WU20127MOD5S
SECTION C - DESCRIPTIONS AND SPECIFICATIONS STATEMENT OF WORK SITE 1: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, 660 S. EUCLID AVE., ST. LOUIS, MO 63110 COORDINATOR: CRAIG A. BUCHMAN, M.D., F.A.C.S. SITE 2: UNIVERSITY OF AKRON SCHOOL OF SPEECH LANGUAGE PATHOLOGY AND AUDIOLOGY, 181 POLSKY, AKRON OH 44325 COORDINATOR: KRISTINE E SONSTROM MALOWSKI, AU.D., PH.D. SITE 3: BIOGENERATOR LABS, SUITE 232, 4340 DUNCAN AVE. , ST. LOUIS, MO 63110 COORDINATOR: JIANXIN BAO, PH.D. SITE 4: THE UNIVERSITY OF TEXAS AT DALLAS, CALLIER CENTER FOR COMMUNICATION DISORDERS, 800 W. CAMPBELL RD. AD15, RICHARDSON, TEXAS, 75080 COORDINATOR: COLLEEN G. LE PRELL, PH.D. ABBREVIATIONS: GWI: GATEWAY BIOTECHNOLOGY, INC.; UA: UNIVERSITY OF AKRON; UTD: UNIVERSITY OF TEXAS AT DALLAS; WUSM: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE. STUDY 1: WE WILL TEST WHETHER THE DRUG ZONISAMIDE (ZNS) CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO DRILLING NOISE DURING SKULL SURGERY. WE WILL DO SO BY ANSWERING THREE CRITICAL QUESTIONS REGARDING POSSIBLE ZNS PROTECTION AGAINST NIHL: (1) WHETHER ZNS CAN PREVENT TEMPORARY THRESHOLD SHIFT (TTS); (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY, OR HIDDEN HEARING LOSS; AND (3) WHETHER ZNS CAN PREVENT PERMANENT THRESHOLD SHIFT (PTS). STUDY 2: WE WILL TEST WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS, THUS DEMONSTRATING THAT ZNS PREVENTS NIHL UNDER CONDITIONS SIMILAR TO MILITARY ENVIRONMENTS. WE WILL DETERMINE: (1) WHETHER ZNS CAN PREVENT TTS 5 MINUTES AFTER THE SHOOTING SESSION; (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY AND PTS AFTER EVERY SHOOTING SESSION; AND (3) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY OR PTS EVERY YEAR FOR A DURATION OF TWO YEARS. STUDY 3: WE WILL DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. WE WILL DO SO BY IDENTIFYING CERTAIN GENETIC VARIANTS ASSOCIATED WITH ZNS PROTECTION AGAINST TTS AND PTS. IF SPECIFIC GENETIC VARIANTS ARE FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH LOWER TTS AND PTS, THIS INFORMATION CAN BE USED TO DEVELOP A PERSONALIZED MEDICATION TO PREVENT NIHL. TASKS TIMELINE SITES STUDY 1: DETERMINE IF ZNS CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO SURGICAL DRILLING NOISE. WUSM, GWI, UTD TAKE PART IN KICK-OFF MEETING AT FORT DETRICK. 01/2019 WUSM, GWI, UA, UTD FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HUMAN RESEARCH PROTECTIONS OFFICE (HRPO). 01/2019-05/2019 WUSM, UTD REQUEST CONSULTATION WITH THE FDA; IND APPLICATION PREPARATION AND SUBMISSION TO THE FDA 01/2019-05/2019 WUSM RECRUIT AND TEST 30 SUBJECTS (25% OF PLANNED ENROLLMENT) 06/2019-03/2020 WUSM FOR QUALITY ASSURANCE, REVIEW ALL DATA WITH STUDY TEAM AS DATA ARE RECEIVED TO DETERMINE IF DATA ARE MISSING. 06/2019-03/2020 GWI, UTD RECRUIT AND TEST 60 SUBJECTS (75% OF PLANNED ENROLLMENT). 04/2020-04/2021 WUSM FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 04/2020-04/2021 GWI ENLIST INDEPENDENT STATISTICIANS TO PERFORM AN INTERIM MASKED ANALYSIS. 04/2021-05/2021 GWI, UTD RECRUIT AND TEST 30 SUBJECTS (100% OF PLANNED ENROLLMENT). 05/2021-11/2021 WUSM FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 05/2021-11/2021 GWI COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 11/2021-01/2022 WUSM, GWI, UTD MEETINGS WITH FDA AND COMPLETE ADDITIONAL STUDIES NECESSARY FOR THE PHASE 3 STUDIES. 01/2022-03/2023 WUSM PREPARE AND SUBMIT THE FINAL REPORT. 04/2023-012/2023 WUSM, GWI, UTD OBTAIN FDA APPROVAL FOR THE PHASE 3 STUDY. 