HHS SBIR/STTR PHS 2018-2 GRANT

CLINICAL TRIAL PARENT WEBINAR

Tuesday, February 6, 2018
2:00-4:00PM EST

Matthew Portnoy, Ph.D.

SBIR/STTR Program Coordinator
Director of the Division of Special Programs
Office of Extramural Research, NIH

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AGENDA
Introductions
Reauthorizations
SBIR 101
Clinical Trials Changes
New Omnibus Solicitations
2018 Deadlines
Questions & Answers
Closing

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 - Save the Date -
20th Annual HHS SBIR/STTR Conference

October 30 - November 1, 2018

Dallas, Texas
Stay connected for updates!
@NIHsbir | https://sbir.nih.gov/
 NIH SBIR/STTR Website

https://sbir.nih.gov

4
 NIH SBIR/STTR Website

What are SBIR and STTR Programs?

The NIH SBIR program funds early stage small businesses

that are seeking to commercialize innovative biomedical
SBIR technologies. This competitive program helps small
businesses participate in federal research and
development, develop life-saving technologies, and create
jobs.

The NIH STTR program is similar to the NIH SBIR program,

but requires that the small business formally collaborate with
STTR a research institution in Phase I and Phase II. Learn
more about the NIH SBIR and STTR programs, including
their critical differences.

https://sbir.nih.gov
 New to SBIR/STTR?

http://sbir.nih.gov/infographic
 Congressionally Mandated
Programs
SET ASIDE SMALL BUSINESS INNOVATION
RESEARCH (SBIR) PROGRAM
3.2% Set-aside program for small business concerns
to engage in federal R&D -- with potential for
(FY18)
commercialization

SMALL BUSINESS TECHNOLOGY

TRANSFER (STTR) PROGRAM
.45% Set-aside program to facilitate cooperative
R&D between small business concerns and US
(FY18) research institutions -- with potential for
commercialization
 SBIR Purpose and Goals

• Stimulate technological innovation

• Use small business to meet federal R&D needs
• Foster and encourage participation by minorities and
disadvantaged persons in technological innovation
• Increase private-sector commercialization innovations
derived from federal R&D

Small Business Innovation Development Act of 1982

P.L. 114-328 Re-Authorizes program through FY2022

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 STTR Purpose and Goals

• Stimulate and foster scientific and technological

innovation through cooperative research and
development carried out between small business
concerns and research institutions
• Foster technology transfer between small business
concerns and research institutions

Small Business Research and Development

Enhancement Act of 1992
P.L. 114-328 Re-Authorizes program through FY2022
9
 SBIR/STTR Reauthorization
update

• Congress passed a 5 year SBIR/STTR Reauthorization as

part of S.2943, the 2017 National Defense Authorization
Act (NDAA)
• SBIR/STTR programs reauthorized for 5 year FY18
through FY22
• Simple, one line reauthorization
• No pilot programs extended, all expire 9/30/17
o Direct Phase II
o CRP
o 3% Agency SBIR Admin funds
o NIH Phase 0 Proof of Concept Centers
• Bills circulating in Congress as we speak on these and
other areas. – Stay tuned.
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 SBIR/STTR Budgets by Agency
FY15
Agencies with SBIR and STTR Programs Budget
NASA NSF All
DOE Others Department of Defense (DOD) $1.070B
Department of Health and Human Services (HHS), $797.0M
including the National Institutes of Health (NIH)*

Department of Energy (DOE), including Advanced $206.1M

Research Projects Agency – Energy (ARPA-E)

HHS National Aeronautics and Space Administration $180.1M

(NASA)
National Science Foundation (NSF) $176.0M
DOD
Agencies with SBIR Programs Budget
~ $2.5B in FY2015
U.S. Department of Agriculture (USDA) $25.3M
across all agencies
Department of Homeland Security (DHS): $17.7M
Science and Technology Directorate (S&T) and
Grants Domestic Nuclear Detection Office (DNDO)
Contracts Department of Commerce: National Oceanic and $8.4M
Atmospheric Administration (NOAA) and National
Institute of Standards and Technology (NIST)*

