Digital Health Technologies to Address the

Social Determinants of Health in context of

Substance Use Disorders (SUD)

Webinar #2: Environment and Investigators

Victor Prikhodko, Business Advisor [C]

Office of Translational Initiatives and Program

Innovations (OTIPI), Office of Director (OD)

NIDA

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RFA-DA-20-017 and RFA-DA-20-018

Commercializable, digital health-based products that aim at

positively affecting the fundamental social and environmental

conditions that are risk factors for the populations affected by the

use of drugs, including opioids

Digital Health Technologies to Address the Social

Determinants of Health in context of Substance Use

Disorders (SUD)

Informational Webinars to break

down the application process4

Environment and Investigators

Tuesday June 20, 2019

Significance and InnovationTuesday June 25, 2019 2-4PM EDT

Specific Aims and Approach

Thursday June 27, 2019, 12-2PM EDT

Commercialization PlanTuesday July 2, 2019, 2-4PM EDT

https://sbir.nih.gov/nida/RFA%3ASocial_Determinants

Due Date

July 29th, 2019 5pm

Introduction to SDoH RFATuesday June 18, 2019

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https://sbir.nih.gov/infographic

Complete Five Required

Registrations as soon as possible.

6What goes into the application?

Application Breakdown

Applicant’s Information

BioSketches

Budget

Commercialization Plan

Direct to Phase II

Fast Track

Specific Aims

Research Strategy

6pg for Phase I

12pg for Phase II/Fast Track

Letters of Support

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https://www.niaid.nih.gov/grants-contracts/sample-applications#r43r44

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https://www.niaid.nih.gov/grants-contracts/sample-applications#r43r44

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https://grants.nih.gov/grants/ElectronicReceipt/files/Annotated_Forms_SmallBus_FORMS-E.pdf

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https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/sbir-sttr-forms-e.pdf

Application Evaluation

• Significance

• Innovation

• Approach

• Investigators

• Environment

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https://grants.nih.gov/grants/guide/rfa-files/rfa-da-20-018.html

Summary Statement12

https://www.niaid.nih.gov/grants-contracts/sample-applications#r43r44

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https://www.niaid.nih.gov/grants-contracts/sample-applications#r43r44

Criteria: Environment

Will the scientific environment in which the work will be done

contribute to the probability of success?

Are the institutional support, equipment and other physical

resources available to the investigators adequate for the

project proposed?

Will the project benefit from unique features of the scientific

environment, subject populations, or collaborative

arrangement

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https://grants.nih.gov/grants/guide/rfa-files/rfa-da-20-018.html

Criteria: Environment

(Clinical Trials)

If proposed, are the administrative, data coordinating,

enrollment and laboratory/testing centers, appropriate for the

trial proposed?

Does the application adequately address the capability and

ability to conduct the trial at the proposed site(s) or centers?

Are the plans to add or drop enrollment centers, as needed,

appropriate?

If international site(s) is/are proposed, does the application

adequately address the complexity of executing the clinical

trial?

If multi-sites/centers, is there evidence of the ability of the

individual site or center to: (1) enroll the proposed numbers; (2)

adhere to the protocol; (3) collect and transmit data in an

accurate and timely fashion; and, (4) operate within the

proposed organizational structure?

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https://grants.nih.gov/grants/guide/rfa-files/rfa-da-20-018.html

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https://www.niaid.nih.gov/grants-contracts/sample-applications#r43r44

Example of Environment Section

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https://www.niaid.nih.gov/grants-contracts/sample-applications#r43r44

Example of Environment Section

Environment: Best Practices

and Recommendations

Identify all resources necessary to

complete the proposed project

Is it clear to Reviewers were the work will be

done and that the resources are available

Outline access to all available resources,

not just technical

E.g. Access to additional resources that are

key to commercialization (E.g. Tech Transfer,

Investors, Regulatory Network)

Use the Review Criteria as a Check List

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https://sbir.nih.gov/nida/statebusinessresources

Criteria: Investigators

Are the PD(s)/PI(s), collaborators, and other researchers

well suited to the project?

If Early Stage Investigators or those in the early stages

of independent careers, do they have appropriate

experience and training?

If established, have they demonstrated an ongoing

record of accomplishments that have advanced their

field(s)?

If the project is collaborative or multi-PD/PI, do the

investigators have complementary and integrated

expertise; are their leadership approach, governance

and organizational structure appropriate for the

project?

