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January 2023; 10 (1) Research ArticleOpen Access

Association of Vitamin D Polygenic Risk Scores and Disease Outcome in People With Multiple Sclerosis

Eleni S. Vasileiou, Chen Hu, Charles N. Bernstein, Fred Lublin, Jerry S. Wolinsky, Gary R. Cutter, Elias S. Sotirchos, Kaarina Kowalec, Amber Salter, Shiv Saidha, Ellen M. Mowry, Peter A. Calabresi, Ruth Ann Marrie, Kathryn C. Fitzgerald
First published November 23, 2022, DOI: https://doi.org/10.1212/NXI.0000000000200062
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Article Information

vol. 10 no. 1 e200062
DOI: 
https://doi.org/10.1212/NXI.0000000000200062
PubMed: 
36418179
Published By: 
Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology
Online ISSN: 
2332-7812
History: 
  • Received July 17, 2022
  • Accepted in final form September 26, 2022
  • First Published November 23, 2022.
Copyright & Usage: 
Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives License 4.0 (CCBY-NC-ND), where it is permissible to download and share the work provided it is properly cited. The work cannot be changed in any way or used commercially without permission from the journal.

Author Disclosures

    1. Eleni S. Vasileiou, MD*,
    2. Chen Hu, MS*,
    3. Charles N. Bernstein, MD,
    4. Fred Lublin, MD,
    5. Jerry S. Wolinsky, MD,
    6. Gary R. Cutter, PhD,
    7. Elias S. Sotirchos, MD,
    8. Kaarina Kowalec, PhD,
    9. Amber Salter, PhD,
    10. Shiv Saidha, MBBCh, MD, MRCPI,
    11. Ellen M. Mowry, MD, MCR,
    12. Peter A. Calabresi, MD,
    13. Ruth Ann Marrie, MD, PhD and
    14. Kathryn C. Fitzgerald, ScD
  1. Eleni S. Vasileiou, MD*,
    2. Scientific Advisory Boards:

    1. None

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. None

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  2. Chen Hu, MS*,
    3. Scientific Advisory Boards:

    1. None

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. None

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  3. Charles N. Bernstein, MD,
    4. Scientific Advisory Boards:

    1. Abbvie Canada, Amgen Canada, Avir Pharmaceuticals, Bristol Myers Squibb Canada, JAMP Pharmaceuticals, Janssen Canada, Pfizer Canada, Takeda Canada, Roche Canada, Sandoz Canada

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. Speakers bureau for Abbvie Canada, Janssen Canada, Takeda Canada, Pfizer Canada

    Editorial Boards:

    1. Editorial Advisory board for Journal of Canadian Association of Gastroenterology

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Takeda and Mylan Pharmaceuticals

    Speakers' Bureaus:

    1. Speaker fees from Abbvie Canada, Takeda Canada, Janssen Canada, Pfizer Canada

    Other Activities:

    1. Education grants from Abbvie Canada, Janssen Canada, Pfizer Canada, Takeda Canada and Bristol Myers Squibb Canada

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Abbvie Canada, Sandoz Canada, Amgen Canada, and Pfizer Canada have given unrestricted investigator initiated grants

    Research Support, Government Entities:

    1. Canadian Institutes of Health Research, Research Manitoba

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. None

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. legal consultant to Mylan Pharmaceuticals and Takeda and 3M

  4. Fred Lublin, MD,
    5. Scientific Advisory Boards:

    1. Biogen; EMD Serono; Novartis; Teva; Actelion; Sanofi/Genzyme; Acorda; Roche/Genentech; MedImmune/ Viela Bio; Receptos/Celgene; Mapi Pharma; Brainstorm Cell Therapeutics; Jazz Pharmaceuticals; GW Pharma; Mylan; Immunic; Population Council; Avotres; Janssen, BMS; Neurogene; Banner Life Sciences; Labcorp; Entelexo Biotherapeutics; Neuralight; SetPoint Medical; Hexal/Sandoz

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. Most, if not all, consulting activity and scientific boards listed above and below involved travel, all before March 2020, that was either paid for directly or reimbursed.

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Same as Advisory Boards

    Speakers' Bureaus:

    1. Sanofi Genzyme- non-promotionalEMD Serono- non-promotional

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Novartis; Biogen; Sanofi, NMSS, NIH; Brainstorm Cell Therapeutics

    Research Support, Government Entities:

    1. 1) NIH/NINDS- PI, 2018-20222) NIH/NINDS- PI, 2018-2022

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. 1) National Multiple Sclerosis Society- PI, 2014-20192) National Multiple Sclerosis Society- PI 2019-2024

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. Stock Options- Avotres; Neuralight

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. I have provided occasional expert testimony in various matters

  5. Jerry S. Wolinsky, MD,
    6. Scientific Advisory Boards:

    1. Compensation for service on steering committees or datamonitoring boards for Avotres, Brainstorm Cell Therapeutics, Cleveland Clinic Foundation, EMD Serono, Novartis/Sandoz, Roche/Genentech and University of Alabama Birmingham.

