Non-Dilutive Funding for Pre-Clinical Stage R&D · FreeMind Group Webinar B. Stuart Jacobowitz May...

Non-Dilutive Funding forPre-Clinical Stage R&D

FreeMind Group WebinarB. Stuart JacobowitzMay 18, 2016

@FreeMindGrp

FreeMind Group

FreeMind Group, LLC www.FreeMindConsultants.com

1/26May 18, 2016

FreeMind Group

May 18, 2016FreeMind Group, LLC

www.FreeMindConsultants.com2/26

The Global Non-Dilutive Funding Leader

FreeMind Group, LLC • Est. 1999

• 55 Fulltime Employees

• Diverse Client Base:

Academics, University Medical Centers, and Independent Research Institutes

Industry – Small Startups to Large Pharmaceutical Companies.

• ~400 Applications Annually



• Identify the most relevant funding opportunities

• Multi Submission Granting Strategy

• 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 Max. Your Funding Potential

FreeMind Group, LLC

Non-Dilutive Funding – A Strategic Financial Tool


Non-Dilutive Market

$50B+ Allocated Annually

• HHS- NIH

• 27 institutes and centers including

NCI, NIDDK, NINDS, NIAID, NIMH, NIBIB, NIDA, NHLBI, NEI, NIA, etc.

• Other HHS Organizations

• BARDA, FDA, CDC, NSF

• Department of Defense (DOD)

• US Army, DARPA, DTRA, CDMRP, etc.

• Private Foundations

• Gates, MJ Fox, ADDF, and many more

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Role of Non-Dilutive Funding in the Market

Future Returns on Investment

Milken Institute “Estimating Long-term Economic Returns of NIH on Output in the Bioscience” August 31st 2012

US ROI = $2.3

May 18, 2016 FreeMind Group, LLC 6/26

Role of Non-Dilutive Funding in the Market

Milken Institute “Estimating Long-term Economic Returns of NIH on Output in the Bioscience” August 31st 2012



NIH 2016 Budget - $32.31B

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

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%

~$27,000,000,000

Categorical Spending



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

May 19, 2016 FreeMind Group, LLC

Supports Complete R&D Process

DiscoveryPreclinical

DevelopmentPhase I Phase II Phase III Licensure

Production and Delivery

PHASES

IND NDA/BLA

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•NIH R21, R01

•SBIR PI, PII

•NSF

•DOD – US Army, DTRA, DARPA, CDMRPs

•NGO

•NIH R01, U01

•SBIR PII

•NSF

•DOD – US Army, DTRA, DARPA, CDMRP

•NGO

$500K -$3.5M

•SBIR PII

•U Mechanism

•BARDA

•DOD - CDMRP

•NGO

+3.5M

PROBABILITY OF SUCCESS TO LICENSURE

Licensed Product

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


www.FreeMindConsultants.com

•NIH R21, R01

•SBIR PI, PII

•NSF

•DOD – US Army, DTRA, DARPA, CDMRP

•NGO

$200-$2.5M

Definition of Preclinical



• A stage of research that begins before clinical trials can begin, and during which important feasibility, iterative testing and safety data are collected.

• Main goals in drug development: to determine the safe dose for first-in-man study and assess a product's safety profile.

• Products may include new medical devices, drugs, gene therapy solutions and diagnostic tools.



Pre-Clinical Funding Mechanisms

R21, R01, SBIR/STTR

• R21 - Early stage, exploratory, novel studies, high risk high reward,

• up to $275K + Indirect costs• Max duration 2 years

• R01 - Later stage research, longer term project,

• up to $2.5m + Indirect costs• Max duration 5 years

• SBIR / STTR – Congressionally mandated set-aside for US small businesses

• Phase 1 up to $225k• Phase 2 up to $1.5m



Pre-Clinical Funding Mechanisms

• CDMRP - Once a year program from DoD,

• R&D in areas of interest to Congress

• Budget & duration varies by solicitation

• Broad Agency Announcement (BAA)

• Either highly specific or could be relatively broad & generic, aimed at sourcing ideas in a specific area of interest

• Budget & duration varies by solicitation

CDMRP, BAA


Investigator Initiated

R01 and R21 Omnibus Solicitations

Parent Announcements – Omnibus Solicitations

• R21 - NIH Exploratory/ Developmental Research Grant Program

(Parent R21: PA-16-161)

$275,000 Direct costs up to 2 years

+ up to 40% Indirect Costs

• RO1 - Research Project Grant

(Parent R01: PA-16-160)