01/2023-12/2023 WUSM STUDY 2: DETERMINE WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS. UA, GWI, UTD PREPARE AN IND SUBMISSION WITH PHARM-OLAM. 01/2019-05/2019 WUSM, PHARM-OLAM, UA, UTD FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 UA, UTD RECRUIT AND TEST 60 SUBJECTS (50% OF PLANNED ENROLLMENT). 06/2019-12/2019 UA RECRUIT AND TEST 60 SUBJECTS (100% OF PLANNED ENROLLMENT). 01/2020-12/2020 UA FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 06/2019-02/2020 GWI PERFORM AN INTERIM MASKED ANALYSIS. 02/2020-06/2020 GWI, UTD CONTINUE TO TEST THE REMAINING 60 SUBJECTS. 07/2021-01/2022 UA FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 07/2021-01/2022 GWI COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 08/2022-10/2022 UA, GWI, UTD PERFORM ADDITIONAL DATA ANALYSIS STUDIES BASED ON GENETIC INFORMATION FROM STUDY 3 AND DISCUSSIONS WITH FDA FOR PREPARING THE PHASE 3 CLINICAL STUDIES. 10/2022-12/2023 UA, GWI, UTD SUBMIT AND OBTAIN FDA APPROVAL OF THE PHASE 3 ZNS STUDY 01/2023-12/2023 WUSM, GWI, UTD STUDY 3: DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. GWI, WUSM, UA, UTD FINALIZE REGULATORY DOCUMENTS AND THE IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 GWI OBTAIN GENOMIC DATA ON 90 SUBJECTS. 06/2019-5/2020 GWI OBTAIN GENOMIC DATA ON 120 SUBJECTS. 5/2021 GWI OBTAIN GENOMIC DATA ON 30 SUBJECTS (ALL 240 SUBJECTS). 06/2021-05/2022 GWI COMPLETE GENOMIC DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 06/2022-10/2022 GWI, UTD PREPARE AND SUBMIT THE IND FOR THE PHASE 3 STUDY 10/2022-12/2022 GWI, WUSM, UTD OBTAIN FDA APPROVAL OF THE PHASE 3 STUDY 01/2023-12/2023 GWI (END OF STATEMENT OF WORK) CONTRACTOR MANPOWER REPORTING CONTRACTOR MANPOWER REPORTING (CMR) (SEP 2017) (USAMRAA)
Gateway Biotechnology, Inc.
Definitive Contract W81XWH19C0054
($1m) 10/31/23 WU20126MOD5S
SECTION C - DESCRIPTIONS AND SPECIFICATIONS STATEMENT OF WORK SITE 1: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, 660 S. EUCLID AVE., ST. LOUIS, MO 63110 COORDINATOR: CRAIG A. BUCHMAN, M.D., F.A.C.S. SITE 2: UNIVERSITY OF AKRON SCHOOL OF SPEECH LANGUAGE PATHOLOGY AND AUDIOLOGY, 181 POLSKY, AKRON OH 44325 COORDINATOR: KRISTINE E SONSTROM MALOWSKI, AU.D., PH.D. SITE 3: GATEWAY BIOTECHNOLOGY INC., 4041 FOREST PARK AVENUE, ST. LOUIS, MO 63108 COORDINATOR: JIANXIN BAO, PH.D. SITE 4: THE UNIVERSITY OF TEXAS AT DALLAS, CALLIER CENTER FOR COMMUNICATION DISORDERS, 800 W. CAMPBELL RD. AD15, RICHARDSON, TEXAS, 75080 COORDINATOR: COLLEEN G. LE PRELL, PH.D. ABBREVIATIONS: GWI: GATEWAY BIOTECHNOLOGY, INC.; UA: UNIVERSITY OF AKRON; UTD: UNIVERSITY OF TEXAS AT DALLAS; WUSM: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE. STUDY 1: WE WILL TEST WHETHER THE DRUG ZONISAMIDE (ZNS) CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO DRILLING NOISE DURING SKULL SURGERY. WE WILL DO SO BY ANSWERING THREE CRITICAL QUESTIONS REGARDING POSSIBLE ZNS PROTECTION AGAINST NIHL: (1) WHETHER ZNS CAN PREVENT TEMPORARY THRESHOLD SHIFT (TTS); (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY, OR HIDDEN HEARING LOSS; AND (3) WHETHER ZNS CAN PREVENT PERMANENT THRESHOLD SHIFT (PTS). STUDY 2: WE WILL TEST WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS, THUS DEMONSTRATING THAT ZNS PREVENTS NIHL UNDER CONDITIONS SIMILAR TO MILITARY ENVIRONMENTS. WE WILL DETERMINE: (1) WHETHER ZNS CAN PREVENT TTS 5 MINUTES AFTER THE SHOOTING SESSION; (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY AND PTS AFTER EVERY SHOOTING SESSION; AND (3) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY OR PTS EVERY YEAR FOR A DURATION OF TWO