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https://grants.nih.gov/grants/guide/rfa-files/rfa-da-20-018.html

Definition of a Principal

Director/Project Director

PD/PI Definition: As defined in 42 CFR 52, the PD/PI(s) is or are the

“…individual(s) judged by the applicant organization to have the

appropriate level of authority and responsibility to direct the project

or program supported by the grant and who is or are responsible

for the scientific and technical direction of the project.” When the

proposed PD/PI clearly does not have sufficient qualifications to

assume this role, the application is not likely to receive a favorable

evaluation.

Primary employment means that more than one half (greater than

50%) of the PD/PI’s time is spent in the employ of the SBC. Primary

employment with an SBC precludes fulltime. employment at

another organization…

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https://grants.nih.gov/grants/how-to-apply-application-guide/forms-e/sbir-sttr-forms-e.pdf

Use our Database22

NIDA = DA

SBIR/STTR

https://projectreporter.nih.gov/reporter.cfm

Identify Academic Partners23

NIDA = DA

https://projectreporter.nih.gov/reporter.cfm

Identify Academic Partners24

https://projectreporter.nih.gov/reporter_matchmaker.cfm?source=RPCO&new=1

Example of Using NIH RePORTER25

“addiction digital health clinical research”

Academic Researchers

Identified via NIH RePORTER

1. Aimee Campbell, Columbia2. Kathleen Carroll, Yale3. Jan Gryczynski, Friends Research Institute4. Shannon Mitchell, Friends Research

Institute5. Leonard Jason, Du Paul University6. James Ford, University of Wisconsin7. Andrew Quanbeck, University of

Wisconsin8. David Gustafson, University of Wisconsin9. Jennifer McNeely, NYU10. Shadi Nhavi, Montefiore11. Allison Ober, Katherine Watkins, RAND12. Stacey Sigmon, University of Vermont

1. Kenneth Silverman, Johns Hopkins2. Flavio Marsiglia, Arizona State University3. Anne Mauricio, Arizona State University4. Kevin Haggerty, University of Washington5. Dick Spoth, Iowa State University6. Willie Prado, Miami University

7. Leslie Leve, University of Oregon8. Lisa Saldana, Oregon Social Learning

Center9. Lillian Gelberg, UCLA10. Joel Bennett, University of Pennsylvania11. Sean Young, UCLA12. Marguerita Lightfoot, UCSF13. Todd Molfenter, University of Wisconsin

Madison

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https://projectreporter.nih.gov/reporter_MatchmakerResults.cfm?mqf=1&tab=

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https://www.niaid.nih.gov/sites/default/files/1r44ai112187-01a1_coleman.pdf

Biosketch Example

https://grants.nih.gov/grants/forms/biosketch.htm

28 Biosketch Should be Project Specific

29 Biosketch Should be Project Specific

Investigators: Best Practices

and Recommendations

Identify all personal necessary to

complete the proposed project

Is it clear to Reviewers what each key personal

will complete/be responsible for?

Areas of technical expertise

Areas of end-user expertise

Areas of commercial/product development expertise

Create a custom BioSketches for the

application (don’t cut and paste)

Use the Review Criteria as a Check List

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Informational Webinars to break

down the application process31

1. Social Determinants RFA: Significance and Innovation Tuesday June 25, 2019, 2-4PM EDT https://nih.webex.com/nih/j.php?MTID=mb1be1c452ad75189427ef59355

cd7a17

2. Social Determinants RFA: Writing good Specific Aims and Approach Thursday June 27, 2019, 12-2PM EDT

https://nih.webex.com/nih/j.php?MTID=md4768c931438e34ff961947b97f

aefe3

3. Social Determinants RFA: Writing a good Commercialization Plan Tuesday July 2, 2019, 2-4PM EDT

https://nih.webex.com/nih/j.php?MTID=m9b22449a851e9c695cba34a55

81a2969

Contact us!

nidasbir@mail.nih.gov

1. What problem you are trying to solve?

2. How is it solved today?

3. What are you trying to achieve? (no terminology, please!)

4. Who is your customer? Are they willing to pay? Are they

easy to find?

5. What is new about your approach?

6. If you succeed, what difference do you think it will make?

7. How long do you think it will take?

8. How much will it cost? To develop? To produce? To use?

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