non-dilutive funding for clinical stage r&d · pdf file• post-traumatic...

Meytal WaissDirector, Business DevelopmentFreeMind GroupJune 7, 2017

FreeMindGroup

@FreeMindGrp

FreeMind Group

Non-Dilutive Funding For Clinical Stage R&D

http://www.freemindconsultants.com/


https://www.youtube.com/user/FreeMindGroup


https://twitter.com/freemindgrp




https://www.linkedin.com/company/freemind-group



June 7, 2017 FreeMind Group, LLC

The Global Non-Dilutive Funding Leader

FreeMindGroup, LLC

• 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

2

June 7, 2017 FreeMind Group, LLC 3

• 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

A Tool to Max. Your Funding Potential

Non-Dilutive Funding – A Strategic Financial Tool

FreeMind Group, LLC

Non-Dilutive Funding For Clinical Stage R&D

June 7, 2017 4

FreeMind Group, LLC

Non-Dilutive Market

$50B+ Allocated Annually

• 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

5June 7, 2017

FreeMind Group, LLC 6

NIH 2017 Budget - $34B

June 7, 2017

Categorical Spending


Adapted from the NIH Data Book, www.report.nih.gov

Clinical Research - ~$12.3BClinical Trials - ~$3.5B


Supports Complete R&D Process

DiscoveryPreclinical

DevelopmentPhase I Phase II Phase III Licensure

Production and Delivery

PHASES

IND NDA/BLA

•NIH R21

•SBIR P1

•NSF

•DOD – US Army, DTRA, DARPA

•NGO

$200-$500K

•NIH R01, U01

•SBIR PII

•NSF

•DOD – US Army, DTRA, DARPA, CDMRP

•NGO

$500K -$3.5M

•SBIR PII

•U Mechanism

•BARDA

•DOD - CDMRP

•NGO

+3.5M

PROBABILITY OF SUCCESS TO LICENSURE

Licensed Product

1-3% 10-25% 1-3% 18-35% 45-70% 90%

8


Funding Mechanisms

Mechanisms used to fund clinical

stage R&DTypical 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)


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!

FreeMind Group, LLC

Funding Opportunities

NIH

11June 7, 2017

FreeMind Group, LLC


Clinical Trial Planning Grants

(R34)

12June 7, 2017



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

FreeMind Group, LLC

NIH

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 full-scale trial, based on elements developed under the planning period

Standard Due Dates:Feb 16,

June 16, October 16

14June 7, 2017

R34/U34

NIH - Clinical Trial Planning Grants

FreeMind Group, LLC

9i

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)

15June 7, 2017

NIH - Clinical Trial Planning Grants

FreeMind Group, LLC


NIH Clinical Trial Funding

16June 7, 2017

FreeMind Group, LLC

NIAID

NIAID SBIR Phase II Clinical Trial Implementation Cooperative Agreement (U44)

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.

Next Due Date:

Sep 13, 2017

17June 7, 2017

PAR-16-271

FreeMind Group, LLC

NIDDK

NIDDK Multi-Center Clinical Study Cooperative Agreement (U01)

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.

Next Due Date:

Oct 5, 2017

18June 7, 2017

PAR-15-067

FreeMind Group, LLC

9i

NIH

Additional Clinical Stage Opportunities

19June 7, 2017

• 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)

FreeMind Group, LLC

9i

NINDS

CNS/PNS related Opportunities

• 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)

20June 7, 2017

FreeMind Group, LLC

9i

NINDS

CNS/PNS related Opportunities

• 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)

21June 7, 2017

FreeMind Group, LLC


BARDA

22June 7, 2017


BARDA

1. Broad Agency Announcement (BAA) for the Advanced Research and Chemical, Biological, Radiological, and Nuclear Medical Countermeasures for BARDA BAA-16-100-SOL-00001

2. Broad Agency Announcement (BAA) for the Advanced Development of Medical Countermeasures for Pandemic Influenza - BAA-16-100-SOL-00002

3. Broad Agency Announcement (BAA) for Advanced Research and Development to Expedite the Identification, Development, and Manufacturing of Medical Countermeasures against Infectious Diseases BAA-16-100-SOL-00003

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.

BARDA – Medical Countermeasures

FreeMind Group, LLC 23June 7, 2017


Congressionally Directed Research Programs

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.

Stage 1 Whitepaper

REVIEW

Stage 2Full Application

REVIEW

AWARD $$$

BARDA – Medical Countermeasures

FreeMind Group, LLC


FDA

25June 7, 2017

FreeMind Group, LLC

FDA

Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)

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

Next Due Date:

Feb 1, 2017

26June 7, 2017

RFA-FD-15-001

FreeMind Group, LLC


Congressionally Directed

Medical Research Programs (CDMRPs)

27June 7, 2017

FreeMind Group, LLC

Breast Cancer Research Program (BCRP) –Breakthrough Award Levels 3 and 4

28June 7, 2017

Funding: Level 3 - $4M + Indirect costs.

Level 4 - $10M + Indirect costs.

Scope:

• 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.

CDMRPs

W81XWH-16-BCRP-

BREAKTHROUGH_FL34

Deadlines:Pre-Application

April 27th

Full ApplicationAugust 11th

FreeMind Group, LLC

Department of Defense Peer Reviewed Medical Research Program (PRMRP) – Clinical Trial Award

29June 7, 2017

Funding: Application budgets are not capped, however, must reflect the scope of work.

2017 Topic Areas:

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 DisordersEmerging Infectious Diseases • Epidermolysis Bullosa • Focal Segmental Glomerulosclerosis • Fragile X

• 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

FreeMind Group, LLC

Risk Management

NIH Review Process

Scientific Approach

Leadership

Environment

Significance

Innovation

Risk

Strength

Responsive vs. Competitive

30June 7, 2017


Key Issues

Maximizing your Chances

• Know the interests of the Agency

• Present a complete, focused application

• Ask for what is necessary

• Leverage on research collaborations

Systematic Approach

31


Key Issues

Maximizing your Chances

• Different “pockets of money”

• Different sizes of awards/success rates

• Conduct a thorough strategic assessment

• Multi-submission granting Strategy

Target the Right Mechanism

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


Thank you!

Contact Us!Meytal Waiss

Director, Business Development

[email protected]

617-648-0340 x288

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

mailto:[email protected]











non-dilutive funding for clinical stage r&d · pdf file• post-traumatic...

Documents