The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

as a source of Non-Dilutive Funding

FreeMind Group WebinarJonathan AdalistOctober 13, 2016

@FreeMindGrp

FreeMind Group

FreeMind Group, LLC 1/25October 13, 2016

October 13, 2016 FreeMind Group, LLC 2/25

The Global Non-Dilutive Funding Leader

FreeMindGroup, LLC

• Est. 1999

• 55 Fulltime Employees

• Diverse Client Base:

• Academics, University Medical Centers, and Independent Research Institutes

• Industry – Small Startups to Large Pharmaceutical Companies.

• ~400-450 Applications Annually

October 13, 2016 FreeMind Group, LLC 3/25

• Identify most relevant funding opportunities

• Strategize to maximize application’s chances of success

• Manage complex project production processes

• Lead joint application writing

• Support final contract negotiations

A Tool to Max. Your Funding Potential

Non-Dilutive Funding – A Strategic Financial Tool

FreeMind Group, LLC

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

4/25October 13, 2016

October 13, 2016FreeMind Group, LLC

www.FreeMindConsultants.com5/25

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

October 13, 2016 FreeMind Group, LLC 6/25

• One of the 5 largest institutes in the NIH.

• Supports research on kidney, urologic, hematologic,

digestive, metabolic and endocrine diseases, as well as on

diabetes and nutrition.

• FY 2016 enacted budget of over $1.8 Billion.

The NIDDK

NIDDK - Background

October 13, 2016 FreeMind Group, LLC 7/25

Of the ~$1.82B 2016 enacted budget, ~$1.56 is devoted to

extramural research.

• Diabetes, Endocrinology, and Metabolic Diseases - $641M

• Digestive Diseases and Nutrition - $483M

• Kidney, Urologic, and Hematologic Diseases - $439M

The NIDDK Budget

NIDDK – 2016 Budget breakdown

October 13, 2016 FreeMind Group, LLC 8/25

NIDDK Funding Mechanisms

SBIR/STTRs

FreeMind Group, LLC

NIDDK

Lead Optimization and Pre-Clinical Development of Therapeutic Candidates for Diseases of Interest to the NIDDK (R43/R44)

Funding:

Phase I – Up to $225K over 1 year.

Phase II – Up to $1.5M over 2 years.

Fast Track – Up to $1.725M over 3 years.

Scope:• Designed to support lead optimization and

preclinical development of new therapies for diseases within the mission of the NIDDK.

• Projects must be sufficiently advanced such that an IND/IDE application can be submitted by the end of a Phase II.

• Applications should be milestone driven.

Next Due Date:

Jan 5, 2017

9/25October 13, 2016

PAR-14-055

Has STTR equivalent

October 13, 2016 FreeMind Group, LLC 10/25

• SBIR/STTR to Develop New Diagnostic, Monitoring and

Therapeutics Technologies for the Complications of Type 1

Diabetes

• New Technologies for Viral Hepatitis

• Kidney Precision Medicine Project - Technology

Development and Validation

NIDDK Funding Mechanisms

Additional SBIR/STTRs

FreeMind Group, LLC

NIH. CDC, FDA, ACF

PHS 2016-02 Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])

Funding:

Phase I – Up to $225K over 1 year.

Phase II – Up to $1.5M over 2 years.

Fast Track – Up to $1.725M over 3 years.

Scope:• Funds R&D across a wide variety of topics• Encourages submissions in areas aligned with

the missions of all participating organizations• Allows direct to phase II applications• NIDDK will not fund Clinical Trials via this

mechanism

Next Due Date:

Jan 5, 2017

11/25October 13, 2016

PAR-16-302

October 13, 2016 FreeMind Group, LLC 12/25

NIDDK Funding Mechanisms

Pre-Clinical Research

FreeMind Group, LLC

NIDDK

Assay Development and Screening to Discover Therapeutic or Imaging Agents for Diseases of Interest to the NIDDK (R01)

Funding: Application budgets are not cappedbut must to reflect the actual needs of the proposed project.

Scope:• This mechanism can be used to develop,

validate, or conduct a screen using a novel assay to identify therapeutic or imaging agents relevant to health related outcomes of interest to the NIDDK.

