non-dilutive funding for clinical stage r&d

Non-Dilutive Funding For Clinical Stage R&D

FreeMind Group WebinarJonathan AdalistMarch 16, 2016

@FreeMindGrp

FreeMind Group

FreeMind Group, LLC 1/38March 16, 2016

March 16, 2016 FreeMind Group, LLC 2/38

The Global Non-Dilutive Funding Leader

FreeMindGroup, LLC

• Est. 1999

• 55 Fulltime Employees

• Diverse Client Base:

• Academics, University Medical Centers, and Independent Research Institutes

• Industry – Small Startups to Large Pharmaceutical Companies.

• ~400 Applications Annually


• 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 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

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March 16, 2016FreeMind Group, LLC

www.FreeMindConsultants.com5/38

NIH 2016 Budget - $32.31B

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

Research Projects $17,820,973

55%

Other Research $2,010,924

6%

Training $830,430

3%

Research & Develop. Contracts $2,995,825

10%

Intramural Research $3,581,878

11%

Res. Management & Support 1,692,585

5%

All others $733,9232%

~$27,000,000,000

Categorical Spending

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

Clinical Research - ~$11.9BClinical Trials - ~$3.3B

March 16, 2016 FreeMind Group, LLC

Supports Complete R&D Process

DiscoveryPreclinical

DevelopmentPhase I Phase II Phase III Licensure

Production and Delivery

PHASES

IND NDA/BLA

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•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%


Example Award

Clinical Awards

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$26.3M!


Case Study - nanoMR

2008 2011

$5.5M Series A

$13M Series B

$21M BARDA Contract

Acquisition

By DNAe

20152014

Make or Break

Bought for $21M


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 – May be required with some sources

• IRBs – Usually not required at time of

submission

• Contact PO in advance!

FreeMind Group, LLC

Funding Opportunities

NIH

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FreeMind Group, LLC


Clinical Trial Planning

Grants (R34)

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Clinical Trial Planning Grants

R34/U34Activities 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

NIH Clinical Trial Planning Grants

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

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R34/U34

FreeMind Group, LLC

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R34/U34

Clinical Trial Planning Grants

• 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)

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FreeMind Group, LLC


NIH Clinical Trial Funding

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FreeMind Group, LLC

NIAID

NIAID Clinical Trial Implementation Cooperative Agreement (U01)

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

Scope:• Funds implementation of investigator-

initiated, high-risk clinical trials and mechanistic studies associated with high-risk clinical trials.

• The trials must be related to the research mission of the NIAID.

• Has R01 equivalent for non-high-risk clinical trials.

Next Due Date:

May 13, 2016

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PAR-13-151

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:

May 13, 2016

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PAR-13-250

FreeMind Group, LLC

NHLBI

Investigator Initiated Multi-Site Clinical Trials (Collaborative R01)


Scope:• Funds investigator-initiated multi-site

randomized controlled clinical trials. The trials may address any research question related to the mission and goals of the NHLBI and may test clinical or behavioral interventions.

• Funds phase II/III trials

Next Due Date:

June 5, 2016

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PAR-13-128

FreeMind Group, LLC

NIDDK

NIDDK Multi-Center Clinical Study Cooperative Agreement (U01)


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:

June 5, 2016

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PAR-15-067

FreeMind Group, LLC

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NIH

Additional Clinical Stage Opportunities

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• 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

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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)

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FreeMind Group, LLC

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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)

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FreeMind Group, LLC


BARDA

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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

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FreeMind Group, LLC


FDA

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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

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RFA-FD-15-001

FreeMind Group, LLC


Congressionally

Directed Medical

Research Programs (CDMRPs)

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FreeMind Group, LLC

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

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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 Spinal Cord Injury Research Program (SCIRP) – Clinical Trial Award

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Funding: Up to $2M + Indirect costs.

Scope:Expected to be announced in coming weeks.

CDMRPs

Deadline not yet announced

FreeMind Group, LLC

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

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2016 Topic Areas:

CDMRPs

Deadline not yet announced

• Acute Lung Injury• Antimicrobial Resistance• Chronic Migraine • Post-Traumatic Headaches• Congenital Heart Disease• Constrictive Bronchiolitis• Diabetes• Dystonia• Emerging Infectious Diseases• Focal Segmental Glomerulosclerosis• Fragile X Syndrome• Hepatitis B• Hereditary Angioedema• Hydrocephalus

• Inflammatory Bowel Disease• Influenza• Integrative Medicine• Interstitial Cystitis• Lupus• Malaria• Metals Toxicology• Mitochondrial Disease• Nanomaterials for Bone Regeneration• Non-opioid Pain Management• Pancreatitis• Pathogen-Inactivated Dried Plasma• Polycystic Kidney Disease

• Post-Traumatic Osteoarthritis• Psychotropic Medications• Pulmonary Fibrosis• Respiratory Health• Rett Syndrome• Rheumatoid Arthritis• Scleroderma• Sleep Disorders• 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

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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


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

FreeMind Group, LLC

Two Core Services

FMG Professional Process

Core Service 1- Strategic Consulting

• Long term Strategic approach

•Outline projects

•Tasks to be completed

• Link with existing pockets of money

• Solicited vs. Unsolicited

•Map of relevant funding opportunities

•Ongoing Activity

Core Service 2- Project Production Process

•Project Management - coordinating

•Comprehensive templates

•Ongoing feedback and edits

•Budgets

•Converge information

• Final outcome – single coherent presentation

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FreeMind Group, LLC

Joint Effort

FMG Professional Process

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Contact Us!

Thank you!

Jonathan Adalist

Director, Business [email protected]

(617) 648 0340 ext. 285

www.freemindconsultants.com

FreeMindGroup FreeMindGrp

Watch past presentations and webinars online on our YouTube Channel

mailto:[email protected]

non-dilutive funding for clinical stage r&d

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