South Carolina Clinical & Translational Research Institute ...€¦ · South Carolina Clinical & Translational Research Institute (SCTR) ! PilotProjectProgramInformaonalSession!!!

South Carolina Clinical & Translational Research Institute (SCTR)

Pilot Project Program Informa1onal Session

Dayan Ranwala, PhD

Research Assistant Professor SCTR Pilot Project Program

[email protected]

sctr.musc.edu 843-792-8300

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

sctr.musc.edu 843-792-8300 [email protected]


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


CTSA Mission

AcceleraKng Discoveries Toward BePer Health.

Working together, we can help shape the future of healthcare.


SCTR Partners


SCTR Programs


SUCCESS S C T R R E S E A R C H C O N S U L T A T I O N S

CenterThe “Front Door” of SCTR

services

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

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

https://sctr.musc.edu/index.php/programs/pilot-projects


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

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

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

Pilot Project Grant Categories


•  Discovery Grants §  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*

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 ~200-‐500K §  CIE Director: Tom Finnegan §  Technology Development Officer: Jessie Goodwin, PhD

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

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



•  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.



•  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.

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



•  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



•  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



•  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



•  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



•  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



•  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

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

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

Announcements


•  SCTR CER/PCOR ScienKfic Retreat on October 29,2013 •  Join the SCTR Listserv (email [email protected]) •  Have quesKons, need help/consultaKons, contact SCTR at:

•  via SPARC Request at sparc.musc.edu •  Call 843-‐792-‐8300 •  Email at [email protected]

SCTR Acknowledgment


Please remember to acknowledge NIH/NCATS

SCTR Grant Number

UL1 TR000062

SCTR Resources & Services


Contact SCTR at 843-‐792-‐8300 or [email protected] or visit sctr.musc.edu

Use the online service request system (SPARC) to request services or ask a ques1on.

Documents

South Carolina Clinical & Translational Research Institute ...€¦ · South Carolina Clinical & Translational Research Institute (SCTR) ! PilotProjectProgramInformaonalSession!!!