Attach to Form 990 or Form 990-EZ.
See separate instructions.| (i) Name of supported organization |
(ii) EIN |
(iii) Type of organization (described on lines 1- 9 above or IRC section (see instructions)) |
(iv) Is the organization in col. (i) listed in your governing document? |
(v) Did you notify the organization in col. (i) of your support? |
(vi) Is the organization in col. (i) organized in the U.S.? |
(vii) Amount of support? |
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|---|---|---|---|---|---|---|---|---|---|
| Yes | No | Yes | No | Yes | No | ||||
| Total | |||||||||
| Calendar year(or fiscal year beginning in) | (a) 2006 | (b) 2007 | (c) 2008 | (d) 2009 | (e) 2010 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 1 | Gifts, grants, contributions, and membership fees received. (Do not include any "unusual grants.") .... | 30,038,918 | 48,715,607 | 40,267,050 | 50,530,395 | 55,961,459 | 225,513,429 |
| 2 | Tax revenues levied for the organization's benefit and either paid to or expended on its behalf....... | ||||||
| 3 | The value of services or facilities furnished by a governmental unit to the organization without charge.. | ||||||
| 4 | Total. Add lines 1 through 3.. | 30,038,918 | 48,715,607 | 40,267,050 | 50,530,395 | 55,961,459 | 225,513,429 |
| 5 | The portion of total contributions by each person (other than a governmental unit or publicly supported organization) included on line 1 that exceeds 2% of the amount shown on line 11, column (f).. | 21,585,878 | |||||
| 6 | Public Support. Subtract line 5 from line 4. | 203,927,551 | |||||
| Calendar year(or fiscal year beginning in) | (a) 2006 | (b) 2007 | (c) 2008 | (d) 2009 | (e) 2010 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 7 | Amounts from line 4.. | 30,038,918 | 48,715,607 | 40,267,050 | 50,530,395 | 55,961,459 | 225,513,429 |
| 8 | Gross income from interest, dividends, payments received on securities loans, rents, royalties and income from similar sources.. | 83,242 | 230,227 | 492,533 | 56,756 | 329,668 | 1,192,426 |
| 9 | Net income from unrelated business activities, whether or not the business is regularly carried on.. | 65,317 | 65,317 | ||||
| 10 | Other income. (Explain in Part IV.) Do not include gain or loss from the sale of capital assets.. | 874,059 | 204,892 | 271,807 | -8,054 | 209,147 | 1,551,851 |
| 11 | Total support (Add lines 7 through 10). | 228,323,023 | |||||






| Calendar year(or fiscal year beginning in) | (a) 2006 | (b) 2007 | (c) 2008 | (d) 2009 | (e) 2010 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 1 | Gifts, grants, contributions, and membership fees received. (Do not include any "unusual grants.") . | ||||||
| 2 | Gross receipts from admissions, merchandise sold or services performed, or facilities furnished in any activity that is related to the organization's tax-exempt purpose...... | ||||||
| 3 | Gross receipts from activities that are not an unrelated trade or business under section 513.. | ||||||
| 4 | Tax revenues levied for the organization's benefit and either paid to or expended on its behalf... | ||||||
| 5 | The value of services or facilities furnished by a governmental unit to the organization without charge.. | ||||||
| 6 | Total. Add lines 1 through 5. | ||||||
| 7a | Amounts included on lines 1, 2, and 3 received from disqualified persons... | ||||||
| b | Amounts included on lines 2 and 3 received from other than disqualified persons that exceed the greater of $5,000 or 1% of the amount on line 13 for the year. | ||||||
| c | Add lines 7a and 7b.. | ||||||
| 8 | Public Support (Subtract line 7c from line 6.) | ||||||
| Calendar year (or fiscal year beginning in) | (a) 2006 | (b) 2007 | (c) 2008 | (d) 2009 | (e) 2010 | (f) Total | |
|---|---|---|---|---|---|---|---|
| 9 | Amounts from line 6... | ||||||
| 10a | Gross income from interest, dividends, payments received on securities loans, rents, royalties and income from similar sources.. | ||||||
| b | Unrelated business taxable income (less section 511 taxes) from businesses acquired after June 30, 1975. | ||||||
| c | Add lines 10a and 10b. | ||||||
| 11 | Net income from unrelated business activities not included in line 10b, whether or not the business is regularly carried on. | ||||||
| 12 | Other income. Do not include gain or loss from the sale of capital assets (Explain in Part IV.) | ||||||
| 13 | Total support (Add lines 9, 10c, 11 and 12.). | ||||||




| Facts And Circumstances Test |
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| Explanation |
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| THE ORGANIZATION HAS CHANGED ITS FISCAL YEAR END FROM 6/30 TO 11/30 IN YEAR 2010. THE PREVIOUS RETURN COVERED 6/30/10 TO 11/30/10, AND THIS RETURN IS FOR THE PERIOD 12/1/10 TO 11/30/11. THE INFORMATION INCLUDED IN SCHEDULE A PART II, SECTION A, LINE 1, COLUMN E INCLUDES INFORMATION FROM BOTH RETURNS, 6/30/10 TO 11/30/11. |
| Software ID: | |
| Software Version: |
Attach to Form 990 or 990-EZ.| Identifier | Return Reference | Explanation |
|---|---|---|
| ORGANIZATION'S MISSION STATEMENT | 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. |
| DESCRIPTION OF PROGRAM SERVICE ACCOMPLISHMENTS | FORM 990, PART III, LINES 4A - 4C | LINE 4A - PROGRAM SERVICE ACTIVITY #1 TGEN'S TCRS CLINICIANS FOCUS ON CLINICAL TRIALS WITH TARGETED AGENTS AND GENOMICS-BASED INDIVIDUALIZED THERAPY. THE TCRS, 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. LINE 4B - PROGRAM SERVICE ACTIVITY #2 TGEN'S CANCER AND CELL BIOLOGY DIVISION IS WORKING TO DISCOVER VALID MARKERS AND THERAPEUTIC TARGETS FOR TREATING HUMAN DISEASE. THE DIVISION SUPPORTS LAB PROGRAMS IN BREAST CANCER, MELANOMA, LUNG CANCER, HEAD AND NECK TUMORS AS WELL AS BOTH PRIMARY AND METASTATIC BRAIN TUMORS. LINE 4C - PROGRAM SERVICE ACTIVITY #3 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 - OTHER PROGRAM SERVICES | INTRODUCTION FY11 WAS A YEAR OF ACCELERATED TRANSITION FOR TGEN; ONE THAT LED TO INCREASED OPPORTUNITY TO ADVANCE OUR SCIENCE, BROADEN OUR AUDIENCE, AND - MOST IMPORTANTLY - MAKE A DIFFERENCE FOR PATIENTS. A MAJOR TECHNOLOGY SHIFT AND ONE THAT INFORMED OUR RESEARCH WITH A DEPTH AND PRECISION PREVIOUSLY UNAVAILABLE WAS OUR INCREASED USE OF WHOLE-GENOME SEQUENCING (WGS). WGS PROVIDES THE MOST COMPLETE SET OF COMPARISONS BETWEEN A PATIENT'S NORMAL DNA AND THAT FOUND IN A PATIENT'S CANCEROUS TUMORS. THOUGH IN ITS EARLY STAGES, THE USE OF WGS AS A DIAGNOSTIC, AND IN FACT A THERAPEUTIC AID TO THE PHYSICIAN'S "TOOLKIT," IS PART OF THE FUTURE IN MEDICINE HAPPENING AT TGEN TODAY. THIS IS TECHNOLOGY THAT CAN REALLY MAKE A DIFFERENCE IN PATIENTS WITH CANCER AND, HOPEFULLY SOON, BEYOND. AFTER HELPING IDENTIFY THE SOURCE OF LAST YEAR'S CHOLERA OUTBREAK IN EARTHQUAKE-RAVAGED HAITI, DR. PAUL KEIM, DIRECTOR OF TGEN'S PATHOGEN GENOMICS DIVISION IN FLAGSTAFF, MET WITH INTERNATIONAL HEALTH OFFICIALS ABOUT HOW TESTS DEVELOPED BY TGEN COULD HELP PREVENT INTERNATIONAL DISEASE OUTBREAKS. TGEN