Department of Transportation (DOT) $7.9M

Department of Education (ED) $7.5M
Environmental Protection Agency (EPA) $4.2M
 HHS Program Funding

2017 Budget SBIR STTR

NIH $861M $121M

CDC ~$11.0M N/A

ACL ~$3M N/A

(NIDILRR)

FDA ~$1M N/A

 Program Eligibility Criteria

• Organized as for-profit US business

• Small: 500 or fewer employees, including affiliates

• Work must be done in the US (with few exceptions)

• Individual Ownership:
o Greater than 50% US-owned by individuals and independently operated
OR
o Greater than 50% owned and controlled by other business concern/s
that is/are greater than 50% owned and controlled by one or more
individuals OR
o Be a concern which is more than 50% owned by multiple venture
capital operating companies, hedge funds, private equity firms, or any
combination of these (For FOAs after 1/28/2013 NIH; 7/10/14 CDC)

Determined at Time of Award

 STTR Eligibility Criteria

• Applicant is a Small Business Concern

• Formal Cooperative R&D Effort

o Minimum 40% by small business
o Minimum 30% by US research institution

• US Research Institution
o College or university; other non-profit research
organization; Federal R&D center

• Intellectual Property Agreement

o Allocation of rights in IP and rights to carry out follow-on
R&D and commercialization

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 NIH SBIR/STTR
3-Phase Program
Phase
I Phase I Feasibility Study
Discovery Budget Guide: $150K for SBIR and STTR
Project Period: 6 months (SBIR); 1 year (STTR)

Phase
II Phase II Full Research/R&D
$1M for SBIR and STTR, over two years

Development Phase
Phase IIB Competing Renewal/R&D
IIB
Clinical R&D; Complex Instrumentation/to FDA
Many, but not all, IC’s participate
Varies~$1M per year; up to 3 years

Phase
III Phase III Commercialization
Commercialization
NIH, generally, not the “customer”
Consider partnering and exit strategy early
 SBIR and STTR Critical
Differences

SBIR STTR
Partnering Permits partnering Requires a non-profit research
Requirement institution partner
(e.g. university)

Work Guidelines: May outsource Minimum Work Requirements:

Requirement 33% (Phase I) 50% (Phase II) 40% small business
30% research institution
partner
Principal Primary employment (>50%) PI may be employed by either
Investigator must be with the small the research institution
business partner or small business

Award is always made to the small business

 National Institutes of Health

Office of Research
Infrastructure Programs
Office of the Director http://www.nih.gov/icd

National Institute of National Institute

National National Institute National Institute National of Child Health
Arthritis and
Institute on Alcohol Abuse of Allergy and Cancer and Human
Musculoskeletal and
on Aging and Alcoholism Infectious Diseases Institute Development
Skin Diseases

National Institute
National Institute National Institute
on Deafness and National National Institute National
of Dental and of Diabetes and
Other Institute of Environmental Eye
Craniofacial Digestive and
Communication on Drug Abuse Health Sciences Institute
Research Kidney Diseases
Disorders

National Institute National Heart, National Human National National Institute of National Institute
of General Lung, and Blood Genome Research Institute Neurological of Nursing
Medical Sciences Institute Institute of Mental Health Disorders and Stroke Research

National Institute National Institute

National Center for Fogarty National Center National
on Minority of Biomedical
Complementary and International for Advancing Library
Health and Health Imaging and
Integrative Health Center Translational Sciences of Medicine
Disparities Bioengineering

NIH Clinical Center Center for Information

Center for Scientific Review
Technology

No SBIR/STTR funding authority

NIH SBIR/STTR Budget Allocations FY2017
3.2% SBIR $861.4M
0.45% STTR $121.1M
Total FY17 $982.5M
FY18 - Pending
 NIH SBIR/STTR
3-Phase Program

