FreeMindGroup

@FreeMindGrp

FreeMind Group

Non-Dilutive Funding for Opportunities for CNS/PNS Related R&D

Jonathan H. Adalist

Sr. Director, Business Development

September 6, 2017

FreeMind Group, LLCSeptember 5, 2017 2

FreeMind Group, LLC

FreeMind Group

Est. 1999

60 Fulltime Employees

Diverse Client Base:

• Academics, University Medical Centers, and Independent Research Institutes

• Industry – Small Startups to Large Pharmaceutical Companies

~500 Applications Annually

FreeMind Group, LLCSeptember 5, 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, LLCSeptember 5, 2017 4

NIH 2017 Budget - $34B

Adapted from the NIH Data Book, www.report.nih.gov

$28,000,000

FreeMind Group, LLCSeptember 5, 2017 5

Categorical Spending

Adapted from the NIH Data Book, www.report.nih.gov

Cancer - ~$6BNeurosciences - ~$6BInfectious Diseases - ~$4B

FreeMind Group, LLC

National Institute of Neurological Disorders & Stroke

• Innovation Grants to Nurture Initial Translational Efforts (IGNITE)

• Cooperative Research to Enable and Advance Translational Enterprises (CREATE Bio)

• Blueprint Neurotherapeutics Network (BPN)

• Clinical Research

September 5, 2017 6

NINDS

National Institutes of Health

FreeMind Group, LLC

Innovation Grants to Nurture Initial Translational Efforts

• Assay Development and Therapeutic Agent Identification and Characterization to Support Therapeutic Discovery (R21/R33)

• Pharmacodynamics and In vivo Efficacy Studies for Small Molecules and Biologics/Biotechnology Products (R21/R33)

• Development and Validation of Model Systems and/or Pharmacodynamic Markers to Facilitate the Discovery of Neurotherapeutics (R21/R33)

September 5, 2017 7

IGNITE

National Institute of Neurological Disorders & Stroke

FreeMind Group, LLC

Funding:

Up to $750,000

Scope:

Designed to support development of in vitro and/or ex vivo assays and conduct iterative screening efforts to identify and characterize potential therapeutic agents for neurological disorders.

September 5, 2017 8

NINDS, NIDA

Assay Development and Therapeutic Agent Identification and Characterization to Support Therapeutic Discovery (R21/R33)

PAR-15-070

Next due date:Oct 16

FreeMind Group, LLC

Funding:

Up to $750,000

Scope:

This mechanism provides funding to conduct pharmacodynamics, pharmacokinetics, and in vivo efficacy studies to demonstrate that proposed therapeutic agent(s) have sufficient biological activity to warrant further development to treat neurological disorders.

September 5, 2017 9

NINDS, NIDA

Pharmacodynamics and In vivo Efficacy Studies for Small Molecules and Biologics/Biotechnology Products (R21/R33)

PAR-15-071

Next due date:Oct 16

FreeMind Group, LLC

Funding:

Up to $750,000

Scope:

Development and validation of:

• Animal models and human tissue ex vivo systems that recapitulate the phenotypic and physiologic characteristics of a defined neurological disorder

• Clinically feasible pharmacodynamic markers for therapeutics designed to treat neurological disease.

September 5, 2017 10

NINDS, NIDA

Development and Validation of Model Systems and/or Pharmacodynamic Markers to Facilitate the Discovery of Neurotherapeutics (R21/R33)

RFA-NS-16-013

Next due date:Oct 18

FreeMind Group, LLC

Cooperative Research to Enable and Advance Translational Enterprises for Biologics

• Optimization Track

• Development Track

September 5, 2017 11

CREATE Bio

National Institute of Neurological Disorders & Stroke

FreeMind Group, LLC

Funding:

Application budgets are not limited but must reflect the actual needs of the proposed project.

Scope:

Supports optimization of potential therapeutic Biotechnology Products and Biologics for disorders identified under the NINDS mission.

Biologics may be peptides, proteins, oligonucleotides, gene therapies, cell therapies, or novel emerging modalities.

September 5, 2017 12

NINDS

CREATE Bio Optimization Track for Biologics (U01)

PAR-17-456

Next due date:Feb 13

FreeMind Group, LLC

Funding:

Up to $5,400,000

Scope:

Supports optimization of potential therapeutic Biotechnology Products and Biologics for disorders identified under the NINDS mission.

Biologics may be peptides, proteins, oligonucleotides, gene therapies, cell therapies, or novel emerging modalities.

September 5, 2017 13

NINDS

CREATE Bio Optimization Track for Biologics (SBIR-U44)

PAR-17-457

Next due date:Feb 13

FreeMind Group, LLC

Funding:

Up to $7,250,000

Scope:

Supports development of potential therapeutic Biotechnology Products and Biologics for disorders identified under the NINDS mission.

Supports IND-enabling studies and early-phase clinical trials.