PASSED A MILESTONE IN MAY 2011 WHEN WE LICENSED OUR FIRST DRUG, ONCO-101, A UNIQUE COMPOUND THAT TARGETS CANCER TUMORS BY MODIFYING THE ACTIONS OF PROTEINS. THIS WAS ANOTHER FULFILLMENT TOWARD OUR PRIMARY MISSION OF MOVING LABORATORY DISCOVERIES MORE RAPIDLY INTO THERAPEUTICS FOR PATIENT BENEFIT. CLINICALLY, WE CONTINUE TO LAUNCH INNOVATIVE PROGRAMS THAT EXPAND THE BOUNDARIES OF SCIENCE AND MEDICINE. IN FEBRUARY 2011, COLLABORATING WITH MAYO CLINIC ARIZONA, TGEN FACULTY PERFORMED WHAT WE BELIEVE TO BE THE FIRST WHOLE-GENOME SEQUENCING OF A PATIENT IN AN ACTIVE CLINICAL TRIAL. SEQUENCING PROVIDED A MACRO COMPARISON BETWEEN THE PATIENT'S NORMAL DNA AND THAT OF HIS CANCEROUS TUMOR IN HOPE OF SINGLING OUT AN INDIVIDUAL PROTEIN OR MOLECULAR DRUG TARGET FOR THERAPY. MAYO CLINICIANS USED THE RESULTS TO INFORM THEIR CHOICE OF HOW TO BEST TREAT THE PATIENT. THIS GENOMIC-BASED PERSONALIZED MEDICINE APPROACH MAY SOON BECOME THE STANDARD THERAPEUTIC BAROMETER. FUNDS FROM A FLINN FOUNDATION PROTEOMICS GRANT PROVIDE SIGNIFICANT SUPPORT FOR THE DEVELOPMENT OF A COMPREHENSIVE AND SUSTAINABLE PROGRAM IN PROTEOMIC SCIENCES AT TGEN AND ENABLE THE GOALS OF THE PARTNERSHIP FOR PERSONALIZED MEDICINE (PPM). WE ARE COLLABORATING WITH LOCAL RESEARCH AND TECHNOLOGY DEVELOPMENT PARTNERS TO ACCELERATE OUTCOMES THAT REALIZE THE MISSION OF THE PPM: TO DISCOVER AND VALIDATE NEW PROTEIN-BASED BIOMARKERS OF HUMAN DISEASE THAT WILL DIRECTLY INFORM CLINICAL DECISIONS FOR INDIVIDUAL PATIENTS AND IMPROVE HEALTH CARE. WE ALSO CONTINUE TO BENCHMARK A NUMBER OF ADMINISTRATIVE FUNCTIONS TO FURTHER REFINE AND DEVELOP OUR EFFORTS IN SUPPORT OF SCIENCE. CORE AREAS INCLUDE BUSINESS DEVELOPMENT, CONTRACTS, GRANTS AND PROJECT MANAGEMENT. THIS COMMITMENT TO CONTINUOUS IMPROVEMENT ALLOWS TGEN TO OPERATE AT ITS HIGHEST LEVEL. PEER-REVIEWED LABORATORY RESEARCH, PUBLICATIONS, AND PRESENTATIONS SINCE ITS INCEPTION, THE RESEARCH AND CLINICAL ASPECTS OF TGEN HAVE FOCUSED SOLELY ON THE PATIENT AS THE END POINT. OUR CLINICAL TRIALS - IN COLLABORATION WITH SCOTTSDALE HEALTHCARE, MAYO CLINIC AND OTHERS - NOT ONLY OFFER HOPE TO PATIENTS SUFFERING FROM MANY TYPES OF CANCER, THE RESULTS SERVE TO INFORM OUR RESEARCH STUDIES. SUPPORTED BY A NEW WAVE OF TECHNOLOGY, TGEN'S RESEARCH AND CLINICAL EFFORTS REMAIN EQUAL TO THE STRENGTHS AND CAPABILITIES OF ANY OF TODAY'S LEADING RESEARCH AND CLINICAL INSTITUTES, AND IN FY11 HELPED LAND THREE MAJOR INITIATIVES. 1. AS PART OF A STAND UP TO CANCER MELANOMA DREAM TEAM, TGEN AND THE BARBARA ANN KARMANOS CANCER INSTITUTE WILL LEAD A $6 MILLION NATIONAL AND INTERNATIONAL STUDY OF A DEADLY TYPE OF SKIN CANCER, BRAF WILD-TYPE, FOR WHICH THERE ARE FEW TREATMENT OPTIONS. TGEN PREVIOUSLY RECEIVED A SU2C GRANT FOR PANCREATIC CANCER RESEARCH. 2. DELL ANNOUNCED A MAJOR COMMITMENT OF FUNDING, EMPLOYEE ENGAGEMENT AND CLOUD COMPUTING TECHNOLOGY TO SUPPORT PEDIATRIC CANCER RESEARCH PROGRAMS GLOBALLY, INCLUDING THE WORLD'S FIRST PERSONALIZED MEDICINE TRIAL FOR PEDIATRIC CANCER CONDUCTED BY THE NEUROBLASTOMA AND MEDULLOBLASTOMA TRANSLATIONAL RESEARCH CONSORTIUM (NMTRC), SUPPORTED BY TGEN. WE WILL USE OUR GENOMIC TECHNOLOGY WITHIN DELL'S DONATED CLOUD TO HELP NMTRC IDENTIFY A GREATER DEPTH OF PERSONALIZED TREATMENT STRATEGIES FOR CHILDREN WITH NEUROBLASTOMA ENROLLED IN NMTRC'S CLINICAL TRIAL. 3. TGEN BECAME PART OF A TEAM OF MEDICAL INVESTIGATORS WHO RECEIVED A $3.5 MILLION PROMISE GRANT FROM SUSAN G. KOMEN FOR THE CURE TO STUDY TRIPLE-NEGATIVE BREAST CANCER, ANOTHER TYPE OF CANCER FOR WHICH THERE NOW ARE FEW TREATMENT OPTIONS. AREAS OF RESEARCH FALL INTO THREE CATEGORIES - ONCOLOGY (MELANOMA, BREAST, PROSTATE, OVARIAN, LUNG CANCERS, ETC.), METABOLIC DISEASES (DIABETES AND HEART DISEASE) AND NEUROLOGICAL DISEASES (AUTISM, ALZHEIMER'S, ALS, AND OTHER BRAIN-RELATED DISEASES) - ALL OF WHICH IMPACT ARIZONANS AT ALARMING RATES. THE RESEARCH RESULTS APPEAR IN A NUMBER OF SCIENTIFIC AND MEDICAL JOURNALS AND ADD TO THE GROWING KNOWLEDGE BASE OF MOLECULAR RESEARCH AND MEDICINE. IN FY11, TGEN RESEARCHERS PUBLISHED THEIR RESEARCH RESULTS 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 NATURE, CANCER, JOURNAL OF CLINICAL ONCOLOGY, PLOS, MOLECULAR CANCER RESEARCH, AND A HOST OF OTHER DISEASE-ASSOCIATED PUBLICATIONS (E.G. DIABETES, JOURNAL OF CANCER, ETC). | |
| SELECT HIGHLIGHTS FOR FY11 | 1. IN A STUDY OF 144 PATIENTS WITH ADVANCED CANCER, INCLUDING COLORECTAL, OTHER GASTROINTESTINAL AND PROSTATE CANCERS, RESEARCHERS AT TGEN AND SCOTTSDALE HEALTHCARE DOCUMENTED A STATISTICALLY SIGNIFICANT DECREASE IN PROGRESSION-FREE SURVIVAL WITH EACH SUCCESSIVE STANDARD THERAPY. THE STUDY PUBLISHED NOV. 28 IN THE JOURNAL OF CANCER CONCLUDED THAT NEW THERAPIES THAT REVERSE THIS TREND MIGHT LEAD TO IMPROVED CLINICAL OUTCOMES. CITATION: "PROGRESSION-FREE SURVIVAL DECREASES WITH EACH SUBSEQUENT THERAPY IN PATIENTS PRESENTING FOR PHASE I CLINICAL TRIALS." CHRISTOPHER H. BAILEY, GAYLE JAMESON, CHAO SIMA, SHARON FLECK, ERICA WHITE, DANIEL D. VON HOFF, GLEN J. WEISS. J CANCER 2012; 3:7-13. 2. A TGEN STUDY PUBLISHED NOV. 22 IN THE JOURNAL OF LUNG CANCER SHOWED THAT KEY DOWNSTREAM COMPONENTS OF THE HEDGEHOG SIGNALING PATHWAY (HHSP), WHICH HAS BEEN IMPLICATED IN THE DEVELOPMENT OF MULTIPLE CANCERS, SHOW CORRELATION WITH SONIC HEDGEHOG LIGAND (SHH) EXPRESSION, SUGGESTING THAT LIGAND-DEPENDENT SIGNALING IS MORE PREVALENT IN PRIMARY NON-SMALL CELL LUNG CANCER TUMORS. CITATION: RAZ G, ALLEN KE, KINGSLEY C, CHERNI I, ARORA S, WATANABE A, LORENZO CD, EDWARDS V DK, SRIDHARS, HOSTETTER G, WEISS GJ. "HEDGEHOG SIGNALING PATHWAY MOLECULES AND ALDH1A1 EXPRESSION IN EARLY-STAGE NON-SMALL CELL LUNG CANCER." DOI:10.1016/J.LUNGCAN.2011.10.015. 3. TGEN AND SCOTTSDALE HEALTHCARE COLLABORATORS AT THE VIRGINIA G. PIPER CANCER CENTER DISCOVERED A BETTER TREATMENT FOR PANCREATIC CANCER PATIENTS, ACCORDING TO A STUDY PUBLISHED IN THE PAST MONTH BY THE JOURNAL OF CLINICAL ONCOLOGY. THIS SIGNIFICANT STUDY SHOWED THAT A COMBINATION OF DRUGS HELPED EXTEND SURVIVAL OF PANCREATIC CANCER PATIENTS, PRODUCED "SUBSTANTIAL" ANTI-TUMOR ACTIVITY, AND THAT A PHASE III STUDY IS WARRANTED. CITATION: "GEMCITABINE PLUS NAB-PACLITAXEL IS AN ACTIVE REGIMEN IN PATIENTS WITH ADVANCED PANCREATIC CANCER: A PHASE I/II TRIAL." DANIEL D. VON HOFF, RAMESH K. RAMANATHAN, MITESH J. BORAD, DANIEL LAHERU, LON S. SMITH, TINA E. WOOD, RONALD L. KORN, NEIL DESAI, VUONG TRIEU, JOSE L. IGLESIAS, HUI ZHANG, PATRICK SOON-SHIONG, TAO SHI, N.V. RAJESHKUMAR, ANIRBAN MAITRA, AND MANUEL HIDALGO. J CLIN ONCOL 29. 2011 BY AMERICAN SOCIETY OF CLINICAL ONCOLOGY. ZDOI:10.1200/JCO.2011.36.5742. 