YEARS. STUDY 3: WE WILL DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. WE WILL DO SO BY IDENTIFYING CERTAIN GENETIC VARIANTS ASSOCIATED WITH ZNS PROTECTION AGAINST TTS AND PTS. IF SPECIFIC GENETIC VARIANTS ARE FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH LOWER TTS AND PTS, THIS INFORMATION CAN BE USED TO DEVELOP A PERSONALIZED MEDICATION TO PREVENT NIHL. TASKS TIMELINE SITES STUDY 1: DETERMINE IF ZNS CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO SURGICAL DRILLING NOISE. WUSM, GWI, UTD TAKE PART IN KICK-OFF MEETING AT FORT DETRICK. 01/2019 WUSM, GWI, UA, UTD FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HUMAN RESEARCH PROTECTIONS OFFICE (HRPO). 01/2019-05/2019 WUSM, UTD REQUEST CONSULTATION WITH THE FDA; IND APPLICATION PREPARATION AND SUBMISSION TO THE FDA 01/2019-05/2019 WUSM RECRUIT AND TEST 30 SUBJECTS (25% OF PLANNED ENROLLMENT) 06/2019-03/2020 WUSM FOR QUALITY ASSURANCE, REVIEW ALL DATA WITH STUDY TEAM AS DATA ARE RECEIVED TO DETERMINE IF DATA ARE MISSING. 06/2019-03/2020 GWI, UTD RECRUIT AND TEST 60 SUBJECTS (75% OF PLANNED ENROLLMENT). 04/2020-04/2021 WUSM FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 04/2020-04/2021 GWI ENLIST INDEPENDENT STATISTICIANS TO PERFORM AN INTERIM MASKED ANALYSIS. 04/2021-05/2021 GWI, UTD RECRUIT AND TEST 30 SUBJECTS (100% OF PLANNED ENROLLMENT). 05/2021-11/2021 WUSM FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 05/2021-11/2021 GWI COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 11/2021-01/2022 WUSM, GWI, UTD MEETINGS WITH FDA AND COMPLETE ADDITIONAL STUDIES NECESSARY FOR THE PHASE 3 STUDIES. 01/2022-03/2023 WUSM PREPARE AND SUBMIT THE FINAL REPORT. 04/2023-012/2023 WUSM, GWI, UTD OBTAIN FDA APPROVAL FOR THE PHASE 3 STUDY. 01/2023-12/2023 WUSM STUDY 2: DETERMINE WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS. UA, GWI, UTD PREPARE AN IND SUBMISSION WITH PHARM-OLAM. 01/2019-05/2019 WUSM, PHARM-OLAM, UA, UTD FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 UA, UTD RECRUIT AND TEST 60 SUBJECTS (50% OF PLANNED ENROLLMENT). 06/2019-12/2019 UA RECRUIT AND TEST 60 SUBJECTS (100% OF PLANNED ENROLLMENT). 01/2020-12/2020 UA FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 06/2019-02/2020 GWI PERFORM AN INTERIM MASKED ANALYSIS. 02/2020-06/2020 GWI, UTD CONTINUE TO TEST THE REMAINING 60 SUBJECTS. 07/2021-01/2022 UA FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 07/2021-01/2022 GWI COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 08/2022-10/2022 UA, GWI, UTD PERFORM ADDITIONAL DATA ANALYSIS STUDIES BASED ON GENETIC INFORMATION FROM STUDY 3 AND DISCUSSIONS WITH FDA FOR PREPARING THE PHASE 3 CLINICAL STUDIES. 10/2022-12/2023 UA, GWI, UTD SUBMIT AND OBTAIN FDA APPROVAL OF THE PHASE 3 ZNS STUDY 01/2023-12/2023 WUSM, GWI, UTD STUDY 3: DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. GWI, WUSM, UA, UTD FINALIZE REGULATORY DOCUMENTS AND THE IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 GWI OBTAIN GENOMIC DATA ON 90 SUBJECTS. 06/2019-5/2020 GWI OBTAIN GENOMIC DATA ON 120 SUBJECTS. 5/2021 GWI OBTAIN GENOMIC DATA ON 30 SUBJECTS (ALL 240 SUBJECTS). 06/2021-05/2022 GWI COMPLETE GENOMIC DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 06/2022-10/2022 GWI, UTD PREPARE AND SUBMIT THE IND FOR THE PHASE 3 STUDY 10/2022-12/2022 GWI, WUSM, UTD OBTAIN FDA APPROVAL OF THE PHASE 3 STUDY 01/2023-12/2023 GWI (END OF STATEMENT OF WORK) CONTRACTOR MANPOWER REPORTING CONTRACTOR MANPOWER REPORTING (CMR) (SEP 2017) (USAMRAA)
University Of Texas At Dallas
Definitive Contract W81XWH19C0054