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. Honoraria, travel support and expenses were provided from Roche for CME related activities.

    Editorial Boards:

    1. NONE

    Patents:

    1. US010363245B2; Board of Regents UT System; Methods for treating CNS lesions

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. None

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. Royalties are received for monoclonal antibodiesout-licensed through the University of Texas HealthScience Center at Houston to Millipore (ChemiconInternational) Corporation since 1993.

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  6. Gary R. Cutter, PhD,
    7. Scientific Advisory Boards:

    1. Data and Safety Monitoring Boards: Applied Therapeutics, AI therapeutics, AMO Pharma, Astra-Zeneca, Avexis Pharmaceuticals, Biolinerx, Brainstorm Cell Therapeutics, Bristol Meyers Squibb/Celgene, CSL Behring, Galmed Pharmaceuticals, Green Valley Pharma, Horizon Pharmaceuticals, Immunic, Karuna Therapeutics, Mapi Pharmaceuticals LTD, Merck, Mitsubishi Tanabe Pharma Holdings, Opko Biologics,Prothena Biosciences, Novartis, Regeneron, Sanofi-Aventis, Reata Pharmaceuticals, NHLBI (Protocol Review Committee), University of Texas Southwestern, University of Pennsylvania, Visioneering Technologies, Inc.

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. Multiple Sclerosis Journal: editorial board, (11 yrs); Multiple Sclerosis and Related Disorders: Editorial board; (1 yr);Am journal of the Society of Nephrology. Statistical editor; contributing statistical help (6 yrs); Alzheimer's and Dementia (5) yrs; Neurology Clinical Practice (7yrs recently ended);

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Consulting or Advisory Boards: Alexion, Antisense Therapeutics, Biogen, Clinical Trial Solutions LLC, Entelexo Biotherapeutics, Inc., Genzyme, Genentech, GW Pharmaceuticals, Immunic, Klein-Buendel Incorporated, Merck/Serono, Novartis, Osmotica Pharmaceuticals, Perception Neurosciences, Protalix Biotherapeutics, Recursion/Cerexis Pharmaceuticals, Regeneron, Roche, SAB Biotherapeutics.

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. President of Pythagoras Inc. a consulting company