4. USING WHOLE-GENOME SEQUENCING, TGEN'S PATHOGEN GENOMICS DIVISION PINPOINTED THE SOURCE OF LAST YEAR'S CHOLERA OUTBREAK IN EARTHQUAKE-BATTERED HAITI, ACCORDING TO A STUDY PUBLISHED AUGUST 23 IN THE NEW JOURNAL MBIO. THE RESULTS INDICATED THAT THE SOURCE OF THE INFECTION (CONFIRMED BY MULTIPLE LABORATORIES) WAS THE NEPAL PEACEKEEPING SOLDIERS, WHO UNKNOWINGLY BROUGHT THE DISEASE. DR. KEIM AND HIS TEAM SHOWED CONCLUSIVELY THAT IN THE FUTURE SIMPLE TESTS COULD HELP IDENTIFY QUICKLY THE CAUSATIVE AGENT AND ALLOW RAPID STEPS TO PREVENT SUCH DISEASE OUTBREAKS IN THE WAKE OF FUTURE DISASTERS. CITATION: "POPULATION GENETICS OF VIBRIO CHOLERAE FROM NEPAL IN 2010: EVIDENCE ON THE ORIGIN OF THE HAITIAN OUTBREAK." RENE S. HENDRIKSEN, PAUL S. KEIM, LANCE B. PRICE, DAVID M. ENGELTHALER, ET AL. 2011. MBIO 2(4):E00157-11. DOI:10.1128/MBIO.00157-11. 5. COLLABORATING WITH VAN ANDEL RESEARCH INSTITUTE SCIENTISTS, INCLUDING DR. JEFF MACKEIGAN, TGEN'S DR. GLEN WEISS PRESENTED AN ABSTRACT IN JULY AT THE 14TH WORLD CONFERENCE ON LUNG CANCER IN AMSTERDAM. THE STUDY FOUND THAT THE STAT3 GENE IS ACTIVATED IN SOME NON-SMALL-CELL LUNG CANCER (NSCLC) CELL LINES BY THE JAK2 PROTEIN AND THAT THIS SIGNALING CAN PLAY A CRUCIAL ROLE IN TUMOR-CELL BEHAVIOR THAT MAY NOT BE EFFECTIVELY INHIBITED BY DRUGS THAT SELECTIVELY TARGET THESE MUTATIONS. CITATION: "STAT3 IS ACTIVATED BY JAK2 INDEPENDENT OF KEY ONCOGENIC DRIVER MUTATIONS IN NSCLC." G.J. WEISS, B.D. LOOYENGA, D. HUTCHINGS, I. CHERNI, C. KINGSLEY, C.D. LORENZO, D.K. EDWARDS V, S. SRIDHAR, J.P. MACKEIGAN. ALSO PUBLISHED IN A SUPPLEMENT OF THE JOURNAL OF THORACIC ONCOLOGY. 6. DEADLY BACTERIA MAY BE EVOLVING ANTIBIOTIC RESISTANCE BY MIMICKING HUMAN PROTEINS, ACCORDING TO A TGEN STUDY PUBLISHED MAY 26 IN THE JOURNAL PUBLIC LIBRARY OF SCIENCE (PLOS) ONE. DR. MIA CHAMPION OF TGEN'S PATHOGEN GENOMICS DIVISION SHOWED HOW THIS PROCESS OF "MOLECULAR MIMICRY" MAY HELP EXPLAIN WHY BACTERIAL HUMAN PATHOGENS, MANY OF WHICH WERE AT ONE TIME EASILY TREATABLE WITH ANTIBIOTICS, HAVE RE-EMERGED IN RECENT YEARS AS HIGHLY INFECTIOUS PUBLIC HEALTH THREATS. CITATION: "HOST-PATHOGEN O-METHYLTRANSFERASE SIMILARITY AND ITS SPECIFIC PRESENCE IN HIGHLY VIRULENT STRAINS OF FRANCISELLA TULARENSIS SUGGESTS MOLECULAR MIMICRY." MIA D. CHAMPION. PLOS ONE. 2011; 6(5): E20295. PUBLISHED ONLINE 2011 MAY 26. DOI: 10.1371/JOURNAL.PONE.0020295. 7. A GENE CALLED PVT1 MAY HELP REDUCE THE KIDNEY'S ABILITY TO FILTER BLOOD, LEADING TO KIDNEY DISEASE, KIDNEY FAILURE AND DEATH, ACCORDING TO A STUDY PUBLISHED APRIL 22 IN THE PUBLIC LIBRARY OF SCIENCE (PLOS) ONE. THE TGEN TEAM FOUND PVT1 EXPRESSION LEVELS INCREASED UP TO 5-FOLD IN RESPONSE TO HYPERGLYCEMIA, OR HIGH BLOOD SUGAR, A CONDITION THAT OFTEN ACCOMPANIES DIABETES. CITATION: "FUNCTIONAL CHARACTERIZATION OF THE PLASMACYTOMA VARIANT TRANSLOCATION 1 GENE (PVT1) IN DIABETIC NEPHROPATHY." M. LUCRECIA ALVAREZ AND JOHANNA K. DISTEFANO. PLOS ONE 6(4): E18671. 8. DRUG-RESISTANT STRAINS OF STAPHYLOCOCCUS AUREUS, A BACTERIA LINKED TO A WIDE RANGE OF HUMAN DISEASES, ARE PRESENT IN MEAT AND POULTRY FROM U.S. GROCERY STORES AT UNEXPECTEDLY HIGH RATES, ACCORDING TO A NATIONWIDE TGEN STUDY PUBLISHED APRIL 15 IN THE JOURNAL CLINICAL INFECTIOUS DISEASES. NEARLY HALF OF THE MEAT AND POULTRY SAMPLES - 47 PERCENT - WERE CONTAMINATED WITH S. AUREUS, AND MORE THAN HALF OF THOSE BACTERIA - 52 PERCENT - WERE RESISTANT TO AT LEAST THREE CLASSES OF ANTIBIOTICS. CITATION: "MULTIDRUG-RESISTANT STAPHYLOCOCCUS AUREUS IN U.S. MEAT AND POULTRY." ANDREW E. WATERS, TANIA CONTENTE-CUOMO, JORDAN BUCHHAGEN, CINDY M. LIU, LINDSEY WATSON, KIMBERLY PEARCE, JEFFREY T. FOSTER, JOLENE BOWERS, ELIZABETH M. DRIEBE, DAVID M. ENGELTHALER, PAUL S. KEIM AND LANCE B. PRICE. CLIN INFECT DIS. (2011). 9. PUBLISHED MARCH 24 IN THE PRESTIGIOUS JOURNAL, NATURE, A NATIONWIDE STUDY BY 20 INSTITUTES, INCLUDING TGEN, UNVEILED THE MOST COMPREHENSIVE PICTURE TO DATE OF THE GENETIC BLUEPRINT OF MULTIPLE MYELOMA, AN ALL-TOO-COMMON FORM OF BONE MARROW CANCER. THE STUDY INVOLVED WHOLE GENOME SEQUENCING OF NORMAL AND TUMOR DNA FROM 38 MULTIPLE MYELOMA PATIENTS TO ASSESS TUMOR-SPECIFIC CHANGES ACROSS THE ENTIRE 3-BILLION-LETTER HUMAN GENOME, YIELDING NEW AND UNEXPECTED INSIGHTS INTO THE EVENTS THAT LEAD TO THIS FORM OF CANCER. CITATION: "INITIAL GENOME SEQUENCING AND ANALYSIS OF MULTIPLE MYELOMA." TGEN CONTRIBUTORS WERE: ANGELA BAKER, JOHN CARPTEN AND JEFFREY TRENT. NATURE 471, 467-472 (24 MARCH 2011). 10. A STUDY PUBLISHED IN THE FEBRUARY 2011 EDITION OF MOLECULAR CANCER RESEARCH OUTLINES HOW GENOMIC RESEARCH COULD HELP DOCTORS BETTER TARGET A DRUG, OXALIPLATIN. IT IS WIDELY USED TO TREAT COLORECTAL CANCER PATIENTS, BUT OFTEN HAS SIGNIFICANT SIDE EFFECTS, CREATING AN URGENT NEED TO IDENTIFY PATIENTS MOST LIKELY TO BENEFIT FROM THIS THERAPY. CITATION: "FUNCTIONAL GENOMICS REVEALS DIVERSE CELLULAR PROCESSES THAT MODULATE TUMOR CELL RESPONSE TO OXALIPLATIN." KELLY A HARRADINE, MICHELLE KASSNER, DONALD CHOW, MERAJ AZIZ, DANIEL D. VON HOFF, JOFFRE BAKER, HOLLY YIN AND ROBERT J. PELHAM. MOL CANCER RES; PUBLISHED ONLINEFIRST DECEMBER 17, 2010; DOI:10.1158/1541-7786.MCR-10-0412. 11. CANCER PATIENTS ARE WILLING TO UNDERGO MANY TESTS TO RECEIVE ADVANCED EXPERIMENTAL TREATMENT IN CLINICAL TRIALS, ACCORDING TO A TGEN-LED STUDY PUBLISHED IN JANUARY IN THE JOURNAL CANCER. RESEARCHERS SAID PATIENTS' WILLINGNESS TO UNDERGO TESTS BODES WELL FOR THE FUTURE OF PERSONALIZED MEDICINE, IN WHICH SPECIFIC TREATMENTS ARE PRESCRIBED DEPENDING ON THE DNA GENETIC MAKEUP OF PATIENTS' TUMORS. CITATION: "PATIENT WILLINGNESS TO UNDERGO PHARMACODYNAMIC AND PHARMACOKINETIC TESTS IN EARLY PHASE ONCOLOCY TRIALS." RAOUL TIBES, MD, PHD; BARBARA F. PIPER, DNSC, RN;JESSICA A. SMITH, BA; RAYSENIA L. JAMES, MPH; MARTIN A. BENJAMIN, BS; JAY H. YIM; RAMESH K. RAMANATHAN, MD; DANIEL D. VON HOFF, MD; R. CURTIS BAY, PHD; AND MITESH J. BORAD, M.D. CANCER. 2011 JAN 18. | |
| CLINICAL RESEARCH | ESTABLISHED IN 2006, A STRATEGIC ALLIANCE WITH SCOTTSDALE HEALTHCARE (SHC) PROVIDES A DIRECT CLINICAL RESEARCH SITE FOR TGEN. THE COLLABORATION 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. IN THE PAST SIX YEARS, THESE CLINICAL TRIALS HAVE PROVIDED OPTIONS THAT DID NOT EXIST BEFORE TO PHOENIX-AREA PATIENTS AS WELL AS PATIENTS FROM ALL OVER THE COUNTRY. TRIALS IN FY11 PROVIDED HOPE FOR PATIENTS WITH ADVANCED AND/OR RARE CANCERS. ELIGIBLE CANCER PATIENTS WHO CONSENT TO PARTICIPATE IN A CLINICAL TRIAL STUDY WILL RECEIVE TREATMENT COORDINATED BY SCOTTSDALE HEALTHCARE. THE TREATMENT TEAM MAY INCLUDE RESEARCH PHYSICIANS, RESEARCH NURSES, DATA MANAGERS AND COMMUNITY ONCOLOGISTS. TGEN PHYSICIAN-IN-CHIEF DANIEL D. VON HOFF, M.D., LEADS THE TRIALS. DR. VON HOFF ALSO SERVES AS CHIEF SCIENTIFIC OFFICER FOR SCOTTSDALE HEALTHCARE RESEARCH INSTITUTE. OTHER MEMBERS OF THE CLINICAL TEAM INCLUDE: RAMESH K. RAMANATHAN, M.D. MEDICAL DIRECTOR, TCRS; DIRECTOR, GASTROINTESTINAL ONCOLOGY PROGRAM GLEN J. WEISS, M.D. DIRECTOR, THORACIC ONCOLOGY PROGRAM JASGIT SACHDEV, M.D. ASSOCIATE INVESTIGATOR GAYLE JAMESON, MSN, ACNP, AOCN DIRECTOR, SUPPORTIVE CARE PROGRAM, ASSISTANT INVESTIGATOR CATHY MAST, APRN-BC, AOCNP NURSE PRACTITIONER JOYCE SCHAFFER, RN, MSN,OCN CANCER CLINICAL TRIALS COORDINATOR PARTICIPANTS IN CLINICAL TRIALS CAN PLAY A MORE ACTIVE ROLE IN THEIR OWN HEALTH CARE, GAIN ACCESS TO NEW RESEARCH TREATMENTS BEFORE THEY ARE WIDELY