

What do we do?

1. Identify ALL relevant funding opportunities

2. Create a multi-submission granting strategy

3. Submit as many top quality applications as possible

Page 32: Non-Dilutive Funding Opportunities for Cancer R&D · Nanotechnology, advanced materials and manufacturing. Biomedical technologies: Diagnostic assays & platforms and Drug delivery

April 5, 2017 FreeMind Group, LLC

Contact Us!

Thank you!

Shira Aharoni Machluf, MBADirector, Business Development

[email protected]

617-648-0340 ext 285

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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