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

https://www.youtube.com/user/FreeMindGroup


https://twitter.com/freemindgrp




https://www.linkedin.com/company/freemind-group



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, 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


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.

December 6, 2017 7

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

December 6, 2017 8

NIBIB Director

NIBIB Mission and Goals


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

December 6, 2017 10

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

December 6, 2017 11

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.


December 6, 2017 12

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.


December 6, 2017 13

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.

December 6, 2017 14

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)

December 6, 2017 15

Investigator Initiated

R01, R21 and SBIR/STTR Omnibus Solicitations

Next due dates:R21 – Feb 16, 2018R01 – Feb 5, 2018SBIR/STTR –

Jan 5, 2018


Biomedical Advanced Research and Development Authority

(BARDA)


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

December 6, 2017 18

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.


US ARMY


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

December 6, 2017 20

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.

December 6, 2017 21

Typical DoD and BARDA Submission Process

Stage 1 Whitepaper

REVIEW

Stage 2Full Application

Technical Review

AWARD $$$

Stage 3Cost Proposal Negotiations


Summary


Funding is available for medical devices at all R&D stages and in essentially all medical fields.


Risk Management

NIH Review Process

Scientific Approach

Leadership

Environment

Significance

Innovation

Risk

Strength

Responsivevs.

Competitive


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

December 6, 2017 25

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

December 6, 2017 26

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


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

http://bit.ly/NonDilutiveFundingSummit




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

http://www.freemindconsultants.com/










mailto:[email protected]

medical device non-dilutive funding: trends & opportunities · research or clinical problem in...

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