AVAILABLE, AND HELP OTHERS BY CONTRIBUTING TO MEDICAL RESEARCH. CLINICAL TRIALS ARE CONDUCTED IN PHASES. THE TRIALS AT EACH PHASE HAVE A DIFFERENT PURPOSE AND HELP SCIENTISTS ANSWER DIFFERENT QUESTIONS: IN PHASE I TRIALS, RESEARCHERS TEST AN EXPERIMENTAL DRUG OR TREATMENT IN A SMALL GROUP OF PEOPLE (20-80) FOR THE FIRST TIME TO EVALUATE ITS SAFETY, DETERMINE A SAFE DOSAGE RANGE, AND IDENTIFY SIDE EFFECTS. IN PHASE II TRIALS, THE EXPERIMENTAL STUDY DRUG OR TREATMENT IS GIVEN TO A LARGER GROUP OF PEOPLE (100-300) TO SEE IF IT IS EFFECTIVE AND TO FURTHER EVALUATE ITS SAFETY. IN PHASE III TRIALS, THE EXPERIMENTAL STUDY DRUG OR TREATMENT IS GIVEN TO LARGE GROUPS OF PEOPLE (1,000-3,000) TO CONFIRM ITS EFFECTIVENESS, MONITOR SIDE EFFECTS, COMPARE IT TO COMMONLY USED TREATMENTS, AND COLLECT INFORMATION THAT WILL ALLOW THE EXPERIMENTAL DRUG OR TREATMENT TO BE USED SAFELY. IN PHASE IV TRIALS, POST-MARKETING STUDIES DELINEATE ADDITIONAL INFORMATION INCLUDING THE DRUG'S RISKS, BENEFITS, AND OPTIMAL USE. PATIENT PARTICIPATION IN CLINICAL TRIALS AT TCRS - 300 VISITS PER MONTH - 35-45 NEW PATIENTS PER MONTH - AVERAGE 95 ACTIVE CLINICAL TRIAL PATIENTS | |
| GRANT SUPPORT | GRANT FUNDING IS OFTEN THE LIFEBLOOD OF RESEARCH. IN FY11, TGEN INVESTIGATORS SUBMITTED 145 GRANTS TOTALING $152,705,359. TGEN WAS AWARDED 17 GRANTS, TOTALING $4,189,894, WITH AN ADDITIONAL 56 GRANTS PENDING AND IN REVIEW TOTALING $64,521,876. ADDITIONALLY, TGEN RECEIVED $3,441,653 FROM PREVIOUS FY PENDING GRANTS, BRINGING THE AWARDED TOTAL FOR GRANTS IN FY11 TO $7,631,547. TGEN'S SUCCESS RATE CURRENTLY RESTS AT 24 PERCENT OF TOTAL GRANTS SUBMITTED, PLACING THE INSTITUTE NEARLY FOUR PERCENT HIGHER THAN THE NATIONAL AVERAGE (NIH OVERALL SUCCESS RATE). A FY11 BIOMARKER GRANT ALLOWED TGEN TO ENHANCE OUR SCIENTIFIC INFRASTRUCTURE AND BUILD A COMPLETE BIOMARKER DEVELOPMENT PIPELINE, FROM THE IDENTIFICATION OF APPROPRIATE PATIENT POPULATIONS FOR CLINICAL STUDIES TO THE ACQUISITION, PROCESSING, AND QUALITY CONTROL OF BIOSPECIMENS AND FROM BIOMARKER DISCOVERY TO CLINICAL APPLICATION. BIOMARKERS - OBJECTIVE BIOLOGICAL INDICATORS OF AN INDIVIDUAL'S STATE OF HEALTH OR DISEASE - HAVE THE POTENTIAL TO REVOLUTIONIZE MEDICAL DIAGNOSIS AND PROGNOSIS THROUGH EARLY DISEASE DETECTION, THERAPY MONITORING, AND MATCHING THE RIGHT PATIENT WITH THE RIGHT DRUG, THE HALLMARK OF PERSONALIZED, PRECISION MEDICINE. YET, DESPITE THE MORE THAN 40,000 PUBLICATIONS PURPORTING AN ASSOCIATION OF BIOMARKERS TO SPECIFIC DISEASES, AND THE PROMINENT REFERENCE TO BIOMARKER USE IN FDA INITIATIVES TO OVERHAUL OUR HEALTH CARE SYSTEM, THE APPROVAL RATE FOR PROTEIN BIOMARKERS HAS BEEN LOW: FEWER THAN TWO DOZEN BIOMARKERS HAVE BEEN APPROVED BY THE FDA. THE REASONS FOR THE LOW ADOPTION RATE INCLUDE A HIGH FALSE MARKER DISCOVERY RATE, BUT PERHAPS MORE IMPORTANTLY, A LACK OF METHODOLOGIES FOR ANALYZING CANDIDATE BIOMARKERS IN LARGE NUMBERS OF CLINICAL SAMPLES IN A ROBUST, HIGH THROUGHPUT MANNER (SO CALLED BIOMARKER VERIFICATION) THAT MAKES VALIDATION FOR CLINICAL USE POSSIBLE. TGEN IS COMMITTED TO THE REALIZATION OF PERSONALIZED MEDICINE ACKNOWLEDGING THE IMPORTANT CHALLENGES THAT MUST BE MET TO ENSURE ITS SUCCESS. HISTORICALLY, BIOMARKER DEVELOPMENT HAS BEEN HAMPERED BY A LACK OF STANDARDIZED TECHNOLOGIES AND METHODOLOGIES THAT ARE CRITICALLY NEEDED TO MORE EFFECTIVELY DISCOVER AND VALIDATE MARKERS THAT ARE INDICATIVE OF DISEASE CONDITIONS. LIKEWISE, SYSTEMATIC METHODS FOR CONSISTENT BIOSPECIMEN COLLECTION AND PROCESSING AS WELL AS INTEGRATION AND INTERPRETATION OF DATA IN A ROBUST, STATISTICALLY SIGNIFICANT MANNER AMONGST DIFFERENT LABORATORIES ARE DESPERATELY NEEDED TO APPROPRIATELY VALIDATE BIOMARKERS FOR CLINICAL USE. THE INFRASTRUCTURE DEVELOPED AT TGEN SPEAKS DIRECTLY TO THESE GAPS IN THE BIOMARKER DEVELOPMENT PIPELINE. TGEN HAS LEVERAGED FUNDS IN THIS AREA TO DEVELOP A COMPREHENSIVE AND SUSTAINABLE PROGRAM TO ENABLE ALL STAGES OF BIOMARKER DEVELOPMENT FROM DISCOVERY THROUGH VALIDATION. THE GRANT SUPPORTS SEVERAL TGEN-LED COLLABORATIONS WITH RESEARCH AND TECHNOLOGY DEVELOPMENT PARTNERS THROUGHOUT ARIZONA TO ADVANCE UNIQUE PIECES OF THE BIOMARKER DEVELOPMENT PIPELINE INCLUDING: o TGEN ESTABLISHED THE MACROMOLECULAR ANALYSIS AND PROCESSING CENTER, A CENTRALIZED BIOREPOSITORY THAT APPLIES BEST PRACTICES FOR BIOSPECIMEN PROCUREMENT AND DNA, RNA, AND PROTEIN ISOLATION FOR DOWNSTREAM ANALYSIS o ROBOTIC AUTOMATION FOR BIOSPECIMEN PROCESSING - A COLLABORATION WITH DR. DEIDRE MELDRUM'S CENTER FOR BIOSIGNATURES DISCOVERY AUTOMATION AT THE BIODESIGN INSTITUTE AT ASU TO AUTOMATE ALL THE TIME AND LABOR-INTENSIVE STEPS OF BIOSPECIMEN PROCESSING TO LIMIT SAMPLE TO SAMPLE VARIABILITY FOR LARGE-SCALE BIOMARKER VALIDATION STUDIES o DATA ANALYSIS AND INFORMATION MANAGEMENT - TGEN HAS DEVELOPED OR PURCHASED REQUISITE SYSTEMS TO STREAMLINE DATA ACQUISITION, ANALYSIS, AND STORAGE FOR GENOMIC AND PROTEOMIC STUDIES. THIS ANALYSIS INFRASTRUCTURE SUPPORTED BY THE FLINN FOUNDATION GRANT HAS BEEN LEVERAGED BY SEVERAL OF TGEN'S PERSONALIZED MEDICINE STUDIES, INCLUDING ONE THAT ATTEMPTS TO IDENTIFY GENOMIC AND PROTEOMIC BIOMARKERS THAT PREDICT WHICH CHEMOTHERAPY WILL BE MOST EFFECTIVE IN THE TREATMENT OF INDIVIDUAL PATIENTS WITH LUNG CANCER. IN TOTAL, FLINN SUPPORT HAS ALLOWED TGEN TO ENHANCE OUR SCIENTIFIC INFRASTRUCTURE AND BUILD A COMPLETE BIOMARKER DEVELOPMENT PIPELINE, FROM THE IDENTIFICATION OF APPROPRIATE PATIENT POPULATIONS FOR CLINICAL STUDIES TO THE ACQUISITION, PROCESSING, AND QUALITY CONTROL OF BIOSPECIMENS AND FROM BIOMARKER DISCOVERY TO CLINICAL APPLICATION. THE PROTEOMICS PIPELINE SUPPORTS THE INITIAL GOALS OF OUR FIRST PARTNERSHIP FOR PERSONALIZED MEDICINE DEMONSTRATION PROJECT IN LUNG CANCER, BUT MORE IMPORTANTLY, DEVELOPS THE REQUIRED INFRASTRUCTURE TO POSITION TGEN FAVORABLY FOR ATTRACTING ADDITIONAL PARTNERS TO DEVELOP DIAGNOSTIC BIOMARKERS FOR A MULTITUDE OF HUMAN DISEASES. | |
| FY11 HIGHLIGHTS | 1. TWO-YEAR GRANT FROM THE NATIONAL INSTITUTES OF HEALTH (NIH) TOTALING $3 MILLION TO DR. JOHANNA DISTEFANO TO STUDY THE PROGRESSION AND GENETIC ORIGINS OF NONALCOHOLIC FATTY LIVER DISEASE (NAFLD). 2. TWO-YEAR GRANT FROM THE MULTIPLE MYELOMA RESEARCH FOUNDATION (MMRF) TOTALING $672,000 TO DR. JOHN CARPTEN FOR WHOLE-TRANSCRIPTOME RNA SEQUENCING OF MULTIPLE MYELOMA TUMORS USING NEXT-GENERATION TECHNOLOGY. 3. TWO-YEAR GRANT FROM THE MMRF TOTALING $250,000 TO DR. JONATHAN KEATS FOR A STUDY OF THE CONSEQUENCES OF LOSING THE GENE KDMSA/UTX, A TUMOR SUPPRESSOR IN MULTIPLE MYELOMA. 4. TWO-YEAR GRANT FROM THE MMRF TOTALING $249,999 TO DR. JONATHAN KEATS TO CHARACTERIZE COMMERCIAL MYELOMA CELL LINES. 5. THREE-YEAR GRANT FROM ARIZONA BIOMEDICAL RESEARCH COMMISSION TOTALING $218,000 TO DR. HAIYONG HAN TO EVALUATE COMPOUNDS IN CELL LINES TO VALIDATE THEIR ANTI-TUMOR POTENTIAL. 6. ONE-YEAR GRANT FROM NIH TOTALING $139,500 TO DR. HOLLY YIN AND DR. NATHALIE MEURICE TO DEVELOP TESTS FOR GENES RELATED TO SUBSTANCE ABUSE, ESPECIALLY TOBACCO SMOKING, AS WELL AS PARKINSON'S DISEASE. 