CTSA Program Webinar Wednesday, January 23, 2019 2:00 – 3:00 ET
Agenda Time Topic Presenter Welcome Christopher P. Austin 2:00 - 2:15 NCATS and CTSA Program Updates Clare Schmitt 2:15 – 2:20 Common Metrics Update Deborah Ossip (CLIC) 2:20 - 2:25 CD2H IDEA Competition Justin Guinney (CD2H) Ming Lei 2:25 - 2:55 IDeA Presentation Rafael Gorospe 2:55 - 3:00 Adjourn 2
NCATS and CTSA Program Updates Christopher P. Austin & Clare Schmitt
Year in Review Fiscal Year 2018 4
FY 2018: NIH IC Budgets NIH IC FY2018 Final NCI $5,965 NIAID $5,260 NHLBI $3,383 NIGMS $2,785 NIA $2,574 NINDS $2,188 NIDDK $2,121 OD $1,926 NIMH $1,755 NICHD $1,452 NIDA $1,384 NIEHS $828 NEI $772 NCATS $742 NIAMS $587 NHGRI $557 NIAAA $510 NIDCD $460 NIDCR $448 NLM $429 NIBIB $378 NIMHD $303 NINR $158 NCCIH $142 FIC $76 Note: Does not reflect $20.1M in HEAL Transfer from NINDS to NCATS
FY 2018: NCATS Distribution Total $760.7M (Includes $20.1M for HEAL) DPI CAN Rare SBIR DCI Diseases (CTSA) HEAL NTU Other
FY 2012-2018: Trends in NCATS Budget $900 $800 $700 $600 (Dollars in Millions) $500 Actuals $400 $300 $200 $100 $0 2012 2013 2014 2015 2016 2017 2018 Fiscal Year Heal Funds
Division of Clinical Innovation
CTSA Program Spending by Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year Fiscal Year NCATS Clinical and Translational Science Awards Program 2014 Actual 2015 Actual 2016 Actual 2017 Actual 2018 Estimate CTSA Program Hubs Number of Hub awards 58 58 57 57 58 Hub Awards (A UL1 award with a linked KL2 award and an optional TL1 award) $404,954,499 $441,922,552 $449,584,228 $447,800,122 $459,342,839 Administrative Supplements to Hub Awards $44,204,713 $18,534,775 $9,851,866 $6,367,377 $21,790,276 Bridge Awards (U54) $16,798,746 $3,528,613 $3,560,718 $3,497,558 $0 CTSA Program Collaboration Initiatives (per IOM Recommendations) - all awards to CTSA institutions CTSA Program Collaborative Innovation Awards (U01/R21) $8,602,736 $14,402,042 $24,130,055 Consortium Centers (U24/U54) RIC/TIC/CD2H/Coordination $2,420,706 $2,741,255 $16,354,755 $29,878,310 $22,037,558 Subtotal of Funding to CTSA Program Institutions $468,378,664 $466,727,195 $487,954,303 $501,945,409 $527,300,728 Other CTSA Program Activities 6 Other (K23/R13/U13/U19/T15/U2C/U24) $1,402,448 $1,277,800 $265,000 $600,000 $643,697 Loan Repayment Program $2,006,148 $1,986,781 $2,001,190 $2,009,444 $2,508,139 Program Management (Includes NIH and DHHS assessments and transfers) $5,432,517 $7,399,063 $9,779,507 $11,569,957 $12,326,808 Grand Total $477,219,777 $477,390,839 $500,000,000 $516,124,810 $542,779,372 https://ncats.nih.gov/files/ctsa-funding-information.pdf 9
FY18 CTSA Program Hub Awards Albert Einstein College of Medicine Case Western Reserve University Duke University Harvard Medical School Indiana University - Purdue University at Indianapolis 16 Awards Ohio State University Scripps Research Institute $ 134,887,166 expended Tufts University Boston University of Colorado Denver University of Iowa University Of Miami School of Medicine University of Minnesota University of North Carolina Chapel Hill University of Texas Health Science Center University of Utah Virginia Commonwealth University 10
11 FY18 CTSA Program Administrative Supplements Enhancing Network Capacity (PA-16-328) Dissemination of local innovations • Informatics • Training and education 7 Awards • Methods and processes $3,379,290 expended • Community engagement strategies • Entrepreneurship • Team science • Clinical trial management and recruitment • Regulatory guidance • Precision Medicine
FY18 CTSA Program Administrative Supplements Priority Research Areas (NOT-TR-18-022) Community/ Collaboration Engagement Research Software 4% Applications • Total: ~ $14 M Education and/or 48% Training • 27 Awards 11% • 24 CTSA Program Hub Informatics 5% Institutions Instrumentation 1% • 15 Additional hubs participating Methods and • 2 CTSA Program Processes 13% Collaborative Innovation Awards Opioid Crisis Rare Diseases 16% Research 2% Supplements awarded to CTSA Program UL1s and Collaborative Innovation Awards by priority research area as a percentage of total awarded supplements
Looking ahead to remainder of FY 2019 …
FY 2019 Ø P.L. 115-245 - Department of Defense and Labor, Health and Human Services, and Education Appropriations Act, 2019 and Continuing Appropriations Act, 2019 • Became law on 9/28/2018 • NIH: $39.084 billion ($2 billion increase, or 5.4%, above FY 2018)
