2024-04-05T10:17:37-05:00 2023-12-31 410746749 CLIFTONLARSONALLEN LLP 420 SOUTH ORANGE AVENUE SUITE 900 ORLANDO FL 32801 990 2023-01-01 593187624 JAEB CENTER FOR HEALTH RESEARCH FOUNDATION INC JAEB 8139758690 15310 AMBERLY DRIVE 350 TAMPA FL 33647 ERICA VOGT TREASURER 8139758690 2024-04-02 1 ERICA VOGT 999009999 1 TINA HENTON P00630282 4078021200 2024-04-02 3 AAL1 IAL1 2023 2023-04-26 12:10:37Z ADAM GLASSMAN 15310 AMBERLY DRIVE 350 TAMPA FL 33647 55500575 0 X WWW.JAEB.ORG X 1998 FL DESIGN AND CONDUCT WORLD-CLASS CLINICAL TRIALS AND EPIDEMIOLOGIC RESEARCH. 5 4 165 4 0 0 28983474 35083784 8818282 17927381 5171 209814 0 0 37806927 53220979 3161 911714 0 0 17020908 18429062 0 0 0 17312640 25547640 34336709 44888416 3470218 8332563 10449118 23767716 14538729 19487316 -4089611 4280400 X OUR MISSION IS TO EXPAND SCIENTIFIC KNOWLEDGE AND IMPROVE PUBLIC HEALTH BY DESIGNING AND CONDUCTING WORLD-CLASS CLINICAL TRIALS AND EPIDEMIOLOGIC RESEARCH. 0 0 37585083 911714 17927381 SEE SCHEDULE O DURING 2023, JCHR WAS ENGAGED IN 53 CLINICAL STUDIES. THESE STUDIES RESULTED IN 42 SCIENTIFIC PUBLICATIONS AND 59 PRESENTATIONS AT NATIONAL AND INTERNATIONAL MEETINGS.IN 2023, JCHR RECEIVED GRANTS FROM THE NATIONAL INSTITUTES OF HEALTH (8), HELMSLEY CHARITABLE TRUST (8), JDRF (6), FOUNDATION FIGHTING BLINDNESS (5), CYSTIC FIBROSIS FOUNDATION (4), AND FOOD AND DRUG ADMINISTRATION (1). COLLABORATIONS WITH INDUSTRY CONTINUE TO FORM AN INTEGRAL PART OF OUR BUSINESS. JCHR WAS ENGAGED IN STRATEGIC COLLABORATIONS WITH 10 INDUSTRY PARTNERS IN 2023. THESE COLLABORATIONS SPANNED 15 STUDIES. SEVERAL STUDIES ARE FUNDED BY MULTIPLE SOURCES. FOR EXAMPLE, ONE CLINICAL TRIAL EVALUATING FENOFIBRATE FOR DIABETIC RETINOPATHY IS A LARGE COLLABORATION WITH FUNDS PROVIDED BY THE NATIONAL INSTITUTES OF HEALTH (NATIONAL EYE INSTITUTE AND NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASE), JDRF, HELMSLEY CHARITABLE TRUST, AND ROCHE. JCHR ALSO SELF-FUNDED TWO STUDIES AND NUMEROUS STATISTICAL ANALYSIS PROJECTS USING DATASETS FROM PREVIOUSLY COMPLETED STUDIES. AMONG 2,894 ENTITIES RECEIVING NIH FUNDING IN 2023, JCHR RANKS IN THE TOP 8 PERCENT. OUT OF 66,149 NIH GRANTS PROVIDED IN 2023, JCHR HAD THE 136TH- (TOP 0.2 PERCENT) AND 210TH- (TOP 0.3 PERCENT) LARGEST GRANTS (SOURCE: BLUE RIDGE INSTITUTE FOR MEDICAL RESEARCH, 2023).IN 2023, THE JCHR COORDINATED RANDOMIZED TRIAL OF A BIONIC PANCREAS IN INDIVIDUALS WITH TYPE 1 DIABETES LEAD TO FDA 510(K) CLEARANCE FOR THE BETA BIONICS ILET BIONIC PANCREAS. IN ADDITION, RESULTS FROM THE