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. ACTIVE*Title: UAB-UCSD O'Brien Center for Acute Kidney Injury ResearchMajor Goals: Acute kidney injury (AKI) is a major cause for morbidity and mortality in hospitalized patients and is being increasingly recognized as a cause for chronic kidney disease. AKI doubles the length of stay in the hospital, increasing health care resources. The UAB-UCSD O'Brien Center has brought together a team of investigators to serve unmet needs of our investigator base and to fill the gaps in knowledge in the field of AKI and AKI-related research.*Status of Support: Active Project Number: P30 DK079337Name of PD/PI: Agarwal, Anupam*Source of Support: NIDDKD*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 8/1/2018-7/31/2023*Total Award Amount (including Indirect Costs): $1,136,699*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)Person Months (##.##)4. 20220.88 calendar5. 20230.15 calendar*Overlap: There is no scientific or budgetary overlap*Title: The Exercise and Physical Activity Collaborative Team (ExPACT): a Proposed MoTrPAC Clinical CenterMajor Goals: The goals are to help lead the NIH Common Fund initiative – Molecular Transducers of Physical Activity Consortium (MoTrPAC) – by serving as one of six adult clinical centers conducting a large-scale, randomized, controlled trial (RCT) of resistance vs. endurance exercise training vs. no-exercise control. The RCT will be complemented by molecular acute response studies in RCT participants as well as highly trained athletes; all with the goal of generating molecular maps that reveal potential underpinnings of exercise-induced health benefits.*Status of Support: Active Project Number: U01 AR071133Name of PD/PI: Trappe, S; Bufford, T; Goodpaster, B Name of Individual: Cutter, Gary R. Commons ID: CUTTERG*Source of Support: NIAMS*Primary Place of Performance: Ball State University Project/Proposal Start and End Date: 12/06/2016 - 11/30/2022*Total Award Amount (including Indirect Costs): $13,450,506*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)Person Months (##.##)6. 20222.88 calendar*Overlap: There is no scientific or budgetary overlap*Title: Host Immune Responses to Chlamydia trachomatis Candidate Vaccine Antigens and their Association with Clinical Correlates of Protective Immunity in WomenMajor Goals: The purpose of the study is to evaluate systemic and mucosal cellular and humoral immune responses induced by promising chlamydia vaccine candidate antigens and to assess association of the immune responses with clinical correlates of protection against chlamydia in women.*Status of Support: Active Project Number: R01 AI148359Name of PD/PI: Geisler, William Michael*Source of Support: NIAID*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 5/11/2020-4/30/2025*Total Award Amount (including Indirect Costs): $3,201,254*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)Person Months (##.##)2. 20220.30 calendar3. 20230.30 calendar4. 20240.30 calendar5. 20250.30 calendar*Overlap: There is no scientific or budgetary overlap*Title: Slow Wave Sleep as a Biomarker of Rehabilitation-Induced Cognitive Improvement in Parkinson's DiseaseMajor Goals: This study will investigate deep sleep as a marker of rehabilitation-induced improvement in cognition in Parkinson’s disease to guide selection of the optimal exercise prescription for individuals with Parkinson's disease.*Status of Support: Active Project Number: R01 HD100670 Name of Individual: Cutter, Gary R. Commons ID: CUTTERGName of PD/PI: Amara, Amy Willis*Source of Support: NICHD*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 4/1/2021 - 3/31/2026*Total Award Amount (including Indirect Costs): $ 3,043,715*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)Person Months (##.##)2. 20230.29 calendar3. 20240.60 calendar4. 20250.60 calendar5. 20261.20 calendar*Overlap: There is no scientific or budgetary overlap*Title: Childhood Follow-Up Study of Obesity and Neurodevelopment After Perinatal Exposure to Adjunctive Azithromycin Prophylaxis for Cesarean DeliveryMajor Goals: Cesarean delivery, the most common major surgical procedure in the US, is the strongest risk factor for maternal infection (a top 3 cause of death during childbirth). Adjunctive azithromycin compared to standard antibiotic prophylaxis alone is proven (through our large C/SOAP trial and other studies) to be highly effective in preventing infection after cesarean - with authorities now recommending consideration of its use while calling for more information on long-term health outcomes after exposure at birth. We propose a US multi-center long-term follow-up study of children from the parent C/SOAP trial at age 7 (6-9) years to evaluate childhood obesity/growth and neurodevelopment after perinatal exposure to adjunctive azithromycin (complementing our NICHD grant evaluating pulmonary and gastrointestinal health scored at the 6th percentile); findings from this study will be used to inform and strengthen national and global health care policy regarding the safety of adjunctive azithromycin to reduce maternal infection after cesarean delivery.*Status of Support: Active Project Number: R01 HD102962Name of PD/PI: Subramaniam, Akila*Source of Support: NICHD*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 7/20/2020-6/30/2025*Total Award Amount (including Indirect Costs): $ 3,343,613*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)Person Months (##.##)2. 20220.12 calendar3. 20230.12 calendar4. 20240.12 calendar Name of Individual: Cutter, Gary R. Commons ID: CUTTERGYear (YYYY)Person Months (##.##)5. 20250.12 calendar*Overlap: There is no scientific or budgetary overlap*Title: Pregnancy as a Window to the Future: Outcomes of Antihypertensive Therapy and Superimposed Preeclampsia in Pregnant Women with Mild Chronic Hypertension (CHAP Maternal Follow-Up Study)Major Goals: This follow-up study of the well-characterized CHAP cohort will define the impact of preeclampsia and antihypertensive treatment during pregnancy on long-term risk for maternal cardiovascular outcomes and assess the predictive role of factors included in the ASCVD risk score for women aged <40 years. These results will help identify optimal blood pressure preventive strategies to enhance the long-term health of reproductive-aged women with CHTN*Status of Support: Active Project Number: R01 HL120338Name of PD/PI: Tita, Alan Thevenet N.