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1894881 F EQUITY INVESTMENT IN PMED 22954713 F 24849594 DUE FROM TGEN FOUNDATION 4360312 IN-KIND DONATED ASSETS 906759 INVESTMENT IN 457(B) PLAN 964890 6231961 0 DUE TO EMPLOYEE 457(B) PLAN 964890 CAPITAL LEASE OBLIGATION 787725 1752615 X SCHEDULE D, PART V, LINE 4 TGen's policy for appropriating the distribution of its summer internship program endowment has been designed to support a specific number of summer interns each year for the next 25 years. The Institute considered the long-term expected return on its endowment. SCHEDULE D, PART X, LINE 2 Management is of the opinion that substantially all of TGens and the Foundations activities are related to their exempt purposes, and no material uncertain tax positions have been identified or recorded in the accompanying consolidated financial statements at December 31, 2014 or 2013. TGen and the Foundation file Forms 990 in the U.S. federal jurisdiction and comparable forms in the state of Arizona. TAX FILINGS FOR 2011 THROUGH 2014 ARE SUBJECT TO EXAMINATION; HOWEVER, THE INSTITUTE HAS NOT BEEN NOTIFIED OF ANY SUCH EXAMINATIONS. East Asia and the Pacific Program services RESEARCH SERVICES 48231 East Asia and the Pacific Program services SOFTWARE SERVICES 1890 Europe (Including Iceland and Greenland) Program services RESEARCH SERVICES 174950 South Asia Program services SOFTWARE SERVICES 107024 North America Program Services RESEARCH SERVICES 27496 359591 359591 false false false false false false SCHEDULE F, PART I, LINE 3, COLUMN (F) THE AMOUNTS REPORTED IN COLUMN (F) ARE DETERMINED BASED ON THE ACCRUAL METHOD OF ACCOUNTING. X true true X X X X false false false false false false false true false Jeffrey M Trent PhD BOARD MEMBER/PRES/SCIENCE DIR. 911776 0 350000 0 33558 0 110400 0 9937 0 1415671 0 0 0 Teresa Burleson Chief Operating Officer 402080 0 361352 0 935 0 60400 0 7075 0 831842 0 0 0 Charles K Coleson Chief Financial Officer 245076 0 15000 0 4069 0 10400 0 8048 0 282593 0 0 0 Michael Berens Deputy Director of Research 300634 0 63792 0 21681 0 10400 0 9042 0 405549 0 0 0 John Carpten Deputy Director of Sciences 309100 0 190441 0 985 0 60400 0 10162 0 571088 0 0 0 David Craig Deputy Director of Informatics 266813 0 244759 0 605 0 60400 0 9649 0 582226 0 0 0 James Lowey Vice President, Technology 185791 0 15000 0 770 0 8056 0 1349 0 210966 0 0 0 Patrick Smith VP, Corporate Development 273330 0 350221 0 634 0 0 0 8942 0 633127 0 0 0 Stephanie A McRae General Counsel 231869 0 43989 0 18570 0 10400 0 7663 0 312491 0 0 0 Johanna Distefano Professor 231358 0 1500 0 867 0 9344 0 733 0 243802 0 0 0 David Duggan Associate Professor 216567 0 10000 0 848 0 9504 0 12349 0 249268 0 0 0 Manuel Estrada Vice President, Finance 187778 0 32500 0 424 0 5908 0 8235 0 234845 0 0 0 James Harris Vice President, Business Dev. 155914 0 6000 0 20416 0 7536 0 8988 0 198854 0 0 0 DANIEL VON HOFF EXECUTIVE VICE PRESIDENT 616210 0 62280 0 7913 0 60400 0 0 0 746803 0 0 0 SCHEDULE J, PART I, LINE 1A First class travel is permitted by executive staff only and must, per TGen policy, be pre-approved by the Chief Operating Officer. These expenses were not considered as taxable compensation to the recipient since they were reimbursements for business use under an accountable plan. SCHEDULE J, PART I, LINE 7 SOME OF THE PERSONS LISTED IN FORM 990, PART VII WERE PAID BONUSES WHICH WERE BASED ON ACCOMPLISHMENTS OF SPECIFIC MILESTONES AND/OR PERFORMANCE BASES, AS APPROVED BY THE TGEN BOARD OF DIRECTORS. Schedule J, Part II DEFERRED COMPENSATION INCLUDES RETENTION AGREEMENTS FOR THE PRESIDENT AND CHIEF SCIENTIFIC OFFICER (DR. JEFFREY TRENT), THE CHIEF OPERATING OFFICER (TERESA BURLESON), EXECUTIVE VICE PRESIDENT (DANIEL VON HOFF) AND TWO DEPUTY DIRECTORS (JOHN CARPTEN AND DAVID CRAIG). DR. TRENT IS ELIGIBLE TO RECEIVE $500,000 ON 03/12/2017, TERESA BURLESON IS ELIGIBLE TO RECEIVE $250,000 ON 11/30/2017, DANIEL VON HOFF IS ELIGIBLE TO RECEIVE $150,000 ON 11/30/2015, AND THE DEPUTY DIRECTORS ARE ELIGIBLE TO RECEIVE $192,000 EACH ON 11/30/2015 PAYABLE BY TGEN. AMOUNTS ACCRUED BY TGEN DURING CALENDAR YEAR 2014 UNDER THESE AGREEMENTS HAVE BEEN REPORTED IN SCHEDULE J, PART II, COLUMN (C) AS DEFERRED COMPENSATION AS FOLLOWS: JEFFERY M. TRENT, PH.D. $100,000 TERESA BURLESON $50,000 DANIEL VON HOFF $50,000 JOHN CARPTEN $50,000 DAVID CRAIG $50,000 TECH66 LLC WILLIAM BURLESON SPOUSE OF OFFICER 181625 CONSULTING SERVICES false X COMPUTER EQUIPMENT 1 1868838 COST OR SALES PRICE false true false SCHEDULE M, PART I, COLUMN (B) THE ORGANIZATION IS REPORTING IN PART I, COLUMN (B) THE NUMBER OF CONTRIBUTIONS RECEIVED. 50% membership interest in PMed 2014-02-14 49021598 SALE PRICE 320447911 CL PERSONALIZED MEDICINE LLC 400 N MICHIGAN AVE CHICAGO IL 60611 LLC false false false false SCHEDULE N, PART II On 02/14/2014, TGen Health Ventures, LLC, a single-member LLC owned by The Translational Genomics Research Institute (TGEN) SOLD 50% OF ITS MEMBERSHIP INTEREST IN Ashion PMed Management, LLC and Personalized Medicine Partners, LLC, (collectively, "PMED") FOR $25M TO AN UNRELATED THIRD PARTY IN A JOINT VENTURE TRANSACTION FOR THE PURPOSE OF COMMERCIALIZING PERSONALIZED MEDICINE. IN CONNECTION WITH THIS JOINT VENTURE TRANSACTION, TGEN AGREED TO CONTRIBUTE A CERTIFIED AND COMPLIANT LABORATORY TO THE JOINT VENTURE, WHICH HAD A NET BOOK VALUE OF APPROXIMATELY $1M WHEN COMPLETED AND TRANSFERRED IN MAY 2014. UPON COMPLETION OF THE LABORATORY CONTRIBUTION, TGEN RECOGNIZED REVENUE OF $25M FOR CASH RECEIVED AND APPROXIMATELY $24M AS A GAIN ON SALE OF THE LABORATORY. THIS TRANSACTION EXCEEDS 25% OF TGEN'S NET ASSETS. IN ACCORDANCE WITH THE FORM INSTRUCTIONS FOR SCHEDULE N, A SIGNIFICANT DISPOSITION OF NET ASSETS INCLUDES CONTRIBUTION OF ASSETS TO ESTABLISH A JOINT VENTURE IF THE CONTRIBUTION EXCEEDS 25% OF NET ASSETS AT THE BEGINNING OF THE YEAR. SCHEDULE N, PART II, LINE 1 REFLECTS THE NET ACTIVITY OF THIS TRANSACTION: CASH RECEIVED $ 25,000,000 CONTRIBUTION OF LAB ASSETS $ (978,402) GAIN ON SALE OF LAB ASSETS $ 25,000,000 ------------------- TOTAL $ 49,021,598 FORM 990, PART I, LINE 1, AND PART III, LINE 1 The Translational Genomics Research Institute (TGen) is a nonprofit biomedical research institute focused on developing earlier diagnostics and smarter treatments by employing innovative advances arising from the human genome project and applying them to the development of diagnostics, prognostics and therapies for cancer, neurological disorders, diabetes and other complex diseases. FORM 990, PART III, LINE 2 IN 2014, THE TRANSLATIONAL GENOMICS RESEARCH INSTITUTE (TGEN) UNDERTOOK THE FOLLOWING NEW ACTIVITIES: (1) TGEN'S new CLIA (Clinical Laboratory Improvement Amendments) laboratory, the Dorrance Clinical Laboratory, received all required state and federal certifications, quickening its ability to provide physicians with genomic analysis that can help benefit their patients immediately. (2) TGEN ANIMAL HEALTH: AN INTERNAL RESEARCH PROJECT WITH A LOCAL ARIZONA FIRM TO EVALUATE THE PORTABILITY OF HUMAN DIAGNOSTIC TOOLS IN THE TREATMENT OF CANINE CANCER. TGEN IS ONE OF THE EARLY ADOPTERS OF THE CANINE MODEL AS A VEHICLE TO ACCELERATE HUMAN RESEARCH. FORM 990, PART III, LINE 3 IN 2014, THE TRANSLATIONAL GENOMICS RESEARCH INSTITUTE (TGEN) SOLD 50% OF ITS MEMBERSHIP INTEREST IN PMED MANAGEMENT, LLC (PMED) TO AN UNRELATED THIRD PARTY IN A JOINT VENTURE TRANSACTION FOR THE PURPOSE OF COMMERCIALIZING PERSONALIZED MEDICINE. TGEN RETAINED A 50% MEMBERSHIP INTEREST OF PMED WHICH IS RECORDED AS A PROGRAM RELATED INVESTMENT ON FORM 990, PART X, LINE 13. TGEN RECOGNIZED A $49.0 MILLION GAIN ON THE SALE OF ITS MAJORITY INTEREST. THIS GAIN IS REPORTED ON FORM 990, PART VIII, LINE 7. FORM 990, PART III, LINE 4A TGEN'S INTEGRATED CANCER GENOMICS DIVISION BRINGS TOGETHER BIOINFORMATICS, CUTTING-EDGE TECHNOLOGIES AND BASIC RESEARCH TO CREATE A COMPREHENSIVE ATTACK ON CANCER WITH THE ULTIMATE GOAL OF DEVELOPING NEW DIAGNOSTICS AND TREATMENTS. SPECIFIC AREAS OF FOCUS INCLUDE PROSTATE CANCER, MELANOMA, FAMILIAL BREAST CANCER, COLON CANCER, MULTIPLE MYELOMA AND RENAL TUMOR RESEARCH. KEEPING IN LINE WITH TGEN'S MISSION OF DEVELOPING EARLIER DIAGNOSTICS AND SMARTER TREATMENTS, WE HOPE THIS INTEGRATED APPROACH TO CANCER GENOME RESEARCH WILL HELP TO UNCOVER IMPORTANT INHERITED AND TUMOR DERIVED ALTERATIONS, WHICH ARE ASSOCIATED WITH CANCER SUSCEPTIBILITY AND IMPORTANT TUMOR CHARACTERISTICS SUCH AS PROGRESSION AND RESPONSE TO THERAPY. FORM 990, PART III, LINE 4B THE NEUROGENOMICS DIVISION HAS TWO GOALS, BOTH OF WHICH DERIVE FROM THE OVERARCHING MISSION OF THE TRANSLATIONAL GENOMICS RESEARCH INSTITUTE (TGEN). IT IS COMMON KNOWLEDGE THAT EARLY INTERVENTION AND TREATMENT SAVES LIVES WHEN IT COMES TO NEUROLOGICAL DISEASES. THEREFORE, OUR FIRST GOAL IS TO IMPROVE THE ABILITY TO DIAGNOSE NEUROLOGICAL DISEASE BEFORE IT STRIKES. BECAUSE THESE DISEASES IMPACT SO MANY LIVES AROUND THE WORLD EITHER DIRECTLY (BY HAVING A DISEASE), OR INDIRECTLY (BY CARING FOR A LOVED ONE WITH A DISEASE), THE SECOND GOAL CENTERS ON THE DEVELOPMENT OF NEW 'SMART-DRUG' THERAPIES. THERE ARE FIVE LABS WITHIN THE DIVISION, ENCOMPASSING THE ENTIRE BREADTH OF NEUROLOGICAL DISEASE. FORM 990, PART III, LINE 4C TGEN'S GENOTYPING TECHNOLOGY CENTER ANALYZES BITS OF DNA CALLED SINGLE NUCLEOTIDE POLYMORPHISMS (SNPS) WHICH GIVE RESEARCHERS THE POWER TO IDENTIFY DISEASE-CAUSING GENES, ASSOCIATIONS, AND DNA SIGNATURES, ALL OF WHICH HAVE PROFOUND IMPLICATIONS FOR DETECTION, PROGNOSIS AND THERAPEUTIC INTERVENTION. THE SNP GENOTYPING CENTER OFFERS INNOVATIVE SOLUTIONS THAT ADDRESS THE REQUIREMENTS FOR FLEXIBILITY, SIMPLICITY, THROUGHPUT, ECONOMY AND ACCURACY. FORM 990, PART III, LINE 4D Introduction In FY14, our 12th year of operations, we experienced significant scientific and medical progress across multiple areas of the institute, many of which reached new heights and forged the potential for significantly greater achievements in the future. Unique to this past year is the crystallization of enterprise initiatives that will leverage internal discoveries and developments in genomics research and informatics tools: - TGen Animal Health: An internal research project with a local Arizona firm to evaluate the portability of human diagnostic tools in the treatment of canine cancer. TGen is one of the early adopters of the canine model as a vehicle to accelerate human research. - TGen's Center for Rare Childhood Disorders, which we announced late last year, has blossomed during FY14, providing parents an opportunity to discover answers about their children's diagnosis and potential Treatments. It was also a year when celebrities and pop culture collided in meaningful ways with TGen to highlight for the general public our goals of using genomic science to further the prevention, detection and treatment of the many significant diseases that plague humanity. The General Manager of the New York Yankees, Brian Cashman, joined our National Advisory Council for Pancreatic Cancer Research. Arizona State University's football team agreed to join us along with Riddell