the national institute of diabetes and digestive and kidney … · 2017-08-31 · the national...
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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
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• 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
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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
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• 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
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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
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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
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• 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
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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
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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
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• 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
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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
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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
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Joint Effort
FMG Professional Process
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Contact Us!
Thank you!
Jonathan Adalist
Senior Director, Business [email protected]
(617) 648 0340 ext. 285
www.freemindconsultants.com
FreeMindGroup FreeMindGrp
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