Biodefense and Infectious Diseases Funding Opportunities

Transcription

1 FreeMindGroup FreeMind Biodefense and Infectious Diseases Funding Opportunities Jonathan Adalist Senior Director, Business Development FreeMind Group FreeMind Group, LLC

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 Applications Annually FreeMind Group, LLC 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 FreeMind Group, LLC 3

4 NIH 2016 Budget - $32.31B Intramural Research $3,581,878 11% Res. Management & Support 1,692,585 5% Research & Develop. Contracts $2,995,825 10% Training $830,430 3% Other Research $2,010,924 6% ~$27,000,000,000 Research Projects $17,820,973 55% Adapted from the NIH Data Book, FreeMind Group, LLC 4

5 Pocket of Money NIAID Budget NIAID Budget (Dollars in Millions) FY 2014 Actual FY 2015 Actual FY2016 Enacted FY 2017 President's Budget NIAID Budget (Dollars in Millions) FreeMind Group, LLC 5

6 Pocket of Money NIH Categorical Spending $5.25B in funding for Infectious diseases ~$1.9B in funding for Biodefense NIAID has one of the best success rates in the NIH with 24% success in contrast to the 19.1% average for FreeMind Group, LLC 6

7 NIAID Bugs of Interest NIAID emerging-infectious-diseasespathogens Newly appeared in a population or Existed but rapidly increasing in incidence or geographic range, or Are caused by one of the NIAID Category A, B, or C priority pathogens. A Anthrax Botulism Dengue Plague Ebola Tularemia etc B Q Fever Brucellosis Salmonella Hepatitis A West Nile Virus etc C Yellow Fever Tuberculosis Influenza Rabies Chikungunya SARS etc FreeMind Group, LLC 7

8 Submission Types Routes Funding Routes 1. Solicited Address a specific area of interest 2. Unsolicited Investigator Initiated R21, RO1, SBIR - Try to establish interest prior to submitting 3. Broad Agency Announcements (BAAs) FreeMind Group, LLC 8

9 NIH - Preclinical NIH NIH Preclinical Funding FreeMind Group, LLC 9

10 Partnerships for the Development of Tools to Advance Therapeutic Discovery for Select Antimicrobial-Resistant Gram-Negative Bacteria (R01) NIAID R01 Deadline: May 17, 2017 RFA-AI Funding: Direct costs of up to $750k per year over up to 5 years Additional $300k for purchasing equipment. Total award including overhead may be up to $5.25M Scope: Supports milestone-driven projects focused on developing and utilizing novel predictive assays, models and/or research tools. Must focus on one or more of the following: CRE, MDR Acinetobacter or MDR Pseudomonas aeruginosa. Projects must complete assay/tool/model development prior to the end of the third year of the project period. FreeMind Group, LLC 10

11 Countermeasures Against Chemical Threats (CounterACT): Identification of Therapeutic Lead Compounds (U01) NIH U01 Deadline: September 12, 2017 PAR Funding: Direct costs of up to $300k per year over up to 3 years Total award including overhead may be up to $1.2M Scope: CounterACT aims to develop new and improved therapeutics to treat and/or prevent injuries resulting from chemical threats. Supported activities: confirmation of molecular targets, demonstration of in vitro activity, preliminary in vivo efficacy, preliminary ADME/Tox evaluations and PK/PD data. FreeMind Group, LLC 11

12 Countermeasures Against Chemical Threats (CounterACT): Optimization of Therapeutic Lead Compounds (U01) NIH U01 Deadline: September 12, 2017 PAR Funding: Budgets are not capped, funding for up to 5 years. We recommend not asking for more than $2.5M without pre-approval. Scope: Supported activities: GLP IND-enabling safety studies and pivotal efficacy studies in animals, cgmp production, and human safety clinical trials. Viewed by BARDA as a stepping stone towards receiving BARDA support. FreeMind Group, LLC 12

13 NIH - Preclinical NIH NIH Clinical Funding FreeMind Group, LLC 13

14 NIAID Clinical Trial Planning Grant (R34) NIAID R34 Deadline: May 12, 2017 PAR Funding: Up to ~$200k total award Scope: Fundable activities include establishing the team, site & collaborator identification, study design, protocol development and various other activities. FreeMind Group, LLC 14

15 NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) NIAID U44 Deadline: May 12, 2017 PAR Funding: Up to $1.5M for Phase II, $1.7M for Fast Track. Cap may be exceeded for research on specific topics, one of these is Discovery & development of therapeutics for infectious diseases. Scope: Support for hypothesis-driven, milestone-driven clinical trials. Commercialization Plan must be included NIAID can decide if IND / IDE is required FreeMind Group, LLC 15

16 NIAID Clinical Trial Implementation Cooperative Agreement (U01) NIAID U01 Funding: No budget cap, up to 5 years of funding. Deadline: May 12, 2017 PAR Scope: Will accept applications for implementation of investigator-initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials. Has R01 equivalent for Low-risk trials. FreeMind Group, LLC 16

