ORSP Research Updates
September 15, 2015
11:00 am
IOP Auditorium
Topics Covered
• MUSC FRD & SBIR/STTR Programs
• Dual Use Research of Concern (DURC)
• Updates and Reminders
Foundation for Research Development
&
SBIR/STTR Overview
September 16, 2015
Presented by: Christine Dixon Thiesing
Associate Director, Business Development & Licensing
MUSC Foundation for Research Development
Agenda
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Foundation for Research Development
SBIR/STTR Background
FRD SBIR/STTR Support
Q&A
MUSC Navigation – Who Does What?
• Research Opportunity Core
• Regulatory & Navigation
Consults
• Pilot Project Funding
• Scientific Retreats
SCTR
Institute
FRD
• Invention Disclosures
• Patent Filing
• Copyright Registration
• Marketing and Licensing of
Intellectual Property
•SBIR/STTR Support
IP
• Sponsored Research
Agreements
• Post Award Support Services
• MTAs
ORSP
CIE
• Business Plan Assistance
• Company Formation
• Education & Outreach
FRD Services
• IP management
– Review grant submissions for IP
• Invention reporting for federally funded
research
• Marketing and licensing of MUSC technologies
to corporate partners
How You Can Help
• Ask researchers if their grant possibly creates:
– a new therapeutic
– a new diagnostic test
– a new research tool (reagent, cell line or animal
model)
– new software or surveys
– a new device
• Ask at submission, at annual reports, at grant
closeout
SBIR/STTR Primer
SBIR – Small Business Innovative Research Program
STTR – Small Business Technology Transfer program
• Purpose: To foster and stimulate small business
development of technology for Federal R&D
needs
• Increase private sector commercialization
• SBIR: 2.5% of research budget; will be increasing to
3.2% over 6 years
• STTR: 0.3% of research budget; increasing to 0.45%
over 5 yrs.
SBIR Program Eligibility
• Applicant is a small business
• Business has to be at least 51% U.S.- owned and
independently operated
• Small business located in the U.S. (<500 employees)
• Only 30% of award can be subcontracted; at least
70% of work must be completed by company
• P.I.’s primary employment with small business
during project
STTR Program Eligibility
• Applicant is a small business
– Formal cooperative R&D effort
• Business has to be at least 51% U.S.- owned
• Small business located in the U.S. (<500 employees)
• Minimum 40% of work completed by small business
• Minimum 30% of work completed by U.S. research
institution
• U.S. research institution
• Intellectual property agreement
SBIR/STTR: Critical Differences
SBIR
• PI employment (>50%) must be with small business
• W-2 employees of the company must complete at least 70%
of the work under the contract.
STTR
• PI can be from research institution and/or from small
business concern
• W-2 employees of the company must complete at least 40%
of the work under the contract; research institution must do
at least 30% of work under the contract.
Milestone-Driven Award Process
3-Phase Program
PHASE I Feasibility Study
 Budget Guide: $150K (SBIR); $150K (STTR) Total Costs
 Project Period: 6 months (SBIR); 1 year (STTR)
PHASE II Full Research/R&D
 $1M (STTR), $1M (SBIR) over two years
PHASE IIB Competing Renewal/R&D
 Clinical R&D; Complex Instrumentation/Tools to FDA
 Many, but not all, ICs participate
 Varies ~$1M/year; 3 years
PHASE III Commercialization Stage
 Funded by the company, not NIH
 Consider partnering and exit strategy early
Key Points
SBIR and STTR are not an alternative
source for funding basic research.
They are designed to help small
businesses turn innovative ideas into
market worthy products.
Submitting Winning Proposals
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Decide to apply – Commercialization Focus
Look at past awards to find focus areas
Talk to the Government P.I. about your idea
Register early – may take a few weeks
Strong proposals take time to develop
Carefully read the entire solicitation
Assemble a strong technical team
Get access to facilities and equipment
Get letters of support from customers (phase II)
Know the rules (www.acquisition.gov/FAR)
Proposals evaluated equally on technical merit, team
qualifications and commercialization plan
• Win Rate: 17% for Phase I, 55% for Phase II
FRD SBIR/STTR Program
• Initiated October 2014
• Part of FRD Strategic Plan: Move MUSC
technologies towards commercialization
• IP and Commercialization Expertise
SBIR STTR Applications
16
14
# of Submissions
12
10
Projected
Awarded
8
Submitted
6
4
2
0
2010
2011
2012
Year
2013
2014
2015
FRD’s Role
Help with Company Registrations
Assist with Commercial Plan
Review Proposals
Connect with Consultants/Resources
MUSC Startup-Friendly SBIR/STTR Option Terms
SC Launch SBIR Matching and USAP
EPSCoR Phase 0 SBIRs/STTRs
MUSC’s Role
Provide support for subawards to MUSC
•
Complete Proposal Package to ORSP 3
business days prior to submission deadline
•
Letter from ORSP
Funding Cycles
Due Date
National
Advisory
Award Date
Technical Merit Council/ Board (Earliest)
Review
Review
September 5
October/
November
February/
March
June/July
January 5
April 5
January/
February
May/June
March
August
September or
December
July
Contact Information
Michael Rusnak
Executive Director
rusnak@musc.edu
Jesse Goodwin, Ph.D.
