Steering Committee Chair Report Emma Fernández-Repollet, Ph.D. RTRN Steering Committee, Chair December 13, 2016

Update Overview Steering Committee Chair Protocol Review Committee Ratifications Chair Protocol Review Committee RCMI U54 – FOA IRB Harmonization Issues Technology Transfer Survey 2016 Status Activities FY 2016-2017 Meeting Dates FY 2017

Ratifications FY 2016-2017 DATE ACTION 10/27/2016 Ratification of four IRB documents which will facilitate the implementation of the RTRN IRB Harmonization initiative. 10/18/2016 Ratification RTRN Research Enhancement Awards 6/07/2016 Ratification RTRN Small Grants Awards

Update Chair Protocol Review Committee Dr. Vincent C Bond Morehouse School of Medicine Dr. Jesús Angulo Hunter College

IRB Harmonization Issues Renewal Agreement (6/30/2017) Update IRB Harmonization Issues Renewal Agreement (6/30/2017) i2b2 Implementation Adoption SCILHS Network Policies

Update RCMI U54 – FOA December 9, 2016

Update Key Dates RCMI U54 – FOA Posted Date : December 9, 2017   Open Date (Earliest Submission Date): February 7, 2017 Letter of Intent Due Date(s): February 7, 2017 Application Due Date(s): March 7, 2017, by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on this date.

Update RCMI U54 – FOA Eligibility Recruitment Core Award Budget Community Engagement

TECHNOLOGY TRANSFER FY 2016-2017

Technology Transfer Survey 18 RCMI institutions received the survey 18 institutions answered the survey 100% Response Rate Deadline: September 26, 2016 Technology Transfer Survey 2007 (10) 2015 (9) 2016 (18) Response Rate 56% (N=10) 50% (N=9) 100% (N=18)

Technology Transfer Resources Have a Technology Transfer Office 72% Have an Intellectual Property Policy 94% Employee Invention Report (EIR)- Disclosure 83% Confidential Disclosure Agreement 78% Inter-Institutional Agreement (IIA) 56% Inter-Institutional Research and Commercialization 61% License Application N=18 RCMI Institutions; Questions 3, 5-10

Technology Transfer Resources Model License Agreements 61% Material Transfer Agreement (MTA) 89% Data Sharing Policy 67% Intellectual Property Agreement between Collaborating Investigators IP Agreement between Faculty and Students 44% Has your institution been awarded an SBIR and/or STTR grant during the period of 2000 to 2016? 28% Has your institution acquired 20 or more patents during the period of 2000-2016? 35% N=18 RCMI Institutions; Questions 11-16 and 18

Technology Transfer Survey Provisional Patents University of Hawaii of Texas at San Antonio of Texas at El Paso Morehouse School of Medicine Hunter College UPR Medical Sciences Campus Tuskegee University 730 198 148 27 21 15 7 Charles R. Drew University Texas Southern University Meharry Medical College Florida A&M University Clark Atlanta University Ponce Health Sciences University Jackson State University 4 3 2 1 Provisional Patents 1,163 14 out of 15 RCMI institutions provided this information

Licensed technologies Technology Transfer Survey Licensed Technologies University of Hawaii of Texas at San Antonio Hunter College of Texas at El Paso Morehouse School of Medicine 116 43 12 11 2 Florida A&M University Ponce Health Sciences University Jackson State University Universidad Central del Caribe 1 Licensed technologies 188 9 out of 15 RCMI institutions provided this information

Available for licensing Technology Transfer Survey Technologies Available for Licensing University of Hawaii of Texas at San Antonio of Texas at El Paso UPR Medical Sciences Campus Florida A&M University Morehouse School of Medicine Hunter College 568 149 127 50 26 25 18 Jackson State University Tuskegee University Texas Southern University Charles R. Drew University Universidad Central del Caribe Clark Atlanta University 8 6 3 2 1 Available for licensing 986 13 out of 15 RCMI answered this question

Registered Trademarks Technology Transfer Survey Registered Trademarks UPR Medical Sciences Campus University of Texas at San Antonio Morehouse School of Medicine 12 9 4 Registered Trademarks 25 N=3/14 RCMI institutions

Technology Transfer Survey Technology Transfer Activities Technology Transfer Survey Yes No N Has your institution been awarded an SBIR (R43, R44) and/or STTR (R41, R42) grant during the period of 2000 to 2016? 5 28% 13 72% 18

Technology Transfer Survey SBIR/STTRs Awards Reported by RCMI Institutions 13 SBIRs 9 STTRs * Not yet identified as SBIRs 4 out of 18 RCMI Institutions were able to provide this information

NOTE UTEP reported 3 SBIR grants from the  Air Force Office of Scientific Research for which we were unable to find information online.   MSM reported 3 grants (2 SBIR and 1 STTR) which grant numbers do not appear in the NIH or NSF database.  

