The Medical University of South Carolina

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1 The Medical University of South Carolina

2 Why is Biotechnology Commercialization important? Facilitate the commercialization of research results for the public good Reward, retain and recruit faculty Induce closer ties to industry Generate income and promote economic growth Association of University Technology Managers,

3 Recent MUSC commitments to biomedical commercialization: Participation in the Centers of Economic Excellence Endowed Chairs program Drug Discovery and Bioengineering Buildings Established Office of Industry Partnerships Promoting Entrepreneurialism is one of the foci of the Strategic Plan Partnering for off-campus laboratory space

4 SCRA MUSC Innovation Center in Charleston

5 The Goals of BIG: 1) Provide a mechanism for sharing biotechnology expertise and enthusiasm within the SCTR community 3) Provide mentorship to SCTR faculty relating to new venture startup, financing (e.g. SBIR/STTR grants and SC resources) and commercialization 4) Provide a forum for the discussion of critical biotechnology issues, including local infrastructure and university policies 4) Promote collaboration both among SCTR faculty and with private and public partners

6 Meeting format: Meets monthly Informal social networking time at beginning and end of each meeting Brief, formal presentation on Biotech topic of interest at each meeting by informed guest speakers and local or network providers Quarterly retreats Suggestions for topics, speakers, etc? or

7 Discussion areas for future meetings: Starting a Company Access to Research Resources University Policies Funding Intellectual Property Company Management

8 Existing Companies-Important Funding Opportunity: Qualifying Therapeutic Discovery Project (QTDP)

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10 Commercial firms offering assistance for a fee. Examples: Wyrick Robbins; Ph: Tax Practice Group: Tom Cook (tcook@wyrick.com) or Adam Snyder (asnyder@wyrick.com); Life Sciences Industry Team: Ken Eheman (keheman@wyrick.com); Hughes Pittman & Gupton, LLP (HPG); Ph: Cherry, Bekaert & Holland, L.L.P. (CB&H); Ph:

11 The Medical University of South Carolina

12 The Medical University of South Carolina

13 The Medical University of South Carolina SCTR Integrated Portal for Research ( A web-based portal which includes information about SCTR and provides linkages to SCTR Programs, Applications, and Research Tools.

14 Research Navigation Consults Regulatory Consults & Training The Front Door for Research Support Intake or Online Request Form Grant Submission/Report Consults Budget Consultations CTRC Proposal Pricing Voucher Requests At SCTR s SUCCESS Center (Support Center for Clinical and Translational Science), Investigators, coordinators, and other research personnel can receive guidance, obtain training, and referrals/linkages to other research services from experienced research professionals within a one-stop, research support shop.

15 MAP-R: MUSC Approval Plan for Research MUSC Approval Plan for Research (MAP-R) An online, algorithm based system of approximately 16 questions designed to generate a customized list of required regulatory approvals and research trainings based on the Investigator s answers pertaining to a particular research study. Questions related to human subject and vertebrate animal research. Guidance, for each question asked, is provided to assist the investigator in making the correct selection. Who, What, When, Where, and How informational sheets are provided to explain the process for each regulatory approval application and training requirement. At the end, the customized map links directly to the required applications & training programs needed to successfully launch the study.

16 The Medical University of South Carolina MUSC HERO Program: Program aimed at changing attitudes and beliefs towards research at MUSC, to raise awareness of the importance of research, and to increase recruitment and retention of research study participants at MUSC. Clinical Trials Registry: This program allows people in the community to search MUSC s Clinical Trials Registry for enrollment in studies that are recruiting human subjects, including CTN studies approved by MUSC s IRB. This program is used to promote human subject recruitment for clinical studies. Research Match: ResearchMatch has a simple goal to bring together two groups of people who are looking for one another: (1) people who are trying to find research studies, and (2) researchers who are looking for people to participate in their studies. It is a free and secure registry that has been developed by major academic institutions across the country who want to involve you in the mission of helping today s studies make a real difference for everyone s health in the future.

17 Research Toolkit Research Tool Kit: This resource was developed to assist research personnel in navigating the research enterprise. The Toolkit addresses the steps involved with submitting, conducting, closing and disseminating results of a research study, and includes links to institutional, state, and federal resources and regulations.

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19 The Medical University of South Carolina

20 Phlebotomy EKG Infusion Complex Specimen Collection PeaPod DEXA BodPod The Medical University of South Carolina Laboratory Processing DNA/RNA Isolation Assays Nutrition Anthropometrics Nutrition Assessment Meals & Snacks

21 The Medical University of South Carolina Perry Halushka, MD, PhD Director, Pilot Project Program Co-PI CTSA grant Tony Alberg, PhD Co-Director, Pilot Project Program

22 The Medical University of South Carolina SCTR Pilot Project Program Pilot Projects: 55 applications received 15 Pilot Projects funded totaling $524,000 including 2 projects co-funded with USC, and 3 projects fully funded by USC Included investigators in 5 MUSC colleges, USC and Clemson University Congratulations to Stan Hoffman-Pilot Recipient Selected for 2010 BIO/Plan Competition hosted by SEBio! Pre-applications submitted and over 50% invited to submit full applications Awards announced early August

23 The Medical University of South Carolina SCTR Translational Assistance and Review (STAR) Consultations

24 The Medical University of South Carolina SCTR STAR Consultation, cont. NEW: VOUCHER- SBIR/STTR PROFESSIONAL REVIEW

25 The Medical University of South Carolina

26 MUSC Office of Industry Partnerships Stuart G. Knight Director

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31 The Medical University of South Carolina

32 The Medical University of South Carolina Small Business Innovation Development Act of 1982 Congress designated 4 Major Goals: 1) Stimulate technological innovation 2) Meet federal R&D needs 3) Foster and encourage participation by minority and disadvantaged persons in technological innovation 4) Increase private-sector commercialization of innovations derived from Federal R&D Commercialization-not research, grants & contracts

33 SBIR/STTR- A 3 Phase Development Process: PHASE I Feasibility Study PHASE II PHASE III $150K and 6-month (SBIR) or 12-month (STTR) Award Full Research/R&D $1M and 2-year Award (SBIR/STTR) Commercialization Stage Use of non-sbir/sttr Funds

34 SBIR/STTR AGENCY FUNDING NASA; 5% NSF; 4.20% DoE; 5% Others; 2.80% NIH; 28.10% DoD; 54.90% Other: DoEdu, DHS, USDA, DoC (NIST/NOAA), DoT

35 IMPORTANT DATES: NIH Active RFA/PA- Regular Submission Deadline Aug 5th: DOD SBIR-Regular Submission Deadline June 23rd: Future DOD: STTR Solicitation 2010.B -- will be posted on July 20, 2010; will begin accepting proposals on August 17, 2010; will close to proposals on September 15, SBIR Solicitation will be posted on July 20, 2010; will begin accepting proposals on August 17, 2010; will close to proposals on September 15, th Annual NIH SBIR/STTR Conference Presentations Until Thursday: Also Visit: For collaborative partner:

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