Non-Dilutive Funding For Clinical Stage R&D

Transcription

1 FreeMindGroup FreeMind Non-Dilutive Funding For Clinical Stage R&D Meytal Waiss Director, Business Development FreeMind Group

2 The Global Non-Dilutive Funding Leader 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 Max. Your Funding Potential Non-Dilutive Funding A Strategic Financial Tool Identify most relevant funding opportunities Strategize to maximize application s chances of success Manage complex project production processes Lead joint application writing Support final contract negotiations 3

4 Non-Dilutive Funding For Clinical Stage R&D 4

5 $50B+ Allocated Annually Non-Dilutive Market HHS- NIH 27 institutes and centers including NCI, NIDDK, NINDS, NIAID, NIMH, NIBIB, NIDA, NHLBI, NEI, NIA, etc. Other HHS Organizations BARDA, FDA, CDC, NSF Department of Defense (DOD) US Army, DARPA, DTRA, CDMRP, etc. Private Foundations Gates, MJ Fox, ADDF, and many more 5

6 NIH 2017 Budget - $34B 6

7 Categorical Spending Clinical Research - ~$12.3B Clinical Trials - ~$3.5B Adapted from the NIH Data Book, 7

8 Supports Complete R&D Process IND NDA/BLA PHASES Discovery Preclinical Development Phase I Phase II Phase III Licensure Production and Delivery $200- $500K NIH R21 SBIR P1 NSF DOD US Army, DTRA, DARPA NGO $500K - $3.5M NIH R01, U01 SBIR PII NSF DOD US Army, DTRA, DARPA, CDMRP NGO +3.5M SBIR PII U Mechanism BARDA DOD - CDMRP NGO PROBABILITY OF SUCCESS TO LICENSURE Licensed Product 1-3% 10-25% 1-3% 18-35% 45-70% 90% 8

9 Funding Mechanisms Mechanisms used to fund clinical stage R&D Typical Mechanisms used to fund Clinical Trials Phase II / Fast-Track SBIR (R44 or U44) Research Project Grant (R01) Research Project Cooperative Agreement (U01) Phased Cooperative Agreement (UH2/UH3) Broad Agency Announcement (BAA) 9

10 Applying for clinical stage funding Important Notes Requirements & Recommendations Clinical Protocol Usually Necessary Investigator s Brochure Highly Recommended Clinical Sites, Site PIs - Helpful IND IRBs Usually not required at time of submission Contact PO in advance! 10

11 Funding Opportunities NIH 11

12 Funding Opportunities Clinical Trial Planning Grants (R34) 12

13 Clinical Trial Planning Grants R34/U34 Activities supported Establishment of the research team Development of tools for data management and research oversight Development of a trial design Finalization of the protocol Preparation of an operations/procedures manual Pilot studies or collection of feasibility data for subsequent research projects 13

14 NIH - Clinical Trial Planning Grants NIH R34/U34 Standard Due Dates: Feb 16, June 16, October 16 Funding: Up to $450k over up to 3 years Designed to: Permit early peer review of the rationale and concept for the proposed clinical trial Support development of essential elements of a clinical trial Lead to an application for support of a fullscale trial, based on elements developed under the planning period 14

15 NIH - Clinical Trial Trial 9i Planning Grants Grants R34/U34 NIA Clinical Research Project Planning Grant Program (R34) NEI Clinical Study Planning Grant Program (R34) NHLBI Clinical Trial Pilot Studies (R34) NIAID Clinical Trial Planning Grant (R34) Clinical Trial Planning Grant for Interventions and Services to Improve Treatment and Prevention of HIV/AIDS (R34) NIDCR Clinical Trial or Biomarker Clinical Validation Study Planning Grant (R34) NIAMS Clinical Trial Planning Cooperative Agreement (U34) NIDDK Multi-Center Clinical Study Implementation Planning Cooperative Agreements (U34) 15

16 Funding Opportunities NIH Clinical Trial Funding 16

17 NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44) NIAID PAR Next Due Date: Sep 13, 2017 Funding: As written in the statute and under appropriate circumstances, NIH can apply for a waiver from SBA to issue an award exceeding $1.5M for Phase II, if this cap will interfere with NIH s ability to meet its mission. Scope: Supports implementation of clinical trials from small businesses that propose clinical trials in research areas that are well matched with the mission and goals of the NIAID. The proposed clinical trial should be hypothesis-driven and milestone-driven. 17

18 NIDDK Multi-Center Clinical Study Cooperative Agreement (U01) NIDDK PAR Next Due Date: Oct 5, 2017 Funding: Application budgets are not capped, however, must reflect the scope of work. Scope: Funds investigator-initiated, multi-center clinical studies. Proposed studies should be hypothesis-driven and focus on a disease relevant to the mission of NIDDK. 18

