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TRANSLATIONAL PROGRAMS AT THE
NATIONAL INSTITUTE ON DRUG ABUSE
(NIDA)OFFICE OF TRANSLATIONAL INITIATIVES AND PROGRAM INNOVATIONS (OTIPI), OFFICE OF DIRECTOR (OD)
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VICTOR PRIKHODKO
THE NATIONAL INSTITUTE ON DRUG ABUSE
(NIDA)
Our mission is to advance science on the causes and consequences of drug use and
addiction and to apply that knowledge to improve individual and public
health.
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FY 2019 Research Budget is $1.42B
THE REACH AND IMPACT OF THE OPIOID CRISIS
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“CEA estimates that in 2015, the economic cost of the
opioid crisis was $504.0 billion, or 2.8 percent of GDP
that year. “
THE CREATION OF NIDA’S MEDICATION
DEVELOPMENT DIVISION
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In an effort to stimulate the
availability of medications to
treat drug addiction, Congress
authorized (P.L. 99-570) a drug
discovery and development program
within NIDA.
A tacit acknowledgement that the
pharmaceutical industry needed
incentives to consider medications
development in the area of
addictive disorders.
THERE HAS BEEN LITTLE FUNDING FROM THE
VC COMMUNITY INTO ADDICTION STARTUPS
http://go.bio.org/rs/490-EHZ-999/images/BIO_HPCP_Series-Pain_Addiction_2018-02-08.pdf
AGENDA
1. Medication Development Program to Treat SUD
2. Blueprint Therapeutics Network
3. Step Up for SUD: A Drug Target Initiative for Researchers
Engaged in Fundamental Research
4. NIDA’s Ultimate Translational Program: SBIR/STTR
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NIDA IS POISED TO INNOVATIVE EVEN WITHIN
THE TRADITIONAL GRANT MAKING PROGRAM
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A VIRTUAL PHARMA MODEL: NIH BLUEPRINT
NEURO THERAPEUTICS PROGRAM
PAR-18-546
Blueprint Neurotherapeutics Network
(BPN): Small Molecule Drug Discovery
and Development of Disorders of the
Nervous System (UG3/UH3)
Application Due Dates: February
11, 2020, by 5:00 PM
https://grants.nih.gov/grants/guide/p
a-files/PAR-18-546.html
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THE UNIQUE CORNERSTONE OF BPN INFRASTRUCTURE
IS THE LEAD DEVELOPMENT TEAM
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APPLYING LEAN PRODUCT DEVELOPMENT
PRACTICES TO DRUG DISCOVERY
RFA-DA-20-025
Step Up for Substance Use
Disorders (SUD): A Drug Target
Initiative for Scientists Engaged in
Fundamental Research
Application Due Date: February 13,
2020
https://grants.nih.gov/grants/guide/r
fa-files/RFA-DA-20-025.html
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NOT A BRIDGE BUT JUST ONE STEP UP
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STOPBack to basic
researchTarget
rigorously
invalidated
Exit:
patent,
license,
DTMC,
SBIR, BPN
Pharma (manufacturing,
marketing, distribution)
NIDA
Purposefully focus
on value creation or
risk reduction
IN-KIND RESOURCES
NIDA Drug Supply Program
Support: Provides chemical and research probes that are either unavailable, difficult to obtain, or very expensive to buy to researchers, including marijuana plant materials, cannabinoids, opioids, stimulants, sedatives, hypnotics, standardized research E-Cigarettes and nicotine research. Also provides analytical services for the analysis of researchers’ experimental samples.
NIDA Center for Genetic Studies, aka NIDA genetic Repository
Support: produce, store, and distribute clinical data and biomaterial (DNA samples and cell lines) in opioid, cocaine, and nicotine dependence.
Addiction Treatment Discovery Program (ATDP)
Support: Screens compounds in animal models of addiction. Provides in nitro selectivity assays and predictive safety tests.
NIDA Toxicology Program
Support: Provides IND-directed toxicology services for substance abuse indications.
Regulatory Affairs Assistance for Medications Development
Support: Consultation on regulatory, nonclinical and clinical medication development requirements, and strategy.
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NIDA’S SBIR/STTR PROGRAM IS OUR ULTIMATE
TRANSLATIONAL PROGRAM
Funds research tools and platform technologies (for normal and diseases CNS),
med development, clinical research, prevention and services research.