$500,000 Direct costs per year, up to 5 years

+ up to 40% Indirect Costs

Next Deadline:RO1 – June 5R21 – June 16

Standard Due Dates:R01 – June, Oct & Feb 5th

R21 – June, Oct & Feb 16th


www.freemindconsultants.com13/26


Investigator Initiated

SBIR / STTR Omnibus Solicitations

Parent Announcements – Omnibus Solicitations

• SBIR - NIH Exploratory/ Developmental Research Grant Program (PA-15-269)

• STTR - Research Project Grant

(PA-15-270)

Phase I: up to $225,000

Phase II: up to $1.5m up to 2 years

Next Deadline:SBIR & STTR: September 5

StandardDue Dates:

SBIR & STTR: Sept, Jan &

April 5



Funding Opportunities

Case StudiesInfectious Disease, Oncology

and Neuro



Case Study #1



Bac(t) to the Future • Background: US based company with 17

employees, raised $5M Series A. Developing novel broad spectrum antibiotics for the use in drug resistant bacteria.

• Stage of Development: Hit compound identified.

• R&D Plan: Initiate in-vivo studies to determine the PK, metabolism, formulation and toxicity as part of IND enabling studies.

Infectious Diseases

Case Study #1



NIH – NIAID• SBIR/STTR, R21, R01 Parent Announcements• Partnerships for Countermeasures Against

Select Pathogens (R01 - RFA-AI-16-034)

USAMRMC• BAA for Extramural Medical Research

(W81XWH-16-R-BAA1)

CDMRP• Military Infectious Diseases Research

Program (MIDRP)

Wellcome Trust• Translation Fund

Infectious Diseases

Case Study #2



OnCurable• Background: Small US company, with 3

co-founders/employees, invested themselves and raised $1m from friends & family. Developing immunotherapy based treatment for breast cancer.

• Stage of Development: the company has identified the antibody, and its safety and is now initiating in-vivo studies to determine the potency

• R&D Plan: Initiate in-vivo studies to determine efficacy of their treatment, as part of their IND enabling studies.

Oncology

Case Study #2



NIH – NCI• NIH Research Project Grant (Parent R01)• Direct Phase II SBIR Grants to Support

Biomedical Technology Development• NCI Clinical and Translational

Exploratory/Developmental Studies (R21)• Metabolic Reprogramming to Improve

Immunotherapy (R01 / R21) [PAR-16-228] [PAR-16-229]

CDMRP• Peer Reviewed Cancer Research Program Idea

Award with Special FocusBreast Cancer Research Foundation

Oncology

Case Study #3



Brain Freeze• Background: A US company, with 10

employees, spun out from University, raised $2M from various local grants. Developing a small molecule novel drug to treat ALS and other neurodegenerative diseases.

• Stage of Development: Hit compound identified.

• R&D Plan: Initiate in-vivo studies to determine the PK, metabolism, formulation and toxicity of their compound as part of their IND enabling studies.

Neurology

Case Study #3



NIH – NINDS• SBIR/STTR, R21, R01 Parent Announcements• Innovation Grants to Nurture Initial

Translational Efforts or IGNITE (R21 / R33)• BPN: Small Molecule Drug Disc. & Dev. for

Disorders of the Nervous System (U44)• Opportunities for Collaborative Research at the

NIH Clinical Center (U01) [PAR-15-287]• NeuroNEXT Infrastructure Resource Access

(X01) [PAR-15-195]CDMRP• Amyotrophic Lateral Sclerosis Research

Program Therapeutic Development AwardALS Association

Neurology


Risk Management

NIH Review Process

Scientific Approach

Leadership

Environment

Significance

Innovation

Risk

Strength

Responsive vs. Competitive

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Key Issues

Maximizing your Chances

• Know the interests of the Agency

• Present a complete, focused application

• Ask for what is necessary

• Leverage on research collaborations

Systematic Approach



Key Issues

Maximizing your Chances

• Different “pockets of money”

• Different sizes of awards/success rates

• Conduct a thorough strategic assessment

• Multi-submission granting Strategy

Target the Right Mechanism

FMG 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



Contact Us!

Thank you!

B. Stuart JacobowitzDirector, Business [email protected]

(617) 648 0340 ext. 288www.freemindconsultants.com

FreeMindGroup

FreeMindGrp

Watch past presentations and webinars online on our YouTube Channel

mailto:[email protected]

Non-Dilutive Funding for Pre-Clinical Stage R&D · FreeMind Group Webinar B. Stuart Jacobowitz May...

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