*Source of Support: NHLBI*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 9/1/2021 - 8/31/2026*Total Award Amount (including Indirect Costs): $10,527,329*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)Person Months (##.##)1. 20220.48 calendar2. 20230.60 calendar3. 20240.60 calendar4. 20250.60 calendar5. 20260.60 calendar*Overlap: There is no scientific or budgetary overlap*Title: Rare Disease Network for Myasthenia GravisMajor Goals: We propose development of the Myasthenia Gravis Clinical Research Consortium (MGNet) to coordinate investigators in collection of detailed clinical information and biological specimen along with performance of pilot investigations of a therapeutic and biomarker discovery. We link our efforts to a program to develop new investigators in myasthenia gravis.This is all done with the purpose of enhancing performance clinical trials and care of patients to one day find a cure for myasthenia gravis.*Status of Support: Active Project Number:Name of PD/PI: Kaminski, Henry J*Source of Support: NIH Name of Individual: Cutter, Gary R. Commons ID: CUTTERG*Primary Place of Performance: George Washington University Project/Proposal Start and End Date: 9/1/2019-5/31/2024*Total Award Amount (including Indirect Costs): $ 321,265*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)Person Months (##.##)3. 20220.22 calendar4. 20230.30 calendar5. 20240.30 calendar*Overlap: There is no scientific or budgetary overlap*Title: 2/2 Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease (Tele-COPD)Major Goals: Twenty percent of patients hospitalized for acute exacerbations of chronic obstructive pulmonary disease (COPD) are readmitted within 30 days of discharge. Pulmonary rehabilitation is associated with a reduction in hospitalization in patients with COPD, but significant barriers in availability and access limit its use. We propose a multicenter randomized controlled trial that will test whether a video telehealth pulmonary rehabilitation intervention that overcomes these barriers will reduce hospital readmissions, improve quality of life, and be cost- effective.*Status of Support: Active Project Number: U24 HL155807Name of PD/PI: Aban, Inmaculada*Source of Support: NHLBI*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 9/1/2021 - 7/31/2027*Total Award Amount (including Indirect Costs): $ 1,844,073*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)Person Months (##.##)1. 20220.53 calendar2. 20230.60 calendar3. 20240.60 calendar4. 20250.60 calendar5. 20260.60 calendar6. 20270.60 calendar*Overlap: There is no scientific or budgetary overlap Name of Individual: Cutter, Gary R. Commons ID: CUTTERG*Title: Premature Infants Receiving Cord Milking or Delayed Cord Clamping (PREMOD)Major Goals: Delayed cord clamping reduces overall bleeding in the brain of premature infants, but not the most severe types. “Milking” the umbilical cord, a method used to transfer blood from the placenta into the baby before the umbilical cord is clamped, may provide additional blood volume to the brain and other vital organs thereby reducing bleeding in the brain and improving long-term outcomes in premature babies. This study will determine whether umbilical cord milking reduces bleeding in the brain or death in premature newborns delivered by Cesarean section compared to delaying clamping of the umbilical cord.*Status of Support: Active Project Number:Name of PD/PI: Szychowski, Jeffery M*Source of Support: NIH*Primary Place of Performance: Sharp Healthcare Foundation Project/Proposal Start and End Date: 4/1/2019-3/31/2023*Total Award Amount (including Indirect Costs): $ 547,855*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)Person Months (##.##)4. 20230.12 calendar*Overlap: The scientific overlap is only in the potential for babies that require resuscitation, they could potentially be eligible for the OptiStart trial if the site participates in both trials, but the scientific question is different and there is no budgetary overlap*Title: Preventing Epilepsy Using Vigabatrin in Infants with Tuberous Sclerosis Complex Major Goals: This study focuses on the developmental impact of early vigabatrin treatments ininfants with Tuberous Sclerosis Complex who are at risk of developing epilepsy. Also, the study aims to determine the effectiveness of early vigabatrin treatment in clinical seizure prevention and its impact on the development of drug resistant epilepsy at 24 months of age. This is the first seizure prevention trial in patients with TSC in the United States.*Status of Support: Active Project Number: U01 NS092595 Name of PD/PI: Bebin*Source of Support: NINDS*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 06/01/2016 – 05/31/2022*Total Award Amount (including Indirect Costs): $ 1,235,496*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)Person Months (##.##)6. 20220.06 calendar Name of Individual: Cutter, Gary R. Commons ID: CUTTERG*Overlap: There is no scientific or budgetary overlapPENDING*Title: Myasthenia Gravis Patient Registry Work Order #15 Major Goals:*Status of Support: Pending Project Number:Name of PD/PI: Aban, Inmaculada B*Source of Support: MGFA*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 9/1/2021-9/30/2023*Total Award Amount (including Indirect Costs): $137,817*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)Person Months (##.##)2. 20230.30 calendar*Overlap: There is no scientific or budgetary overlap*Title: Transferring Speed of Processing Gains to Everyday Cognitive Tasks after StrokeMajor Goals: The goal is to test in adults with chronic cognitive impairment after stroke whether a set of behavioral techniques, adapted from CI Movement therapy, for transferring therapeutic gains from the treatment to everyday setting enhances the scope, size, and durability of gains in carrying out everyday tasks with important cognitive components observed after speed of cognitive processing training.*Status of Support: Pending Project Number: R01 AG070049 Name of PD/PI: Taub, Edward*Source of Support: NIA*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 9/5/2021 - 8/31/2025*Total Award Amount (including Indirect Costs): $2,245,294*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)Person Months (##.##)1. 20230.30 calendar2. 20240.30 calendar3. 