$0 10/31/23 WU20126MOD4S
SECTION C - DESCRIPTIONS AND SPECIFICATIONS STATEMENT OF WORK SITE 1: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, 660 S. EUCLID AVE., ST. LOUIS, MO 63110 COORDINATOR: CRAIG A. BUCHMAN, M.D., F.A.C.S. SITE 2: UNIVERSITY OF AKRON SCHOOL OF SPEECH LANGUAGE PATHOLOGY AND AUDIOLOGY, 181 POLSKY, AKRON OH 44325 COORDINATOR: KRISTINE E SONSTROM MALOWSKI, AU.D., PH.D. SITE 3: GATEWAY BIOTECHNOLOGY INC., 4041 FOREST PARK AVENUE, ST. LOUIS, MO 63108 COORDINATOR: JIANXIN BAO, PH.D. SITE 4: THE UNIVERSITY OF TEXAS AT DALLAS, CALLIER CENTER FOR COMMUNICATION DISORDERS, 800 W. CAMPBELL RD. AD15, RICHARDSON, TEXAS, 75080 COORDINATOR: COLLEEN G. LE PRELL, PH.D. ABBREVIATIONS: GWI: GATEWAY BIOTECHNOLOGY, INC.; UA: UNIVERSITY OF AKRON; UTD: UNIVERSITY OF TEXAS AT DALLAS; WUSM: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE. STUDY 1: WE WILL TEST WHETHER THE DRUG ZONISAMIDE (ZNS) CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO DRILLING NOISE DURING SKULL SURGERY. WE WILL DO SO BY ANSWERING THREE CRITICAL QUESTIONS REGARDING POSSIBLE ZNS PROTECTION AGAINST NIHL: (1) WHETHER ZNS CAN PREVENT TEMPORARY THRESHOLD SHIFT (TTS); (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY, OR HIDDEN HEARING LOSS; AND (3) WHETHER ZNS CAN PREVENT PERMANENT THRESHOLD SHIFT (PTS). STUDY 2: WE WILL TEST WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS, THUS DEMONSTRATING THAT ZNS PREVENTS NIHL UNDER CONDITIONS SIMILAR TO MILITARY ENVIRONMENTS. WE WILL DETERMINE: (1) WHETHER ZNS CAN PREVENT TTS 5 MINUTES AFTER THE SHOOTING SESSION; (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY AND PTS AFTER EVERY SHOOTING SESSION; AND (3) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY OR PTS EVERY YEAR FOR A DURATION OF TWO YEARS. STUDY 3: WE WILL DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. WE WILL DO SO BY IDENTIFYING CERTAIN GENETIC VARIANTS ASSOCIATED WITH ZNS PROTECTION AGAINST TTS AND PTS. IF SPECIFIC GENETIC VARIANTS ARE FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH LOWER TTS AND PTS, THIS INFORMATION CAN BE USED TO DEVELOP A PERSONALIZED MEDICATION TO PREVENT NIHL. TASKS TIMELINE SITES STUDY 1: DETERMINE IF ZNS CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO SURGICAL DRILLING NOISE. WUSM, GWI, UTD TAKE PART IN KICK-OFF MEETING AT FORT DETRICK. 01/2019 WUSM, GWI, UA, UTD FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HUMAN RESEARCH PROTECTIONS OFFICE (HRPO). 01/2019-05/2019 WUSM, UTD REQUEST CONSULTATION WITH THE FDA; IND APPLICATION PREPARATION AND SUBMISSION TO THE FDA 01/2019-05/2019 WUSM RECRUIT AND TEST 30 SUBJECTS (25% OF PLANNED ENROLLMENT) 06/2019-03/2020 WUSM FOR QUALITY ASSURANCE, REVIEW ALL DATA WITH STUDY TEAM AS DATA ARE RECEIVED TO DETERMINE IF DATA ARE MISSING. 06/2019-03/2020 GWI, UTD RECRUIT AND TEST 60 SUBJECTS (75% OF PLANNED ENROLLMENT). 04/2020-04/2021 WUSM FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 04/2020-04/2021 GWI ENLIST INDEPENDENT STATISTICIANS TO PERFORM AN INTERIM MASKED ANALYSIS. 04/2021-05/2021 GWI, UTD RECRUIT AND TEST 30 SUBJECTS (100% OF PLANNED ENROLLMENT). 05/2021-11/2021 WUSM FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 05/2021-11/2021 GWI COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 11/2021-01/2022 WUSM, GWI, UTD MEETINGS WITH FDA AND COMPLETE ADDITIONAL STUDIES NECESSARY FOR THE PHASE 3 STUDIES. 01/2022-03/2023 WUSM PREPARE AND SUBMIT THE FINAL REPORT. 04/2023-012/2023 WUSM, GWI, UTD OBTAIN FDA APPROVAL FOR THE PHASE 3 STUDY. 