non-dilutive funding for pre-clinical...

Jonathan AdalistSenior Director, Business DevelopmentFreeMind GroupMay 10, 2017

Non-Dilutive Funding for Pre-Clinical Research

FreeMindGroup

@FreeMindGrp

FreeMind Group

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


https://twitter.com/freemindgrp




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



May 10, 2017 FreeMind Group, LLC 2/26

FreeMind Group

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


Role of Non-Dilutive Funding in the Market

Future Returns on Investment

Milken Institute, “Estimating Long-term Economic Returns of NIH on Output in the Bioscience.” August 31, 2012.


Role of Non-Dilutive Funding in the Market

Milken Institute, “Estimating Long-term Economic Returns of NIH on Output in the Bioscience.” August 31, 2012.


Non-Dilutive Market

$50B+ Allocated Annually

HHS- NIH

27 institutes and centers including

NCI, NIDDK, NINDS, NIAID, NIBIB, NHLBI, NEI, NIA, NIMH, etc.

Other HHS Organizations

BARDA, FDA, CDC, NSF

Department of Defense (DOD)

US Army, DARPA, DTRA, CDMRP, etc.

Private Foundations

Gates, MJ Fox, JDRF, and many more


NIH 2016 Budget - $32.31B

Research Projects $17,820,973

55%

Research Centers $2,644,811

8%

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

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

Categorical Spending


Cancer - ~$6BNeurosciences - ~$6BInfectious Diseases - ~$4B

~$27,000,000,000

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

8/26

Pre-Clinical Funding Mechanisms

• R21 - Early stage, exploratory, novel studies, high risk high reward-

• Up to $275K + Indirect costs• Max duration 2 years

• R01 - Later stage research, longer term project-

• Up to $2.5m + Indirect costs• Max duration 5 years

• SBIR / STTR – Congressionally mandated, set-aside for US small businesses-

• Phase 1 up to $225k• Phase 2 up to $1.5m

R21, R01, SBIR/STTR

May 10, 2017 FreeMind Group, LLC

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Pre-Clinical Funding Mechanisms

• CDMRP - Once a year program from DoD,

• R&D in areas of interest to Congress

• Budget & duration varies by solicitation

• Broad Agency Announcement (BAA)

• Either highly specific or could be relatively broad & generic, aimed at sourcing ideas in a specific area of interest

• Budget & duration varies by solicitation

CDMRP, BAA



Investigator Initiated

SBIR and STTR Omnibus Solicitations

Parent Announcements – Omnibus Solicitations

• SBIR- Omnibus Solicitation of the NIH, CDC, FDA and ACF for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44])(PA-16-302)

• STTR - Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] (PA-16-303)

Deadline:SBIR – Sept 5th

STTR– Sept 5th

10/26

Standard Due Dates:April, Sept, Jan 5th


Funding Mechanisms

SBIR/STTR

• Funding level

• Can exceed suggested limits by up to 50% if justified

• Eligibility:

• US Small businesses, under 500 employees

• Majority ownership by US citizens/residents

• SBIR restrictions:

• Over 50/66% conducted in-house

• No virtual companies (?)

• Commercialization plan

• 3.65% of available granting agency budget


Investigator Initiated

RO1 and R21 Omnibus Solicitations

Parent Announcements – Omnibus Solicitations

• R21 - NIH Exploratory Developmental Research Grant Program (Parent R21)– PA-16-161

• RO1 - Research Project Grant (Parent R01) – PA-16-160

Deadline:RO1 – June 5th

R21 –June 16th

12/26

Standard Due Dates:RO1 – Feb, June, Oct 5th

R21 – Feb, June Oct 16th

Funding Opportunities

Case StudiesInfectious Disease, Oncology and

Neuro

13/26May 10, 2017 FreeMind Group, LLC

Case Study #1

14/26

Bac2Future Inc.• Background: US based company with 17

employees, raised $5M Series A. Developing novel broad spectrum antibiotics for the use in drug resistant bacteria.