20250.30 calendar*Overlap: There is no scientific or budgetary overlap Name of Individual: Cutter, Gary R. Commons ID: CUTTERG*Title: Endovascular vs. Surgical Arteriovenous Fistula OutcomesMajor Goals: Arteriovenous fistulas (AVFs) are the preferred type of vascular access for hemodialysis, and surgical creation of AVFs is the current gold standard, yet many surgical AVFs fail to mature for use. Endovascular AVF creation, a novel percutaneous (non-surgical) method to create a vascular access, was recently approved by the FDA. The goal of the proposed research is to establish a solid foundation for the design and conduct of a randomized clinical trial to compare the clinical and economic impact of endovascular AVFs and surgical AVFs.*Status of Support: Pending Project Number:Name of PD/PI: Al-Balas, Alian Ali*Source of Support: Southern Society for Clinical Investigation*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 07/01/2020-06/30/2025*Total Award Amount (including Indirect Costs): $930,946*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)`Person Months (##.##)1. 20210.6 calendar2. 20220.6 calendar3. 20230.6 calendar4. 20240.6 calendar5. 20250.6 calendar*Overlap: There is no scientific or budgetary overlap*Title: Optimization of Saturation Targets and Resuscitation Trial (OptiSTART)Major Goals: Multicenter randomized controlled trial to evaluate two different ranges of target goal saturations for preterm resuscitation in the delivery room*Status of Support: Pending Project Number: R01 HD104970 Name of PD/PI: Kapadia, Vishal*Source of Support: NICHD*Primary Place of Performance: University of Texas Southwestern Medical Center Project/Proposal Start and End Date: 4/1/2022 - 3/31/2027*Total Award Amount (including Indirect Costs): $ 2,928,922*Person Months (Calendar/Academic/Summer) per budget period. Name of Individual: Cutter, Gary R. Commons ID: CUTTERGYear (YYYY)`Person Months (##.##)1. 20230.12 calendar2. 20240.12 calendar3. 20250.12 calendar4. 20260.12 calendar5. 20270.12 calendar*Overlap: The scientific overlap is only in the potential for babies that require resuscitation, they could potentially be eligible for the PREMOD trial if the site participates in both trials, but the scientific question is different and there is no budgetary overlap*Title: Early Epilepsy Surgery in Tuberous Sclerosis ComplexMajor Goals: This study will determine if epilepsy surgery improves language and behavior in children with tuberous sclerosis complex that are not seizure free on medications. It will provide guidance for doctors and caregivers to understand how the timing of epilepsy surgery impacts language development and discover what contributes to decision making about which patients undergo surgery.*Status of Support: Pending Project Number:Name of PD/PI: Aban, Inmaculada B.*Source of Support: NIH*Primary Place of Performance: Stanford University Project/Proposal Start and End Date: 2/1/2022 - 1/31/2028*Total Award Amount (including Indirect Costs): 281,882*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)`Person Months (##.##)1. 20230.12 calendar2. 20240.3 calendar3. 20250.3 calendar4. 20260.6 calendar5. 20270.6 calendar6. 20280.6 calendar*Overlap: There is no scientific or budgetary overlap*Title: NB-UVB Phototherapy with Established Disease-Modifying-Therapies to Counteract Demyelination and Attenuate NeuroinflammationMajor Goals: The specific Aims are (1) Evaluate the efficacy of octal-interval-frequency (O.I.F.) NB-UVB phototherapy in attenuating EAE, (2) Determine the underlying mechanism of anti- inflammatory and anti-oxidative responses and, (3) Determine whether NB-UVB treatment promotes neuronal repair and/or slows progression of neuronal damage. The results from this pre-clinical study will provide the foundation for a Phase 2/Phase 3 clinical study in partnership with LumaVive that is expected to begin within two years from onset of this pre-clinical study. Name of Individual: Cutter, Gary R. Commons ID: CUTTERG*Status of Support: Pending Project Number:Name of PD/PI: Raman, Chander*Source of Support: NMSS*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 6/1/2021-6/1/2023*Total Award Amount (including Indirect Costs): $599,999*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)`Person Months (##.##)1. 20220.6 calendar2. 20230.6 calendar*Overlap: There is no scientific or budgetary overlap*Title: Intrathecal production of CXCL13: A prognostic biomarker in MS Major Goals:*Status of Support: Pending Project Number:Name of PD/PI: Pachner, Andrew*Source of Support: NIH*Primary Place of Performance: Dartmouth-Hitchcock Clinic Project/Proposal Start and End Date: 9/1/2022-8/31/2027*Total Award Amount (including Indirect Costs): $ 26,315*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)`Person Months (##.##)1. 20230.6 calendar2. 20240.6 calendar3. 20250.6 calendar4. 20260.6 calendar5. 20270.6 calendar*Overlap: There is no scientific or budgetary overlap*Title: Chemopreventive role of Melatonin and its Metabolites in UVB Induced CancerogenesisMajor Goals: We will establish melatonin as a potent chemo preventive natural product against UVB-induced photocarcenogenesis and determine if its metabolites are more potent in this activity. The in vivo testing will use a unique genetically altered mouse model of UVB-induced squamous and basal cell carcinomas, which faithfully recapitulates the pathogenesis of human Name of Individual: Cutter, Gary R. Commons ID: CUTTERGcancers. We will also elucidate the mechanisms of action, which will include melatonin/metabolites regulation of AhR and/or IL-17 and NRF2 signaling.*Status of Support: Pending Project Number:Name of PD/PI: Slominski, Andrzej Tadeusz*Source of Support: NIH*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 7/1/2022-6/30/2027*Total Award Amount (including Indirect Costs): $3,712,495*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)`Person Months (##.##)1. 20230.3 calendar2. 20240.3 calendar3. 20250.3 calendar4. 20260.3 calendar5. 20270.3 calendar*Overlap: There is no scientific or budgetary overlap*Title: Reducing Future Fractures and Improving Outcomes in People with Fragility FracturesMajor Goals: RESTORE aims to test whether a “specialist-FLS service” where patients are contacted by a patient navigator and referred to a bone health specialist (who is more likely to prescribe a bone medicine) is better than an FLS service where patient navigators encourage patients to engage with their outpatient primary care providers. We also aim to determine the influence of race, ethnicity, sex, poverty level, geographic region, and timing of entry into the trial after a fracture on the effectiveness of the two strategies to prevent another fracture.*Status of Support: Pending Project Number:Name of PD/PI: Saag, Kenneth G*Source of Support: PCORI*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 12/1/2022-11/30/2027*Total Award Amount (including Indirect Costs): $13,845,791*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)`Person Months (##.