Sports in neurogenomic research that could help prevent serious sports injuries in the future. Miss Arizona, who struggled with her own childhood disorder, agreed to advocate for TGen's neurogenomic research into rare childhood diseases, and Wonder Woman actress Lynda CARTER advocated for our Alzheimer's research. She even convinced a fellow actor, Ashton Kutcher, to help spread the word on social media about our MindCrowd.org study. We are multiplying our investigative and scientific efforts. Thanks to Stand Up To Cancer, Dell, and The Ben & Catherine Ivy Foundation, 2014 will see patients enrolled into groundbreaking clinical trials in the study of melanoma and adult brain tumors, bringing to patients the very latest investigational treatments. Our new CLIA (Clinical Laboratory Improvement Amendments) laboratory - the Dorrance Clinical Laboratory - received all required state and federal certifications, quickening our ability to provide physicians with genomic analysis that can help benefit their patients immediately. Of particular note was the Sept. 6 approval by the U.S. Food and Drug Administration of the drug Abraxane for treatment of advanced pancreatic cancer. Physician-In-Chief Dr. Daniel Von Hoff is to be commended for his scientific tenacity and dedication to his patients in supervising the immensely complex international clinical trial involving more than 800 patients at more than 150 community and academic centers on three continents that resulted in this significant medical advancement. His study was published Oct. 16, 2014 in the prestigious New England Journal of Medicine. In addition, the following overview provides a snapshot of recent progress in scientific publications, grants, contracts, philanthropy, education and outreach, media and community recognition. Peer-Reviewed Laboratory Research Publications and Presentations As it has been from our very founding in 2002, the focus of our work remains the patient: but not the patient of the future. Our work is having an impact on patients in need today, many of who cannot afford to wait months or years for treatments that may work. Our work leverages the latest technology to survey the human genome at depths few could have imagined a decade ago. And our capacity to understand and leverage what the genome is telling us has never been greater. Our long-term hope is that doctors will leverage this information to inform decisions about patient care as the standard rather than the exception. While this is happening today on a limited basis, we envision a day in the not too distant future where it will happen for all patients across all diseases. Much of what we learn is published in leading scientific and medical journals, which continuously adds to the growing knowledge base of molecular research and medicine. In FY14, TGen researchers published their research results extensively in numerous scholarly peer-reviewed academic journals and through presentations at leading national and international conferences. These include publication in leading scientific journals such as New England Journal of Medicine, Nature Genetics, PLos One, the Journal of Clinical Psychiatry, Journal of the American Medical Association, Proceedings of the National Academy of Sciences USA, and a host of other disease-associated publications. FY14 Select Highlights a) Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. Von Hoff DD, Ervin T, Arena FP, Chiorean EG, Infante J, Moore M, Seay T, Tjulandin SA, Ma WW, Saleh MN, Harris M, Reni M, Dowden S, Laheru D, Bahary N, Ramanathan RK, Tabernero J, Hidalgo M, Goldstein D, Van Cutsem E, Wei X, Iglesias J, Renschler MF. N Engl J Med. 2013 Oct 31;369(18):1691-703. b) Phase I trial of AEG35156 an antisense oligonucleotide to XIAP plus gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma. Mahadevan D, Chalasani P, Rensvold D, Kurtin S, Pretzinger C, Jolivet J, Ramanathan RK, Von Hoff DD, Weiss GJ. Am J Clin Oncol. 2013 Jun;36(3):239-43. c) Ligand-dependent EphB1 signaling suppresses glioma invasion and correlates with patient survival. Teng L, Nakada M, Furuyama N, Sabit H, Furuta T, Hayashi Y, Takino T, Dong Y, Sato H, Sai Y, Miyamoto K, Berens ME, Zhao SG, Hamada J. Neuro Oncol. 2013 Dec;15(12):1710-20. d) Implications of Rho GTPase Signaling in Glioma Cell Invasion and Tumor Progression. Fortin Ensign SP, Mathews IT, Symons MH, Berens ME, Tran NL. Front Oncol. 2013 Oct 4;3:241. e) Whole genome sequencing reveals potential targets for therapy in patients with refractory KRAS mutated metastatic colorectal cancer. Shanmugam V, Ramanathan RK, Lavender NA, Sinari S, Chadha M, Liang WS, Kurdoglu A, Izatt T, Christoforides A, Benson H, Phillips L, Baker A, Murray C, Hostetter G, Von Hoff DD, Craig DW, Carpten JD. BMC Med Genomics. 2014 Jun 18;7:36. f) Association analysis of 9,560 prostate cancer cases from the International Consortium of Prostate Cancer Genetics confirms the role of reported prostate cancer associated SNPs for familial disease. Teerlink CC, Thibodeau SN, McDonnell SK, Schaid DJ, Rinckleb A, Maier C, Vogel W, Cancel-Tassin G, Egrot C, Cussenot O Carpten J (et.al); International Consortium for Prostate Cancer Genetics, Camp NJ, Cannon-Albright LA. Hum Genet. 2014 Mar;133(3):347-56. g) Small cell carcinoma of the ovary, hypercalcemic type, displays frequent inactivating germline and somatic mutations in SMARCA4. Ramos P, Karnezis AN, Craig DW, Sekulic A, Russell ML, Hendricks WP, Corneveaux JJ, Barrett MT (et.al). Nat Genet. 