The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) as a source of Non-Dilutive Funding

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Magdalene Bell
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1 @FreeMindGrp FreeMind Group The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) as a source of Non-Dilutive Funding FreeMind Group Webinar Jonathan Adalist FreeMind Group, LLC 1/25

2 The Global Non-Dilutive Funding Leader FreeMind Group, LLC Est Fulltime Employees Diverse Client Base: Academics, University Medical Centers, and Independent Research Institutes Industry Small Startups to Large Pharmaceutical Companies. ~ Applications Annually FreeMind Group, LLC 2/25

3 A Tool to Max. Your Funding Potential Non-Dilutive Funding A Strategic Financial Tool 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 FreeMind Group, LLC 3/25

Other HHS Organizations BARDA, FDA, CDC, NSF Department of Defense (DOD) US Army,

4 $50B+ Allocated Annually Non-Dilutive Market 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 FreeMind Group, LLC 4/25

5 NIH 2016 Budget - $32.31B Res. Management & Support 1,692,585 5% All others $733,923 2% Intramural Research $3,581,878 11% Research & Develop. Contracts $2,995,825 10% Research Projects $17,820,973 55% Training $830,430 3% Other Research $2,010,924 6% ~$27,000,000,000 Research Centers $2,644,811 8% Adapted from the NIH Data Book, FreeMind Group, LLC 5/25

6 The NIDDK NIDDK - Background 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. FreeMind Group, LLC 6/25

7 The NIDDK Budget NIDDK 2016 Budget breakdown 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 FreeMind Group, LLC 7/25

8 NIDDK Funding Mechanisms SBIR/STTRs FreeMind Group, LLC 8/25

9 Lead Optimization and Pre-Clinical Development of Therapeutic Candidates for Diseases of Interest to the NIDDK (R43/R44) NIDDK PAR 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. Next Due Date: Jan 5, 2017 Has STTR equivalent 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. FreeMind Group, LLC 9/25

10 Additional SBIR/STTRs NIDDK Funding Mechanisms 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 FreeMind Group, LLC 10/25

11 PHS Omnibus Solicitation of the NIH, CDC, FDA, and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44]) NIH. CDC, FDA, ACF PAR 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. Next Due Date: Jan 5, 2017 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 FreeMind Group, LLC 11/25

12 NIDDK Funding Mechanisms Pre-Clinical Research FreeMind Group, LLC 12/25

13 Assay Development and Screening to Discover Therapeutic or Imaging Agents for Diseases of Interest to the NIDDK (R01) NIDDK PAR Next Due Date: Feb 5, 2017 Funding: Application budgets are not capped but 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. FreeMind Group, LLC 13/25

14 Early-Stage Preclinical Validation of Therapeutic Leads for Diseases of Interest to the NIDDK (R01) NIDDK PAR Next Due Date: Feb 5, 2017 Funding: Application budgets are not capped but 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 healthrelated outcomes relevant to the NIDDK. FreeMind Group, LLC 14/25

15 NIDDK Funding Mechanisms Clinical Research FreeMind Group, LLC 15/25

16 NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34) NIDDK PAR Next Due Date: Jan 20, 2017 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. FreeMind Group, LLC 16/25

17 Pilot and Feasibility Clinical Trials in Diabetes, and Endocrine and Metabolic Diseases (R21) NIDDK Funding: Up to $275K in Direct Costs (~$350K- 385K total award) over up to 2 years. PAR Next Due Date: Feb 16, 2017 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. FreeMind Group, LLC 17/25

18 NIDDK Funding Mechanisms Similar mechanisms funding pilot clinical trials 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) FreeMind Group, LLC 18/25

19 NIDDK Multi-Center Clinical Study Cooperative Agreement (U01) NIDDK PAR Next Due Date: Feb 5, 2017 Funding: Application budgets are not capped but 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. FreeMind Group, LLC 19/25

20 NIH Review Process Risk Management Responsive vs. Competitive Leadership Innovation Scientific Approach Environment Risk Strength Significance FreeMind Group, LLC 20/25

21 Maximizing your Chances Key Issues Systematic Approach Know the interests of the Agency Present a complete, focused application Ask for what is necessary Leverage on research collaborations FreeMind Group, LLC 21/25

22 Maximizing your Chances Key Issues Target the Right Mechanism Different pockets of money Different sizes of awards/success rates Conduct a thorough strategic assessment Multi-submission granting Strategy FreeMind Group, LLC 22/25

FMG Professional Process Two Core Services Core Service 1- Strategic Consulting

2- Project Production Process Project Management - coordinating Comprehensive

23 FMG Professional Process Two Core Services 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 FreeMind Group, LLC 23/25

24 FMG Professional Process Joint Effort FreeMind Group, LLC 24/25

25 Thank you! Contact Us! Jonathan Adalist Senior Director, Business Development FreeMindGroup FreeMindGrp Watch past presentations and webinars online on our YouTube Channel (617) ext FreeMind Group, LLC 25/25

Non-Dilutive Funding For Clinical Stage R&D

FreeMindGroup FreeMind Group @FreeMindGrp Non-Dilutive Funding For Clinical Stage R&D Meytal Waiss Director, Business Development FreeMind Group The Global Non-Dilutive Funding Leader FreeMind Group, LLC