##)1. 20230.6 calendar2. 20240.6 calendar3. 20250.6 calendar4. 20260.6 calendar Name of Individual: Cutter, Gary R. Commons ID: CUTTERGYear (YYYY)`Person Months (##.##)5. 20270.9 calendar*Overlap: There is no scientific or budgetary overlap*Title: Technique to Enable Return-to-Work by Employees with Long COVID Brain FogMajor Goals: The goals are to (a) refocus a new cognitive rehabilitation therapy for persistent brain fog and cognitive impairment in adults with long COVID to target return-to-work in this population and (b) evaluate the feasibility and acceptability of the modified intervention.*Status of Support: Pending Project Number:Name of PD/PI: Uswatte, Gitendra*Source of Support: Administration for Community Living/DHHS*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 09/01/22-08/31/25*Total Award Amount (including Indirect Costs): $599,726*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)`Person Months (##.##)1. 20230.3 calendar2. 20240.3 calendar3. 20250.3 calendar*Overlap: There is no scientific or budgetary overlap*Title: A Therapy for Long COVID Brain Fog and Cognitive Impairment.Major Goals: The goal is to evaluate the efficacy of a new cognitive rehabilitation therapy for persistent brain fog and cognitive impairment in adults with long COVID. The new therapy combines cognitive speed of processing training with a set of behavioral change techniques, adapted from CI Movement therapy.*Status of Support: Pending Project Number:Name of PD/PI: Taub, Edward*Source of Support: NIH*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 09/01/2022 -08/31/2026*Total Award Amount (including Indirect Costs): $2,462,212*Person Months (Calendar/Academic/Summer) per budget period. Name of Individual: Cutter, Gary R. Commons ID: CUTTERGYear (YYYY)`Person Months (##.##)1. 20230.3 calendar2. 20240.3 calendar3. 20250.3 calendar4. 20260.3 calendar*Overlap: There is no scientific or budgetary overlap*Title: Neutrophil Dysregulation as a Critical Driver in the Pathogenesis of Multiple SclerosisMajor Goals: Multiple sclerosis (MS) is a chronic autoimmune disease caused by demyelination of neurons in the central nervous system (CNS). Neutrophils are implicated to play a major role in demyelination in mice with experimental autoimmune encephalitis (EAE). The overall goals of this proposal are to define the role of neutrophil subpopulations as driving mechanisms of MS, and to identify the mechanisms responsible for chronic neutrophilic activation in MS in order to reveal the specific checkpoints for intervention.*Status of Support: Pending Project Number:Name of PD/PI: Raman, Chander*Source of Support: NIH*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 09/01/2022-08/31/2027*Total Award Amount (including Indirect Costs): $ 3,681,085*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)`Person Months (##.##)1. 20230.6 calendar2. 20240.6 calendar3. 20250.6 calendar4. 20260.6 calendar5. 20270.6 calendar*Overlap: There is no scientific or budgetary overlap*Title: Improving COVID-19 Vaccine Uptake Among Racial and Ethnic Minority Groups with Rheumatic DiseasesMajor Goals: People with autoimmune rheumatic diseases (AIRDs) such as rheumatoid arthritis or systemic lupus erythematosus, especially those on immunosuppressive treatment, often experience poorer outcomes following COVID-19 infection. Individuals with AIRDs, including Black and Latinx persons, are concerned about side effects, may have limited awareness about the complexity of COVID-19 vaccination and timing of subsequent vaccine doses in the context of AIRD and/or immunosuppressive treatment, or may have barriers to obtaining a COVID-19 vaccine dose. This study aims to test whether a novel intervention using first-person narratives (i.e., “storytelling”) recounting personal experiences with the COVID-19 vaccination as well as patient navigation to provide logistics support for and reinforce safety and effectiveness of Name of Individual: Cutter, Gary R. Commons ID: CUTTERGCOVID-19 vaccination will result in an increase in vaccination uptake among Black and Latinx adults with AIRDs.*Status of Support: Pending Project Number:Name of PD/PI: Danila, Maria I*Source of Support: NIH*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 12/01/2022-11/30/2027*Total Award Amount (including Indirect Costs): $ 3,669,258*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)`Person Months (##.##)1. 20230.6 calendar2. 20240.6 calendar3. 20250.6 calendar4. 20260.6 calendar5. 20270.6 calendar*Overlap: There is no scientific or budgetary overlap*Title: Canonical and Non-Canonical Secosteroid Activation and Signaling Pathways in Immunomodulation of Multiple SclerosisMajor Goals: Vitamin D deficiency in MS is common and vitamin D has an essential function in regulating the immune system to counteract an autoimmunity, however, benefits of vitamin D supplementation have been mixed. We have discovered novel pathways of vitamin D activation with products that are non-calcemic and that can affect immune cells activities in unique ways. Using comprehensive and unbiased approaches, we will determine if any of these immune cell intrinsic pathways are defective in MS and whether CYP11A1 derivatives will affect functions of lymphocytes in control and MS patients with a long-term objective to utilize immunoregulatory and anti-oxidative properties of novel vitamin D derivatives in therapy of MS.*Status of Support: Pending Project Number:Name of PD/PI: Raman, Chander*Source of Support: NIAID*Primary Place of Performance: University of Alabama at Birmingham Project/Proposal Start and End Date: 10/01/2022-09/30/2027*Total Award Amount (including Indirect Costs): $ 3,697,405*Person Months (Calendar/Academic/Summer) per budget period.Year (YYYY)`Person Months (##.##)1. 20230.6 calendar Name of Individual: Cutter, Gary R. Commons ID: CUTTERGYear (YYYY)`Person Months (##.##)2. 20240.6 calendar3. 20250.6 calendar4. 20260.6 calendar5. 20270.6 calendar*Overlap: There is no scientific or budgetary overlapIn-KindNone*Overlap (summarized for each individual):I have reviewed my obligations and confirm that the aggregate effort on all currently active projects does not exceed 12 months. In the event that funding of pending grants leads to an effort level greater than 12 months, my effort will be reduced and the effort of other qualified personnel on the project will be increased.