7. FIVE-YEAR GRANT FROM THE NATIONAL INSTITUTES OF HEALTH TOTALING $775,899 TO DR. DAVID CRAIG TO INVESTIGATE PHARMACOGENOMICS OF MOOD STABILIZER RESPONSE IN BIPOLAR DISORDER. 8. FOUR-YEAR GRANT FROM THE NATIONAL INSTITUTES OF HEALTH TOTALING $457,976 TO DR. JOHN CARPTEN TO STUDY GENETIC RISK FACTORS IN AFRICAN AMERICAN COLORECTAL CANCER PATIENTS. 9. TWO-YEAR GRANT FROM THE NATIONAL INSTITUTES OF HEALTH TOTALING $184,881 TO DR. JOHANNA DISTEFANO TO STUDY THE GENETIC DETERMINANTS OF TOTAL CHOLESTEROL LEVELS IN AMERICAN INDIANS. 10. FIVE-YEAR GRANT FROM THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES TOTALING $1.7 MILLION TO DR. MICHAEL BITTNER TO SUPPORT THE DEVELOPMENT OF A GENE EXPRESSION-BASED BIODOSIMETER TO MEASURE RADIATION. 11. TWO-YEAR GRANT FROM THE U.S. DEPARTMENT OF HOMELAND SECURITY TOTALING $1.1 MILLION TO DR. PAUL KEIM TO STUDY HOW NEXT-GENERATION SEQUENCING TECHNIQUES COULD HELP DETECT RARE VARIANTS IN BACILLUS ANTHRACIS (ANTHRAX) CULTURES. 12. TWO-YEAR GRANT FROM THE U.S. DEPARTMENT OF DEFENSE TOTALING $1 MILLION TO DR. LANCE PRICE TO INVESTIGATE - IN COLLABORATION WITH THE ARIZONA BURN CENTER - NOVEL TOOLS AND ANALYSIS TO MOLECULARLY CHARACTERIZE BURN WOUND MICROBIAL COLONIZATION AND THEIR EFFECTS ON HEALING, GRAFT REJECTION AND INFECTION. 13. ONE-YEAR GRANT FROM THE U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES TOTALING $297,000 TO PURCHASE NEXT GENERATION SEQUENCING EQUIPMENT. 14. TWO-YEAR GRANT FROM THE NATIONAL INSTITUTES OF HEALTH TOTALING $117,000 STUDY BACTERIAL AND FUNGAL ECOLOGY IN THE CHRONIC RHINSINUSITIS MICROBIOME AS PART OF THE HUMAN MICROBIOME PROJECT, WHICH SEEKS TO ASSESS THE ASSOCIATIONS BETWEEN MICROBIOTA AND HUMAN HEALTH AND DISEASE. ENTERPRISE EFFORTS AND COLLABORATION THE TECHNOLOGY TRANSFER OFFICE (TTO) FACILITATES AND ACCELERATES THE COMMERCIALIZATION OF TGEN'S SCIENTIFIC DISCOVERIES FOR THE BENEFIT OF HUMAN HEALTH BY: o IDENTIFYING, PATENTING AND LICENSING NEW TECHNOLOGY; o FACILITATING ACCESS AND EXCHANGE OF RESEARCH MATERIALS, TECHNOLOGIES, AND DATA VIA MATERIAL TRANSFER AGREEMENTS (MTAS) OR CONFIDENTIAL DISCLOSURE AGREEMENTS (CDAS); o NEGOTIATING COLLABORATIVE RESEARCH AGREEMENTS; AND o ASSISTING IN THE FORMATION OF START-UP COMPANIES WHEN APPROPRIATE. INVENTION DISCLOSURES TGEN SCIENTISTS WORK WITH THE OFFICE OF TECHNOLOGY TRANSFER (OTT) TO FILE INVENTION DISCLOSURES AS THE FIRST STEP TOWARD A POSSIBLE PATENT APPLICATION OR OTHER APPROPRIATE FORM OF INTELLECTUAL PROPERTY PROTECTION. TGEN FILED 27 INVENTION DISCLOSURES IN FY11 BASED ON DISCOVERIES STEMMING FROM TGEN-LED RESEARCH, AND FILED 29 PROVISIONAL PATENT APPLICATIONS. | |
| COMMERCIALIZATION / SPIN OFFS | TGEN'S OFFICE OF BUSINESS DEVELOPMENT WORKS TO DEVELOP AN APPROPRIATE ADMINISTRATIVE STRUCTURE TO HANDLE COMMERCIALIZATION OF ITS INTELLECTUAL PROPERTY, AS WELL AS DEVELOP EFFECTIVE WAYS TO PARTNER WITH THE COMMERCIAL SECTOR. FY11 ACTIVITIES INCLUDED: AS MENTIONED IN THE INTRODUCTION, TGEN LICENSED ITS FIRST DRUG IN MAY 2011. ONCO-101 IS A UNIQUE COMPOUND THAT TARGETS CANCER TUMORS BY MODIFYING THE ACTIONS OF PROTEINS. ONCO-101 MAY PROVE EFFECTIVE AGAINST OVARIAN AND ENDOMETRIAL CANCER. ONCOHOLDINGS, IN TURN, HAS CONTRACTED WITH A TGEN SUBSIDIARY, SCOTTSDALE-BASED TGEN DRUG DEVELOPMENT (TD2), TO HELP GUIDE CONTINUED PRE-CLINICAL TESTING, AND EVENTUALLY MOVE ONCO-101 INTO FIRST IN-HUMAN CLINICAL TRIALS, WHERE IT COULD IMMEDIATELY HELP CANCER PATIENTS. ANNAI SYSTEMS ACQUIRED MEDTRUST ONLINE LLC, A SPIN OUT OF TGEN IN 2008. THE COMBINED ENTERPRISE WILL PROVIDE A UNIQUE COMBINATION OF A RICH DATABASE OF INFORMATION REGARDING ONCOLOGY-FOCUSED DRUGS, WITH A UNIQUE ENTERPRISE SOLUTION INCORPORATING BOTH HIGH SPEED AND HIGH CAPACITY EXCHANGE OF INFORMATION. TGEN'S PROTEOMIC CENTER (SUPPORTED BY THE FLINN FOUNDATION) WAS ONE OF TWELVE SITES SELECTED AS A "CENTER OF INNOVATION" BY THE WATER'S CORPORATION, A GLOBAL LEADER IN THE DEVELOPMENT AND MANUFACTURING OF INSTRUMENTATION FOR PROTEOMICS ANALYSIS. IN ADDITION TO INSTRUMENTATION ALREADY PLACED AT TGEN FOR EVALUATION, TGEN WILL HAVE EARLY ACCESS TO NEW PRODUCTS AND PLAY A VITAL ROLE IN THE ASSESSMENT AND DEVELOPMENT OF NEW PROTEOMICS TECHNOLOGY. TGEN PARTICIPATED IN TWO SMALL BUSINESS INNOVATION RESEARCH (SBIR) GRANT APPLICATIONS: o BIOMATRICA OF SAN DIEGO, CA, A WELL-ESTABLISHED BIOSTABILITY CORPORATION, APPLIED FOR AN SBIR GRANT WITH TGEN AND THE VAN ANDEL RESEARCH INSTITUTE TO DEVELOP A ROOM-TEMPERATURE, ENVIRONMENTALLY SUSTAINABLE SOLUTION WITH THE POTENTIAL TO REVOLUTIONIZE BIOSPECIMEN FIXATION, TRANSPORTATION AND STORAGE. THIS NEW TECHNOLOGY CAN BE SEAMLESSLY INTEGRATED INTO EXISTING COLLECTION AND PROCESSING PLATFORMS. FOR PATIENTS, IT CAN POTENTIALLY PROVIDE THE BASIS FOR MORE COMPREHENSIVE TUMOR MOLECULAR PROFILING AND ULTIMATELY, APPLIED PERSONALIZED THERAPIES. o TGEN AND 360 VANTAGE, LLC (CHANDLER, AZ) APPLIED FOR AN SBIR GRANT TO COMMERCIALIZE A UNIQUE PATENT PENDING GENOMIC DATA COMPRESSION AND INDEXING TOOL DEVELOPED BY ONE OF TGEN'S BIOINFORMATICIANS. THIS NEW TOOL REDUCES THE SPACE REQUIRED TO STORE GENOMIC DATA BY UP TO 60% AND ORGANIZES THIS INFORMATION IN SUCH A WAY AS TO ALLOW PARALLEL PROCESSING OF THE DATA THAT SIGNIFICANTLY INCREASES THE SPEED OF PROCESSING THESE VERY LARGE DATA FILES. 360 VANTAGE IS A CLOUD COMPUTING SOLUTION PROVIDER AND IS WORKING WITH TGEN TO DEVELOP A COMMERCIALLY AVAILABLE VERSION OF THIS TOOL THAT WOULD BE DEPLOYED IN A CLOUD ENVIRONMENT. PATHOGENE (FLAGSTAFF, AZ) PARTNERED WITH TGEN AND NACET (NORTHERN ARIZONA CENTER FOR EMERGING TECHNOLOGIES) TO SUBMIT A GRANT APPLICATION IN JANUARY 2012 FOR AN ARIZONA COMMERCE AUTHORITY RURAL DEVELOPMENT GRANT TO DEVELOP A VALLEY FEVER TESTING LABORATORY BASED ON IP DEVELOPED AT TGEN AND LICENSED TO PATHOGENE. THE PREPARATORY WORK FOR THIS GRANT WAS DONE IN THE LAST QUARTER OF 2011. THE AWARD NOTICE IS DUE FEBRUARY 15TH, 2012. IN COLLABORATION WITH PRICEWATERHOUSECOOPERS (PWC), TGEN CONDUCTED A SIX MONTH MARKET ANALYSIS AND DEVELOPMENT OF A GO TO MARKET PLAN FOR A CLINICAL BIOINFORMATICS SOLUTION. TGEN IS PLANNING TO LAUNCH A "PROOF OF CONCEPT" COMMERCIAL PROTOTYPE OF THIS SOLUTION THROUGH TGEN ACCELERATORS IN Q1 OF 2012. THE MARKET ANALYSIS WAS DRIVEN BY THE NUMEROUS REQUESTS FROM HIGHLY CREDIBLE INDUSTRY LEADERS PURSUING SOLUTIONS FOR CLINICAL BIOINFORMATICS FOR A VARIETY OF APPLICATIONS. TGEN CONTINUES TO ACTIVELY EXPLORE THESE OPPORTUNITIES WHILE REFINING THE BUSINESS MODEL AND VALIDATING THE PLAN'S ASSUMPTIONS THROUGH INTERNAL "PROOF OF CONCEPT" ACTIVITIES. TGEN, US ONCOLOGY, AND LIFE TECHNOLOGIES CONTINUED THEIR GROUNDBREAKING COLLABORATION ON A TRIPLE NEGATIVE BREAST CANCER PILOT CLINICAL TRIAL PROJECT TO PROVIDE DEFINITIVE PROOF OF CONCEPT THAT NEXT GENERATION SEQUENCING TECHNOLOGY COULD SUPPORT PRECISION MEDICAL GENOMICS APPLICATIONS. DUE TO THE COMPLEXITIES OF COMBINING COMPONENTS OF A CLINICAL TRIAL WITH PATIENT DATA ANALYSIS AND INTERPRETATION THIS STUDY HAS SPANNED SEVERAL YEARS, WITH THE BULK OF THE WORK BEING DONE IN FY11. THIS PILOT TRIAL PROJECT HAS PROVIDED A VALUABLE OPPORTUNITY TO LEVERAGE TGEN'S UNIQUE CLINICAL EXPERIENCE TO GUIDE THE DEVELOPMENT OF A MORE COMPLETE AND COMPREHENSIVE GENOMICS SOLUTION THAT CAN POTENTIALLY SUPPORT CLINICAL DECISION MAKING FOR THE TREATMENT OF THIS DISEASE. | |