DEXCOM SPONSORED MOBILE STUDY (COORDINATED BY JCHR) SERVED AS THE PRIMARY PIECE OF CLINICAL EVIDENCE THAT LED TO MEDICARE COVERAGE EXPANSION FOR CONTINUOUS GLUCOSE MONITORS, PROVIDING COVERAGE TO PEOPLE WITH DIABETES USING INSULIN, IRRESPECTIVE OF DIABETES TYPE.RESULTS FROM JCHR-AUTHORED MANUSCRIPTS INCLUDE THE FOLLOWING TWO THAT WERE PUBLISHED IN THE NEW ENGLAND JOURNAL OF MEDICINE AND THREE PUBLISHED IN JAMA:A STUDY INVOLVING PREGNANT WOMEN WITH TYPE 1 DIABETES COMPARED THE EFFECTIVENESS OF STANDARD INSULIN THERAPY TO HYBRID CLOSED-LOOP THERAPY, WHICH USES CONTINUOUS GLUCOSE MONITORING. THE RESULTS SHOWED THAT THE CLOSED-LOOP THERAPY GROUP HAD SIGNIFICANTLY BETTER GLYCEMIC CONTROL DURING PREGNANCY COMPARED WITH THE STANDARD-CARE GROUP, WITH FEWER INSTANCES OF HYPERGLYCEMIA AND IMPROVED OVERNIGHT GLUCOSE LEVELS, INDICATING THE POTENTIAL BENEFITS OF THIS APPROACH FOR MANAGING TYPE 1 DIABETES DURING PREGNANCY.IN A 13-WEEK TRIAL INVOLVING YOUNG CHILDREN (AGED 2 TO UNDER 6 YEARS) WITH TYPE 1 DIABETES, A CLOSED-LOOP SYSTEM OF INSULIN DELIVERY WAS COMPARED WITH STANDARD CARE USING EITHER AN INSULIN PUMP OR MULTIPLE DAILY INJECTIONS WITH A CONTINUOUS GLUCOSE MONITOR. RESULTS SHOWED THAT CHILDREN USING THE CLOSED-LOOP SYSTEM SPENT SIGNIFICANTLY MORE TIME WITHIN THE TARGET RANGE COMPARED WITH THOSE IN THE STANDARD-CARE GROUP.IN A DOUBLE-BLIND, RANDOMIZED CLINICAL TRIAL INVOLVING CHILDREN AND ADOLESCENTS NEWLY DIAGNOSED WITH TYPE 1 DIABETES, THE EFFECTS OF VERAPAMIL, A CALCIUM CHANNEL BLOCKER, WERE INVESTIGATED ON PANCREATIC BETA CELL FUNCTION. PARTICIPANTS RECEIVING VERAPAMIL DEMONSTRATED A 30 PERCENT HIGHER C-PEPTIDE LEVEL AT 52 WEEKS COMPARED WITH THOSE ON A PLACEBO, INDICATING PARTIAL PRESERVATION OF PANCREATIC BETA CELL FUNCTION. FURTHER STUDIES ARE NEEDED TO ASSESS THE LONG-TERM DURABILITY OF C-PEPTIDE IMPROVEMENT AND DETERMINE THE OPTIMAL DURATION OF THERAPY. IN A RANDOMIZED, DOUBLE-BLIND CLINICAL TRIAL INVOLVING YOUTH WITH NEWLY DIAGNOSED TYPE 1 DIABETES, INTENSIVE DIABETES MANAGEMENT, INCLUDING THE USE OF AN AUTOMATED INSULIN DELIVERY SYSTEM, WAS COMPARED TO STANDARD CARE. THE STUDY AIMED TO DETERMINE IF ACHIEVING NEAR NORMALIZATION OF GLUCOSE LEVELS IMMEDIATELY AFTER DIAGNOSIS COULD PRESERVE PANCREATIC BETA CELL FUNCTION. DESPITE ACHIEVING EXCELLENT GLUCOSE CONTROL, THE INTENSIVE MANAGEMENT GROUP DID NOT SHOW A SIGNIFICANT DIFFERENCE IN PANCREATIC C-PEPTIDE SECRETION DECLINE AT 52 WEEKS COMPARED TO THE STANDARD CARE GROUP, SUGGESTING THAT THIS APPROACH DID NOT IMPACT THE PRESERVATION