Medical Device Non-Dilutive Funding: Trends & Opportunities · research or clinical problem in...
Transcript of Medical Device Non-Dilutive Funding: Trends & Opportunities · research or clinical problem in...
FreeMindGroup
@FreeMindGrp
FreeMind Group
Medical Device Non-Dilutive Funding: Trends & Opportunities
B. Stuart Jacobowitz
Sr. Director, Business Development
December 6, 2017
FreeMind Group, LLCDecember 6, 2017 2
FreeMind Group, LLC
FreeMind Group
Est. 1999
60 Fulltime Employees
~500 Applications Annually
Diverse Client Base:
• Academics, University Medical Centers, and Independent Research Institutes
• Industry – Small Startups to Large Pharmaceutical Companies
FreeMind Group, LLCDecember 6, 2017 3
FreeMind Group, LLC
A Tool to Maximize Your Funding Potential
• Identify the most relevant funding opportunities
• Strategize to maximize the application’s chance of success
• Manage complex project production processes
• Lead joint application writing
• Support final contract negotiations
Non-Dilutive Funding – A Strategic Financial Tool
FreeMind Group, LLC
HHS - NIH
27 institutes and centers including
NCI, NIDDK, NINDS, NIAID, NIBIB, NHLBI, NEI, NIA, etc.
Other HHS Organizations
BARDA, FDA, CDC
National Science Foundation
Department of Defense (DOD)
US Army, DARPA, DTRA, CDMRP, etc.
Private Foundations
Gates, MJ Fox, JDRF, and many more
December 6, 2017 4
Non-Dilutive Market
$50B+ Allocated Annually
FreeMind Group, LLC
NIH 2017 Budget - $34B
Adapted from the NIH Data Book, www.report.nih.gov
$28,000,000
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Categorical Spending
Adapted from the NIH Data Book, www.report.nih.gov
Cancer - ~$6BNeurosciences - ~$6BInfectious Diseases - ~$4B
Where is the funding for
Medical Deviceshiding?
FreeMind Group, LLC
Goals:
• Develop innovative biomedical technologies that integrate engineering with the physical and life sciences to solve complex problems and improve health.
• Enable patient-centered health care through development of point-of-care, wireless, and personal health informatics technologies.
• Transform advances in knowledge of cell and molecular disease mechanisms into precise medical diagnostics and therapeutics.
• Develop medical technologies that are low-cost, effective, and accessible to everyone.
• Train the next generation of diverse and interdisciplinary scientists, bioengineers, and health care providers and promote the value of research that synergizes these disciplines.
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NIBIBMission and Goals
National Institute of Biomedical Imaging and Bioengineering
“…to improve health by leading the development and accelerating the application of biomedical technologies…”
“…integrating the physical and engineering sciences with the life sciences to advance basic research and medical care…”
The NIBIB is the only NIH
institute to fund platform
technologies without the
need to specify an organ or
disease.
FreeMind Group, LLC
“Medical device makers should focus on creating low cost, non-invasive, mobile technologies but still work on ‘medical moonshots’ that change the world.”
Dr. Roderic Pettigrew Director, NIBIB
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NIBIB Director
NIBIB Mission and Goals
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National Institutes of Health(NIH)
Medical Device Funding Opportunities
FreeMind Group, LLC
• Biomaterials
• Biomedical Informatics
• Biosensors
• Connected Health
• Delivery Systems and Devices for Drugs and Biologics
• Image Processing, Visual Perception and Display
• Image-Guided Interventions
• Immunoengineering
• Magnetic Resonance Imaging
• Magnetic, Biomagnetic and Bioelectric Devices
• Mathematical Modeling, Simulation and Analysis
• Microfluidic Bioanalytical Systems
• Molecular Imaging
• Nuclear Medicine
• Optical Imaging and Spectroscopy
• Point of Care Technologies
• Rehabilitation Engineering and Implantable Medical Devices
• Surgical Tools, Techniques and Systems
• Synthetic Biology for Technology Development
• Tissue Chips
• Tissue Engineering
• Ultrasound: Diagnostic and Interventional
• X-ray, Electron, and Ion Beam
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Broad Areas of Interest
Medical Device Field - NIBIB
FreeMind Group, LLC
Funding:
• $275,000 over two years
• No more than $200,00 per year
Scope:
• Establish the feasibility of technologies, techniques or methods that: 1) explore a unique multidisciplinary approach to a biomedical challenge; 2) are high-risk but have high impact; and 3) develop data that may lead to significant future research.