| CONTRACTS AND COLLABORATIONS | TGEN SIGNED A TOTAL OF 394 AGREEMENTS IN FY11, BROKEN DOWN AS FOLLOWS: 1. TGEN SIGNED 70 CONFIDENTIAL DISCLOSURE AGREEMENTS (CDA) IN FY11. CDAS CREATE A CONFIDENTIAL RELATIONSHIP BETWEEN TGEN AND A HOST OF POTENTIAL COLLABORATORS/PARTNERS. WHILE NOT ALL CDAS RESULT IN A FORMAL COLLABORATION OR PARTNERSHIP, THEY DO PROVIDE A NUMBER OF INSTITUTES AND COMPANIES (LOCALLY, NATIONALLY AND INTERNATIONALLY) A GREATER PICTURE OF TGEN'S CAPABILITIES AND REFLECT POSITIVELY AS A WHOLE ON ARIZONA'S BIOMEDICAL SCIENCE PURSUITS. 2. TGEN SIGNED 83 MATERIAL TRANSFER AGREEMENTS (MTA) IN FY11. MTAS FORM THE BACKBONE OF NUMEROUS TGEN RESEARCH COLLABORATIONS AS SHARED MATERIALS INCLUDE REAGENTS, CELL LINES, SOFTWARE AND MORE. 3. TGEN SIGNED 67 RESEARCH COLLABORATIONS (MANY WITH LOCAL AND STATE AFFILIATIONS), INCLUDING AGREEMENTS THAT FURTHER RESEARCH INTO A HOST OF DISEASES, INCLUDING BRAIN CANCER, MELANOMA, ALZHEIMER'S AND AUTISM. 4. ADDITIONALLY, TGEN SIGNED AN ADDITIONAL 170 AGREEMENTS CONSISTING OF CONSULTING AND PROFESSIONAL SERVICES AGREEMENTS, COMMERCIALIZATION LICENSES, MEMORANDUMS OF UNDERSTANDING, LEASES, AND EVALUATION AGREEMENTS. | |
| FY11 SELECT HIGHLIGHTS | 1. UNIVERSITY HOSPITAL OF BASEL - "CLONAL PROFILING OF TUMORS OF UNKNOWN ORIGIN" (DRS. BARRETT & BUBENDORF) 2. HILLS PET NUTRITION RESEARCH - "CONTINUATION OF CANINE AND FELINE PHENOTYPIC DATA ANALYSIS AND ADDITIONAL GENOTYPING" (DR. HUENTELMAN) 3. ILLUMINA AMENDMENT ONE TO UMBRELLA AGREEMENT - EXTENDS TERM THROUGH 6/2/13 4. M.D. ANDERSON CANCER CENTER AMENDMENT THREE TO IVY CONSORTIUM RESEARCH COLLABORATION CONTRACT - MODIFIES STATEMENT OF WORK AND SITE BUDGET 5. UNIVERSITY OF TENNESSEE RESEARCH COLLABORATION AGREEMENT - UMBRELLA AGREEMENT COVERING PROJECTS RELATED TO THE COMPARATIVE ONCOLOGY TRIAL CONSORTIUM (COTC) 6. CATHOLIC HEALTHCARE WEST RESEARCH PLAN 06 - "EVALUATION OF RNA ISOLATION METHODS FROM HUMAN CSF" (DRS. BOMPREZZI & JENSEN) 7. VAN ANDEL RESEARCH PLAN - "DEVELOPMENT OF GENOMIC-BASED PREDICTORS OF DRUG 8. "RESPONSE IN PANCREATIC CANCER" (DRS. POSNER & WEBB) 9. VAN ANDEL-ORTHOPAEDIC ASSOCIATES OF MICHIGAN RESEARCH COLLABORATION AGREEMENT - FOR GENOME-WIDE ASSOCIATION STUDY OF BONE-GROWTH GERMLINE GENETIC MARKERS (DRS. WILLIAMS, CRAIG & JONES) 10. UNIVERSITY OF MINNESOTA RESEARCH COLLABORATION AGREEMENT - UMBRELLA AGREEMENT COVERING PROJECTS RELATED TO THE COMPARATIVE ONCOLOGY TRIAL CONSORTIUM (COTC) 11. SCOTTSDALE HEALTHCARE RESEARCH PLAN 05 - "MOLECULAR ANALYSIS OF ENDOCRINE TUMORS" (DRS. BUSSEY & DEMEURE) 12. UNIVERSITY OF GEORGIA RESEARCH FOUNDATION INC. RESEARCH COLLABORATION AGREEMENT - UMBRELLA AGREEMENT COVERING PROJECTS RELATED TO THE COMPARATIVE ONCOLOGY TRIAL CONSORTIUM (COTC) 13. MULTIPLE MYELOMA RESEARCH CONSORTIUM AMENDMENT 3 TO RESEARCH AGREEMENT - EXTENDS TERM THROUGH DECEMBER 31, 2011, AND AMENDS MILESTONE PAYMENTS TO BROAD 14. PURDUE UNIVERSITY RESEARCH COLLABORATION AGREEMENT - UMBRELLA AGREEMENT COVERING PROJECTS RELATED TO THE COMPARATIVE ONCOLOGY TRIAL CONSORTIUM (COTC) 15. ASTRAZENECA AMENDMENT 1 TO RESEARCH PLAN AZ02 - EXTENDS TERM THROUGH JULY 11, 2012 16. MICHIGAN STATE UNIVERSITY RESEARCH COLLABORATION AGREEMENT - UMBRELLA AGREEMENT COVERING PROJECTS RELATED TO THE COMPARATIVE ONCOLOGY TRIAL CONSORTIUM (COTC) 17. UNIVERSITY OF LUXEMBOURG RESEARCH COLLABORATION AGREEMENT - PROJECT ENTITLED "GENOMIC ANALYSIS OF WASTEWATER LIPID - ACCUMULATING BACTERIAL CONSORTIA" (DRS. KEIM/PRICE & WILMES) 18. TUFTS UNIVERSITY - UMBRELLA AGREEMENT COVERING PROJECTS RELATED TO THE COMPARATIVE ONCOLOGY TRIAL CONSORTIUM (COTC) 19. MAYO STATEMENT OF WORK #4 - "EPIGENETICS OF DIET AND NEURODEGENERATION" (DRS. DUNCKLEY & DRIVER-DUNCKLEY/CASELLI/ADLER) 20. CASE WESTERN RESERVE UNIVERSITY RESEARCH COLLABORATION AGREEMENT - UMBRELLA AGREEMENT COVERING FUTURE JOINT RESEARCH PROJECTS CONCERNING DISCOVERY OF BIOMARKERS IN BRAIN TUMORS (DR. BERENS) 21. UNIVERSITY OF CALIFORNIA DAVIS RESEARCH COLLABORATION AGREEMENT - UMBRELLA AGREEMENT COVERING PROJECTS RELATED TO THE COMPARATIVE ONCOLOGY TRIAL CONSORTIUM (COTC) 22. MAYO CLINIC AMENDMENT TO MASTER RESEARCH AGREEMENT - ADDS THE "SEED GRANT PROGRAM" PROVISION. 23. MAYO CLINIC THIRD AMENDMENT TO RESEARCH COLLABORATION CONTRACT FOR IVY CONSORTIUM - EXTENDS TERM THROUGH 1/31/12 (DR. BERENS). 24. PATHOGENE FIRST AMENDMENT TO RESEARCH PLAN 04 ("CANINE VALLEY FEVER MOLECULAR DIAGNOSIS STUDY") - CHANGES TITLE OF PROJECT TO "ASSAY EVALUATION BY EXTERNAL COMPANIES"; AMENDS TERM AND COSTS OF STUDY; INCORPORATES TECHNICAL PLAN (DR. PRICE). 25. SCOTTSDALE HEALTHCARE FIRST AMENDMENT TO RESEARCH PLAN 01 ("DIAGNOSTIC MIRNAS FOR PANCREATIC CANCER FROM BLOOD SAMPLES") - ADDS PCRT ACKNOWLEDGEMENT OF MATERIAL PROVISION TO STUDY (DR. WEISS). 26. UNIVERSITY OF TENNESSEE RESEARCH COLLABORATION AGREEMENT - UMBRELLA JOINT AGREEMENT COVERING FUTURE RESEARCH PROJECTS. 27. COLORADO STATE UNIVERSITY RESEARCH COLLABORATION AGREEMENT - UMBRELLA AGREEMENT COVERING PROJECTS RELATED TO THE COMPARATIVE ONCOLOGY TRIAL CONSORTIUM (COTC). 28. UNIVERSITY OF WISCONSIN - MADISON RESEARCH COLLABORATION AGREEMENT - UMBRELLA AGREEMENT COVERING PROJECTS RELATED TO THE COMPARATIVE ONCOLOGY TRIAL CONSORTIUM (COTC). 29. CATHOLIC HEALTHCARE WEST RESEARCH PLAN 04 - "EVALUATION OF RNA ISOLATION METHODS FROM HUMAN CSF" (DRS. JENSEN & BOMPREZZI). 30. SCRIPPS RESEARCH RCA & RESEARCH PLAN - "GENOMIC CHARACTERIZATION OF PRIMARY, LOCALLY RECURRENT AND METASTATIC DISEASE FROM A PATIENT WITH METAPLASTIC INFLAMMATORY BREAST CANCER." (DRS. HEATHER CUNLIFFE & BRUNHILDE FELDING-HABERMANN). 31. CATHOLIC HEALTHCARE WEST RESEARCH PLAN 05 - "MEASURE INTRA-TUMOR PH IN BOTH PRIMARY XENOGRAFT AND TRANSGENIC MOUSE MODELS." (DRS. CLIFF WHATCOTT & GREGORY TURNER). 32. HILLS PET NUTRITION RESEARCH PLAN RP01 - "CANINE GENOTYPING & DEVELOPMENT OF A PHENOTYPIC DATA PRIORITY LIST." (DR. MATTHEW HUENTELMAN). 33. HILLS PET NUTRITION RESEARCH PLAN RP02 - "FELINE GENOTYPING & DEVELOPMENT OF A PHENOTYPIC DATA PRIORITY LIST." (DR. MATTHEW HUENTELMAN). 34. ONCOHOLDINGS INC. - TD2 RESEARCH COLLABORATION AGREEMENT - FOR FUTURE COLLABORATIONS USING TD2 AS PREFERRED PROVIDER FOR PRECLINICAL, CLINICAL AND REGULATORY SERVICES. 35. PATHOGENE AMENDMENT 1 TO MASTER RESEARCH AGREEMENT - EXTENDS TERM THROUGH NOV. 14, 2012. 36. MAYO CLINIC STATEMENT OF WORK 01 - "A PILOT STUDY EXAMINING THE UTILITY OF WHOLE GENOME TUMOR SEQUENCING (WGS) AND WHOLE GENOME EXPRESSION PROFILE TO FIND POTENTIAL TARGETS FOR THERAPY IN PATIENTS WITH ADVANCED CANCER" (DRS. RAMESH RAMANATHAN & KEITH STEWART). 37. CHILDREN'S HOSPITAL LOS ANGELES AMEND TO COLLABORATION AGREEMENT - EXTENDS TERM THROUGH JAN. 10, 2012. 38. PHOENIX CHILDREN'S HOSPITAL RESEARCH COLLABORATION AGREEMENT - UMBRELLA JOINT RESEARCH AGREEMENT COVERING FUTURE PROJECTS. 39. ASTRAZENECA RESEARCH PLAN AZ02 - "DETECTION OF STRUCTURAL REARRANGEMENTS, INCLUDING GENE FUSION CANDIDATES IN BREAST CARCINOMA GENOMES." 40. BANNER RESEARCH INSTITUTE RESEARCH PLAN 01 - "COMPARE CHANGES IN RNA EXPRESSION AS BIOMARKERS FOR ALZHEIMER'S DISEASE AND PARKINSON'S DISEASE, A COMPARISON OF CSF AND BLOOD." 41. ADAMAS AMENDMENT 9 TO COLLABORATION AGREEMENT - REVISES WORK-PLAN AND EXTENDS TERM THROUGH JAN. 31, 2011. 42. ASTRAZENECA AMENDMENT 1 TO RESEARCH AGREEMENT - EXTENDS TERM THROUGH DEC. 12, 2012. | |