OF BETA CELL FUNCTION IN THE STUDIED POPULATION.A STUDY COMPARING INTRAVITREAL AFLIBERCEPT TREATMENT TO A SHAM PROCEDURE IN INDIVIDUALS WITH MODERATE TO SEVERE NONPROLIFERATIVE DIABETIC RETINOPATHY (NPDR) WITHOUT CENTER-INVOLVED DIABETIC MACULAR EDEMA (CI-DME) REVEALED THAT OVER FOUR YEARS, AFLIBERCEPT SIGNIFICANTLY REDUCED THE LIKELIHOOD OF DEVELOPING VISION-THREATENING COMPLICATIONS COMPARED TO THE SHAM PROCEDURE. HOWEVER, DESPITE ANATOMICAL IMPROVEMENT, THERE WAS NO SIGNIFICANT DIFFERENCE IN VISUAL ACUITY BETWEEN THE TWO GROUPS. THE STUDY SUGGESTS THAT USING AFLIBERCEPT PREVENTIVELY IN PATIENTS WITH NPDR WITHOUT CI-DME MAY NOT BE GENERALLY NECESSARY BASED ON THE OBSERVED OUTCOMES.JCHR'S INVOLVEMENT IN DIABETES STUDIES CONTINUES TO EXPAND AS IT SOLIDIFIED ITS REPUTATION AS THE PREMIERE COORDINATING CENTER WORLDWIDE FOR DIABETES DEVICE STUDIES. 37585083 1 1 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 1 0 0 1 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 103 0 1 165 1 0 0 0 0 0 0 0 0 0 0 0 0 X 5 4 0 0 1 0 0 0 0 1 0 0 0 1 1 1 1 1 1 1 1 0 X X ERICA VOGT 8139758690 15310 AMBERLY DRIVE STE 350 TAMPA FL 33647 ROY BECK MEDICAL DIRECTOR (PRESIDENT THRU 09/23) 40.00 1.00 X 486749 0 87294 DANA BALL DIRECTOR 1.00 1.00 X 0 0 0 NEIL BRESSLER DIRECTOR 1.00 1.00 X 0 0 0 ANNE LINDBLAD DIRECTOR 1.00 1.00 X 0 0 0 SHAN SHIKARPURI DIRECTOR 1.00 1.00 X 0 0 0 ERICA VOGT CHIEF FINANCIAL OFFICER 40.00 1.00 X 221629 0 17165 ADAM GLASSMAN PRESIDENT (EXECTIVE DIRECTOR THRU 09/23) 40.00 1.00 X 332525 0 44515 JEANNIE PERKINS CHIEF RESEARCH COMPLIANCE OFFICER 40.00 0.00 X 190500 0 20643 CRAIG KOLLMAN DIRECTOR OF BIOSTATISTICS 40.00 0.00 X 243094 0 39684 ALLISON AYALA BIOSTATISTICIAN IV 40.00 0.00 X 185529 0 19331 B MICHELE MELIA BIOSTATISTICIAN V 40.00 0.00 X 224250 0 19884 PETER CALHOUN BIOSTATISTICIAN IV 40.00 0.00 X 202727 0 19780 RAYMOND KRAKER EPIDEMIOLOGIST IV 40.00 0.00 X 168949 0 39681 2255952 0 307977 76 0 1 0 NOTAL VISION INC 7717 COPPERMINE DRIVE MANASSAS VA 20109 AI SERVICES, SOFTWARE SERVICES, DEVICE R 1607457 JOSLIN DIABETES CENTER 1 JOSLIN PLACE BOSTON MA 02215 PATIENT-FACING RESEARCH SERVICES 567000 MAYO CLINIC PO BOX 860334 ROCHESTER MN 55486 PATIENT-FACING RESEARCH SERVICES 483825 DUKE UNIVERSITY PO BOX 602651 CHARLOTTE NC 28260 READING CENTER SERVICES, PATIENT-FACING 442628 UNIVERSITY OF COLORADO DENVER PO BOX 910238 DENVER CO 80291 PATIENT-FACING RESEARCH SERVICES 430498 60 6177957 18644335 10261492 35083784 INDUSTRY PROGRAM SERVICE EXCHANGE 541700 17927381 17927381 17927381 