01/2023-12/2023 WUSM STUDY 2: DETERMINE WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS. UA, GWI, UTD PREPARE AN IND SUBMISSION WITH PHARM-OLAM. 01/2019-05/2019 WUSM, PHARM-OLAM, UA, UTD FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 UA, UTD RECRUIT AND TEST 60 SUBJECTS (50% OF PLANNED ENROLLMENT). 06/2019-12/2019 UA RECRUIT AND TEST 60 SUBJECTS (100% OF PLANNED ENROLLMENT). 01/2020-12/2020 UA FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 06/2019-02/2020 GWI PERFORM AN INTERIM MASKED ANALYSIS. 02/2020-06/2020 GWI, UTD CONTINUE TO TEST THE REMAINING 60 SUBJECTS. 07/2021-01/2022 UA FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 07/2021-01/2022 GWI COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 08/2022-10/2022 UA, GWI, UTD PERFORM ADDITIONAL DATA ANALYSIS STUDIES BASED ON GENETIC INFORMATION FROM STUDY 3 AND DISCUSSIONS WITH FDA FOR PREPARING THE PHASE 3 CLINICAL STUDIES. 10/2022-12/2023 UA, GWI, UTD SUBMIT AND OBTAIN FDA APPROVAL OF THE PHASE 3 ZNS STUDY 01/2023-12/2023 WUSM, GWI, UTD STUDY 3: DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. GWI, WUSM, UA, UTD FINALIZE REGULATORY DOCUMENTS AND THE IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 GWI OBTAIN GENOMIC DATA ON 90 SUBJECTS. 06/2019-5/2020 GWI OBTAIN GENOMIC DATA ON 120 SUBJECTS. 5/2021 GWI OBTAIN GENOMIC DATA ON 30 SUBJECTS (ALL 240 SUBJECTS). 06/2021-05/2022 GWI COMPLETE GENOMIC DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 06/2022-10/2022 GWI, UTD PREPARE AND SUBMIT THE IND FOR THE PHASE 3 STUDY 10/2022-12/2022 GWI, WUSM, UTD OBTAIN FDA APPROVAL OF THE PHASE 3 STUDY 01/2023-12/2023 GWI (END OF STATEMENT OF WORK) CONTRACTOR MANPOWER REPORTING CONTRACTOR MANPOWER REPORTING (CMR) (SEP 2017) (USAMRAA)
University Of Texas At Dallas
Definitive Contract W81XWH19C0054
$41.9k 3/15/23 WU20127MOD4S
SECTION C - DESCRIPTIONS AND SPECIFICATIONS STATEMENT OF WORK SITE 1: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, 660 S. EUCLID AVE., ST. LOUIS, MO 63110 COORDINATOR: CRAIG A. BUCHMAN, M.D., F.A.C.S. SITE 2: UNIVERSITY OF AKRON SCHOOL OF SPEECH LANGUAGE PATHOLOGY AND AUDIOLOGY, 181 POLSKY, AKRON OH 44325 COORDINATOR: KRISTINE E SONSTROM MALOWSKI, AU.D., PH.D. SITE 3: BIOGENERATOR LABS, SUITE 232, 4340 DUNCAN AVE. , ST. LOUIS, MO 63110 COORDINATOR: JIANXIN BAO, PH.D. SITE 4: THE UNIVERSITY OF TEXAS AT DALLAS, CALLIER CENTER FOR COMMUNICATION DISORDERS, 800 W. CAMPBELL RD. AD15, RICHARDSON, TEXAS, 75080 COORDINATOR: COLLEEN G. LE PRELL, PH.D. ABBREVIATIONS: GWI: GATEWAY BIOTECHNOLOGY, INC.; UA: UNIVERSITY OF AKRON; UTD: UNIVERSITY OF TEXAS AT DALLAS; WUSM: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE. STUDY 1: WE WILL TEST WHETHER THE DRUG ZONISAMIDE (ZNS) CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO DRILLING NOISE DURING SKULL SURGERY. WE WILL DO SO BY ANSWERING THREE CRITICAL QUESTIONS REGARDING POSSIBLE ZNS PROTECTION AGAINST NIHL: (1) WHETHER ZNS CAN PREVENT TEMPORARY THRESHOLD SHIFT (TTS); (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY, OR HIDDEN HEARING LOSS; AND (3) WHETHER ZNS CAN PREVENT PERMANENT THRESHOLD SHIFT (PTS). STUDY 2: WE WILL TEST WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS, THUS DEMONSTRATING THAT ZNS PREVENTS NIHL UNDER CONDITIONS SIMILAR TO MILITARY ENVIRONMENTS. WE WILL DETERMINE: (1) WHETHER ZNS CAN PREVENT TTS 5 MINUTES AFTER THE SHOOTING SESSION; (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY AND PTS AFTER EVERY SHOOTING SESSION; AND (3) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY OR PTS EVERY YEAR