FY 2018 & 2019: NIH IC Budgets (Dollars in Millions) FY2018 FY2019 NIH IC Final Enacted NCI $5,965 $6,144 NIAID $5,260 $5,383 NHLBI $3,383 $3,488 NIA $2,574 $3,083 NIGMS $2,785 $2,873 NINDS $2,188 $2,274 NIDDK $2,121 $2,030 OD $1,926 $1,917 NIMH $1,755 $1,870 NICHD $1,452 $1,506 NIDA $1,384 $1,420 NCATS** $742 $806 NEI $772 $797 NIEHS $828 $775 NIAMS $587 $605 NHGRI $557 $576 NIAAA $510 $526 NIDCD $460 $474 NIDCR $448 $462 NLM $429 $442 NIBIB $378 $389 NIMHD $303 $315 NINR $158 $163 NCCIH $142 $146 FIC $76 $78 **Does not include $20.1M in HEAL Transfer from NINDS in 2018
Barry Coller, M.D. Rockefeller University CTSA Program Steering Committee Co-Chair 2019 - 2020
Welcome New CTSA Program Steering Committee Members! 2019 – 2021 Cohort John Buse, M.D., Ph.D. Rachel Hess, M.D., M.S. Julianne Imperato - Gerald Stacy Patricia Winokur, M.D. University of North Carolina, University of Utah McGinley, M.D. University of Chicago University of Iowa Chapel Hill UL1 Member Weill Cornell Administrator Member UL1 Member UL1 Member UL1 Member
NIH Helping to End Addiction Long-Term (HEAL) SM Initiative • Application receipt date extended to February 11, 2019 • Pain Management Effectiveness Research Network Funding Opportunity (NS-19-021): https://grants.nih.gov/grants/guide/rfa- files/RFA-NS-19-021.html • TIN Resources: https://trialinnovationnetwork.org/heal-pain- ern-other-heal-foas/ • Questions? Please contact Jane Atkinson (jatkinso@mail.nih.gov) or Cynthia Boucher (cynthia.boucher@nih.gov)
NIH HEAL SM Initiative - NCATS Opportunities 3-D Bioprinted Tissue Models of Pain, Opioid Use Disorder and Overdose (RFA-TR-19-005) • Letters of Intent Due: Jan. 28, 2019; Applications Due: Feb. 28, 2019 • NCATS is supporting collaborations with the external research community to develop and use 3-D biofabricated tissue models as new drug screening platforms to advance pre-clinical discovery and development of non-addictive treatments for pain, opioid use disorder and overdose. NCATS intends to fund approximately two to three awards for a total of $1.5 million in fiscal year 2019. Tissue Chips to Model Pain, Addiction and Overdose (RFA-TR-19-003) • Letters of Intent Due: Jan. 28, 2019; Applications Due: Feb. 28, 2019 • Selected applicants will receive funding to create and test devices that can model the mechanisms or effects of pain-relevant signaling, addiction or opioid use disorders using human tissues in tissue- and organ-on-chip systems. NCATS intends to commit approximately $5 million in fiscal year 2019 to fund four to six awards. ASPIRE Design Challenges (NOT-TR-18-031) • Challenges Open: Dec. 31, 2018; Submission Deadline: May 31, 2019 • Winners Announced: August 2019 • NCATS has issued a series of challenge competitions for novel chemical compound concepts that have the potential to address pain, addiction and overdose. NCATS will issue up to 22 prizes for the creation of a database, an electronic laboratory knowledge portal, machine learning algorithms and biological assays. An additional challenge will focus on a combined solution for two or more areas. View and the ASPIRE Design Challenges page to learn more. 19
FOA Updates • CCIA FOA renewed for FY19 • Enhancing Network Capacity (2 receipt dates FY19) • Competitive Supplements for FY20 awards • Future FOA • Obtain feedback on process (RFA issues) and program objectives • Internal: NCATS • External • RFI & Town Hall • Study Section Reviewers • CTSA Program Steering Committee: solicit and present feedback from pods
FY19 NCATS CTSA Program Collaborative Suite of Awards Eligibility Review Type Purpose Collaborative Collaborative 2 or more External Peer Innovation – Innovation CTSA Program High Risk/ Review Foster research collaboration to hubs Award (R21) High Reward develop, demonstrate and disseminate innovative, experimental approaches to overcoming translational science roadblocks. Collaborative 3 or more External Peer Collaborative Innovation CTSA Program Review Innovation hubs Award (U01) Enhance network capacity through Enhancing implementing, assessing, and/or Network 2 or more Internal disseminating discoveries in methods, Capacity CTSA Program Administrative Dissemination approaches, education, and training in hubs Review (Administrative clinical and translational science Supplements) within the scope of the parent grant. https://ncats.nih.gov/ctsa/projects/ccia December 2018
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