• At the end of the project period, a successful project will have either developed and validated a novel assay, or identified a prototype therapeutic or imaging agent.

Next Due Date:

Feb 5, 2017

13/25October 13, 2016

PAR-16-374

FreeMind Group, LLC

NIDDK

Early-Stage Preclinical Validation of Therapeutic Leads for Diseases of Interest to the NIDDK (R01)

Funding: Application budgets are not cappedbut must to reflect the actual needs of the proposed project.

Scope:• The goal of this mechanism is to translate

basic science research into knowledge and tools that can be utilized to provide strong justification for later-phase therapeutics discovery and development efforts in health-related outcomes relevant to the NIDDK.

Next Due Date:

Feb 5, 2017

14/25October 13, 2016

PAR-16-121

October 13, 2016 FreeMind Group, LLC 15/25

NIDDK Funding Mechanisms

Clinical Research

FreeMind Group, LLC

NIDDK

NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34)

Funding: Up to 450K over 2 years.

Scope:• Designed to:

• Permit early peer review of the rationale for the proposed clinical study

• Permit assessment of the design and protocol of the proposed study

• Provide support for the development of documents needed for the conduct of the study, including a manual of operations;

• Support the development of other essential elements required for the conduct of a clinical study.

Next Due Date:

Jan 20, 2017

16/25October 13, 2016

PAR-15-068

FreeMind Group, LLC

NIDDK

Pilot and Feasibility Clinical Trials in Diabetes, and Endocrine and Metabolic Diseases (R21)

Funding: Up to $275K in Direct Costs (~$350K-385K total award) over up to 2 years.

Scope:• Supports short-term clinical trials in humans

to acquire preliminary data and/or refine power calculations that would lead to a larger, more definitive study.

Next Due Date:

Feb 16, 2017

17/25October 13, 2016

PAR-15-176

October 13, 2016 FreeMind Group, LLC 18/25

• Pilot and Feasibility Clinical and Translational Research Studies in

Digestive Diseases and Nutrition (R21)

• Pilot and Feasibility Clinical Research Grants in Kidney Diseases (R21)

• Pilot and Feasibility Clinical Research Grants in Urologic Disorders (R21)

• Exploratory/Developmental Clinical Research Grants in Obesity (R21)

NIDDK Funding Mechanisms

Similar mechanisms funding pilot clinical trials

FreeMind Group, LLC

NIDDK

NIDDK Multi-Center Clinical Study Cooperative Agreement (U01)

Funding: Application budgets are not cappedbut must to reflect the actual needs of the proposed project.

Scope:• Funds investigator-initiated, multi-center

clinical studies. Proposed studies should be hypothesis-driven and focus on a disease relevant to the mission of NIDDK.

Next Due Date:

Feb 5, 2017

19/25October 13, 2016

PAR-15-067

FreeMind Group, LLC

Risk Management

NIH Review Process

Scientific Approach

Leadership

Environment

Significance

Innovation

Risk

Strength

Responsive vs. Competitive

20/25October 13, 2016

October 13, 2016 FreeMind Group, LLC 21/25

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

October 13, 2016 FreeMind Group, LLC 22/25

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

FreeMind Group, LLC

Two Core Services

FMG Professional Process

Core Service 1- Strategic Consulting

• Long term Strategic approach

•Outline projects

•Tasks to be completed

• Link with existing pockets of money

• Solicited vs. Unsolicited

•Map of relevant funding opportunities

•Ongoing Activity

Core Service 2- Project Production Process

•Project Management - coordinating

•Comprehensive templates

•Ongoing feedback and edits

•Budgets

•Converge information

• Final outcome – single coherent presentation

23/25October 13, 2016

FreeMind Group, LLC

Joint Effort

FMG Professional Process

24/25October 13, 2016

October 13, 2016 FreeMind Group, LLC 25/25

Contact Us!

Thank you!

Jonathan Adalist

Senior Director, Business Developmentjonathan@freemindconsultants.com

(617) 648 0340 ext. 285

www.freemindconsultants.com

FreeMindGroup FreeMindGrp

Watch past presentations and webinars online on our YouTube Channel