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. None

    Stock/Stock Options/Board of Directors Compensation:

    1. Consortium of MS Centers - Past President and Board Member - only expenses covered

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  7. Elias S. Sotirchos, MD,
    8. Scientific Advisory Boards:

    1. Scientific advisory boards:1) Alexion 2) Horizon Therapeutics 3) Genentech 4) Viela Bio 5) Ad Scientiam

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. Speaker honoraria:1) Alexion 2) Viela Bio

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. National Institutes of Health (NIH) K23NS117883

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. 1) National MS Society (NMSS) FP-1607-249992) National MS Society (NMSS) TA-1904-338343) Sumaira Foundation

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  8. Kaarina Kowalec, PhD,
    9. Scientific Advisory Boards:

    1. None

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. NONE

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. (1) Commercial entity: Consulting with Emerald Lake Safety Ltd. (2017-2018).

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. None

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  9. Amber Salter, PhD,
    10. Scientific Advisory Boards:

    1. (1) DSMB for Premature Infants Receiving Milking or Delayed Cord Clamping: PREMOD2(2) OSMB for Central Vein Sign: A Diagnostic Biomarker in Multiple Sclerosis(3) DSMB for Ocrelizuamb for Preventing Clinical Multiple Sclerosis in Individuals With Radiologically Isolated Disease: CELLO(4) DSMB for Video Telehealth Pulmonary Rehabilitation to Reduce Hospital Readmission in Chronic Obstructive Pulmonary Disease: Tele-COPD

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. Circulation: Cardiovascular Imaging, Statistical Editor, 2018-2021Neurology, Editorial board member, 2021-2022

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Gryphon Bio, LLC

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. (1) Department of Defense, Principal Investigator, 2021-2024

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. (1) Consortium of Multiple Sclerosis Centers (2) National Multiple Sclerosis Society (3) MS Society of Canada

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  10. Shiv Saidha, MBBCh, MD, MRCPI,
    11. Scientific Advisory Boards:

    1. Dr. Saidha has served on scientific advisory boards for TG Therapeutics, Novartis, Biogen, Bristol Myers Squibb, and Genentech.

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. I am a member of the editorial board of Multiple Sclerosis Journal and editor of Multiple Sclerosis Journal Experimental, Translational and Clinical

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. Consulting fees from Medical Logix for the development of CME programs in neurology, and has received equity compensation and consulting fee for consulting from JuneBrain LLC, a retinal imaging device developer. He has also consulted for Carl Zeiss Meditec and Novartis.

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Dr. Saidha is the PI of investigator-initiated studies funded by Genentech Corporation, Biogen, and Novartis, is the site PI of a trial sponsored by Novartis, and was also the site investigator of a trial sponsored by MedDay Pharmaceuticals.

    Research Support, Government Entities:

    1. NONE

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. Dr. Saidha receives research funding from the National MS Society

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  11. Ellen M. Mowry, MD, MCR,
    12. Scientific Advisory Boards:

    1. DSMB member for NIAID

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. Editorial boards: Multiple Sclerosis Journal, 2020-

    Patents:

    1. NONE

    Publishing Royalties:

    1. UptoDate chapter editor

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. 1.BeCare Link LLC, 2022-

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. (1)Free glatiramer acetate for a clinical trial from Teva Neuroscience.(2)Research funding paid to my institution from Biogen and Genentech (for investigator-initiated studies).(3) Site PI of studies sponsored by Biogen and Genentech

    Research Support, Government Entities:

    1. (1)Department of Defense, W81XWH-16-1-0693, 9/2016-9/2022(2)National Institutes of Health, 1R01NR018851-01A1, 9/2020-6/2025

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. 1. National Multiple Sclerosis Society. 2. Patient-Centered Outcomes Research Institute (PCORI)

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  12. Peter A. Calabresi, MD,
    13. Scientific Advisory Boards:

    1. 1. DiSARM Therapeutics (now part of Lilly)2. Biogen3. Avidea Technologies

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. 1. NMSS (travel only)2. Myelin Repair Foundation (honorarium)

    Editorial Boards:

    1. Neurology Editorial Board 2007 to 2017Journal of Clinical Investigation Associate Editor-2017-2022Multiple Sclerosis Journal Editorial Board-present

    Patents:

    1. Report of invention filed for use of bryostatin in autoimmune disease.

    Publishing Royalties:

    1. Optical Coherence Tomography in Neurological Diseases (book)Royalties for being co-editor received from Cambridge Press.