| JOB CREATION / ROI | 20 NEW FULL-TIME EQUIVALENT POSITIONS WERE CREATED IN FY11 WITH SALARIES AND BENEFITS TOTALING APPROXIMATELY $1,330,161. STUDENT SALARIES WERE JUST OVER $374,000, BRINGING THE OVERALL TOTAL TO $1,704,161. TGEN STAFF TOTALED 261, OF WHICH 86 PERCENT HOLD A COLLEGE DEGREE (49 PERCENT HOLD AN ADVANCED DEGREE). FY11 POSITIONS FILLED INCLUDE: ADMINISTRATIVE ASSISTANT; ASSOCIATE PROFESSOR; BIOINFORMATICIAN; ASSOCIATE CLINICAL DATA COORDINATOR; KNOWLEDGE COMPUTING ARCHITECT; JR. PROJECT MANAGER; POST-DOC FELLOW; RESEARCH ASSOCIATE; RESEARCH ASSOCIATE II; STAFF SCIENTIST; VICE PRESIDENT, TGEN FOUNDATION WE HAVE STRESSED IN THE PAST THAT INTERNSHIPS SERVE AS A PIPELINE TO TGEN IN TERMS OF FUTURE RECRUITMENT AND SUPPORT OF THE STATEWIDE INITIATIVE TOWARDS EDUCATION AND DEVELOPMENT FOR THE STUDENTS IN THE LIFE SCIENCES. ADDITIONALLY, TGEN IS A PROVING GROUND WHERE TALENTED UNDERGRADUATES GAIN VALUABLE EXPERIENCE PRIOR RETURNING TO EARN ADVANCED DEGREES IN THE BIOMEDICAL SCIENCES. IN FY11, 9 EMPLOYEES RETURNED TO UNIVERSITY TO FURTHER THEIR BIOMEDICAL EDUCATION, WITH 4 OF THE 9 CHOOSING AN ARIZONA-BASED UNIVERSITY. RETURN ON STATE INVESTMENT IN LATE 2011, IN THE THIRD SUCH STUDY FOR TGEN, TRIPP UMBACH CONCLUDED WHEN THE IMPACT OF TGEN-GENERATED BUSINESS SPIN-OFFS AND COMMERCIALIZATION ARE INCLUDED, TGEN PRODUCED $25.04 FOR EVERY $1 INVESTED BY THE STATE OF ARIZONA, SUPPORTED 1,124 JOBS, GENERATED $10.1 MILLION IN STATE TAX REVENUES, AND PRODUCED $137.7 MILLION IN TOTAL ANNUAL ECONOMIC IMPACT ON ARIZONA. TRIPP UMBACH PREDICTS SIGNIFICANT CONTINUED GROWTH IN THE FUTURE. EDUCATION AND PUBLIC OUTREACH INTERNSHIPS TGEN, THROUGH ITS EDUCATION AND OUTREACH PROGRAMS, SEEKS TO INCREASE THE WORKING KNOWLEDGE OF GENOMICS WITHIN THE COMMUNITY AT LARGE AND HELP EDUCATE, TRAIN, AND INSPIRE THE NEXT GENERATION OF RESEARCHERS AND PHYSICIANS. THE MAJOR PROGRAMMATIC FOCUS OF TGEN'S EDUCATION EFFORTS CENTERS ON THE HELIOS SCHOLARS PROGRAM AT TGEN, AN ANNUAL SUMMER INTERNSHIP PROGRAM THAT PAIRS A STUDENT WITH A TGEN SCIENTIST/MENTOR THAT PROVIDES HANDS-ON LABORATORY TRAINING. TGEN ALSO OFFERS AN ACADEMIC YEAR INTERNSHIP PROGRAM, PROVIDING A LIMITED NUMBER OF VOLUNTEER INTERNSHIP POSITIONS DURING THE ACADEMIC YEAR, BASED ON THE NEEDS AND PROJECTED WORKLOAD OF THE HOST LABORATORIES. EFFORTS ARE CURRENTLY UNDERWAY TO ESTABLISH A FORMAL ACADEMIC YEAR INTERNSHIP PROGRAM. BY ALL ACCOUNTS, 2011 WAS A SUCCESSFUL YEAR WITH 45 BIOSCIENCE STUDENTS COMPLETING THE 2011 HELIOS SCHOLARS PROGRAM AT TGEN, AND 48 NON-HELIOS STUDENTS CONDUCTING INTERNSHIPS - SCIENTIFIC AND ADMINISTRATIVE - IN A NUMBER OF TGEN LABS AND DEPARTMENTS. WHILE NUMEROUS SUMMER JOBS OFFER STUDENTS THE OPPORTUNITY TO EARN MONEY, TGEN INTERNSHIPS PROVIDE AN EXPERIENTIAL LEARNING OPPORTUNITY FOR STUDENTS TO BUILD ON THEIR ACADEMIC STUDIES. UNDER THE GUIDANCE OF EXPERIENCED MENTORS, AN ACTIVE GROUP OF LIKE-MINDED STUDENTS EXPLORE AND LEARN FIRST HAND TECHNIQUES AND PROCESSES THAT EXPOSE THEM TO THE LATEST IN GENOMIC RESEARCH. THIS TRAINING OFTEN SOLIDIFIES A STUDENTS' CAREER CHOICE AND, IN MANY WAYS, BECOMES THE SPRINGBOARD TO THEIR FUTURE IN THE BIOMEDICAL SCIENCES. TWENTY-SEVEN FEMALES AND 18 MALES COMPRISED THE HELIOS SCHOLARS, BROKEN DOWN AS FOLLOWS: 15 PERCENT HIGH SCHOOL, 76 PERCENT UNDERGRADUATE, AND 9 PERCENT GRADUATE/MEDICAL SCHOOL. TEACHER TRAINING PROGRAM IN FY11, TGEN COMPLETED ITS FOURTH YEAR OF A 5-YEAR TRAINING AWARD IN COLLABORATION WITH NORTHERN ARIZONA UNIVERSITY TO CONDUCT A SUMMER GENOMICS WORKSHOP FOR TEACHERS AND GRADUATE STUDENTS AS PART OF AN NSF GRANT CALLED BIOTECHNOLOGY INTEGRATION OPPORTUNITIES FOR TEACHER EDUCATION AND CONTENT (BIOTEC). THIS GRANT PARTNERS THE COLLEGE OF ENGINEERING AND NATURAL SCIENCES, THE COLLEGE OF EDUCATION AT NORTHERN ARIZONA UNIVERSITY, AND TGEN IN ORDER TO ENHANCE INQUIRY-BASED SCIENCE TEACHING IN GRADES 5, 7, AND 9 WHILE EXPANDING THE INTERDISCIPLINARY PREPARATION OF GRADUATE STUDENTS IN BIOTECHNOLOGY. THE WORKSHOP IS DESIGNED TO UPDATE TEACHERS AND FELLOWS ON GENOMIC SCIENCE, THE CONTINUING EFFORT TO FIND THE GENETIC BASIS OF VARIOUS DISEASES AND DISORDERS, AND TO PRESENT CURRENT TOPICS ON THE ETHICAL, LEGAL, AND SOCIAL IMPLICATIONS OF GENOMICS. CAREERS AND ESSENTIAL RESEARCH SKILLS WILL BE EMPHASIZED DURING THE PROGRAM CULMINATING ACTIVITY. TEACHERS WILL LEARN TO INCORPORATE ALL OF THIS INFORMATION IN THE BIOSCIENCES INTO THEIR CLASSROOMS. EDUCATIONAL AND PUBLIC TOURS TGEN VALUES THE OPPORTUNITY TO SHARE ITS STATE-OF-THE-ART RESEARCH FACILITY WITH THE COMMUNITY THROUGH PUBLIC TOURS OF TGEN. THE COMMUNITY'S INTEREST IN TOURS CONTINUES TO GROW. IN FY11, TGEN HOSTED NUMEROUS PUBLIC TOURS FOR A DIVERSE RANGE OF COMMUNITY MEMBERS AND ORGANIZATIONS (TOTALING NEARLY 500 IN NUMBER), AS WELL AS SENT REPRESENTATIVES INTO THE COMMUNITY TO PRESENT AT FUNCTIONS, CAREER AND EDUCATIONAL FAIRS. TOUR REQUESTS MAY BE SUBMITTED VIA THE WEBSITE AT: HTTP://WWW.TGEN.ORG/EDUCATION/TOUR_REQUEST.CFM | |
| STIMULATING GROWTH OF ARIZONA'S LIFE SCIENCE INDUSTRIES | AN IMPORTANT FACTOR IN CONTINUING TGEN'S SUCCESS IS COMMUNICATION WITH VARIOUS STAKEHOLDERS AND THE BROADER ARIZONA COMMUNITY. TOWARD THAT GOAL, TGEN SR. LEADERSHIP PARTICIPATES IN A MYRIAD OF COMMUNITY-RELATED ACTIVITIES THROUGH PRESENTATIONS AT REGIONAL MEETINGS AND AS A MEMBER OR PARTICIPANT OF VARIOUS COMMITTEES AND GROUPS, INCLUDING THE ARIZONA ALZHEIMER'S CONSORTIUM BOARD, ARIZONA BIOSCIENCE ROADMAP STEERING COMMITTEE AND ARIZONA BIOSCIENCE ROADMAP EDUCATION & WORKFORCE DEVELOPMENT COMMITTEE, ARIZONA TECHNOLOGY COUNCIL, GREATER PHOENIX LEADERSHIP, NSF STEP GRANT ADVISORY BOARD- FOR ESTRELLA MOUNTAIN CC, AND A MEMBER OF ARIZONA SCIENCE CENTER PATHWAYS TO DISCOVERY GRANT (NOW IN YEAR 3). MEDIA TGEN REMAINS ACTIVE IN PURSING POSITIVE EARNED MEDIA EXPOSURE FOR THE INSTITUTE'S RESEARCH AND PHILANTHROPIC ACTIVITIES. MEDIA EXPOSURE RAISES AWARENESS AND BRINGS ADDED CREDIBILITY TO THE INSTITUTE AND THE STATE. IN TOTAL, TGEN RECEIVED GREATER THAN 1,100 MEDIA MENTIONS IN FY11 IN VARIOUS TRADE AND PUBLIC MEDIA: LOCALLY, NATIONALLY AND INTERNATIONALLY. WHILE CITING TGEN SPECIFICALLY, THESE ARTICLES AND NEWS BRIEFS HELP BUILD A GREATER PRESENCE FOR THE CONTINUOUSLY EXPANDING BIOMEDICAL SCIENCE INITIATIVES OCCURRING IN ARIZONA. MEDIA OUTLETS INCLUDE: USA TODAY ORLANDO