2014 May;46(5):427-9. h) Whole genome analyses of a well-differentiated liposarcoma reveals novel SYT1 and DDR2 rearrangements. Egan JB, Barrett MT, Champion MD, Middha S, Lenkiewicz E, Evers L, Francis P, Schmidt J, Shi CX, Van Wier S, Badar S, Ahmann G, Kortuem KM, Boczek NJ, Fonseca R, Craig DW, Carpten JD, Borad MJ, Stewart AK. PLoS One. 2014 Feb 5;9(2):e87113. i) Genetic relationship between five psychiatric disorders estimated from genome-wide SNPs. Cross-Disorder Group of the Psychiatric Genomics Consortium, Lee SH, Ripke S, Neale BM, Faraone SV, Purcell SM, Perlis RH, Mowry BJ, Thapar A, Goddard ME, Witte JS, Absher D, Agartz I Craig DW (et.al). Nat Genet. 2013 Sep; 45(9):984-94. j) Whole-genome sequencing of an aggressive BRAF wild-type papillary thyroid cancer identified EML4-ALK translocation as a therapeutic target. Demeure MJ, Aziz M, Rosenberg R, Gurley SD, Bussey KJ, Carpten JD. World J Surg. 2014 Jun;38(6):1296-305. k) Emerging roles for miRNAs in the development, diagnosis, and treatment of diabetic nephropathy. DiStefano JK, Taila M, Alvarez ML. Curr Diab Rep. 2013 Aug;13(4):582-91. l) Whole genome analysis of Exserohilum rostratum from the outbreak of fungal meningitis and other infections. Litvintseva AP, Hurst S, Gade L, Frace MA, Hilsabeck R, Schupp JM, Gillece JD, Roe C, Smith D, Keim P, Lockhart SR, Changayil S, Weil MR, MacCannell DR, Brandt ME, Engelthaler DM. J Clin Microbiol. 2014 Jun 20. m) The 2010 cholera outbreak in Haiti: how science solved a controversy. Orata FD, Keim PS, Boucher Y. PLoS Pathog. 2014 Apr 3;10(4):e1003967. n) Phase II study of induction fixed-dose rate gemcitabine and bevacizumab followed by 30 Gy radiotherapy as preoperative treatment for potentially resectable pancreatic adenocarcinoma. Van Buren G 2nd, Ramanathan RK, Krasinskas AM, Smith RP, Abood GJ, Bahary N, Lembersky BC, Shuai Y, Potter DM, Bartlett DL, Zureikat AH, Zeh HJ, James Moser A. Ann Surg Oncol. 2013 Nov;20(12):3787-93. o) The alzheimer's prevention initiative composite cognitive test score: sample size estimates for the evaluation of preclinical alzheimer's disease treatments in presenilin 1 E280A mutation carriers. Ayutyanont N, Langbaum JB, Hendrix SB, Chen K, Fleisher AS, Friesenhahn M, Ward M, Aguirre C, Acosta-Baena N, Madrigal L, Muoz C, Tirado V, Moreno S, Tariot PN, Lopera F, Reiman EM. J Clin Psychiatry. 2014 Jun;75(6):652-60. p) Corrigendum: Small cell carcinoma of the ovary, hypercalcemic type, displays frequent inactivating germline and somatic mutations in SMARCA4. Ramos P, Karnezis AN, Craig DW, Sekulic A, Russel ML, Hendricks WP, Corneveaux JJ, Barrett MT, Shumansky K, Yang Y, Shah SP, Prentice LM, Marra MA, Kiefer J, Zismann VL, McEachron TA, Salhia B, Prat J, D'Angelo E, Clarke BA, Pressey JG, Farley JH, Anthony SP, Roden RB, Cunliffe HE, Huntsman DG, Trent JM. Nat Genet. 2014 Jun 26;46(7):759. q) Small cell carcinoma of the ovary, hypercalcemic type, displays frequent inactivating germline and somatic mutations in SMARCA4. Ramos P, Karnezis AN, Craig DW, Sekulic A, Russell ML, Hendricks WP, Corneveaux JJ, Barrett MT, Shumansky K, Yang Y, Shah SP, Prentice LM, Marra MA, Kiefer J, Zismann VL, McEachron TA, Salhia B, Prat J, D'Angelo E, Clarke BA, Pressey JG, Farley JH, Anthony SP, Roden RB, Cunliffe HE, Huntsman DG, Trent JM. Nat Genet. 2014 May;46(5):427-9. r) Brain differences in infants at differential genetic risk for late-onset Alzheimer disease: a cross-sectional imaging study. Dean DC 3rd, Jerskey BA, Chen K, Protas H, Thiyyagura P, Roontiva A, O'Muircheartaigh J, Dirks H, Waskiewicz N, Lehman K, Siniard AL, Turk MN, Hua X, Madsen SK, Thompson PM, Fleisher AS, Huentelman MJ, Deoni SC, Reiman EM. JAMA Neurol. 2014 Jan;71(1):11-22. s) Integrated genomic and epigenomic analysis of breast cancer brain metastasis. Salhia B, Kiefer J, Ross JT, Metapally R, Martinez RA, Johnson KN, DiPerna DM, Paquette KM, Jung S, Nasser S, Wallstrom G, Tembe W, Baker A, Carpten J, Resau J, Ryken T, Sibenaller Z, Petricoin EF, Liotta LA, Ramanathan RK, Berens ME, Tran NL. PLoS One. 2014 Jan 29;9(1):e85448. t) Profiles of extracellular miRNA in cerebrospinal fluid and serum from patients with Alzheimer's and Parkinson's diseases correlate with disease status and features of pathology. Burgos K, Malenica I, Metpally R, Courtright A, Rakela B, Beach T, Shill H, Adler C, Sabbagh M, Villa S, Tembe W, Craig D, Van Keuren-Jensen K. PLoS One. 2014 May 5;9(5):e94839. u) CRL4A-FBXW5-mediated degradation of DLC1 Rho GTPase-activating protein tumor suppressor promotes non-small cell lung cancer cell growth. Kim TY, Jackson S, Xiong Y, Whitsett TG, Lobello JR, Weiss GJ, Tran NL, Bang YJ, Der CJ. Proc Natl Acad Sci U S A. 2013 Oct 15;110(42):16868-73. Clinical Research / Clinical Trials TGen has a direct clinical research site through a strategic alliance with the Virginia G. Piper Cancer Center (VGPCC) Clinical Trials Program at Scottsdale Healthcare. Dr. Daniel Von Hoff, TGen's Physician-in-Chief, also serves as the program's Chief Scientific Officer. The program focuses on clinical trials with targeted agents and genomics-based individualized therapy and with an initial focus on cancer, allows the unique opportunity for TGen to transition its laboratory-based research to patient care centered on individualized therapy. The program brings new clinical research into the community, to those patients who would otherwise have to travel someplace else for access to new therapies or prevention agents. According to the National Institutes of Health, only 3% of adults with cancer are participating