Discovery Development Competing Renewal Award Commercialization

Phase I Phase II Phase IIB Phase III

$3M for up to 3 years

Feasibility Full R/D

Commercialization
Readiness Pilot (CRP)
Phase I Phase II Congressional
authority expired
Fast-Track $3M for up to 3 years

Direct to Phase II
Congressional Only Some ICs
authority expired Participate
 NIH SBIR/STTR
Fast-Track

Discovery Development Competing Renewal Award Commercialization

Phase I Phase II Phase IIB Phase III

$3M for up to 3 years

Feasibility Full R/D Additional R/D

Phase I Phase II • Simultaneous submission

and review of Phase I and II
Fast-Track • Phase I is awarded
• Milestones/aims of Phase I
Direct to Phase II are assessed by program
staff BEFORE Phase II is
awarded
 NIH SBIR/STTR
Direct to Phase II

Discovery Development Competing Renewal Award Commercialization

Phase I Phase II Phase IIB Phase III

$3M for up to 3 years

Feasibility Full R/D Additional R/D

Phase I Phase II

Fast-Track

• SBIR only
Direct to Phase II • Bypass Phase I grant
• Congressional authority EXPIRED
 Phase IIB Competing
Renewal Award
Discovery Development Commercialization
Competing Renewal
Phase I Phase II Phase III
Phase IIB

$3M for up to 3 years

• SBIR/STTR Phase II awardee

• Technologies that require extraordinary time/effort to develop,
and often require FDA regulatory approval
• Awards up to $1M/year for up to 3 years
• IC must accept Competing Renewal applications (NIA, NIAAA,
NIAID, NICHD, NIDA, NIDCD, NIDDK, NEI, NIGMS NHLBI, NIMH,
NINDS, NCATS, ORIP, NCI, NHLBI, NINDS)

Contact NIH Program Staff to discuss!

 NIH SBIR/STTR FOAs

Funding Opportunities Announcements (FOAs)

a publicly available document by which a federal agency makes
known its intentions to award discretionary grants or cooperative
agreements, usually as a result of competition for funds.

https://sbir.nih.gov/funding
 Omnibus vs Targeted FOAs

Omnibus Targeted
Due Dates Standard Due Dates Standard or
Customized Due Dates

Review SBIR/STTR panels at CSR SBIR/STTR panels at CSR

<OR>
SBIR/STTR panel at IC

Application Follow SF424 R&R Follow SF424 R&R

Instructions SBIR/STTR Application Guide SBIR/STTR Application Guide
& Annotated Form Set & Annotated Form Set
<AND>
any additional instructions in
FOA

Read FOA very carefully!

 Solicitations and Due Dates

NIH, CDC, & FDA SBIR/STTR Grant

Solicitation “Parent” FOAs:
Clinical Trial Required

SBIR: PA-18-573 STTR: PA-18-576

Clinical Trial Not Allowed

SBIR: PA-18-574 STTR: PA-18-575

Release: January 16, 2018

Standard Due Dates: April 5th, September 5th (2018)
January 7th, April 5th (2019)
 Contracts
SBIR Contract Solicitation (NIH, CDC) - CLOSED
Closing Date: October 27, 2017
Program Solicitation PHS 2017-2 (SBIR Only)

NIH Guide for Grants and Contracts

Release: Weekly receipt dates specified in each FOA

o NIH Guide Notice: NOT-OD-18-123

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27
Clinical Trials Changes

New Reforms & Initiatives

All Research Research that Meets
Involving Human the NIH Definition of a
Participants Clinical Trial

New forms to collect Training in Good Clinical

human subjects Practice (GCP)
information Clinical trial-specific
Use of a single Funding Opportunity
Institutional Review Announcements (FOAs)
Board (IRB) for New review criteria
domestic multi-site
studies Expanded registration
and results reporting in
ClinicalTrials.gov
28
Clinical Trials Changes

NIH Definition of a Clinical Trial

Know NIH Definition of a Clinical Trial
A research study in which one or more human subjects are prospectively
assigned to one or more interventions (which may include placebo or other
control) to evaluate the effects of those interventions on health-related
biomedical or behavioral outcomes.