• Hypothesis-driven, discovery-driven, developmental, or design-directed research and is appropriate for evaluating unproven approaches for which there is minimal or no preliminary data.
• Clinical Trial optional
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NIH Multi-Institutional
Exploratory/Developmental Bioengineering Research Grants (EBRG) [R21]
PA-18-286
Next due date:Feb 16, 2018
FreeMind Group, LLC
Funding:
• Not capped - reflect scope of work (recommended $500K/year)
• Max project period: 5 years
Scope:
• To encourage collaborations between the life and physical sciences;
• Apply a multidisciplinary bioengineering approach to the solution of a biomedical problem; and
• Integrate, optimize, validate, translate or otherwise accelerate the adoption of promising tools, methods and techniques for a specific research or clinical problem in basic, translational, or clinical science and practice.
• Clinical Trial optional
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NIBIB -Multi-Institutional
Bioengineering Research Grants (BRG) [R01]
PAR-18-206
Next due date:Feb 5, 2018
FreeMind Group, LLC
Funding:
• Not capped - reflect scope of work
• Max project period: 5 years
Scope:
• Accelerate the development and adoption of promising tools and technologies that can address important biomedical problems;
• Establish these tools and technologies as robust, well-characterized solutions that fulfill an unmet need and are capable of enhancing our understanding of life science processes or the practice of medicine.
• Focus on supporting multidisciplinary teams that apply an integrative, quantitative bioengineering approach to developing technologies, and engage biomedical researchers or clinicians throughout the project.
• Clinical Trial optional
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NIBIB -Multi-Institutional
Bioengineering Research Partnerships [U01]
PAR-18-208
Next due date:May 8, 2018
FreeMind Group, LLC
Program aimed at the development and integration of novel and emerging technologies in the support of cancer research, diagnosis, and treatment.
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NCI
Innovative Molecular Analysis Technologies (IMAT)
Mechanism Theme Molecular / CellularAnalysis
Cancer-relevant Biospecimen Science
R21
Project type: Exploratory-pilotRequired: Innovative technology/approach; Quantitative Milestones;Not required (but allowed): Preliminary data.
RFA-CA-18-002 RFA-CA-18-004
R33
Project type: DevelopmentalRequired: Quantitative Milestones; Feasibility data
RFA-CA-18-003 RFA-CA-18-005
FreeMind Group, LLC
Parent Announcements – Omnibus
R21 - NIH Exploratory / Developmental Research Grant Program (Parent R21– PA-16-161)
R01 - Research Project Grant (Parent R01 – PA-16-160)
SBIR - Small Business Innovative Research (PA-16-302)
STTR - Small Business Technology Transfer (PA-16-303)
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Investigator Initiated
R01, R21 and SBIR/STTR Omnibus Solicitations
Next due dates:R21 – Feb 16, 2018R01 – Feb 5, 2018SBIR/STTR –
Jan 5, 2018
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Biomedical Advanced Research and Development Authority
(BARDA)
Medical Device Funding Opportunities
FreeMind Group, LLC
BARDA – Medical Countermeasures
Adapted from The BARDA Multi-Broad Agency Announcement Pre-Proposal Conference 2012
DiscoveryPreclinical
DevelopmentPhase I Phase II Phase III Licensure
Production and Delivery
PHASES
IND NDA/BLA
Licensed Product
1-3% 10-25% 1-3% 18-35% 45-70% 90%
PROBABILITY OF SUCCESS TO LICENSURE
NIH ($11.8B)
BARDA ($540M)
Project BioShield ($5.6M)
Valley of Death
3- 7 yr 0.5 - 2 yr 1 - 2 yr 2 – 3.5 yr 2.5 – 4 yr 1 - 2 yrTime
PipelinePhase Cost
$100M – 130M $60M – 70M $70M – 100M $130M – 160M $190M – 220M $18M – 20M
FreeMind Group, LLC
Open solicitation: BAA-18-100-SOL-0003
• Covers 14 Research & Development areas of interest
• Issued: November 6, 2017
• Multiple awards of various values are anticipated and are dependent upon the program priorities, proposals’ scientific/technical merits, how well the proposals fit BARDA’s areas of interest, and available funds.