FOR A DURATION OF TWO YEARS. STUDY 3: WE WILL DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. WE WILL DO SO BY IDENTIFYING CERTAIN GENETIC VARIANTS ASSOCIATED WITH ZNS PROTECTION AGAINST TTS AND PTS. IF SPECIFIC GENETIC VARIANTS ARE FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH LOWER TTS AND PTS, THIS INFORMATION CAN BE USED TO DEVELOP A PERSONALIZED MEDICATION TO PREVENT NIHL. TASKS TIMELINE SITES STUDY 1: DETERMINE IF ZNS CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO SURGICAL DRILLING NOISE. WUSM, GWI, UTD TAKE PART IN KICK-OFF MEETING AT FORT DETRICK. 01/2019 WUSM, GWI, UA, UTD FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HUMAN RESEARCH PROTECTIONS OFFICE (HRPO). 01/2019-05/2019 WUSM, UTD REQUEST CONSULTATION WITH THE FDA; IND APPLICATION PREPARATION AND SUBMISSION TO THE FDA 01/2019-05/2019 WUSM RECRUIT AND TEST 30 SUBJECTS (25% OF PLANNED ENROLLMENT) 06/2019-03/2020 WUSM FOR QUALITY ASSURANCE, REVIEW ALL DATA WITH STUDY TEAM AS DATA ARE RECEIVED TO DETERMINE IF DATA ARE MISSING. 06/2019-03/2020 GWI, UTD RECRUIT AND TEST 60 SUBJECTS (75% OF PLANNED ENROLLMENT). 04/2020-04/2021 WUSM FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 04/2020-04/2021 GWI ENLIST INDEPENDENT STATISTICIANS TO PERFORM AN INTERIM MASKED ANALYSIS. 04/2021-05/2021 GWI, UTD RECRUIT AND TEST 30 SUBJECTS (100% OF PLANNED ENROLLMENT). 05/2021-11/2021 WUSM FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 05/2021-11/2021 GWI COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 11/2021-01/2022 WUSM, GWI, UTD MEETINGS WITH FDA AND COMPLETE ADDITIONAL STUDIES NECESSARY FOR THE PHASE 3 STUDIES. 01/2022-03/2023 WUSM PREPARE AND SUBMIT THE FINAL REPORT. 04/2023-012/2023 WUSM, GWI, UTD OBTAIN FDA APPROVAL FOR THE PHASE 3 STUDY. 01/2023-12/2023 WUSM STUDY 2: DETERMINE WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS. UA, GWI, UTD PREPARE AN IND SUBMISSION WITH PHARM-OLAM. 01/2019-05/2019 WUSM, PHARM-OLAM, UA, UTD FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 UA, UTD RECRUIT AND TEST 60 SUBJECTS (50% OF PLANNED ENROLLMENT). 06/2019-12/2019 UA RECRUIT AND TEST 60 SUBJECTS (100% OF PLANNED ENROLLMENT). 01/2020-12/2020 UA FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 06/2019-02/2020 GWI PERFORM AN INTERIM MASKED ANALYSIS. 02/2020-06/2020 GWI, UTD CONTINUE TO TEST THE REMAINING 60 SUBJECTS. 07/2021-01/2022 UA FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 07/2021-01/2022 GWI COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 08/2022-10/2022 UA, GWI, UTD PERFORM ADDITIONAL DATA ANALYSIS STUDIES BASED ON GENETIC INFORMATION FROM STUDY 3 AND DISCUSSIONS WITH FDA FOR PREPARING THE PHASE 3 CLINICAL STUDIES. 10/2022-12/2023 UA, GWI, UTD SUBMIT AND OBTAIN FDA APPROVAL OF THE PHASE 3 ZNS STUDY 01/2023-12/2023 WUSM, GWI, UTD STUDY 3: DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. GWI, WUSM, UA, UTD FINALIZE REGULATORY DOCUMENTS AND THE IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 GWI OBTAIN GENOMIC DATA ON 90 SUBJECTS. 06/2019-5/2020 GWI OBTAIN GENOMIC DATA ON 120 SUBJECTS. 5/2021 GWI OBTAIN GENOMIC DATA ON 30 SUBJECTS (ALL 240 SUBJECTS). 06/2021-05/2022 GWI COMPLETE GENOMIC DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 06/2022-10/2022 GWI, UTD PREPARE AND SUBMIT THE IND FOR THE PHASE 3 STUDY 10/2022-12/2022 GWI, WUSM, UTD OBTAIN FDA APPROVAL OF THE PHASE 3 STUDY 01/2023-12/2023 GWI (END OF STATEMENT OF WORK) CONTRACTOR MANPOWER REPORTING CONTRACTOR MANPOWER REPORTING (CMR) (SEP 2017) (USAMRAA)
Gateway Biotechnology, Inc.