- Prospectively Assigned: a pre-defined process (e.g., randomization)

specified in an approved protocol that stipulates the assignment of research
subjects (individually or in clusters) to one or more arms (e.g.,
intervention, placebo, or other control) of a clinical trial.
- Intervention: a manipulation of the subject or subject’s environment for the
purpose of modifying one or more health-related biomedical or behavioral
processes and/or endpoints.

- Health-related Biomedical or Behavioral Outcome: the pre-specified

goal(s) or condition(s) that reflect the effect of one or more interventions
on human subjects’ biomedical or behavioral status or quality of life.

Learn more at https://grants.nih.gov/policy/clinical-trials/definition.htm

29
Clinical Trials Changes

Determine if Your Study is an NIH-

defined Clinical Trial
Does your study…
1. Involve one or more human participants?
If “yes” to ALL
2. Prospectively assign human participant(s)
to intervention(s)?
of these
questions, your
3. Intend to evaluate the effect of an
study is
intervention on human participants
considered a
4. Have a health-related biomedical or clinical trial
behavioral outcome?

Clinical Trial Interactive Decision Tree: https://grants.nih.gov/ct-

decision/index.htm
30
Clinical Trials Changes

Clinical Trial-Specific
Clinical Trial-SpecificFunding Opportunities
Funding Opportunities
Applications/proposals involving 3 Types of FOAs
clinical trials (due dates on or after
January 25, 2018) must be submitted
to an FOA/RFP that accepts clinical  Clinical Trials Not Allowed – only
trials accepting applications not
proposing clinical trial(s)
NOT-OD-16-147:
https://grants.nih.gov/grants/gui  Clinical Trials Required – only
de/notice-files/NOT-OD-16- accepting applications proposing
147.html clinical trial(s)
NOT-OD-17-043:
https://grants.nih.gov/grants/gui  Clinical Trials Optional –
de/notice-files/NOT-OD-17- accepting applications that either
043.html propose or do not propose
clinical trial(s)
31
Clinical Trials Changes

Public
Website on
Clinical Trial
Requirements

https://grants.nih.gov/policy/clinical-trials.htm
 Clinical Trials FOAs

2018 Program
Descriptions and
Research Topics
Document

32
 Clinical Trials Changes

New Human Subjects and Clinical Trials

Change
Information Form
 Required for all applications with due dates on or after
January 25, 2018
 Consolidates human subjects and clinical trial
information into one place
 Expands information required for studies meeting
definition of NIH clinical trial
 Collects information at the study level
 Aligns with ClinicalTrials.gov

NOT-OD-17-062 New NIH "FORMS-E" Grant Application Forms and Instructions

NOT-OD-17-119 New “FORMS-E” Grant Application Instructions Available
Clinical Trials Changes
 Institutes allowing
Clinical Trials under Omnibus
National Cancer Institute (NCI)
National Eye Institute (NEI)
National Heart, Lung, and Blood Institute (NHLBI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Dental and Craniofacial Research (NIDCR)
National Institute on Drug Abuse (NIDA)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Institute on Minority Health and Health Disparities (NIMHD)
National Center for Complementary and Integrative Health (NCCIH)

SBIR Omnibus/Parent Clinical Trial Required Funding Opportunity Announcement (PA-18-573)

STTR Omnibus/Parent Clinical Trial Required Funding Opportunity Announcement (PA-18-576)

35
 Clinical Trials Updates

https://sbir.nih.gov/faqs#ct

36
 SBIR/STTR Program
Descriptions and Research Topics

Our Ideas: Suggested topic areas*

• Biodefense • Biosilicon devices

• Biosensors • Biocompatible
• Nanotechnologies materials
• Bioinformatics • Acousto-optics / opto-
• Diagnostic and electronics
Therapeutic Devices • Health IT
• Telehealth • Imaging devices
• Proteomics / Genomics • Genetically engineered
proteins
• …
37
 SBIR/STTR Program
Descriptions and Research Topics