206410 206410 2283000 2279596 3404 3404 3404 53220979 17927381 0 209814 911714 911714 1401020 412463 988557 12636855 9409039 3227816 1950641 1395712 554929 1341277 979772 361505 1099269 773683 325586 25187 25187 125887 125887 3813 3813 1040420 933222 107198 1202 1202 32360 32360 651967 1152 650815 507952 507952 1000683 964533 36150 109083 109083 135013 135013 SUBCONTRACTOR PAYMENTS 18433305 18433305 RESEARCH EXPENSES 3321200 3321200 TRAINING 53457 1350 52107 DUES & SUBSCRIPTIONS 37697 37697 68414 47938 20476 44888416 37585083 7303333 0 4590445 9063779 0 2633881 5073199 7699495 0 12138 183416 464581 1280054 1041604 149921 238450 0 2574929 452137 1080463 10449118 23767716 1406415 4597583 12707254 13768197 425060 1121536 14538729 19487316 X -4089611 4280400 -4089611 4280400 10449118 23767716 8332563 37448 0 X 0 1 X 1 1 1 X 28232464 31738886 24875930 28983474 35083784 148914538 28232464 31738886 24875930 28983474 35083784 148914538 13288696 135625842 219897 59752 2389 5171 206410 493619 149408157 41671296 0.90780 0.85860 X RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED RESTRICTED 78047 78047 1202007 1041604 160403 238450 LEASE LIABILITY 1121536 1121536 NORTH AMERICA 0 3 PROGRAM SERVICES CLINICAL RESEARCH SITES CONTRACTED TO ENROLL PATIENTS AND CONDUCT RESEARCH ACTIVITIES 46656 EUROPE (INCLUDING ICELAND & GREENLAND) 0 4 PROGRAM SERVICES CLINICAL RESEARCH SITES CONTRACTED TO ENROLL PATIENTS AND CONDUCT RESEARCH ACTIVITIES 153123 MIDDLE EAST AND NORTH AFRICA 0 1 PROGRAM SERVICES CLINICAL RESEARCH SITES CONTRACTED TO ENROLL PATIENTS AND CONDUCT RESEARCH ACTIVITIES 13980 0 8 0 0 0 8 213759 0 213759 0 0 0 0 0 0 1 JAEB CENTER RESEARCH TRUST INC 15310 AMBERLY DRIVE TAMPA FL 33647 270717710 501(C)(3) 911714 0 N/A N/A GENERAL SUPPORT 1 0 PART I, LINE 2: JCHR MADE GRANTS ONLY TO ITS OWN RELATED ORGANIZATION. X X X 0 0 0 0 0 0 0 0 0 ROY BECK MEDICAL DIRECTOR (PRESIDENT THRU 09/ 486749 0 0 0 0 0 22838 0 64456 0 574043 0 0 0 ADAM GLASSMAN PRESIDENT (EXECTIVE DIRECTOR THRU 09 332525 0 0 0 0 0 15000 0 29515 0 377040 0 0 0 CRAIG KOLLMAN DIRECTOR OF BIOSTATISTICS 243094 0 0 0 0 0 11250 0 28434 0 282778 0 0 0 B MICHELE MELIA BIOSTATISTICIAN V 224250 0 0 0 0 0 9713 0 10171 0 244134 0 0 0 ERICA VOGT CHIEF FINANCIAL OFFICER 221629 0 0 0 0 0 9500 0 7665 0 238794 0 0 0 PETER CALHOUN BIOSTATISTICIAN IV 202727 0 0 0 0 0 9250 0 10530 0 222507 0 0 0 JEANNIE PERKINS CHIEF RESEARCH COMPLIANCE OFFICER 190500 0 0 0 0 0 8400 0 12243 0 211143 0 0 0 RAYMOND KRAKER EPIDEMIOLOGIST IV 168949 0 0 0 0 0 8300 0 