Definitive Contract W81XWH19C0054
$2.2m 1/27/23 WU20127MOD3S
SECTION C - DESCRIPTIONS AND SPECIFICATIONS STATEMENT OF WORK SITE 1: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE, 660 S. EUCLID AVE., ST. LOUIS, MO 63110 COORDINATOR: CRAIG A. BUCHMAN, M.D., F.A.C.S. SITE 2: UNIVERSITY OF AKRON SCHOOL OF SPEECH LANGUAGE PATHOLOGY AND AUDIOLOGY, 181 POLSKY, AKRON OH 44325 COORDINATOR: KRISTINE E SONSTROM MALOWSKI, AU.D., PH.D. SITE 3: BIOGENERATOR LABS, SUITE 232, 4340 DUNCAN AVE. , ST. LOUIS, MO 63110 COORDINATOR: JIANXIN BAO, PH.D. SITE 4: THE UNIVERSITY OF TEXAS AT DALLAS, CALLIER CENTER FOR COMMUNICATION DISORDERS, 800 W. CAMPBELL RD. AD15, RICHARDSON, TEXAS, 75080 COORDINATOR: COLLEEN G. LE PRELL, PH.D. ABBREVIATIONS: GWI: GATEWAY BIOTECHNOLOGY, INC.; UA: UNIVERSITY OF AKRON; UTD: UNIVERSITY OF TEXAS AT DALLAS; WUSM: WASHINGTON UNIVERSITY SCHOOL OF MEDICINE. STUDY 1: WE WILL TEST WHETHER THE DRUG ZONISAMIDE (ZNS) CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO DRILLING NOISE DURING SKULL SURGERY. WE WILL DO SO BY ANSWERING THREE CRITICAL QUESTIONS REGARDING POSSIBLE ZNS PROTECTION AGAINST NIHL: (1) WHETHER ZNS CAN PREVENT TEMPORARY THRESHOLD SHIFT (TTS); (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY, OR HIDDEN HEARING LOSS; AND (3) WHETHER ZNS CAN PREVENT PERMANENT THRESHOLD SHIFT (PTS). STUDY 2: WE WILL TEST WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS, THUS DEMONSTRATING THAT ZNS PREVENTS NIHL UNDER CONDITIONS SIMILAR TO MILITARY ENVIRONMENTS. WE WILL DETERMINE: (1) WHETHER ZNS CAN PREVENT TTS 5 MINUTES AFTER THE SHOOTING SESSION; (2) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY AND PTS AFTER EVERY SHOOTING SESSION; AND (3) WHETHER ZNS CAN PREVENT COCHLEAR SYNAPTOPATHY OR PTS EVERY YEAR FOR A DURATION OF TWO YEARS. STUDY 3: WE WILL DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. WE WILL DO SO BY IDENTIFYING CERTAIN GENETIC VARIANTS ASSOCIATED WITH ZNS PROTECTION AGAINST TTS AND PTS. IF SPECIFIC GENETIC VARIANTS ARE FOUND TO BE SIGNIFICANTLY ASSOCIATED WITH LOWER TTS AND PTS, THIS INFORMATION CAN BE USED TO DEVELOP A PERSONALIZED MEDICATION TO PREVENT NIHL. TASKS TIMELINE SITES STUDY 1: DETERMINE IF ZNS CAN PREVENT NOISE-INDUCED HEARING LOSS (NIHL) DUE TO SURGICAL DRILLING NOISE. WUSM, GWI, UTD TAKE PART IN KICK-OFF MEETING AT FORT DETRICK. 01/2019 WUSM, GWI, UA, UTD FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HUMAN RESEARCH PROTECTIONS OFFICE (HRPO). 01/2019-05/2019 WUSM, UTD REQUEST CONSULTATION WITH THE FDA; IND APPLICATION PREPARATION AND SUBMISSION TO THE FDA 01/2019-05/2019 WUSM RECRUIT AND TEST 30 SUBJECTS (25% OF PLANNED ENROLLMENT) 06/2019-03/2020 WUSM FOR QUALITY ASSURANCE, REVIEW ALL DATA WITH STUDY TEAM AS DATA ARE RECEIVED TO DETERMINE IF DATA ARE MISSING. 