YOUR Ideas: Investigator-initiated R&D

• Research projects related to the NIH mission

• “Other” areas of research within the mission

of an awarding component

Keyword Search the Solicitation

Ctrl + F

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 NIH 2017 SBIR/STTR Grants
Success Rate by Phase

40%
39%
37%

29%
28%

19%
17%
16% 16%

Fast Track Phase I Regular Phase II Phase IIB Direct Phase II CRP
SBIR STTR
 NIH-wide SBIR/STTR
Grant Success Rates 2017
Number of Number of
Success
Fiscal Year SBIR/STTR Phase Applications Applications Total Funding
Rate
Reviewed Awarded

2017 SBIR Phase I 3,508 549 15.6% $130,684,068

2017 SBIR Fast Track 536 101 18.8% $33,615,578

2017 SBIR Total Phase II 975 324 33.2% $264,381,192

2017 SBIR Regular Phase II 525 194 37.0% $151,035,773

2017 SBIR Direct Phase II 397 109 27.5% $94,532,103

2017 SBIR Phase IIB 53 21 39.6% $18,813,316

2017 SBIR CRP 90 26 28.9% $17,543,972

2017 STTR Phase I 1,049 169 16.1% $40,460,681

2017 STTR Fast Track 88 15 17.0% $4,140,054

2017 STTR Total Phase II 88 34 38.6% $25,306,914

2017 STTR Regular Phase II 88 34 38.6% $25,306,914

2017 STTR Phase IIB 0 0 0.0% $0

2017 FY TOTAL 6,334 1,218 19.2% $516,132,459

Success Rates Posted Online: https://sbir.nih.gov/statistics/award-data

 National Institutes of Health When is SBIR/STTR appropriate?
Office of Extramural Research

Lift Labs
• Develops new technologies to
provide proactive care for people
with essential tremor and
Parkinson's Disease
• Acquired by Google in September Anupam Pathak, Ph.D.
2014 Founder & CEO
NINDS SBIR Awardee

http://www.liftlabsdesign.com/
41
 National Institutes of Health When is SBIR/STTR appropriate?
Office of Extramural Research

SenesTech
• Limits rodent fertility in a non-lethal
and environmentally-friendly way
• Works with NYC Subway System,
and Chicago Transit Authority

Loretta Mayer, Ph.D.

Founder & CSO
NIEHS SBIR Awardee

http://senestech.com/
42
 When is SBIR/STTR appropriate?

Be Prepared to Resubmit!

“[SBIR] has been a long, trying, but worthwhile

journey...from multiple submissions that were not
discussed...to applications that scored below the funding
levels...to concurrent applications (one Phase II and a
Phase I) emerging from the rigorous peer review
process with impact scores in the “Excellent" range.” Laverne Morrow
Carter, Ph.D.
Founder & President, REESSI
NIMHD SBIR Awardee

http://www.reessi.com
 When is SBIR/STTR appropriate?

“As a native Spanish-speaking curriculum designer with

a background in literary and performing arts, I work as a
principal investigator on a number of NIH-funded
projects. The SBIR and STTR programs allow me to
translate evidence-based practices into web-based
multimedia programs that offer skill-building tools for
improving health and educational outcomes among Jessie Marquez
Latino audiences.” Instructional Designer at
IRIS Educational Media

http://www.irised.com/
 Electronic Submission

SBIR/STTR grant applications and SBIR contract proposals

must be submitted electronically.

Registrations are required!!!

o DUNS Number (Company)
o System for Award Management (SAM)
o Grants.gov (Company)
o eRA Commons (Company and all PD/PIs)
o SBA Company Registry at SBIR.gov

• Helpful NIH Grants Registration Infographic

• For contracts, submit proposals with electronic Contract Proposal

Submission (eCPS) website
Submit via ASSIST or Workspace
 Electronic Submission
Annotated Form Set for NIH Grant Applications
FORMS-E Series
(Application due dates on/after January 25, 2018)

47
 Timeline: New Applications

Scientific Council Award

Due Date Date
Review Review
(earliest)