in clinical trials. A recent study shows that if given the opportunity and access to clinical trials, 63% of the population would participate, according to a survey by the Charlton Research Co. With more than 50 active clinical trials for advanced and/or rare cancers, the program is one of the leading centers for Phase I oncology trials in the nation. Clinical trials with agents directed at specific targets in patients' tumors were launched in November 2005. These clinical trials give options that did not exist before to Phoenix-area patients as well as patients from all over the country. The program conducts clinical trials across a number of cancer types. Further development of cancer specific divisions in pancreatic cancer, breast cancer, leukemia, prostate cancer, lung cancer, and melanoma are under development. In addition to clinical trials, a molecular profiling pilot study has been designed and implemented to test the hypothesis that treatment with a cancer agent selected based on the unique molecular profile of a patient's tumor may be more beneficial than a treatment selected based on the specific cancer type. Patient participation in clinical trials is a necessary component to the research process. As noted earlier, only 3% of adults with cancer are participating in clinical trials. At the VGPCC Clinical Trials Program, the clinical trial participation rate is a remarkable 60%. Patient participation in clinical trials includes: - 125 visits per month - 35-45 new patients per month - 400-600 patient samples collected per month FY14 Highlights In July 2013, the Side-Out Foundation's breast cancer pilot study showed that cancer patients do better when their treatment is guided by molecular profiling. Specifically, 52 percent of patients with advanced breast cancer received clinical benefit - meaning their disease was controlled for a longer time - when their cancer was treated based on addressing the abnormal proteins in their tumor. Each patient's treatment was "personalized," meaning that the therapy they received was based on their individual tumor biology. In September 2013, the U.S. Food and Drug Administration approved Abraxane for patients with advanced pancreatic cancer, following 7 years of rigorous clinical trials. Abraxane, the brand name for nab-paclitaxel, was approved for use in combination with gemcitabine, the previous standard drug therapy, following a large-scale international clinical trial headed by Dr. Daniel D. Von Hoff, TGen Physician-in-Chief. This is a new standard for treatment of metastatic pancreatic cancer that could become the backbone for other new treatment regimens. Dr. Von Hoff was the Principal Investigator of MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial), the Phase III clinical study of 861 cancer patients at 121 sites in North America, Europe and Australia. In September 2013, Scottsdale Healthcare and the TGen initiated the first-in-human clinical trial for pancreatic cancer patients using a compound derived from a plant known as "Thunder God vine." The first patient to participate in this clinical trial received treatment at Scottsdale Healthcare's VPCCC, a partnership of Scottsdale Healthcare and TGen. The Thunder God vine (Tripterygium wilfordii), also known as lei gong teng, is native to China, Japan and Korea. Traditional Chinese medicine has used the vine for more than 2,000 years as a treatment for everything from fever to inflammation and autoimmune diseases, such as multiple sclerosis and rheumatoid arthritis. In February 2014, TGen and Mayo CLINIC personalized drug treatments using genomic sequencing technologies for patients with cholangiocarcinoma. Potential new treatment approaches are being validated to develop new tests that physicians can use to guide therapy for this aggressive cancer of the bile ducts that progresses quickly and is difficult to treat. Clinically important findings suggest that targeting the EGFR and FGFR cellular pathways may benefit thousands of patients with this disease, according to the study published in the journal PLOS Genetics. Half of the patients treated in this study responded to either ponatinib (typically used for certain types of leukemia) or pazopinib (a kidney cancer drug), depending on the genetic alterations identified through sequencing. In June 2014, TGen and SHC BEGAN TO study a new cancer immunotherapy to see if it can successfully help patients with advanced pancreatic cancer. The Phase 2B clinical trial of CRS-207 and GVAX Pancreas vaccines opened at SHC, where cancer patients are treated with promising new drugs. Participants in the study, named ECLIPSE (Efficacy of Combination Listeria/GVAX Immunotherapy in the Pancreatic Cancer Setting), will be randomized so patients receive only the CRS-207 vaccine, or that vaccine combined with the GVAX Pancreas vaccine and low doses of cyclophosphamide. A third group of patients will receive a standard chemotherapy. Grant Support In additional to philanthropic donations and research contracts, grant funding is an important funding source for research. In FY14, TGen investigators submitted 142 grants totaling $99M. TGen was awarded 13 grants, totaling $2.3M, with an additional 76 grants pending and under review totaling $42M. Additionally, TGen received $6.3M from 2012 and 2013 pending grants. TGen's success rate currently rests at 22 percent of total grants submitted, placing the Institute nearly 4 percent higher than the national average (NIH overall success rate). FY14 Highlights a) A four-year grant