06/2019-03/2020 GWI, UTD RECRUIT AND TEST 60 SUBJECTS (75% OF PLANNED ENROLLMENT). 04/2020-04/2021 WUSM FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 04/2020-04/2021 GWI ENLIST INDEPENDENT STATISTICIANS TO PERFORM AN INTERIM MASKED ANALYSIS. 04/2021-05/2021 GWI, UTD RECRUIT AND TEST 30 SUBJECTS (100% OF PLANNED ENROLLMENT). 05/2021-11/2021 WUSM FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 05/2021-11/2021 GWI COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 11/2021-01/2022 WUSM, GWI, UTD MEETINGS WITH FDA AND COMPLETE ADDITIONAL STUDIES NECESSARY FOR THE PHASE 3 STUDIES. 01/2022-03/2023 WUSM PREPARE AND SUBMIT THE FINAL REPORT. 04/2023-012/2023 WUSM, GWI, UTD OBTAIN FDA APPROVAL FOR THE PHASE 3 STUDY. 01/2023-12/2023 WUSM STUDY 2: DETERMINE WHETHER ZNS CAN PREVENT NIHL IN POLICE OFFICERS. UA, GWI, UTD PREPARE AN IND SUBMISSION WITH PHARM-OLAM. 01/2019-05/2019 WUSM, PHARM-OLAM, UA, UTD FINALIZE REGULATORY DOCUMENTS AND IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 UA, UTD RECRUIT AND TEST 60 SUBJECTS (50% OF PLANNED ENROLLMENT). 06/2019-12/2019 UA RECRUIT AND TEST 60 SUBJECTS (100% OF PLANNED ENROLLMENT). 01/2020-12/2020 UA FOR QUALITY ASSURANCE, REVIEW ALL TESTING PROTOCOLS FOR INVESTIGATORS, AND DETERMINE THE PERCENTAGE OF MISSING DATA. 06/2019-02/2020 GWI PERFORM AN INTERIM MASKED ANALYSIS. 02/2020-06/2020 GWI, UTD CONTINUE TO TEST THE REMAINING 60 SUBJECTS. 07/2021-01/2022 UA FOR QUALITY ASSURANCE, ENSURE ALL INVESTIGATORS PERFORM SECOND REVIEW OF ALL TESTING PROTOCOLS. 07/2021-01/2022 GWI COMPLETE PRIMARY AND SECONDARY ENDPOINT DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 08/2022-10/2022 UA, GWI, UTD PERFORM ADDITIONAL DATA ANALYSIS STUDIES BASED ON GENETIC INFORMATION FROM STUDY 3 AND DISCUSSIONS WITH FDA FOR PREPARING THE PHASE 3 CLINICAL STUDIES. 10/2022-12/2023 UA, GWI, UTD SUBMIT AND OBTAIN FDA APPROVAL OF THE PHASE 3 ZNS STUDY 01/2023-12/2023 WUSM, GWI, UTD STUDY 3: DETERMINE IF THERE IS A PHARMACOGENETIC (PGX) LINK BETWEEN NIHL AND ZNS TREATMENT. GWI, WUSM, UA, UTD FINALIZE REGULATORY DOCUMENTS AND THE IRB PROTOCOL, AND OBTAIN APPROVAL BY THE U.S. ARMY HRPO. 01/2019-05/2019 GWI OBTAIN GENOMIC DATA ON 90 SUBJECTS. 06/2019-5/2020 GWI OBTAIN GENOMIC DATA ON 120 SUBJECTS. 5/2021 GWI OBTAIN GENOMIC DATA ON 30 SUBJECTS (ALL 240 SUBJECTS). 06/2021-05/2022 GWI COMPLETE GENOMIC DATA ANALYSES AND SUBMISSION OF THE FINAL REPORT FOR THE BASE TASK PERIOD. 06/2022-10/2022 GWI, UTD PREPARE AND SUBMIT THE IND FOR THE PHASE 3 STUDY 10/2022-12/2022 GWI, WUSM, UTD OBTAIN FDA APPROVAL OF THE PHASE 3 STUDY 01/2023-12/2023 GWI (END OF STATEMENT OF WORK) CONTRACTOR MANPOWER REPORTING CONTRACTOR MANPOWER REPORTING (CMR) (SEP 2017) (USAMRAA)
Gateway Biotechnology, Inc.
Definitive Contract W81XWH19C0054
$792.4k 2/9/22