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

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Amy Wilkins
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FreeMindGroup FreeMind Group @FreeMindGrp Non-Dilutive Funding for Opportunities for

1 FreeMindGroup FreeMind Non-Dilutive Funding for Opportunities for CNS/PNS Related R&D Jonathan H. Adalist Sr. Director, Business Development September 6, 2017

2 FreeMind Group FreeMind Group, LLC Est Fulltime Employees Diverse Client Base: Academics, University Medical Centers, and Independent Research Institutes Industry Small Startups to Large Pharmaceutical Companies ~500 Applications Annually 2

3 A Tool to Maximize Your Funding Potential FreeMind Group, LLC 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 3

4 NIH 2017 Budget - $34B $28,000,000 Adapted from the NIH Data Book, 4

5 Categorical Spending Cancer - ~$6B Neurosciences - ~$6B Infectious Diseases - ~$4B Adapted from the NIH Data Book, 5

6 National Institutes of Health NINDS 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 6

7 National Institute of Neurological Disorders & Stroke IGNITE 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) 7

8 Assay Development and Therapeutic Agent Identification and Characterization to Support Therapeutic Discovery (R21/R33) NINDS, NIDA Funding: Up to $750,000 PAR Next due date: Oct 16 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. 8

9 Pharmacodynamics and In vivo Efficacy Studies for Small Molecules and Biologics/Biotechnology Products (R21/R33) NINDS, NIDA Funding: Up to $750,000 PAR Next due date: Oct 16 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. 9

10 Development and Validation of Model Systems and/or Pharmacodynamic Markers to Facilitate the Discovery of Neurotherapeutics (R21/R33) NINDS, NIDA RFA-NS Next due date: Oct 18 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. 10

11 National Institute of Neurological Disorders & Stroke CREATE Bio Cooperative Research to Enable and Advance Translational Enterprises for Biologics Optimization Track Development Track 11

12 CREATE Bio Optimization Track for Biologics (U01) NINDS PAR Next due date: Feb 13 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. 12

13 CREATE Bio Optimization Track for Biologics (SBIR-U44) NINDS Funding: Up to $5,400,000 PAR Next due date: Feb 13 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. 13

14 NINDS CREATE Bio Development Track: Preclinical and Early-phase Clinical Development for Biotechnology Products and Biologics (UH2/UH3) NINDS Funding: Up to $7,250,000 PAR Next due date: Expected to be in February 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 FreeMind Group, LLC 14

15 NINDS CREATE Bio Development Track: Preclinical and Early-phase Clinical Development for Biotechnology Products and Biologics (U44) NINDS Funding: Up to $6,500,000 PAR Next due date: Expected to be in February 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 FreeMind Group, LLC 15

16 National Institute of Neurological Disorders & Stroke BPN Blueprint Neurotherapeutics Network The Blueprint Neurotherapeutics Network provides non-dilutive support for small molecule drug discovery and development, from hitto-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 FreeMind Group, LLC 16

17 Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44) NIH PAR Next due date: Feb 6 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 FreeMind Group, LLC 17

18 Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (UG3/UH3) NIH PAR Next due date: Feb 7 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 FreeMind Group, LLC 18

19 Additional CNS/PNS related opportunities NINDS 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 FreeMind Group, LLC 19

20 Additional CNS/PNS related opportunities NINDS 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 FreeMind Group, LLC 20

21 Department of Defense DoD 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 TBI and 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 FreeMind Group, LLC 21

22 FY17 DoD USAMRMC Broad Agency Announcement for Extramural Medical Research DoD W81XWH-17-R-BAA1 Next due date: Rolling 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 FreeMind Group, LLC 22

Biological Mechanisms Therapeutic Development Disease-Modifying Strategies Symptomatic

23 Michael J. Fox Foundation MJFF 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 FreeMind Group, LLC 23

Alzheimer s Drug Discovery Foundation ADDF ADDF Funding Opportunities Preclinical Drug Discovery Biomarkers Development Prevention Beyond the Pipeline

24 Alzheimer s Drug Discovery Foundation ADDF 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 FreeMind Group, LLC 24

25 NIH Review Process Risk Management Leadership Innovation Scientific Approach Environment Risk Significance Strength 25

26 Turn NDF into a Strategic Source of Funding Strategic Approach Angels NDF VCs Maximize the Company s Funding Potential 26

agencies Correlate the granting strategy with your long term R&D plan Target the Right Mechanism Different

27 Maximize Your Chances for Award Strategic Approach NDF 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 Plan and execute a long-term, multi-submission granting strategy 27

28 Maximizing Your Chances for Award Risk Management NDF 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 28

29 FreeMind Group, LLC What do we do? Maximize Funding Potential 1. Identify ALL relevant funding opportunities 2. Create a multi-submission granting strategy 3. Submit as many top quality applications as possible 29

30 Thank you! Contact Us! Jonathan H. Adalist Sr. Director, Business Development (617) ext. 285 FreeMindGroup FreeMind 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 30

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) as a source of Non-Dilutive Funding

@FreeMindGrp FreeMind Group The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) as a source of Non-Dilutive Funding FreeMind Group Webinar Jonathan Adalist FreeMind Group, LLC