April 5th May/June Aug/Sept October

Sept 5th Oct/Nov Jan/Feb March

Jan 5th Feb/Mar May/June July

 NIH Application & Review Process

Applicant initiates Small Business Submits SBIR/STTR NIH Center for

research idea Concern confirms grant application to Scientific Review
Eligibility NIH electronically assigns to IC and IRG

1-2 Months

3 Months

IC staff prepare Advisory Council or Scientific Review

funding plan for Board recommend Group evaluates
IC Director Approval scientific merit
2-4 Months

IC allocates Grantee conducts

funds research
 Review Criteria

Overall Impact Score

Scored Review Criteria (score 1-9)
• Significance (Real Problem/Commercial Potential)
• Investigators (PI and team)
• Innovation (New or Improved?)
• Approach (Research Design, Feasible)
• Environment (Facilities/Resources)

Additional Review Criteria (not scored individually)

• Protection of Human Subjects
• Inclusion of Women, Minorities & Children
• Vertebrate Animals
• Biohazards

50
 Most Important Piece of Advice

Talk to a HHS Program Officer at least a month before a deadline for

application specific advice.

Click here for the list of HHS SBIR Program Managers

Not sure who to contact? Email sbir@od.nih.gov

What is a Women-Owned Small
Business (WOSB)?
• A firm must be at least 51%
owned and controlled by one or
more women, and primarily
managed by one or more women
(who must be US citizens)
• The firm must be “small” in its
primary industry in accordance
with SBA’s size standards for that
industry
• SBCs self certify on the SF 424
(R&R) Form
WOSB and SDB Definitions
What is a Socially and Economically
Disadvantaged Business (SDB)?
• The firm must be 51% or more
owned and control by one or
more disadvantaged persons
• The disadvantaged person or
persons must be socially
disadvantaged and economically
disadvantaged
• The firm must be small,
according to SBA’s size standards
• You must self-certify by
registering your business in
the System for Award
Management
52
 Multi-IC Technology Development Programs
(open to eligible Awardees from participating ICs)

12 Participating ICs + CDC

I-CorpsTM at NIH
An intensive Entrepreneurial
Immersion course for scientists

Investor

Facilitating Forum

Partnerships
 NIH Technical Assistance Programs

Niche Assessment • Helps jump start commercialization

efforts
Program-Foresight S&T
• Determines competitive advantages
(Phase I Awardees)
• Develops market entry strategy

Commercialization
Accelerator Program - • Technical Assistance/Training in:
Strategic/business planning
Larta, Inc. o

o FDA requirements
(Phase II Awardees)
o Technology evaluation
o Manufacturing issues
o Patent and licensing issues
• Helps build strategic alliances
• Facilitates investor partnerships
• Individualized mentoring/consulting
 More Information

Get Connected!

• Subscribe to the SBIR/STTR Listserv:

o Email LISTSERV@LIST.NIH.GOV with the following text in the
message body: subscribe SBIR-STTR your name

• NIH Guide for Grants and Contracts (weekly notification)

• Follow us on Twitter: @NIHsbir

• Read our NIH SBIR/STTR Success Stories

• Connect with Us

• Email: sbir@od.nih.gov
 For More Information

Matthew Portnoy, PhD Robert Vinson

NIH SBIR/STTR Program Coordinator SBIR/STTR Program Manager
Phone: 301-435-2688 Phone: 301-435-2713
Email: mportnoy@mail.nih.gov Email: vinsonr@mail.nih.gov

JP Kim, JD, MBA, MSc

SBIR/STTR Program Manager
Phone: 301-435-0189
Email: jpkim@nih.gov

Julie Beaver, MD, MS Patricia Swayne

SBIR/STTR Statistician SBIR/STTR Communications
Phone: 301-496-8807 Specialist
Email: julie.beaver@nih.gov Phone: 301-402-1632
Email: patricia.swayne@nih.gov

56
QUESTIONS?
Submit using the “Questions”
tab of your GoToWebinar
Control Panel.

57