Executive Director s Report Joe Selby, MD, MPH, Executive Director PCORI Board of Governors Meeting Washington, DC September 23, 2013
Board of Governors Dra. 2013 Dashboard (As of July 15, 2013) CommunicaBons & & OperaBonal Excellence: Reach Web visits up 10% to 59K; Email tripled to 10K; Twi;er reach steady at 2.7M; Media=TBD Award to Contract Time % w/in target (TBD) Response to Queries Time % of Target (TBD) Establish Advisory Panels to Guide Topic SelecBon Establish 7 Panels ü Assessing Options ü Improving Systems ü Addressing Disparities ü Patient Engagement Rare Disease Clinical Trials Communication & Dissemination Employ Them to Identify High Priority Topics ü Assessing Options 4 topics identified & undergoing refinement 2 for discussion at Sept panel meeting; 2 for Dec ü Addressing Disparities 5 topics identified 4 undergoing refinement 3 aimed for PFA 2014 Q1 ü Improving Systems 5 topics identified & undergoing refinement 1 to PDC in July; 1 in Nov 3 for discussion at Q3/4 advisory panel meetings Launch Targeted PFAs Launch PFAs Issued ü Severe Asthma 6/18/13 ü Falls (with NIH) 7/7/13 PFAs in Process $20M Uterine Fibroids MOU with AHRQ in process $XM Back Pain In development Obesity $XM In development Establish Programs to Build Capacity for PCOR Engagement Awards Knowledge Training & Development ü Pipeline to Proposal launched 6/15/2013 Dissemina>on Our Goals: $17M $30M Matching Challenge Winners Announced 6/3/13 Increase InformaBon Speed ImplementaBon Influence Research Featured Studies Our 2013 Priority AcBviBes Fund Research through Broad PFAs Cycles Funded Cycle Closing $89M 51 Projects Dec 2012 Awarded May 2013 Cycles To Be Funded $108M To be awarded Aug 2013 $80M To be awarded Dec 2013 Apr 2013 Aug 2013 Launch Plan to Disseminate & Implement Methodology Standards Plan developed Launch planned for September Methods Report planned for release in conjunclon with November Board meelng FUNDS COMMITTED FOR EXTERNAL RESEARCH Total Since Beginning (2012) 126 Projects 2013 YTD (Target=$355-425M) 51 Projects Launch PaBent- Centered Research Network Launch PFAs Issued ~$4M Sep 2013 Award $12M Dec 2013 Awards $56M Dec 2013 Awards $161M Funds $89M Funds Coordina>ng Center Due: 7/31/13 PPRNs Due 9/27/13 CDRNs Due 9/27/13 Develop EvaluaBon Framework & Baselines Framework in development Baselines in development PCORI Evalua>on Group in formalon Surveys partner sought; agenda in development 50 Pilots=$31M 76 Broad=$130M 00 Targeted=$0M 00 CDRN/PPRN=$0M 51 Broad=$89M 00 Targeted=$0M 00 CDRN/PPRN=$0M Legend Completed On Track To Discuss For Board Ac>on Develop Skilled Community for PCORI People Trained to Support PCORI Research Processes Function Advisory Panelists Merit Reviewers Mentors Research Awardees Number 84/84 of those appointed 1587 to date 26 to date To be initiated for next cycle Stakeholder Engagement Survey Results TBD Implement AcBve Porgolio Management Kick- off calls w/ awardees inilated Report at September BOG Develop DisseminaBon Plan & Infrastructure w/ AHRQ Plan in development Roundtable 7/29/13 Due date Q1 of 2014
Full Speed Ahead 2013 Research Funding Funding stream Solicited in 2013 Awarded to date Broad funding announcements Targeted funding announcements - Asthma - Fall prevention - Uterine fibroids $283M $203M $17M $30M $20M ---- $30M $20M Infrastructure awards $77M $9M TOTAL $427M $262M Awarded to NIH and AHRQ Board of Governors Meeting, September 2013 3
Continuous Improvement Merit review process Contracting process Topic generation - Enhanced integration with and oversight from Science - Standing review panels - Revised review criteria - Enhanced training of reviewers - Revised contract document with input from research administrators - Streamlined awardee document collection/review process - Refining role of Advisory Panels Engagement Board of Governors Meeting, September 2013 4 - Sharpening the integration of engagement with research - Planning for dissemination
Current Staff and Preliminary Projection of Staffing Needs by End of CY 2013 Planned (through 7/1/13) Current 8/30/13 Additional need Total Science 28 32 20 52 Engagement 12 11 2 13 Communications 10 9 1 10 Executive 4 4 1 5 Operations 34 24 14 38 TOTAL 88 80 38 118 Board of Governors Meeting, September 2013 5
Reasons for Staff Growth, Primarily in Science Rapid growth in size of portfolios A strategic decision to employ active portfolio management, both pre- and post-award A strategic decision to commit to more funding in early years A strategic decision to develop and fund the NCRN (Infrastructure Program) A decision to replace additional consultants with permanent staff to serve as Scientific Review Officers Board of Governors Meeting, September 2013 6
General Counsel Mary Hennessey Joins PCORI s executive team Leads organizational compliance effort Supports and advises Board, Executive Director, and executive team on legal issues, policy development and updating Oversees legal aspects of all contracts Performs all other general legal functions Determines when outside legal support is needed Board of Governors Meeting, September 2013 7
New PCORI Staff from April 8, 2013 September 13, 2013 Shown (Top, Left to Right): Carly Vieira, PHR, Christine S. Stencel, MA, Julie Miller, MA, PhD, Diane E. Bild, MD, MPH, Kristin Margosian, MA, Katherine Hughes, MA, James Hawkins, Maggi LeDuc, Paul Moses, Stanley Ip, MD and Mychal Weinert Shown (Bottom, Left to Right): Victoria Szydlowski, Lynn D. Disney, PhD, JD, MPH, Rachel Witsaman, MPH, PMP, Courtney Clyatt, MA, Alex Hartzman, MPH, MPA, Mary C. Hennessey, Esq., Frances Correa, Bryan Luce, PhD, MBA, Tracey Marable, APM and Chao Wang, CPA, CGMA, MBA Not Shown: Jason Gerson, PhD, and Katie Jones Board of Governors Meeting, September 2013 8
Progress Report on Infrastructure Awards Coordinating center awarded CDRN/PPRN application deadline IOM meeting on common data models Application reviews Applications awarded IOM meeting: Involving Systems in CER X X X X SEPT OCT NOV DEC X Board of Governors Meeting, September 2013 9
Rare Diseases Advisory Panel Community Input Multi-Stakeholder Roundtable, Sept 11 th 22 RD community participants - patients, clinicians, industry, payers FDA, NIH/ ORDR, researchers Suggested revisions to draft charter Review Staff Review and Revision Committee Review by COEC, PDC, MC Board Review/ Approval October early November Call Application Period Opens January 2014 Application period aligned with reopening of application period for existing panels Board of Governors Meeting, September 2013 10
Questions " Are there key questions or input from the research community on aspects of PCORI s merit review process or on ways to improve it? " Are there additional issues other than those already mentioned that our General Counsel should attend to? " Further questions, suggestions on the National Patient- Centered Clinical Research Network and/or the related IOM meetings. Board of Governors Meeting, September 2013 11