September 6, 2017 14

NINDS

NINDS CREATE Bio Development Track: Preclinical and Early-phase Clinical Development for Biotechnology Products and Biologics (UH2/UH3)

PAR-14-288

Next due date:Expected to be in

February

FreeMind Group, LLC

Funding:

Up to $6,500,000

Scope:

Supports development of potential therapeutic Biotechnology Products and Biologics for disorders identified under the NINDS mission.

Supports IND-enabling studies and early-phase clinical trials.

September 6, 2017 15

NINDS

NINDS CREATE Bio Development Track: Preclinical and Early-phase Clinical Development for Biotechnology Products and Biologics (U44)

PAR-14-289

Next due date:Expected to be in

February

FreeMind Group, LLC

Blueprint Neurotherapeutics Network

The Blueprint Neurotherapeutics Network provides non-dilutive support for small molecule drug discovery and development, from hit-to-lead chemistry through phase I clinical testing.

The network offers funding for work that you wish to do yourself, access to NIH-funded CROs for activities that you prefer to outsource, and access to consultants with expertise in various aspects of drug discovery and development.

• Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44 or UG3/UH3)

September 6, 2017 16

BPN

National Institute of Neurological Disorders & Stroke

FreeMind Group, LLC

Funding:

Up to $6,500,000

Scope:

Encourages applications from small businesses seeking support to advance their small molecule drug discovery and development projects into the clinic.

Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry, or at the Development stage, to advance a development candidate through IND-enabling toxicology studies and phase I clinical testing.

September 6, 2017 17

NIH

Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44)

PAR-17-201

Next due date:Feb 6

FreeMind Group, LLC

Funding:

Application budgets are not limited but need to reflect the actual needs of the proposed project.

Scope:

Encourages applications seeking support to advance small molecule drug discovery and development projects into the clinic.

Projects can enter either at the Discovery stage, to optimize promising hit compounds through medicinal chemistry, or at the Development stage, to advance a development candidate through IND-enabling toxicology studies and phase I clinical testing.

September 6, 2017 18

NIH

Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (UG3/UH3)

PAR-17-205

Next due date:Feb 7

FreeMind Group, LLC

Paired Solicitations:

• Neurobiology of Migraine – R21/R01

• Research on Autism Spectrum Disorders – R21/R01

• Drug Discovery for Nervous System Disorders R21/R01

September 6, 2017 19

NINDS

Additional CNS/PNS related opportunities

FreeMind Group, LLC

Funding for clinical trials:

• NINDS Direct Phase II SBIR Grants to Support Exploratory Clinical Trials (R44)

• NINDS Exploratory Clinical Trials (R01)

• NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44)

• NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U01)

• NINDS Phase III Investigator-Initiated Efficacy Clinical Trials (U01)

• NeuroNEXT Clinical Trials (U01)

September 6, 2017 20

NINDS

Additional CNS/PNS related opportunities

FreeMind Group, LLC

United States Army Medical Research & Materials Command

• Combat Casualty Care Research Program:

Research and development of technologies to diagnose and to limit the immediate, short- and long-term impairments that follow TBIand spinal cord injury.

• Military Operational Medicine Research Program:

The psychological health research program area is interested in research aimed at increasing resilience and psychological health and decreasing post-traumatic stress disorder (PTSD), suicide, and risk behaviors (e.g., substance abuse, anger/aggression, sexual harassment and assault, and violence within the military).

September 6, 2017 21

DoD

Department of Defense

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.

Scope:

To provide solutions to medical problems of importance to the American war fighter.

September 6, 2017 22

DoD

FY17 DoD USAMRMC Broad Agency Announcement for Extramural Medical Research

W81XWH-17-R-BAA1

Next due date:Rolling

FreeMind Group, LLC

MJFF Funding Opportunities

• Target Advancement

• Research Models

• Biological Mechanisms

• Therapeutic Development

• Disease-Modifying Strategies

• Symptomatic Strategies

• Outcome Measures

• Imaging Studies

• Clinical/Non-Invasive Physiological Studies

• Biochemical Assays & Outcome Measures

September 6, 2017 23

MJFF

Michael J. Fox Foundation

FreeMind Group, LLC

ADDF Funding Opportunities

• Preclinical Drug Discovery

• Biomarkers Development

• Prevention Beyond the Pipeline

• Program to Accelerate Clinical Trials

Upcoming deadlines:

Letter of intent – November 17

Full Proposal – December 8

September 6, 2017 24

ADDF

Alzheimer’s Drug Discovery Foundation

FreeMind Group, LLCSeptember 5, 2017 25

Risk Management

NIH Review Process

Scientific Approach

Leadership

Environment

Significance

Innovation

Risk

Strength

FreeMind Group, LLCSeptember 5, 2017 26

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

September 5, 2017 27

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

September 5, 2017 28

Risk Management

Maximizing Your Chances for Award

NDF

FreeMind Group, LLC

Maximize Funding Potential

September 5, 2017 29

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

FreeMind Group, LLCSeptember 5, 2017 30

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

Jonathan H. AdalistSr. Director, Business Development

jonathan@freemindconsultants.com

(617) 648-0340 ext. 285