South Carolina Clinical & Translational Research Institute (SCTR)

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1 South Carolina Clinical & Translational Research Institute (SCTR) Pilot Project Program Informa1onal Session Dayan Ranwala, PhD Research Assistant Professor SCTR Pilot Project Program

2 South Carolina Clinical & Translational Research Institute (SCTR) Kathleen T. Brady, PhD. MD - SCTR PI Perry V. Halushka, PhD. MD - SCTR Co- PI Randal Davis - SCTR Project Director Royce Sampson, MSN, RN - SCTR Chief OperaKng Officer success@musc.edu

3 Acronyms NIH - NaKonal InsKtute of Health NCATS - NaKonal Center for Advancing TranslaKonal Sciences CTSA - Clinical and TranslaKonal Science Awards SCTR - South Carolina Clinical & TranslaKonal Research InsKtute SUCCESS Center - Support Center for Clinical & TranslaKonal Science SPARC Request - Services, Pricing & ApplicaKon for Research Centers Please remember to acknowledge the SCTR Grant Number NIH/NCATS SCTR Grant Number UL1 TR000062

4 CTSA Mission AcceleraKng Discoveries Toward BePer Health. Working together, we can help shape the future of healthcare.

5 SCTR Partners

6 SCTR Programs SUCCESS Center S C T R R E S E A R C H C O N S U LTAT I O N S The Front Door of SCTR services

7 SCTR SUCCESS Center Resources & Consultations BiostaKsKcs* Budget and JusKficaKon Regulatory Recruitment REDCap Research NEXUS (Coordinator Core, Nursing, Lab, Space etc.) ComparaKve EffecKveness Research Novel Device or Smart App Development Clinical Data Warehouse Tech Transfer - Intellectual Property CommercializaKon

8 SCTR Pilot Project Program Perry V. Halushka, PhD. MD - Director Tony Alberg, PhD - Associate Director Dayan Ranwala, PhD - Program Manager Patrick Flume, MD Chairman, ScienKfic Review CommiPee

9 Pilot Project Program Overview To facilitate scien1fically meritorious and innova1ve translakonal research To promote scienkfic interackons among inveskgators and community To accelerate processes from discovery, innovakon to improved pakent care To provide research support for promising trainees/junior faculty To support development of new technologies and methodologies

10 Pilot Project Program Expectations Proof- of- concept studies, clinical applicability and disseminakon GeneraKon of cri1cal preliminary data Successful applicakons of extramural grant funding mechanisms Successful publica1ons of research data & findings Development of potenkal Intellectual Property (IP) and commercializakon of technologies

11 Pilot Project Program RFA Ins1tu1onal Funds: MUSC - $500K/year USC - $200K/year Grant Categories (all awards are for 12 months): Discovery Grants (SCTR funds up to $25K) Fast- Forward Seed Grants (up to $10K*) High InnovaKon High Reward Grants (up to $10K) *Requires 1:1 Match - $5K SCTR funds, $5K matching funds

12 Discovery Grants Pilot Project Grant Categories Two cycles per year Pre- applicakon is required, due by noon on 11/22/2013 Selected pre- applicants will be invited to submit full applicakons by 1/22/2014 Fast Forward Seed Grants Three cycles per year No pre- applicakon process, full applicakon due by noon on 2/14/14 Limited to resubmission of extramural grant applicakons Requires 1:1 match as new money (not from exiskng grants/salaries) Requires to provide the source and amount of the match*

13 Pilot Project Grant Categories High Innova1on High Reward Grants Three cycles per year No pre- applicakon process, full applicakon due by noon on 2/14/14 Limited to MUSC PIs leading to substankal development of IP for high reward SCTR and Center for InnovaKon and Entrepreneurship (CIE) will provide consultakons as needed related to IP and commercializakon. PIs may want to request a consult before applying. Successful projects will be invited to submit a LePer of Intent (LOI) to CIE for a high reward grant ~ K CIE Director: Tom Finnegan Technology Development Officer: Jessie Goodwin, PhD

14 Pilot Project Application Process Apply online via SCTR Pilot Project web page using the Apply link Required Components: PI and inveskgator team informakon File uploads based on grant category (page limitakons*) Ø Each inveskgator biosketch NIH Format Ø Project DescripKon Ø Research proposal* Ø Budget and juskficakon (not required for Discovery pre- apps, two budget forms required for Fast Forward Seed apps due to the matching fund requirement as matching budget and SCTR budget) Ø New informakon on matching funds will be in the new RFA Ø Matching fund commitment leper required for FFS apps

15 Discovery Pre-application - Proposal One page (two pages allowed only for EC inves1gators who apply as PIs): One page must include: Research design and methods BiostaKsKcal juskficakon for the sample size* Brief descripkon of the mulkdisciplinary team Each team members role PotenKal for extramural grant funding *ApplicaKons will be reviewed by a biostakskcian. ApplicaKons must be adequately powered to provide meaningful informakon about the feasibility and size for your planned future studies to apply for extramural grant applicakons. Note: SCTR provides free biostat consulta8ons if needed

16 Discovery Pre-application - Proposal Early Career (EC) inves1gators who apply as PIs must include below in the second page*: a perknent senior Co- InvesKgator/s as mentor/s and include the mentor/s name and their support leper/s at the end of the proposal a strong mentorship plan a Kmetable for becoming independent and a plan for achieving research independence potenkal to lead to independent funding (with a plan to submit K or R applicakons) NOTE: Please carefully read Review Criteria for Scoring giving special a?en8on to the Inves8gator/s criteria in order to properly submit an EC inves8gator applica8on. *Applica8ons will be reviewed for these criteria.

