Non-Dilutive Funding for Opportunities for CNS/PNS Related R&D€¦ · A Tool to Maximize Your...
Transcript of Non-Dilutive Funding for Opportunities for CNS/PNS Related R&D€¦ · A Tool to Maximize Your...
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
(617) 648-0340 ext. 285