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. 1. DiSARM Therapeutics (now Lilly)2. Biogen3. Avidea technologies4. Idorsia

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. We utilize OCT in the clinic and bill for patients not enrolled in research studies. I have been a co-author on papers outlining guidelines for use of OCT.

    Research Support, Commercial Entities:

    1. 1. Principia (expired 2021)2. Genentech (active)3. Myelin Repair Foundation (active)

    Research Support, Government Entities:

    1. NIH, NINDS R-01 NS041435 2020-2025 PINIH, NINDS R-01 NS082347 2018-2023 PIDoD, CDRMS W81XWH1910622 2019-2021 PI

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. National MS Society (NMSS) The role of complement C3 in retinal neuroprotection in EAENMSS, sNfL healthy control normative data

    Stock/Stock Options/Board of Directors Compensation:

    1. 1. Disarm Therapeutics 2. Avidea technologies (now Vaccitech)Katharine Whartenby, PhD (my wife)1. Shares of MyMD

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  13. Ruth Ann Marrie, MD, PhD and
    14. Scientific Advisory Boards:

    1. None

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. Multiple Sclerosis Journal, Editorial BoardMultiple Sclerosis Journal-ETC, Co-Editor (ended Dec 2020)Neurology, Editorial Board (2022)

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. Roche Canada (no direct funding to me or my institution), Biogen (no direct funding to me or my institution)

    Research Support, Government Entities:

    1. Received support as principal investigator from theCanadian Institutes of Health Research (2010-2023), and Research Manitoba (2014-2022) and as co-investigator from US Department of Defense (2020-2023).

    Research Support, Academic Entities:

    1. Waugh Family Chair in Multiple Sclerosis

    Research Support, Foundations and Societies:

    1. Received support as principal investigator from Multiple Sclerosis Society of Canada (2009-2025) and theNational Multiple Sclerosis Society (2013-2023), and as co-principal investigator from Multiple Sclerosis Scientific Foundation (2009-2021). Received support from Consortium of Multiple Sclerosis Centers (2004-2009, 2011-2014, 2016-2022), Crohn's and Colitis Canada (2014-2023), The Arthritis Society (2021-2023)

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  14. Kathryn C. Fitzgerald, ScD
    15. Scientific Advisory Boards:

    1. Data safety monitoring board for NIH-funded study.

    Gifts:

    1. NONE

    Funding for Travel or Speaker Honoraria:

    1. None

    Editorial Boards:

    1. Frontiers in Epidemiology Associate Editor

    Patents:

    1. NONE

    Publishing Royalties:

    1. NONE

    Employment, Commercial Entity:

    1. NONE

    Consultancies:

    1. NONE

    Speakers' Bureaus:

    1. NONE

    Other Activities:

    1. NONE

    Clinical Procedures or Imaging Studies:

    1. NONE

    Research Support, Commercial Entities:

    1. NONE

    Research Support, Government Entities:

    1. NIH NIMH 1-K01MH121582-01, PI, 2019-2023

    Research Support, Academic Entities:

    1. NONE

    Research Support, Foundations and Societies:

    1. Career Transition Fellowship (TA-1805-31136) from the National MS Society

    Stock/Stock Options/Board of Directors Compensation:

    1. NONE

    License Fee Payments, Technology or Inventions:

    1. NONE

    Royalty Payments, Technology or Inventions:

    1. NONE

    Stock/Stock Options, Research Sponsor:

    1. NONE

    Stock/Stock Options, Medical Equipment & Materials:

    1. NONE

    Legal Proceedings:

    1. NONE

  1. From the Department of Neurology (E.S.V., C.H., E.S.S., S.S., E.M.M., P.A.C., K.C.F.), Johns Hopkins University School of Medicine, Baltimore, MD; Department of Internal Medicine (C.N.B.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Neurology (F.L.), Icahn School of Medicine at Mount Sinai, New York, NY; Department of Neurology (J.S.W.), McGovern Medical School, The University of Texas Health Science Center at Houston (UTHealth); Department of Biostatistics (G.R.C.), University of Alabama at Birmingham; College of Pharmacy (K.K.), Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada; Department of Medical Epidemiology and Biostatistics (K.K.), Karolinska Institute, Solna, Sweden; Department of Neurology (A.S.), University of Texas Southwestern, Dallas; and Department of Community Health Sciences (R.A.M.), Max Rady College of Medicine, Rady Faculty of Health Sciences, University of Manitoba, Winnipeg, Canada.
  1. Correspondence
    Dr. Fitzgerald fitzgerald{at}jhmi.edu
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