• Stage of Development: Compound tested in-vitro and validated in animal study.

• R&D Plan: Initiate ADME/Tox studies as part of IND package.

Infectious Diseases


Case Study #1

15/26

NIH – NIAID• SBIR/STTR• R01 Parent Announcement

USAMRMC• BAA for Extramural Medical Research

(W81XWH-17-R-BAA1)

CDMRP• Military Infectious Diseases Research

Program (MIDRP)

CARB-X

Wellcome Trust• Translation Fund

Infectious Diseases


Case Study #2

16/26

OnCAR-T LLC• Background: Small US company, with 3

co-founders/employees, invested themselves and raised $1m from friends & family. Developing immunotherapy approach for treatment of breast cancer.

• Stage of Development: The company has developed & engineered the CAR T cells.

• R&D Plan: Initiate in-vivo studies to determine efficacy of their treatment.

Oncology


Case Study #2

17/26

NIH – NCI• NIH Research Project Grant (Parent R01)• Fast Track SBIR (PA-16-302)• Metabolic Reprogramming to Improve

Immunotherapy (R01) [PAR-16-228]

CDMRP• Brest Cancer Research Program -

Breakthrough Award Level 2

Breast Cancer Research Foundation

Oncology


Case Study #3

18/26

IceBucketChallangeRx• Background: A US company, with 6 employees,

spun out of an Ivy League University, raised $2M from various local grants. Developing a small molecule novel drug to treat ALS, may have potential in other neurodegenerative diseases.

• Stage of Development: Lead compound identified and validated in-vitro.

• R&D Plan: Initiate in-vivo studies to determine efficacy, PK-PD, metabolism and toxicity of their compound as part of their IND enabling studies.

Neurology


Case Study #3

19/26

NIH – NINDS• SBIR/STTR, R21, R01 Parent Announcements• Innovation Grants to Nurture Initial

Translational Efforts or IGNITE (R21 / R33)• BPN: Small Molecule Drug Disc. & Dev. for

Disorders of the Nervous System (U44)• Opportunities for Collaborative Research at the

NIH Clinical Center (U01) [PAR-15-287]• NeuroNEXT Infrastructure Resource Access

(X01) [PAR-15-195]CDMRP• Amyotrophic Lateral Sclerosis Research

Program Therapeutic Development AwardALS Association

Neurology



Risk Assessment

Review Process

Scientific Approach

Leadership

Environment

Significance

Innovation

Risk

Strength

Responsive vs. Competitive


Strategic Approach

Turn NDF into a Strategic Source of Funding

Maximize the Company’s

Funding Potential

VCs

NDFAngles


vMaximize your Chances for Award

Seek insight into the interests and goals of the funding agencies

Correlate the granting strategy with your long term R&D plan

Identify ALL relevant funding opportunities

Plan and execute a long-term multi-submission granting strategy

NDF

Strategic Approach


Risk Management

Maximize your Chances for Award

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

Reduce the risk of being selected for funding

NDF


The Professional

Team

FreeMind’s NIH Team

60 full time employees

Senior Advisors

Client Strategists

Managers

Writers

Professional Leaders:

Guy Harchen, M.Sc., MBA,

Chief Client Strategist

Joel Knopf, M.Sc., MBA,

Manager Consulting Services


Maximize Funding Potential

FreeMind Group, LLC

What do we do?

1. Identify ALL relevant funding opportunities

2. Create a multi-submission granting strategy

3. Submit as many top quality applications as possible


Contact Us!

Thank you!

Jonathan Adalist, M.Sc.Sr. Director, Business Development

[email protected]

617-648-0340 x285

26/26

Watch past presentations and webinars online on our YouTube Channel

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www.freemindconsultants.com

FreeMindGroup

@FreeMindGrp

FreeMind Group

mailto:[email protected]

http://www.freemindconsultants.com/










non-dilutive funding for pre-clinical...

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