from the Department of Defense totaling $938,715 to Dr. Paul Keim to conduct genomic profiles of the various near-neighbor forms of the pathogen B. pseudomallei, a biological warfare agent. b) Five-year grant from NIH totaling $663,574 to Dr. Daniel Von Hoff to identify potential glycomarkers for pancreatic and breast cancer in an effort toward early cancer detection. c) Five-year grant from the National Science Foundation totaling $499,759 to Dr. Lance Price to study microbial biodiversity in relation to soil carbon cycles. d) Five-year grant from NIH totaling $974,565 to Dr. Matt Huentelman to leverage our genome-wide and Next Generation Sequencing (NGS) genetic data, as well as transcriptome and proteome datasets, to map novel risk loci for late onset Alzheimer's disease (LOAD) that are acting either in epistasis with, or independently of, the APOE E4 allele, which has previously been identified as the strongest LOAD risk signal within the human genome. e) Three-year grant from the Defense Science and Technology Laboratory/Porton Down totaling $558,186 to Dr. Paul Keim to study the temporal molecular response of Yersinia pestis (plague) to survival in aerosols. f) Five-year grant from NIH totaling $479,304 to Dr. Dave Duggan to continue and expand the international, multi-site Colon Cancer Family Registry Cohort (CCFRC) program, which now is comprised of more than 10,000 families and individuals at increased risk of colorectal and other cancers. g) One-year grant from NIH totaling $259,267 to Dr. Bridget Barker to study the possible genetic origins of Valley Fever, specifically, to significantly expand our knowledge of Coccidioides pathogenesis mechanisms, which may lead to novel vaccine candidates and/or new therapeutic options. h) Two-year grant from the Michael J. Fox Foundation totaling $242,028 to Dr. Kendall Jensen to investigate RNA biomarkers in blood plasma and cerebrospinal fluid that might better diagnose Parkinson's disease. i) Four-year grant from NIH totaling $93,492 to Dr. Dave Duggan to identify multiple susceptibility loci that may better quantify the proportion of variation in complex diseases explained by genetic variants, identify population-specific loci and provide insights into shared molecular pathways that will more efficiently direct subsequent prevention and treatment strategies in the diverse U.S. population. j) Up to Two-year grant from SU2C funding up to $125,000 to Dr. Jeffrey Trent (Dr. Richard Lo, UCLA), for the Phillip A. Sharp Innovation in Collaboration Award to promote development of genome-scale analyses of melanoma treatment sensitivity and resistance. k) Two-year grant from the Michael J. Fox Foundation totaling $234,354 to Dr. Kendall Jensen for a study identifying miRNA biomarkers of dementia to help measure cognitive decline among Parkinson's disease patients. Preliminary data suggests using extracellular miRNA could act as an indicator of at-risk patients for future neurological, cognitive, and behavioral complications. l) One-year grant from the Michael J. Fox Foundation totaling $42,450 to Dr. Travis Dunckley to help develop a diagnostic test for early-stage Parkinson's disease by identifying unique PD signatures using miRNA from saliva, enabling test date to be gathered in a relatively non-invasive fashion. m) One-year grant from NIH totaling $208,737 to Dr. Holly Yin to study ERK inhibitor resistance and ERK isoform-dependent growth in pancreatic cancer. n) Two-year grant from the Melanoma Research Alliance totaling $194,763 to Dr. Jeffrey Trent to discover and characterize therapeutic molecular targets in acral melanoma. o) One-year grant from NIH totaling $162,146 to Dr. John Carpten to study the effects of NM23-H1 on the suppression of melanoma initiation and progression. p) Three-year grant from USDA totaling $107,856 to Dr. Lance Price to study whether raw meat is a risk factor for colonization and infection from Staphylooccus Aureus. q) TGen's Dr. Muhammed Murtaza is one of four recipients of the 2014 Bisgrove Scholars scholarship, named after Jerry Bisgrove, a TGen Foundation Board Member and a businessman who helped with the initial funds to launch Science Foundation Arizona. Dr. Murtaza will receive $200,000 over two years towards his research into how to track the evolution of cancer through DNA analysis. Enterprise Efforts, Collaboration, Spin-offs and Job Creation During FY14, TGen formed and secured investment for three companies. Invention Disclosures TGen filed 20 invention disclosures in FY14 based on discoveries stemming from TGen-led research, and 20 provisional patent applications. Contracts and Collaborations TGen signed a total of 436 contracts in FY14, broken down as follows: a) 103 Confidential Disclosure Agreements b) 66 Material Transfer Agreements c) 69 Research Collaborations d) 30 Consulting Agreements e) 61 Professional Service Agreements f) 4 Commercialization Licenses g) 103 agreements covering miscellaneous activities A listing of a number of the major research collaborators include: AstraZeneca Pharmaceuticals; Mayo Clinic; Ventana Medical Systems; Side-Out Foundation; Daiichi Sankyo; Onyx Pharmaceuticals; Illumina Inc.; George Mason University; GE Healthcare/Janssen Research & Development; Sarcoma Alliance for Research thru Collaboration (SARC); Eli Lilly; GlaxoSmith Kline; Baylor Research Institute; Cancer Treatment Centers of America; Allina Health; Ignyta Operating Inc.; Hills Pet Nutrition; Spectrum Health Hospitals; Flagship Biosciences. Job Creation Eighteen new