19 9i Additional Clinical Stage Opportunities NIH Pilot Clinical Trials for the Spectrum of Alzheimer s Disease and Age-related Cognitive Decline (R01) Phase III Clinical Trials for the Spectrum of Alzheimer's Disease and Age-related Cognitive Decline (R01) Clinical Evaluation of Adjuncts to Opioid Therapies for the Treatment of Chronic Pain (R01) First in Human and Early Stage Clinical Trials of Novel Investigational Drugs or Devices for Psychiatric Disorders (U01) NIDCR Clinical Trial or Biomarker Clinical Validation Study Cooperative Agreement (U01) NIDCD Phase I/II/III Clinical Trials in Communication Disorders (U01) 19

20 9i CNS/PNS related Opportunities NINDS NINDS Direct Phase II SBIR Grants to Support Exploratory Clinical Trials (R44) NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Exploratory Clinical Trials and Clinical Research (R44) 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) NeuroNEXT Clinical Trials (U01) NeuroNEXT Small Business Innovation in Clinical Trials Direct to Phase II (U44) 20

21 9i CNS/PNS related Opportunities NINDS NINDS Phase III Investigator-Initiated Efficacy Clinical Trials (U01) NINDS CREATE Bio Development Track: Preclinical and Early-phase Clinical Development for Biotechnology Products and Biologics (UH2/UH3 or U44) NINDS CREATE Devices: Translational and Clinical Studies on the Path to 510(k) (UH2/UH3 or U44) NINDS CREATE Devices: Translational and Clinical Studies to Inform Final Device Design (UH2/UH3 or U44) 21

22 Funding Opportunities BARDA 22

23 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. 1. Broad Agency Announcement (BAA) for the Advanced Research and Chemical, Biological, Radiological, and Nuclear Medical Countermeasures for BARDA BAA SOL Broad Agency Announcement (BAA) for the Advanced Development of Medical Countermeasures for Pandemic Influenza - BAA SOL Broad Agency Announcement (BAA) for Advanced Research and Development to Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases BAA SOL

24 Congressionally BARDA Medical Directed Countermeasures Research Programs Stage 1 Whitepaper REVIEW Stage 2 Full Application REVIEW AWARD $$$ 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. 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. 24

25 Funding Opportunities FDA 25

26 Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01) FDA RFA-FD Next Due Date: Feb 1, 2017 Funding: Up to $2M Scope: Designed to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the product being developed will be superior to the existing therapy. Funds Phases I/II/III 26

27 Funding Opportunities Congressionally Directed Medical Research Programs (CDMRPs) 27

28 Breast Cancer Research Program (BCRP) Breakthrough Award Levels 3 and 4 CDMRPs W81XWH-16- BCRP- BREAKTHROUGH_ FL34 Deadlines: Pre-Application April 27 th Full Application August 11 th Funding: Level 3 - $4M + Indirect costs. Scope: Level 4 - $10M + Indirect costs. Funding Level 3: Advanced translational studies that have potential for near-term clinical investigation. Small-scale clinical trials may apply. Funding Level 4: Large-scale projects that will transform and revolutionize the clinical management and/or prevention of breast cancer. Near-term clinical impact is expected. PIs are expected to have experience in successfully leading large-scale projects. 28

29 CDMRPs Pre-App Deadline July 20, 2017 Acute Lung Injury Antimicrobial Resistance Arthritis Burn Pit Exposure Chronic Migraine and Post-Traumatic Headache Congenital Heart Disease Constrictive Bronchiolitis Diabetes Diarrheal Diseases Dystonia Early Trauma Thermal Regulation Eating Disorders Emerging Infectious Diseases Epidermolysis Bullosa Focal Segmental Glomerulosclerosis Fragile X Department of Defense Peer Reviewed Medical Research Program (PRMRP) Clinical Trial Award Funding: Application budgets are not capped, however, must reflect the scope of work Topic Areas: Guillain-Barré Syndrome Hepatitis B and C Hereditary Angioedema Hydrocephalus Immunomonitoring of Intestinal Transplants Inflammatory Bowel Diseases Influenza Integrative Medicine Interstitial Cystitis Malaria Metals Toxicology Mitochondrial Disease Musculoskeletal Disorders Nanomaterials for Bone Regeneration Non-Opioid Pain Management Pancreatitis Pathogen-Inactivated Dried Cryoprecipitate Polycystic Kidney Disease Post-Traumatic Osteoarthritis Pulmonary Fibrosis Respiratory Health Rett Syndrome Rheumatoid Arthritis Scleroderma Sleep Disorders Spinal Muscular Atrophy Sustained-Release Drug Delivery Tinnitus Tuberculosis Vaccine Development for Infectious Disease Vascular Malformations Women s Heart Disease 29

30 NIH Review Process Risk Management Responsive vs. Competitive Leadership Innovation Scientific Approach Environment Risk Strength Significance 30

31 Maximizing your Chances Key Issues Systematic Approach Know the interests of the Agency Present a complete, focused application Ask for what is necessary Leverage on research collaborations 31

32 Maximizing your Chances Key Issues Target the Right Mechanism Different pockets of money Different sizes of awards/success rates Conduct a thorough strategic assessment Multi-submission granting Strategy 32

33 FMG 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 33

34 Thank you! Contact Us! Meytal Waiss Director, Business Development x288 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 34