31381 0 208630 0 0 0 ALLISON AYALA BIOSTATISTICIAN IV 185529 0 0 0 0 0 8150 0 11181 0 204860 0 0 0 PART I, LINE 3 THE BOARD OF DIRECTORS SHALL ANNUALLY REVIEW AND APPROVE THE COMPENSATION OF THE CORPORATE OFFICERS, ANY KEY EMPLOYEES (AS DEFINED BY THE IRS), AND THE NEXT FIVE HIGHEST COMPENSATED EMPLOYEES AS LISTED ON THE ORGANIZATION'S PRIOR YEAR FORM 990. IT IS THE BOARD'S INTENTION THAT THIS POLICY AND ITS ASSOCIATED PROCEDURES WILL MEET THE REBUTTABLE PRESUMPTION TEST UNDER IRC 4958 AND TREASURY REGULATION 53.4958-6. THE PURPOSE OF THE ANNUAL REVIEW IS TO ENSURE THAT THE COMPENSATION PROGRAM FALLS WITHIN A REASONABLE RANGE OF COMPETITIVE PRACTICES FOR COMPARABLE POSITIONS AMONG SIMILARLY SITUATED ORGANIZATIONS. THE BOARD WILL KEEP ROBUST MINUTES OF ITS DELIBERATIONS AND DECISIONS, THE PRESIDENT'S REPORTS, THE CORPORATE TREASURER'S REPORTS, AND ANY OTHER SUPPORTING DOCUMENTATION THAT IT RELIES ON FOR ITS COMPENSATION DECISIONS. ALL THESE DOCUMENTS WILL BE DELIVERED TO THE CORPORATE SECRETARY PROMPTLY AFTER THE BOARD MEETING FOR ENTRY INTO THE CORPORATE BOOKS AND RECORDS. FORM 990, PART VI, SECTION A, LINE 4 THE ORGANIZATION'S ARTICLES OF INCORPORATION AND BYLAWS WERE UPDATED IN 2023. FORM 990, PART VI, SECTION A, LINE 8B THERE ARE NO COMMITTEES WITH AUTHORITY TO ACT ON BEHALF OF THE GOVERNING BODY. FORM 990, PART VI, SECTION B, LINE 11B THE BOARD OF DIRECTORS REVIEWS AND APPROVES FORM 990 PRIOR TO THE FORM'S FILING. FORM 990, PART VI, SECTION B, LINE 12C ANY BOARD DIRECTOR, CORPORATE OFFICER, OR MEMBER OF A BOARD COMMITTEE WHO HAS DIRECT OR INDIRECT FINANCIAL INTEREST, AS DEFINED BELOW, IS AN INTERESTED PERSON. IF A PERSON IS AN INTERESTED PERSON WITH RESPECT TO ANY AFFILIATE OR SUBSIDIARY OF THE CORPORATION, HE/SHE IS AN INTERESTED PERSON WITH RESPECT TO THE CORPORATION AND ALL AFFILIATED OR SUBSIDIARY ENTITIES. A CONFLICT OF INTEREST SHALL BE DEEMED TO EXIST AT ANY TIME WHEN AN INTEREST HELD, INCLUDING WITHOUT LIMITATION A FINANCIAL INTEREST, OR RELATIONSHIP MAINTAINED BY AN INTERESTED PERSON, PROHIBITS OR INHIBITS, OR POTENTIALLY PROHIBITS OR INHIBITS, THE INTERESTED PERSON FROM EXERCISING INDEPENDENT JUDGMENT IN THE BEST INTERESTS OF THE CORPORATION. A CONFLICT OF INTEREST SHALL NOT EXIST IF RESULTING SOLELY FROM THE NORMAL CONDUCT OF ACTIVITIES AND BUSINESS BY AND BETWEEN THE CORPORATION OR OTHER AFFILIATES OF THE CORPORATION. AN INTERESTED PERSON MUST DISCLOSE THE EXISTENCE OF THE FACTS AND CIRCUMSTANCES OF ANY CONFLICT OF INTEREST OR CONFLICT OF LOYALTY TO THE APPROPRIATE