Deputy Director
goodwijs@musc.edu
Christine Dixon Thiesing, MBA
Associate Director; Business
Development & Licensing
dixonthi@musc.edu
Call FRD with any questions 876-1900 or visit us in Suite 101 of BEB
http://frd.musc.edu
U.S. Government Policy for Institutional
Oversight of Life Sciences Dual Use Research
of Concern (DURC)
http://www.phe.gov/s3/dualuse
Policy effective
per
September 24,
2015
September 2015
Definition of Dual Use Research of Concern
“…research that, based on current
understanding, can be reasonably
anticipated to provide knowledge,
products, or technologies that could be
directly misapplied by others to pose a
threat to public health and safety,
agricultural crops and other plants,
animals, the environment or materiel”.
September 2015
15 Agents listed in DURC policy
 Avian
influenza virus
(highly pathogenic)
 Bacillus anthracis
 Botulinum neurotoxin
 Burkholderia mallei
 Burkholderia
pseudomallei
 Ebola virus
 Foot-and-mouth
disease virus
September 2015
 Francisella
tularensis
 Marburg virus
 Reconstructed 1918
Influenza virus
 Rinderpest virus
 Toxin-producing
strains of Clostridium
botulinium
 Variola major virus
 Variola minor virus
 Yersinia pestis
15 Agents listed in DURC policy
 Avian
influenza virus
(highly pathogenic)
 Bacillus anthracis
 Botulinum neurotoxin
 Burkholderia mallei
 Burkholderia
pseudomallei
 Ebola virus
 Foot-and-mouth
disease virus
September 2015
 Francisella
tularensis
 Marburg virus
 Reconstructed 1918
Influenza virus
 Rinderpest virus
 Toxin-producing
strains of Clostridium
botulinium
 Variola major virus
 Variola minor virus
 Yersinia pestis
MUSC Process for Oversight of DURC
1. PI identifies research that involves one of 15 listed
agents
o Institutional Review Boards (IRB)
o Institutional Animal Care and Use Committee
(IACUC)
o Institutional Biosafety Committee (IBC)
2. PI submits IBC application* via erma.musc.edu
* IBC = designated Institutional Review Entity
3. IBC determines DURC potential
4. PI and IBC develop risk mitigation plan
September 2015
Questions?
Yashmin Karten, MBA, PhD
IBC Program Manager
Email: karteny@musc.edu
Phone: 843-792-6521
September 2015
Office of Research and Sponsored Programs
UPDATES AND REMINDERS
Updates & Reminders
• Minimum Stipend/Salary for PhD seeking
students is $24,000.00/year
• Effective 9/1/2015
• Please plan and budget accordingly
• PLEASE verify tuition rates with College of
Graduate Studies
• Contact Karla Locklear at 876-2406 or
locklear@musc.edu
Updates & Reminders
BONUS: The State of South Carolina has approved a one-time $800 bonus. The
bonus will be allowed on all grants and contracts. The payment will be distributed
to eligible employees based off of their salary distribution at the time of the
bonus payout. For example, if the employee is 50% MUCU Project and 50% MUCR
Project, $400 will be charged to each UDAK. The anticipated pay date for the
bonus is October 21, 2015.
PAY PER PERFORMANCE: MUSC has approved a pay for performance increase for
fiscal year 2015-2016. Pay per performance increases are allowable on all grants
and contracts. Employees who are at or near the pay band maximum may be
eligible for a lump sum bonus. These bonus payments are also allowed on all
grants and contracts and will charged based on the employees pay distribution at
the time of the payout.
• If you have any questions, please contact your grant administrator or Michael
Laird at lairdmi@musc.edu or 792-8540.
Updates & Reminders
• IACUC – Inter-institutional agreements (IIA)
– Related to SBIR-STTR Awards
– NIH OLAW typically provides Dr. Sothmann’s name as
the Institutional Official
– PLEASE DO NOT route IIAs to the Provost Office
– IIAs are reviewed and approved by the IACUC office,
then signed by IACUC Chair
– ORSP signs as the Institutional Official
Updates & Reminders
• PLEASE list correct fiscal unit on the ePDS
• Causes Delays for PI: spending/work on the project
• Creates administrative delays: PEARS, etc.
• Wastes everyone’s time (YOURS, GCA and ORSP)
• Trainees MUST complete MUSC COI survey too
• When applying for fellowships, or
• When listed on training grants
• COI survey must be completed annually
Updates & Reminders
• ORSP Training Sessions
– Grants Administration 101, October 20th, 2015
– Cayuse 424, October 13th, 2015
– Electronic Routing of Proposals (ePDS training)
September 22, 2015
http://academicdepartments.musc.edu/research/o
rsp/training/
(descriptions and sign up at above link)
THANK YOU
• Questions/Comments?
• PLEASE complete a survey & THANK YOU
• Next ORSP Information Session:
October 14th, 2015 @ 11:00 am, IOP Auditorium