17 Discovery Pre-application - Proposal Novel Methods/Technology Core Facility Development related applica1ons must include*: potenkal value to mulkple inveskgators facilitakng clinical and translakonal research and supporkng extramurally- funded research projects cost effeckveness of allowing mulkple inveskgators to use an adequate business plan - if selected to submit as a full applicakon NOTE: Please carefully read Review Criteria for Scoring giving special a?en8on to the Innova8on criteria. *Applica8ons will be reviewed for these criteria.

18 Pilot Project Review Process Review Process: Similar to a NIH study seckon ScienKfic Review CommiPee (SRC) scienkfic merit Review criteria: Ø Significance Ø InvesKgator Ø InnovaKon Ø Approach Ø Environment Ø Overall Impact ExecuKve CommiPee funding decisions

19 Pilot Project Review Process Significance: Ø How well the applicakon address an important problem or a crikcal barrier Ø Explain how the proposed project will improve scienkfic knowledge, technical capability, and/or clinical prackce Ø Describe how the concepts, methods, technologies, treatments, services or prevenkve intervenkons will be changed if the proposed aims are achieved

20 Pilot Project Review Process Inves1gator: Ø How the PIs, collaborators, and other researchers are suited to the project Ø If an Early Career or new inveskgator, or in the early stages of an independent career provide informakon related to your experience and training include/update in the biosketch too Ø For established inveskgators provide an ongoing record of accomplishments demonstrakng that you have advanced the field Ø For CollaboraKve Projects include how the inveskgators have complementary and integrakve experkse, their leadership approach, governance etc. as appropriate

21 Pilot Project Review Process Innova1on: Ø How the applicakon challenge and seek to shik current research or clinical prackce by uklizing novel theorekcal concepts, approaches or methodologies, instrumentakon or intervenkons Ø Describe any novel concepts, approaches, methodologies, instrumentakon or intervenkons Ø Define any refinement, improvement or new applicakon of theorekcal concepts, approaches or methodologies, instrumentakon or intervenkons proposed

22 Pilot Project Review Process Approach: Ø Describe the overall strategy, methodology, and analyses, well- reasoned and appropriate to accomplish the specific aims of the project Ø Discuss potenkal problems, alternakve strategies, and benchmarks for success Ø If the project is in early stages of development, describe the strategy to establish feasibility and how the risky aspects be managed

23 Pilot Project Review Process Environment: Ø Address how the scienkfic environment in which the work will be done contribute to the probability of success Ø Describe the insktukonal/departmental/laboratory support, equipment and other physical resources available to the inveskgators adequate for the proposed project Ø Include the benefits from unique features of the scienkfic environment, subject populakons or collaborakve arrangements

24 Pilot Project Review Process Overall Impact Score: Ø Reviewer's assessment of a project s ability to powerfully influence its field Ø By considering the core review criteria and any addikonal ones that apply

25 Pilot Project Budgets Budget: Ø Refer to new RFA for details (release by October 25, 2013) o InvesKgator efforts o Matching funds related requirements Ø NoKficaKon will be sent out aker RFA Release

26 Post Award Notifications & Progress Reports Requirements No1fica1ons: Review comments will be sent to the PIs except for the pre- applicakons For funded projects: Ø JIT will be sent to PIs and their Business Managers Ø Pilot Project Program OrientaKons for funded projects teams to help speed up the post- award processes Ø NOA will be sent to PIs and their Business Managers Ø Signed NOA by PI and the Business Manager is required before releasing the funds Ø Requirement to cite the SCTR Grant number (UL1 TR000062) Progress Reports: Required at 6 and 12 months, and yearly for 5 years Ø such as publicakons, extramural grant applicakons, IP etc. Finance Reports: Required at 6 and 12 months

27 Announcements SCTR CER/PCOR ScienKfic Retreat on October 29,2013 Join the SCTR Listserv ( Have queskons, need help/consultakons, contact SCTR at: via SPARC Request at sparc.musc.edu Call at

28 SCTR Acknowledgment Please remember to acknowledge NIH/NCATS SCTR Grant Number UL1 TR000062

SCTR Resources & Services Contact SCTR at 843-792- 8300 or success@musc.

29 SCTR Resources & Services Contact SCTR at or or visit Use the online service request system (SPARC) to request services or ask a ques1on.

MUSC Center for Global Health Request for Applications (RFA) for Faculty Pilot Project Grants

MUSC Center for Global Health Request for Applications (RFA) for Faculty Pilot Project Grants RFA Release Date: Monday, April 10, 2017 Full Proposal (6 page limit) Deadline: May 16, 2017 12 p.m. (noon)