GOVERNANCE BODY WITH RESPECT TO ANY ACTION OR PROPOSED ACTION THAT GIVES RISE TO A CONFLICT OF INTEREST OR CONFLICT OF LOYALTY. DISCLOSURE MUST BE MADE TO THE BOARD OF DIRECTORS OR THE BOARD OF DIRECTORS COMMITTEE AS APPROPRIATE TO THE CIRCUMSTANCES. AFTER DISCLOSURE OF THE CONFLICT OF INTEREST OR CONFLICT OF LOYALTY AND ALL MATERIAL FACTS RELATED THERETO, AND AFTER ANY DISCUSSION WITH THE INTERESTED PERSON, THE INTERESTED PERSON SHALL LEAVE ANY BOARD OF DIRECTORS OR COMMITTEE MEETING WHILE THE DETERMINATION OF A CONFLICT OF INTEREST IS DISCUSSED AND VOTED UPON. THE REMAINING BOARD DIRECTORS OR COMMITTEE MEMBERS SHALL DECIDE IF A CONFLICT OF INTEREST EXISTS. IN THE CASE OF A DISCLOSURE TO A COMMITTEE, THE COMMITTEE MAY REFER THE MATTER FOR DECISION TO THE BOARD OF DIRECTORS. PENDING REVIEW AND RESOLUTION BY THE BOARD OF DIRECTORS OR BOARD COMMITTEE, THE INTERESTED PERSON SHALL LEAVE DURING ANY DELIBERATIONS OR ACTION CONCERNING THE MATTER THAT GIVES RISE TO A CONFLICT OF INTEREST. FORM 990, PART VI, SECTION B, LINE 15 THE BOARD OF DIRECTORS SHALL ANNUALLY REVIEW AND APPROVE THE COMPENSATION OF THE CORPORATE OFFICERS, ANY KEY EMPLOYEES (AS DEFINED BY THE IRS), AND THE NEXT FIVE HIGHEST COMPENSATED EMPLOYEES AS LISTED ON THE ORGANIZATION'S PRIOR YEAR FORM 990. IT IS THE BOARD'S INTENTION THAT THIS POLICY AND ITS ASSOCIATED PROCEDURES WILL MEET THE REBUTTABLE PRESUMPTION TEST UNDER IRC 4958 AND TREASURY REGULATION 53.4958-6. THE PURPOSE OF THE ANNUAL REVIEW IS TO ENSURE THAT THE COMPENSATION PROGRAM FALLS WITHIN A REASONABLE RANGE OF COMPETITIVE PRACTICES FOR COMPARABLE POSITIONS AMONG SIMILARLY SITUATED ORGANIZATIONS. THE BOARD WILL KEEP ROBUST MINUTES OF ITS DELIBERATIONS AND DECISIONS, THE PRESIDENT'S REPORTS, THE CORPORATE TREASURER'S REPORTS, AND ANY OTHER SUPPORTING DOCUMENTATION THAT IT RELIES ON FOR ITS COMPENSATION DECISIONS. ALL THESE DOCUMENTS WILL BE DELIVERED TO THE CORPORATE SECRETARY PROMPTLY AFTER THE BOARD MEETING FOR ENTRY INTO THE CORPORATE BOOKS AND RECORDS. THE PROCESS DESCRIBED HERE WAS LAST COMPLETED IN 2023. FORM 990, PART VI, SECTION C, LINE 19 THE GOVERNING DOCUMENTS, CONFLICT OF INTEREST POLICY, AND FINANCIAL STATEMENTS ARE MADE AVAILABLE TO THE PUBLIC ON THE ORGANIZATION'S WEBSITE AND UPON REQUEST. JAEB CENTER RESEARCH TRUST INC 15310 AMBERLY DRIVE TAMPA FL 33647 270717710 SUPPORT FL 501(C)(3) LINE 12B, II N/A 0 0 1 1 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 JAEB CENTER RESEARCH TRUST INC B 911714 CASH JAEB CENTER RESEARCH TRUST INC C 6177957 CASH