TRANSLATIONAL PROGRAMS AT THE NATIONAL INSTITUTE ON DRUG ABUSE (NIDA) - OFFICE OF TRANSLATIONAL INITIATIVES AND PROGRAM INNOVATIONS (OTIPI) ...
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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)
VICTOR PRIKHODKO
1
THE NATIONAL INSTITUTE ON DRUG ABUSE
(NIDA)
FY 2019 Research Budget is $1.42B
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.
2
THE REACH AND IMPACT OF THE OPIOID CRISIS
“CEA estimates that in 2015, the economic cost of the
opioid crisis was $504.0 billion, or 2.8 percent of GDP
that year. “
3
THE CREATION OF NIDA’S MEDICATION
DEVELOPMENT DIVISION
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.
4
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
6
NIDA IS POISED TO INNOVATIVE EVEN WITHIN
THE TRADITIONAL GRANT MAKING PROGRAM
7
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
8
THE UNIQUE CORNERSTONE OF BPN INFRASTRUCTURE
IS THE LEAD DEVELOPMENT TEAM
9
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
10NOT A BRIDGE BUT JUST ONE STEP UP
Pharma (manufacturing,
marketing, distribution)
Exit:
patent,
Purposefully focus license,
on value creation or DTMC,
risk reduction SBIR, BPN
NIDA
Back to basic
STOP
research
Target
rigorously
invalidated
11IN-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
12
Support: Consultation on regulatory, nonclinical and clinical medication development requirements,
and strategy.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
14
* More than a third of NIDA’s scored applications are now
submitted by the applicants new to NIH and federal governmentWE HELP TO CREATE NEW MARKETS
SBIR RFP : Standardized Rechargeable SBIR RFP: Smokescreen: Genetic Screening Tool for Tobacco
Electronic Nicotine Delivery System Dependence and Treatment Approaches
PAR-17-156: Evaluating the NIDA NOT-DA-16-013: NIDA offers Genotyping on
Standardized Research E-Cigarette in Risk Smokescreen® Genotyping Array to Substance Abuse
Reduction and Related Studies (U01) Disorder Investigators
Product Master File to support the device’s 14 studies completed
use as an Investigational Tobacco Product
Data deposited
More than 40 applications
15BE THE FIRST
RFA-DA-17-007 Growing Great Ideas:
Research Education Course in “Start a SUD Startup” Prize Competition
Product Development and Entrepreneurship (R25)
▪ 4 page proposal
▪ 5 min YouTube video
▪ Focus on company creation
▪ 30 teams
17NIDA 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 Startup Created? Outcomes
commercialization and entrepreneurship
o Academia(faculty) – 35%; Academia (students and Startup
postdocs) – 20%; Hospitals (practicing physicians) – 10%; 8% 8% SBIR
Startups in non-mission area – 35%
25% No 29%
Health IT – 54% startup
63% No go
Research Tools – 8% 67%
TBD
Drug Discovery and Development – 10% In progress
Medical Devices – 28%
o Challenge: Baby box for NAS
o Grant application: 1R43DA049300-01A1
o Title: PRAPELA™ SVS: A COST-EFFECTIVE STOCHASTIC
Lineage
VIBROTACTILE STIMULATION DEVICE TO IMPROVE
THE CLINICAL COURSE OF INFANTS WITH
NEONATAL ABSTINENCE SYNDROME.
Academic
41% Founders
59%
Private
Sector
FoudersWE CONNECT YOU TO INVESTORS, CUSTOMERS,
AND STRATEGIC PARTNERS.
19OPPORTUNITIES 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
20
April 24, 2020: $100,000 for Start a SUD Startup 2020” Spring Challenge
https://www.drugabuse.gov/research/nida-research-programs-activities/nida-challenges-programWHERE DO WE START?
21CONTACT
For additional details, resources, and contact information:
Elena Koustova, PhD, MBA Irina Sazonova, PhD Victor Prikhodko, MBA
Director Program Officer Business Advisor [C]
(P) 301.496.8768 (P) 301.827.9564 (P) 301.451.3183
Elena.koustova@nih.gov Irina.sazonova@nih.gov Victor.prikhodko@nih.gov
Leonardo Angelone, PhD Ram Arudchandran, PhD
Program Officer Program Officer
(P) 301.827.5946 (P) 301.827.6889
leonardo.angelone@nih.gov ramachandran.arudchandran@ni
h.gov
22
NIDASBIR@mail.nih.gov https://sbir.nih.gov/nidaSCHEDULE A MEETING WITH US
Email: NIDASBIR@mail.nih.gov
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/nidaAPPENDIX
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