Medical Device Non-Dilutive Funding: Trends & Opportunities

Transcription

1 FreeMindGroup FreeMind Medical Device Non-Dilutive Funding: Trends & Opportunities B. Stuart Jacobowitz Sr. Director, Business Development December 6, 2017

2 FreeMind Group FreeMind Group, LLC Est Fulltime Employees ~500 Applications Annually Diverse Client Base: Academics, University Medical Centers, and Independent Research Institutes Industry Small Startups to Large Pharmaceutical Companies 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 $50B+ Allocated Annually Non-Dilutive Market 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 4

5 NIH 2017 Budget - $34B $28,000,000 Adapted from the NIH Data Book, FreeMind Group, LLC

6 Categorical Spending Cancer - ~$6B Neurosciences - ~$6B Infectious Diseases - ~$4B Where is the funding for Medical Devices hiding? Adapted from the NIH Data Book, 6

7 National Institute of Biomedical Imaging and Bioengineering NIBIB Mission and Goals The NIBIB is the only NIH institute to fund platform technologies without the need to specify an organ or disease. 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 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. 7

8 NIBIB Mission and Goals NIBIB Director Medical device makers should focus on creating low cost, noninvasive, mobile technologies but still work on medical moonshots that change the world. Dr. Roderic Pettigrew Director, NIBIB 8

9 Medical Device Funding Opportunities National Institutes of Health (NIH) 9

10 Medical Device Field - NIBIB Broad Areas of Interest 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 10

11 Exploratory/Developmental Bioengineering Research Grants (EBRG) [R21] NIH Multi-Institutional PA Next due date: Feb 16, 2018 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 designdirected research and is appropriate for evaluating unproven approaches for which there is minimal or no preliminary data. Clinical Trial optional 11

12 Bioengineering Research Grants (BRG) [R01] NIBIB - Multi-Institutional PAR Next due date: Feb 5, 2018 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 12

13 Bioengineering Research Partnerships [U01] NIBIB - Multi-Institutional PAR Next due date: May 8, 2018 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 13

14 Innovative Molecular Analysis Technologies (IMAT) NCI Program aimed at the development and integration of novel and emerging technologies in the support of cancer research, diagnosis, and treatment. Mechanism Theme Molecular / Cellular Analysis R21 Project type: Exploratory-pilot Required: Innovative technology/approach; Quantitative Milestones; Not required (but allowed): Preliminary data. RFA-CA Cancer-relevant Biospecimen Science RFA-CA R33 Project type: Developmental Required: Quantitative Milestones; Feasibility data RFA-CA RFA-CA

15 R01, R21 and SBIR/STTR Omnibus Solicitations Investigator Initiated Next due dates: R21 Feb 16, 2018 R01 Feb 5, 2018 SBIR/STTR Jan 5, 2018 Parent Announcements Omnibus R21 - NIH Exploratory / Developmental Research Grant Program (Parent R21 PA ) R01 - Research Project Grant (Parent R01 PA ) SBIR - Small Business Innovative Research (PA ) STTR - Small Business Technology Transfer (PA ) 15

16 Medical Device Funding Opportunities Biomedical Advanced Research and Development Authority (BARDA) 16

17 BARDA Medical Countermeasures IND NDA/BLA PHASES Discovery Preclinical Development Phase I Phase II Phase III Licensure Production and Delivery NIH ($11.8B) Project BioShield ($5.6M) BARDA ($540M) Valley of Death Licensed Product 1-3% 10-25% 1-3% 18-35% 45-70% 90% PROBABILITY OF SUCCESS TO LICENSURE Time Pipeline Phase Cost 3-7 yr yr 1-2 yr yr yr 1-2 yr $100M 130M $60M 70M $70M 100M $130M 160M $190M 220M $18M 20M Adapted from The BARDA Multi-Broad Agency Announcement Pre-Proposal Conference 2012 FreeMind Group, LLC

18 BARDA Medical Countermeasures BARDA 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. Open solicitation: BAA 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,

19 Medical Device Funding Opportunities US ARMY 19

20 US Army Broad Agency Announcement (BAA) for Extramural Medical Research USAMRMC FOA # W81XWH18SBAA1 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. 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 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 20

21 Typical DoD and BARDA Submission Process Stage 1 Whitepaper REVIEW Stage 2 Full Application Technical Review Stage 3 Cost Proposal Negotiations 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. AWARD $$$ 21

22 Medical Device Funding Opportunities Summary Funding is available for medical devices at all R&D stages and in essentially all medical fields. 22

23 NIH Review Process Leadership Risk Management Responsive vs. Competitive Innovation Scientific Approach Environment Risk Significance Strength 23

24 Turn NDF into a Strategic Source of Funding Strategic Approach Angels NDF VCs Maximize the Company s Funding Potential 24

25 Maximize Your Chances for Award Strategic Approach 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 NDF Target the Right Mechanism Plan and execute a long-term, Different pockets of money multi-submission granting Different size of award/success rates strategy 25

26 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 26

27 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 27

28 13 th Annual Non-Dilutive Funding Summit Produced by: 13 th Annual N ON- D I L U T I V E January 10, 2018 Marines Memorial Club F U N D I N G S U M M I T Presentations by the FreeMind Group, BARDA, NINDS, USAMRMC, and more! bit.ly/nondilutivefundingsummit 28

29 Thank you! Contact Us! B. Stuart Jacobowitz Sr. Director, Business Development (617) ext. 288 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 29