• Next White Paper submission deadlines: Jan 31, 2018, April 30, 2018
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BARDA
BARDA – Medical Countermeasures
The mission of BARDA is to develop and procure medical countermeasures that address chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.
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US ARMY
Medical Device Funding Opportunities
FreeMind Group, LLC
Funding:
Budgets are not capped and must reflect the scope of the work. Funding can be requested for up to 5 years. You must justify your budget.
Scope:
To provide solutions to medical problems of importance to American Service Members at home and abroad, as well as to the general public at large.
Research Areas of Interest
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USAMRMCFOA #
W81XWH18SBAA1
US Army Broad Agency Announcement (BAA) for Extramural Medical Research
Rolling deadlines:
Pre-application may be submitted at any time.
An invited full proposal / application should be submitted within 90 days of the PI’s receipt of invitation to submit. • Military Infectious
Diseases
• Combat Casualty Care
• Military Operational Medicine
• Clinical and Rehabilitative Medicine
• Medical Biological Defense
• Medical Chemical Defense
• Medical Simulation and Information Sciences
• Radiation Health Effects
FreeMind Group, LLC
Whitepaper submission is the first and one of the most crucial steps for award.
Typically limited to 2 pages.
Majority of applications do not make it past the whitepaper stage. This means, if you are called to submit a full application, your chances increase dramatically.
Carefully craft your whitepaper ensuring your science is well presented and represented and meets the guidelines and specification of the solicitation.
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Typical DoD and BARDA Submission Process
Stage 1 Whitepaper
REVIEW
Stage 2Full Application
Technical Review
AWARD $$$
Stage 3Cost Proposal Negotiations
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Summary
Medical Device Funding Opportunities
Funding is available for medical devices at all R&D stages and in essentially all medical fields.
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Risk Management
NIH Review Process
Scientific Approach
Leadership
Environment
Significance
Innovation
Risk
Strength
Responsivevs.
Competitive
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Strategic Approach
Turn NDF into a Strategic Source of Funding
Maximize the Company’s
Funding Potential
VCs
NDFAngels
FreeMind Group, LLC
Systematic Approach
Conduct a thorough strategic assessment
Identify ALL relevant funding opportunity
Seek insight into the interests and goals of the funding agencies
Correlate the granting strategy with your long term R&D plan
Target the Right Mechanism
Different “pockets of money”
Different size of award/success rates
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Strategic Approach
Maximize Your Chances for Award
NDF
Plan and execute a long-term,
multi-submission granting
strategy
FreeMind Group, LLC
Lower the Risk
Know your weaknesses
Find the right partners (if necessary)
Know the interests of the agency/mechanism
Address the “non-important” admin parts
Establish yourself both as a top researcher as well as an experienced manager
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Risk Management
Maximizing Your Chances for Award
NDF
FreeMind Group, LLC
Maximize Funding Potential
December 6, 2017 27
What do we do?
FreeMind Group, LLC
1. Identify ALL relevant funding opportunities
2. Create a multi-submission granting strategy
3. Submit as many top quality applications as possible
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13th Annual Non-Dilutive Funding Summit
N O N -D ILUTIVE
F U N DING S U M M IT
13th AnnualProduced by:
Presentations by the FreeMind Group, BARDA, NINDS, USAMRMC, and more!
January 10, 2018Marines’ Memorial Club
bit.ly/NonDilutiveFundingSummit
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Contact Us!
Thank you!
Watch past presentations and webinars online on our YouTube Channel
Join our LinkedIn network and follow us on Twitter for updates and announcements relating to non-dilutive funding
www.freemindconsultants.com
FreeMindGroup
@FreeMindGrp
FreeMind Group
B. Stuart JacobowitzSr. Director, Business [email protected]
(617) 648-0340 ext. 288