full-time equivalent positions were created in 2014 with salaries and benefits totaling $1,531,245. Salaries for temporary positions (those positions created for a finite period of time) totaleD$205,700, which includes temporary TGen staff and temporary service fees. Student salaries were just over $439,000, bringing the overall FY14 total to $2,175,944. In terms of education level, eighty-three percent of full-time TGen staff holds a college degree and forty-six percent holds an advanced degree. FY 14 full-time positions filled (new and replacements) included: - Purchasing Assistant - Purchasing Agent - Manager, Accounting - Research Technician - Clinical Research Coordinator - Payroll Administrator - Administrative Assistant - Accountant, Sr. - Executive Assistant - Clinical Research Coordinator - Engineer, HPC - HIPAA Compliance and Risk Management Specialist - Histotechnologist - Patent Attorney - Post-Doc Fellow - Professor - Research Associate - Research Associate II - Staff Scientist - Technician, Facilities - Vice President, Finance Education TGen's science, education, and community outreach initiatives are designed to assist in the growth of the bioscience workforce in Arizona, increase public fluency in translational medicine, and build an accessible community presence. FY14 highlights include: 45 Arizona students - selected from nearly 550 Arizona applicants - participated in TGen's flagship, paid summer internship program, Helios Scholars at TGen. The Program is a 25-year partnership between TGen and the local Helios Education Foundation, an education-focused philanthropic organization. Every TGen division hosted Helios Scholars for hands-on experiences: grants and research administration, environmental health and safety, cancer, neurological disease, diabetes and infectious disease. Cohort demographics: 58 percent attended colleges or universities in Arizona; 22 percent self-identified as races/ethnicities underrepresented in the biosciences; 27 percent were in high school, 71 percent in college and 2 percent in graduate or medical school. TGen engaged the nearly 350 Helios Scholars alumni for the third annual alumni networking reception in July at the Sheraton Phoenix Downtown Hotel. Alumni provide guidance to each new summer intern class via a panel discussion, sit on the internship selection committee and act as ambassadors for the biosciences within their social and professional networks. Keeping them engaged with Arizona and with TGen is a major program goal to ensure the Program delivers on the mission to grow the bioscience workforce in Arizona. The Ben and Catherine Ivy Foundation awarded TGen funding for an expanded third year of the Ivy Neurological Sciences Internship Program, a paid internship program now supporting two high school students for paid summer internships, two undergraduates for academic year paid internships, and one medical school candidate for a full calendar year paid internship in neurological disease research and a clinical training module. The program has expanded each year over three years to support extended, immersive training experiences for top student talent. For the third and final year of the Duke-TGen education partnership, TGen worked directly with Duke University faculty to recruit an undergraduate interested in bioinformatics and genomics to TGen for a 10-week summer internship. The TGen-Duke Biomedical Futures program broadened awareness of TGen nationally and set the stage for future faculty collaborations. The Duke student has continued to work remotely from North Carolina on a TGen computational biology research project. Outside of these programs, TGen hosted approximately 10 additional summer interns, and 50+ academic year interns in FY14 throughout every TGen research division including laboratory and clinical research, research administration, mathematics and computational biology research. Public Outreach In FY14 TGen hosted over 45 public tours (nearly 500 attendees) for students, teachers, community organizations and the general public. Tours typically include a presentation providing an overview of the Institute and information on translational medicine. TGen took a leadership role in the Arizona Science and Engineering Fair (AzSEF) in FY14 by chairing the judging committee responsible for recruiting, planning and coordinating judges for the over one thousand elementary, junior and senior division students and their projects competing in the state fair. The chairs recruited more than 350 judges. More than a dozen TGen faculty and staff volunteered as judges for the event, held March 31-April 2 at the Phoenix Convention Center. AzSEF sends high school level winners to represent Arizona at the Intel International Science and Engineering Fair. This year, BASIS Scottsdale high school student Shrey Gupta, a 2013 Helios Scholar and ongoing academic year intern mentored by TGen's Dr. Seungchan Kim, presented his TGen research at the 2014 Intel ISEF in Los Angeles this May and won a $1,000 Third Place Grand Award in Computer Science and an Arizona State University New American University Provost Scholarship. TGen also developed an AzSEF Special Award: the TGen Excellence in Biomedical Research Award, which recognized two outstanding high school student projects, focusing on research and technology to unravel the genetic underpinnings of human diseases. Winners toured TGen laboratories and ate lunch with Dr. Trent and the team of three TGen postdoctoral fellows that selected them for the award. Students