17 BARDA BARDA Biomedical Advanced Research and Development Authority (BARDA) FreeMind Group, LLC 17

18 BARDA 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. 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 FreeMind Group, LLC 18

19 BARDA Stage 1 Pre-Application REVIEW Stage 2 Full Application Technical Review Stage 3 Contract Negotiations Whitepaper / Quad Chart submission is the first and one of the most crucial steps for award. Most applications do not make it past the whitepaper stage. To mean, 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. Very short documents, must be coherent & concise. AWARD $$$ FreeMind Group, LLC 19

20 Broad Agency Announcement (BAA) for the Advanced Research and Development of Chemical, Biological, Radiological, and Nuclear (CBRN) Medical Countermeasures for BARDA BARDA BAA Deadline: Rolling BAA SOL Funding: No budget cap Extremely high funding levels possible Scope: Clinical development of Vaccines, Antitoxins and Therapeutic Proteins, Antimicrobial Therapeutics, Radiological / Nuclear Threat Medical Countermeasures, Chemical Threat Medical Countermeasures & Clinical Diagnostics. FreeMind Group, LLC 20

21 CARB-X CARB-X CARB-X FreeMind Group, LLC 21

22 The CARB-X Initiative CARB-X Global public-private partnership focused on antibacterial development. Funded by BARDA, NIAID, Wellcome Trust, AMR Center, CLSI & MassBio. Accelerator that provides funding, business services and scientific services. $350M in funding made available over the next 5 years. Next cycle expected in September. FreeMind Group, LLC 22

23 Department of Defense DoD Department of Defense (DoD) FreeMind Group, LLC 23

24 Department of Defense DTRA, USAMRMC, DARPA DARPA: to maintain the technological superiority of the U.S. military. by sponsoring revolutionary, highpayoff research that bridges the gap between fundamental discoveries and their military use. DTRA: Safeguard the United States and its allies from Weapons of Mass Destruction USAMRMC: provide solutions to medical problems of importance to the American warfighter at home and abroad. FreeMind Group, LLC 24

25 Defense Threat Reduction Agency DTRA Defense Threat Reduction Agency (DTRA) FreeMind Group, LLC 25

26 Chemical/Biological Technologies FY2017 Program Build DTRA BAA DTRA BAA Deadline: Rolling HDTRA1-17-S Funding: No budget cap You must justify what you ask for Scope: Detection - Chemical and Biological Information Systems Capability Development Protection - Individual and Collective Hazard Mitigation Threat Agent Science Medical Pretreatments Medical Diagnostics Medical Therapeutics Threat Surveillance - Chemical and Biological. FreeMind Group, LLC 26

27 The US Army USAMRMC US Army FreeMind Group, LLC 27

28 United States Army Medical Research and Materiel Command (USAMRMC) BAA for Extramural Medical Research USAMRMC BAA Deadline: Rolling W81XWH-17-R- BAA1 Funding: No budget cap You must justify what you ask for Scope: Aims provide solutions to medical problems of importance to the American war fighter. Military Infectious Diseases, Combat Casualty Care, Military Operational Medicine, Clinical and Rehabilitative Medicine, Military Biological Defense, Medical Chemical Defense, Medical Simulation & Information Sciences. FreeMind Group, LLC 28

29 Defense Advanced Research Projects Agency DARPA Defense Advanced Research Projects Agency (DARPA) FreeMind Group, LLC 29

30 DARPA Biological Technologies EZ BAA DARPA Deadline: Rolling HR001117S0005 Funding: Up to $750k Scope: Aim to leverage biology as a technology to solve intractable problems Seeks to leverage advances in engineering and computer science to drive and reshape biotechnology for national security Interested in a range of emerging technical areas,including human-machine interfaces, human performance, infectious disease, and synthetic biology. Goal: to develop, demonstrate & transition biologically based technologies as part of the national security toolkit FreeMind Group, LLC 30

31 NIH Review Process Risk Management Leadership Innovation Scientific Approach Environment Risk Significance Strength FreeMind Group, LLC 31

32 Maximizing Your Chances Key Issues Systematic Approach Know the interests of the Agency Present a complete, focused project Ask for what is necessary Leverage on research collaborations FreeMind Group, LLC 32

33 Maximizing Your Chances Key Issues Target the Right Mechanism Different pockets of money Different size of award/success rates Conduct a thorough strategic assessment Multi-Submission Granting Strategy FreeMind Group, LLC 33

34 FreeMind Group Professional Process Core Service 1- Strategic Assessment Long term Strategic approach Outline projects Tasks to be completed Link with existing pockets of money Solicited vs. Unsolicited Map of relevant funding opportunities Core Service 2- Project Production Process Project Management - coordinating Comprehensive templates Ongoing feedback and edits Budgets Converge information Final outcome single coherent presentation FreeMind Group, LLC 34

35 Thank you! Contact Us! Jonathan Adalist Senior Director, Business Development +1 (617) ext 285 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 FreeMindGroup FreeMind FreeMind Group, LLC 35