SENTINEL THE HOUSTON CHRONICLE THE ARIZONA REPUBLIC PHOENIX BUSINESS JOURNAL ARIZONA BUSINESS GAZETTE ARIZONA DAILY STAR JEWISH NEWS OF GREATER PHOENIX GRAND RAPIDS PRESS PLAIN DEALER (CLEVELAND) UPI NATIONAL PUBLIC RADIO NEW YORK TIMES WALL STREET JOURNAL LOS ANGELES TIMES LA WEEKLY REUTERS TIME MAGAZINE BOSTON GLOBE NEWSDAY AGENCE FRANCE PRESSE WIRED MAGAZINE CNN CNN INTERNATIONAL ONLINE TGEN'S ONLINE PRESENCE CONTINUES TO INCREASE ON AN ANNUAL BASIS. WITH TWO ACTIVE SITES (TGEN AND THE TGEN FOUNDATION) MORE THAN 1.5 MILLION PAGE VIEWS WERE RECORDED IN FY11. THE WEBSITE SERVES AS A PORTAL TO ALLOW ARIZONANS - AND OTHERS WORLDWIDE- TO LEARN ABOUT THE RESEARCH AND DISCOVERIES COMING OUT OF TGEN LABS. ADDITIONALLY, THE TGEN FOUNDATION WEB PAGES ALLOW SUPPORTERS TO CREATE MEMORIALS AND FUNDRAISING PAGES IN SUPPORT OF TGEN'S EFFORTS TO DEVELOP IMPROVED DIAGNOSTIC TOOLS AND NEW THERAPEUTICS THAT TARGET A HOST OF DISEASES. IN TERMS OF SOCIAL MEDIA, TGEN'S FACEBOOK AND TWITTER AUDIENCES ARE GROWING AND PROVIDE A FURTHER OPPORTUNITY TO COMMUNICATE WITH NUMEROUS CONSTITUENCIES THROUGH EVER-INCREASING MEDIUMS. | |
| BUSINESS AND FAMILY RELATIONSHIPS | FORM 990, PART VI, LINE 2 | DANIEL VON HOFF AND EDWARD SUH HAVE A BUSINESS RELATIONSHIP. JEFFREY TRENT, DANIEL VON HOFF AND EDWARD SUH HAVE A BUSINESS RELATIONSHIP. ROBERT BULLA AND WILLIAM POST HAVE A BUSINESS RELATIONSHIP. |
| GOVERNANCE STRUCTURE | FORM 990, PART VI, LINES 6, 7A & 7B | LINE 6 - THE SOLE CORPORATE MEMBER OF TGEN IS VAN ANDEL RESEARCH INSTITUTE (VARI), A MICHIGAN CHARITABLE TRUST. LINE 7A - VARI, AS THE SOLE MEMBER OF TGEN, APPOINTS ELECTED DIRECTORS TO TGEN'S BOARD OF DIRECTORS FROM A LIST OF INDIVIDUALS PRESENTED BY THE NOMINATING COMMITTEE. LINE 7B - VARI, AS THE SOLE MEMBER OF TGEN, RETAINS CERTAIN APPROVAL RIGHTS AS OUTLINED IN THE BYLAWS. Effective December 1, 2009, the Institute entered into an alliance and affiliation agreement (the Affiliation Agreement) with the Van Andel Research Institute (VARI), a Michigan charitable trust exempt from tax under Section 501(c)(3) of the Internal Revenue Code. The Institute changed from a director-based, nonprofit organization to a member-based, nonprofit organization, whereby VARI became the sole member of the Institute. VARI agreed to supplement the Institute's funding efforts by providing $10.0 million per year, for three consecutive years, in unrestricted support. SUBSEQUENT TO THE FY11 TAX YEAR END AND Effective March 12, 2012, TGen and VARI agreed to terminate their Affiliation Agreement, and TGen converted from a member-based, Arizona nonprofit corporation to a director-based, Arizona nonprofit corporation, whereby VARI is no longer the sole member of TGen. |
| PROCESS USED BY MANAGEMENT AND/OR GOVERNING BODY TO REVIEW 990 | FORM 990, PART VI, LINE 11 | THE FORM 990 IS PREPARED BY AN OUTSIDE ACCOUNTING FIRM BASED ON INFORMATION PROVIDED BY THE FINANCE DEPARTMENT. THE 990 IS THEN REVIEWED BY THE FINANCE DEPARTMENT AND OTHER MEMBERS OF MANAGEMENT. THE FORM 990 IS POSTED ON THE BOARD WEBSITE PRIOR TO FILING WITH THE IRS. |
| PROCESS USED TO MONITOR TRANSACTIONS FOR CONFLICTS OF INTEREST | FORM 990, PART VI, LINE 12C | TGEN ISSUES A CONFLICT OF INTEREST QUESTIONNAIRE ON AN ANNUAL BASIS TO ALL DIRECTOR LEVEL POSITIONS AND ABOVE IN ADDITION TO ANY KEY EMPLOYEES DESIGNATED BY THE CHIEF OPERATING OFFICER. THE QUESTIONNAIRES ARE REVIEWED BY THE CHIEF FINANCIAL OFFICER. THOSE EMPLOYEES WITH CONFLICTS ARE SENT FOR FURTHER REVIEW TO THE CHIEF OPERATING OFFICER TO ENSURE A PLAN IS SET FORTH. UPDATES TO THE LIST ARE HANDLED ON AN AS-NEEDED BASIS BASED ON CONTRACT REVIEWS AND EMPLOYEE INFORMATION. |
| PROCESS USED TO DETERMINE COMPENSATION | FORM 990, PART VI, LINES 15A AND 15B | TGEN'S GOVERNANCE AND EXECUTIVE COMPENSATION COMMITTEE WILL ACT IN AN "ADVICE AND CONSENT" CAPACITY REVIEWING THE RECOMMENDATIONS FOR THE PRESIDENT AND SCIENTIFIC DIRECTOR REGARDING THE COMPENSATION OF DISQUALIFIED PERSONS AND FORWARDING FINAL RECOMMENDATIONS TO THE FULL BOARD FOR APPROVAL. DISQUALIFIED PERSONS (EXCEPT FOR THE PRESIDENT AND SCIENTIFIC DIRECTOR) WILL NOT BE PRESENT FOR, OR PARTICIPATE IN, COMMITTEE DELIBERATIONS CONCERNING THEIR COMPENSATION (OTHER THAN TO ANSWER QUESTIONS). THE PRESIDENT AND SCIENTIFIC DIRECTOR WILL PARTICIPATE IN THE DELIBERATIONS CONCERNING THE COMPENSATION OF DIRECT REPORTS. DURING THE DECISION MAKING PROCESS, THE COMMITTEE WILL ADHERE TO THE EXECUTIVE COMPENSATION PHILOSOPHY. THE COMMITTEE IS AUTHORIZED (AND PROVIDED WITH SUFFICIENT FUNDING) TO ANNUALLY ENGAGE OUTSIDE INDEPENDENT COMPENSATION AND LEGAL ADVISORS, WHEN DEEMED NECESSARY AND ADVISABLE. THE COMMITTEE WILL COMPLY WITH THE "REBUTTABLE PRESUMPTION OF REASONABLENESS" UNDER SECTION 4958 OF THE INTERNAL REVENUE CODE WHENEVER POSSIBLE. THE COMMITTEE WILL REVIEW AND UNDERSTAND THE INTERNAL REVENUE CODE PROVISIONS DEALING WITH "EXCESS BENEFIT TRANSACTIONS CONCERNING DISQUALIFIED PERSONS' COMPENSATION". WHEN DEVELOPING A COMPENSATION PHILOSOPHY TGEN KEPT IN MIND THE FOLLOWING FACTORS: - THE TGEN MISSION AND STRATEGY - THE TGEN CULTURE - TRENDS IN COMPENSATION IN THE EXTERNAL ENVIRONMENT - TRENDS IN RECRUITMENT OF NEW EMPLOYEES - TRENDS IN ORGANIZATIONAL EMPLOYEE TURNOVER - TGEN'S LIFE CYCLE STAGE |
| AVAILABILITY OF GOVERNING DOCUMENTS, CONFLICT OF INTEREST POLICY, | AND FINANCIAL STATEMENTS TO THE GENERAL PUBLIC | FORM 990, PART VI, LINE 19 THE ORGANIZATION'S GOVERNING DOCUMENTS AND CONFLICT OF INTEREST POLICY ARE PROVIDED TO THE GENERAL PUBLIC UPON REQUEST. |
| BOARD OF GOVERNORS | PART VII, SECTION A, LINE 1A | TGEN HAS A BOARD OF GOVERNORS THAT IS COMPRISED OF CURRENT VOTING DIRECTORS AND SOME FORMER DIRECTORS THAT REMAIN AFFILIATED WITH TGEN IN AN ADVISORY ROLE. THE CURRENT GOVERNORS WHO SERVE IN AN ADVISORY ROLE WITH NO VOTE AND ARE THEREFORE NOT LISTED AS DIRECTORS IN PART VII INCLUDE: BETSEY BAYLESS; RICHARD BOALS; J. LYLE BOOTMAN, PHD; SUSAN CLARK-JOHNSON; THE HONORABLE DIANE ENOS; BERT GETZ; JOHN HAEGER, PHD; SETHURAMAN PANCHANATHAN, PHD; FRANKLYN PRENDERGAST, MD; THE HONORABLE JIM SLATTERY; DR. VICTOR TRASTEK |
| HOURS DEVOTED TO RELATED ORGANIZATION | FORM 990, PART VII | THE FOLLOWING INDIVIDUALS REPORTED IN PART VII DEVOTE TIME TO THE TRANSLATIONAL GENOMICS RESEARCH INSTITUTE (TGEN), THE TRANSLATIONAL GENOMICS RESEARCH INSTITUTE FOUNDATION (FOUNDATION), AND/OR VAN ANDEL RESEARCH INSTITUTE (VARI), RELATED TAX-EXEMPT ORGANIZATIONS, AS INDICATED: JEFFREY TRENT (14 HOURS TGEN; 2 HOURS FOUNDATION; 24 HOURS VARI) TERESA BURLESON (39 HOURS TGEN; 1 HOUR FOUNDATION) DAVID VAN ANDEL AND JOHN KENNEDY ARE BOTH TGEN DIRECTORS WHO ARE COMPENSATED BY VARI, A RELATED TAX-EXEMPT ORGANIZATION; VAN ANDEL AS A CHAIRMAN/CEO AND KENNEDY AS A TRUSTEE. COMPENSATION AND HOURS INFORMATION WAS NOT AVAILABLE FOR DISCLOSURE ON THIS RETURN. |
| OTHER CHANGES IN NET ASSETS OR FUND BALANCES | PART XI, LINE 5 | OTHER CHANGES IN FUND BALANCES $237,530 |
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