from BASIS Scottsdale public charter school and public Chandler High School won the inaugural award. For a second year, TGen participated in the Lesson2Life teacher-training program offered by the Arizona K12 Center. Five teachers visited the Institute for a genomics and biotechnology update, a laboratory tour and interaction with a panel of high school and undergraduate interns. For a third year, as part of the annual Arizona SciTech Festival, TGen hosted nearly 40 local educators on March 1 for a tour, research update and reception called "TGen for Teachers." Over a dozen faculty and staff participated in the program. In addition to inspiring teachers and enhancing their exposure to cutting edge research and technology, the event helped build TGen's reputation as an accessible community partner committed to education. Also in support of the Arizona SciTech Festival, TGen participated in future development of the Festival through the "Meeting of the Minds" planning meeting at the Arizona Innovation Summit, provided panelists for the Arizona Internships Panel, and hosted a student blogger for interviews with scientists and their interns. Also, in March 2014 during the Phoenix Union High School District spring break, TGen engaged three local high school students from the Be a Leader Foundation for the annual Shadow a Professional Day. Each public school student spent a workday with a TGen scientific research associate. TGen believes it has a responsibility to offer workforce knowledge and expertise to our education community partners. In this spirit, TGen is represented on several boards and working groups including but not limited to: Arizona Science Center Pathways Grant Advisory Board; Paradise Valley Unified School District Center for Research in Engineering, Science and Technology (CREST) Advisory Board; Tempe Union High School District Career and Technical Education Evaluation Committee; Deer Valley Unified School District Career and Technical Education Evaluation Committee; Phoenix Healthcare Sector Partnership; Arizona Bioindustry Association Marketing and Communication Committee; Intel ISEF Phoenix Local Arrangements Committee (LAC); Center for the Future of Arizona: STEM Diploma Project Advisory Committee. Media / Public Recognition As noted in years past, the overall goal of TGen's media efforts is to build a strong and compelling communications tool set to tell TGen's story immediately to audiences that, over time, will be increasingly aware of TGen and what makes it unique and essential. To the end, TGen continually pursues earned media exposure for the institute's research activities. In FY14, TGen received just over 1,000 earned media mentions, highlighted by: - In December 2013, Drs. Kendall Jensen (TGen) and Javier Cardenas (Barrow) received prominent national placement on CBS Evening News and CBS This Morning for our work with Riddell, ASU and Barrow Neurological Institute on concussions. - Dr. Paul Keim, Director of TGen's Pathogen Genomics Division, was featured for his research of The Plague in a front-page lead-centerpiece story in the Sunday, May 18, edition of The Arizona Republic. - During spring sweeps week on April 24, 12 News featured TGen Dr. Matt Huentelman describing why we study Obsessive-compulsive disorder (OCD) dogs to find clues for childhood autism. - Dr. Muhammed Murtaza describes his DNA-based cancer blood tests April 30 on Channel 8's Horizon. - CBS Sunday Morning featured TGen Professor Dr. Eric Reiman April 13 in a story about his cutting-edge Alzheimer's research. - TGen's Center for Rare Childhood Disorders and patient Shelby Valint are featured in the popular annual "Best Doctors" issue of Phoenix Magazine. Shelby also is featured in a 12 News report about TGen genomic studies. TGen media releases resulted in additional and numerous media mentions locally, nationally and internationally. In addition to those outlets mentioned above, others include: Forbes Magazine, Washington Business Journal, The Arizona Republic, Phoenix Business Journal, CNBC, 12 News, ABC 15, CBS 5, GenomeWeb Daily News, Arizona Capitol Times, Arizona Daily Sun (Flagstaff), The Greenville News (South Carolina), San Diego Business Journal, Plus Patent News, US Official News, US Fed News, Professional Services Close-Up, Entertainment Close-Up, Business Wire, PRWeb Newswire, States News Service, Targeted News Service, FierceBiotechIT, Express Healthcare, IANS-English, MarketLine NewsWire (Formerly Datamonitor), PressWIRE, Market News Publishing, ENP Newswire, India Pharma News, BioSpectrum (India), India Blooms News Service, Australian Government News. In terms of public recognition, TGen faculty and leadership participate in a number of community activities and serve on a number of boards. Recognition of TGen's effort serves to help showcase the academic and industry efforts across all of Arizona's biomedical sector. FY14 recognition includes: a) Arizona Business magazine names TGen its 2014 Bioscience Company of the Year. b) TGen President Dr. Jeffrey Trent was recognized September 24 by the Arizona Capitol Times as one of Arizona's Leaders of the Year in Public Policy in the category of Healthcare. c) Dr. Trent presented on a panel July 16 during a biomedical conference in Washington, D.C., sponsored by the Brookings Institute. d) In May 2014, TGen was recognized by the Greater Phoenix Chamber of Commerce for the 2014 Impact Awards in the small/medium business category as an Economic Driver. 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