Technology Transfer Survey Research Areas of Reported SBIR/STTR Awards Ponce Health Sciences University UPR Medical Sciences Campus University of Texas at El Paso Morehouse School of Medicine Howard University Research areas Biomarker discovery/ Endometriosis/ Women's Reproductive Health Information Technologies (IT) Combustion and Propulsion Research Bioengineering/ Genetics/ Human Genome Educational Technologies and Applications (EA) Infectious diseases in animals/ Biomedical Technologies (BM)/ Immunization Mechanical Engineering Brain Disorders/ Genetics/ Neurosciences/ Stroke Nanoscale Analytical Sciences Research/ Nanotechnology Biotherapeutics/ Protein therapeutics/ Biomedical Technologies (BM) Advanced Materials and Instrumentation (MI) Biotechnology/ Genetics/ Human Genome/ Rare Diseases Biotechnology/ Brain Disorders/ Mental Health Biotechnology/ Genetics/ Hematology/ Human Genome/ Patient Safety/ Rare Diseases Breast Cancer/ Cancer/ Nutrition/ Obesity Aging/ Biotechnology/ Cancer/ Prostate Cancer/ Urologic Diseases

STTRs & SBIRs Success Rates at RTRN States 2006-2015 All SBIR & STTR Phases RTRN States (12): Alabama California Florida District of Columbia (Washington DC) Georgia New York Hawaii Louisiana Mississippi Tennessee Texas Puerto Rico (US territory) Fiscal Year SBIR1& STTR2 States All SBIR/STTR Phases Number of Applications Reviewed Number of Applications Awarded Success Rate8 Total Funding9 2006 TOTAL RTRN 1,919 401 20.9% $107,106,372 2007 1,661 376 22.6% $104,805,743 2008 1,607 418 26.0% $111,566,023 2009 1,598 365 22.8% $120,805,243 2010 2,351 342 14.5% $100,677,650 2011 2,304 323 14.0% $109,725,611 2012 2,230 400 17.9% $131,681,617 2013 2,053 320 15.6% $115,261,428 2014 2,091 447 21.4% $142,045,696 2015 2,143 373 17.4% $129,098,007 2006-2015 All 19,957 3,765 18.9% $1,172,773,390 SBIR & STTR totals for 2006-2015 US States including D.C. and P.R. 54,024 10,864  20.1% $3,415,203,834 RTRN States SBIR & STTR (Percent) for 2006-2015 37%* 35%* 18.9%  34%* * RTRN States totals / US States including D.C. and P.R. totals

Technology Transfer Survey 2016 Annexes USPTO list per institution Technology Transfer contacts- updated list Responses per institution SBIR and STTR Success Rates per State

Sources for obtaining Patent and SBIR/STTR information PATENTS: USPTO webpage (State –Institutions): http://www.uspto.gov/web/offices/ac/ido/oeip/taf/stcasg/regions_stcorg.htm Period searched: last 10 years: 2000-2015, and 2011-2016 STTRs/SBIRs webpage (1st query SBIR / 2nd query STTR) Award listing (searchable per state): https://www.sbir.gov/sbirsearch/award/all Period Search: 2000-2015 NIH: https://sbir.nih.gov/statistics/award-data Period searched: last 10 years: 2000-2016, and 2011-2016 NSF: http://www.nsf.gov/awardsearch/

ACTIVITIES FY 2015-2016 TIME FRAME STATUS Facilitate IRB Harmonization Agreement Implementation (Ratify 4 SOPs submitted by Ethics & Regulatory Subcommittee/ Single IRB) Jan-Mar, 2017 Conduct and Distribute Technology Transfer Survey 2016 (Achieve participation of 100% RCMI Institutions) Dec, 2016 Update Steering Committee Manual & SOPs Oct-Dec 2017 Ratify Small Grant Program Applications (Approved recommended funding for 7 applications) July 2016- June 2017 Promote and participate in NMRN activities Assist Governance Manual Update Jan-Mar,2017 LEADS PROGRAM (Promote program and identify participation of investigators from RCMI institutions) Assist with SC Evaluation July 2016- June 2017 Disseminate RTRN Resources and Initiatives FY 2015-2016 (Update SC Web Section – coordinate Webinars – distribute Data Sharing Policy) Prepare Progress Report FY 2016-2017 March, 2017 Progress: Red= not complete; Yellow = Partial; Green = completed

Steering Committee Meetings 2016-2017 Third Tuesday of each month December 13, 2016 3:00 PM EST March 21, 2017 3:00 PM EST June 20, 2017 3:00 PM EST

CONTACT INFORMATION Emma Fernández-Repollet, Ph.D. Chair, RTRN Steering Committee 787 763-9401 e.fernandez@upr.edu