“Community Building”
WE WILL HELP YOU CONNECT THE DOTS
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* More than a third of NIDA’s scored applications are now
submitted by the applicants new to NIH and federal government
WE HELP TO CREATE NEW MARKETS
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SBIR RFP : Standardized Rechargeable
Electronic Nicotine Delivery System
PAR-17-156: Evaluating the NIDA
Standardized Research E-Cigarette in Risk
Reduction and Related Studies (U01)
Product Master File to support the device’s
use as an Investigational Tobacco Product
More than 40 applications
SBIR RFP: Smokescreen: Genetic Screening Tool for Tobacco
Dependence and Treatment Approaches
NOT-DA-16-013: NIDA offers Genotyping on
Smokescreen® Genotyping Array to Substance Abuse
Disorder Investigators
14 studies completed
Data deposited
BE THE FIRST
RFA-DA-17-007 Growing Great Ideas:
Research Education Course in
Product Development and Entrepreneurship (R25)“Start a SUD Startup” Prize Competition
▪ 4 page proposal
▪ 5 min YouTube video
▪ Focus on company creation
▪ 30 teams
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NIDA INVESTS IN 10 WINNING IDEAS PER YEAR
FOR POTENTIAL STARTUPS TO ADDRESS THE NEEDS
IN NIDA MISSION SPACE
39 teams awarded
o The selected teams were wonderfully diverse in terms of age, level of education, gender, race and understanding of commercialization and entrepreneurship
o Academia(faculty) – 35%; Academia (students and postdocs) – 20%; Hospitals (practicing physicians) – 10%; Startups in non-mission area – 35%
Health IT – 54%
Research Tools – 8%
Drug Discovery and Development – 10%
Medical Devices – 28%
o Challenge: Baby box for NAS
o Grant application: 1R43DA049300-01A1
o Title: PRAPELA™ SVS: A COST-EFFECTIVE STOCHASTIC VIBROTACTILE STIMULATION DEVICE TO IMPROVE THE CLINICAL COURSE OF INFANTS WITH NEONATAL ABSTINENCE SYNDROME.
67%
25%
8%
Startup Created?
Startup
No
startup
TBD63%
29%
8%
Outcomes
SBIR
No go
In progress
41%
59%
Lineage
Academic
Founders
Private
Sector
Fouders
WE CONNECT YOU TO INVESTORS, CUSTOMERS,
AND STRATEGIC PARTNERS.
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OPPORTUNITIES TO CONTRIBUTE
Feb 11, 2020: Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System https://grants.nih.gov/grants/guide/pa-files/par-17-205.html
The FOA is expected to be published in February of 2020 with an expected application due date in August 2020 https://grants.nih.gov/grants/guide/notice-files/NOT-NS-20-033.html
February 13, 2020: Step Up for Substance Use Disorders (SUD): A Drug Target Initiative for Scientists Engaged in Fundamental Research (U18 - Clinical Trial Not Allowed) https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-20-025.html
March 2-5, 2020: Training in Neurotherapeutics Discovery and Development for Academic Scientists 2020 Session http://www.neurotherapeuticscourse.org/
March 10, 2020: FDA Public Meeting on Patient-Focused Drug Development for Stimulant Use Disorder
March 30 - April 3, 2020: Innovation to Impact - Empowering Substance Use Researchers to Translate their Innovations from the Lab to the World; Yale University West Campus https://medicine.yale.edu/psychiatry/innovationtoimpact/
April 9, 2020, September 8, 2020: HEAL Initiative: America’s Startups and Small Businesses Build Technologies to Stop the Opioid Crisis https://grants.nih.gov/grants/guide/rfa-files/RFA-DA-19-020.html
April 24, 2020: $100,000 for Start a SUD Startup 2020” Spring Challenge https://www.drugabuse.gov/research/nida-research-programs-activities/nida-challenges-program
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WHERE DO WE START?
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CONTACT
For additional details, resources, and contact information:
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https://sbir.nih.gov/nida
Elena Koustova, PhD, MBA
Director
(P) 301.496.8768
Irina Sazonova, PhD
Program Officer
(P) 301.827.9564
Victor Prikhodko, MBA
Business Advisor [C]
(P) 301.451.3183
Leonardo Angelone, PhD
Program Officer
(P) 301.827.5946
Ram Arudchandran, PhD
Program Officer
(P) 301.827.6889
ramachandran.arudchandran@ni
h.gov
SCHEDULE A MEETING WITH US
Email: [email protected]
In the body of the email, please briefly answer the following:
What problem you are trying to solve?
How is this problem solved now? What is the current gold standard to treat/to solve
this problem?
What is your product and how is it different from the current standard?
What is the FDA regulatory path?
Who is the end-user of your product? Who is the purchaser?
https://sbir.nih.gov/nida
APPENDIX
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