Jonathan AdalistSenior Director, Business DevelopmentFreeMind GroupMay 10, 2017
Non-Dilutive Funding for Pre-Clinical Research
FreeMindGroup
@FreeMindGrp
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
May 10, 2017 FreeMind Group, LLC 3/26
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.
May 10, 2017 FreeMind Group, LLC 4/26
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.
May 10, 2017 FreeMind Group, LLC 5/26
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
May 10, 2017 FreeMind Group, LLC 6/26
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
May 10, 2017 FreeMind Group, LLC 7/26
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
9/26
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
May 10, 2017 FreeMind Group, LLC
May 10, 2017 FreeMind Group, LLC
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
May 10, 2017 FreeMind Group, LLC 11/26
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
May 10, 2017 FreeMind Group, LLC
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
May 10, 2017 FreeMind Group, LLC
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
May 10, 2017 FreeMind Group, LLC
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
May 10, 2017 FreeMind Group, LLC
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
May 10, 2017 FreeMind Group, LLC
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
May 10, 2017 FreeMind Group, LLC
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
May 10, 2017 FreeMind Group, LLC
May 10, 2017 FreeMind Group, LLC 20/26
Risk Assessment
Review Process
Scientific Approach
Leadership
Environment
Significance
Innovation
Risk
Strength
Responsive vs. Competitive
May 10, 2017 FreeMind Group, LLC 21/26
Strategic Approach
Turn NDF into a Strategic Source of Funding
Maximize the Company’s
Funding Potential
VCs
NDFAngles
May 10, 2017 FreeMind Group, LLC 22/26
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
May 10, 2017 FreeMind Group, LLC 23/26
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
May 10, 2017 FreeMind Group, LLC 24/26
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
May 10, 2017 FreeMind Group, LLC 25/26
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
May 10, 2017 FreeMind Group, LLC
Contact Us!
Thank you!
Jonathan Adalist, M.Sc.Sr. Director, Business Development
617-648-0340 x285
26/26
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