Non-Dilutive Funding forPre-Clinical Stage R&D
FreeMind Group WebinarB. Stuart JacobowitzMay 18, 2016
@FreeMindGrp
FreeMind Group
FreeMind Group, LLC www.FreeMindConsultants.com
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FreeMind Group
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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
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• 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
FreeMind Group, LLC www.FreeMindConsultants.com
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
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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
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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
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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%
May 18, 2016FreeMind Group, LLC
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•NIH R21, R01
•SBIR PI, PII
•NSF
•DOD – US Army, DTRA, DARPA, CDMRP
•NGO
$200-$2.5M
Definition of Preclinical
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• 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.
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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
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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
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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
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May 19, 2016 FreeMind Group, LLC
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
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Funding Opportunities
Case StudiesInfectious Disease, Oncology
and Neuro
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Case Study #1
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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
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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
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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
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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
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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
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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
FreeMind Group, LLC www.FreeMindConsultants.com
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
FMG Professional Process
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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
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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
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