2. MUSC FRD & SBIR/STTR Programs Dual Use Research of Concern (DURC) Updates and Reminders

3. 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

4. Agenda Foundation for Research Development SBIR/STTR Background FRD SBIR/STTR Support Q&A

5. Business Plan Assistance Company Formation Education & Outreach Sponsored Research Agreements Post Award Support Services MTAs Invention Disclosures Patent Filing Copyright Registration Marketing and Licensing of Intellectual Property SBIR/STTR Support Research Opportunity Core Regulatory & Navigation Consults Pilot Project Funding Scientific Retreats SCTR Institute FRD CIE ORSP IP MUSC Navigation – Who Does What?

6. FRD Services IP management – Review grant submissions for IP Invention reporting for federally funded research Marketing and licensing of MUSC technologies to corporate partners

7. 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

8. SBIR/STTR 101

9. 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.

10. 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

11. 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

12. 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. SBIR/STTR: Critical Differences

13. 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 PHASE I Feasibility Study  Budget Guide: $150K (SBIR); $150K (STTR) Total Costs  Project Period: 6 months (SBIR); 1 year (STTR) Milestone-Driven Award Process 3-Phase Program Phase I/II Fast Track

14. Participating Federal Agencies

15. 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. Key Points

16. Submitting Winning Proposals 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)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

17. FRD SBIR/STTR Program Initiated October 2014 Part of FRD Strategic Plan: Move MUSC technologies towards commercialization IP and Commercialization Expertise

18. SBIR STTR Applications

19. 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

20. MUSC’s Role Provide support for subawards to MUSC Complete Proposal Package to ORSP 3 business days prior to submission deadline Letter from ORSP

21. Funding Cycles Due Date National Technical Merit Review Advisory Council/ Board Review Award Date (Earliest) September 5 October/ November January/ February March January 5 February/ March May/JuneJuly April 5June/JulyAugustSeptember or December

22. SBIR/STTR grant applications must be submitted electronically. Registrations are required!!!  DUNS Number (Company)  System for Award Management (SAM)  Grants.gov (Company)  eRA Commons (Company and all PD/PIs)  SBA Company Registry at SBIR.gov Electronic Submission http://era.nih.gov/applicants/index.cfm

23. Contact Information Christine Dixon Thiesing, MBA Associate Director; Business Development & Licensing dixonthi@musc.edu Jesse Goodwin, Ph.D. Deputy Director goodwijs@musc.edu Michael Rusnak Executive Director rusnak@musc.edu Call FRD with any questions 876-1900 or visit us in Suite 101 of BEB http://frd.musc.edu

24. September 2015 U.S. Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (DURC) Policy effective per September 24, 2015 http://www.phe.gov/s3/dualuse

25. 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”.

26. 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 Francisella tularensis Marburg virus Reconstructed 1918 Influenza virus Rinderpest virus Toxin-producing strains of Clostridium botulinium Variola major virus Variola minor virus Yersinia pestis

27. 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 Francisella tularensis Marburg virus Reconstructed 1918 Influenza virus Rinderpest virus Toxin-producing strains of Clostridium botulinium Variola major virus Variola minor virus Yersinia pestis

28. September 2015 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

29. September 2015 Questions? Yashmin Karten, MBA, PhD IBC Program Manager Email: karteny@musc.edu Phone: 843-792-6521 karteny@musc.edu

30. Office of Research and Sponsored Programs

31. 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 locklear@musc.edu

32. 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.lairdmi@musc.edu

33. 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

34. 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

35. ORSP Training Sessions – Grants Administration 101, October 20 th, 2015 – Cayuse 424, October 13 th, 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)

36. Questions/Comments? PLEASE complete a survey & THANK YOU Next ORSP Information Session: October 14th, 2015 @ 11:00 am, IOP Auditorium