This activity is for healthcare professionals outside of the UK.

This activity is funded by an independent medical education grant from Amicus Therapeutics.

The activity is jointly provided by USF Health and touchIME.
touchIME is an EBAC® accredited provider.

Faculty & Disclosures

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    Faculty & Disclosures
    Prof. Tahseen Mozaffar

    UCI School of Medicine, Irvine, CA, USA

    Prof. Tahseen Mozaffar is a professor of neurology, pathology and laboratory medicine and the director of the Division of Neuromuscular Disorders at the Univeristy of California, Irvine (UCI) School of Medicine, CA, USA. read more

    Dr Mozaffar is the associate director for the Center for Translational Sciences Award (CTSA) at UCI, and also chairs one of the biomedical committees. He is the principal investigator for UCI-NEXT, the NeuroNEXT award to UCI, funded by the NINDS/NIH. He is also the lead investigator for a multicentre NIH/NIAMS funded Natural History Study in sIBM (INSPIRE-IBM), which started April 2021.

    He graduated from medical school at the Aga Khan University in Karachi, Pakistan, in 1989 and trained in neurology and neuromuscular disorders at Washington University/Barnes Hospital in St. Louis, MO, USA. Dr Mozaffar has been at UCI since 2000, where he has built an internationally recognized clinical and research programme in neuromuscular disorders. 

    He is actively involved in clinical and translational research in neuromuscular disorders, including currently serving as principal site investigator on over a dozen clinical trials in myasthenia gravis, rare and ultra-rare myopathies and immune myopathies. He has co-authored over 190 peer-reviewed publications and has authored or co-authored over a dozen book chapters and invited reviews. As an expert in these rare and ultra-rare myopathies, he is actively sought as an advisor by pharmaceutical companies for trial design and identifying disease targets. 

    He is the director of the nationally recognized Annual UCI Neuromuscular Colloquium, now in its 12th year of existence, and the founding director of the Annual Neuromuscular Pathology Colloquium, now in its 7th year.

    Dr Tahseen Mozaffar discloses: Grants/research support from Amicus, Sanofi and Spark Therapeutics (relationships terminated). Consultancy fees from Amicus, Astellas Gene Therapy, Sanofi, Maze Therapeutics (relationship terminated) and Regeneron.
    Dr Jennifer L Cohen

    Duke University, Durham, NC, USA

    Dr Jennifer L Cohen is an assistant professor of paediatrics in the Division of Medical Genetics at Duke University, Durham, NC, USA. read more

    Dr Cohen is actively involved in the Pompe disease gene therapy trial at Duke and is the site lead for a Gaucher disease gene therapy clinical trial. She has been a key part of the Pompe disease newborn screening launch in North Carolina. Dr Cohen attended Yale College and then received her MD from the Icahn School of Medicine at Mount Sinai in NYC. She completed a combined residency programme at the Children’s Hospital of Philadelphia in paediatrics and medical genetics, before joining the faculty at Duke in 2019. Her research interests and expertise are in perinatal genetic medicine with a current focus on earlier diagnosis and management of rare genetic diseases.

    Dr Cohen’s long-time research interests and training have led her to pursue the study of in utero treatment for lysosomal storage diseases in the form of an active clinical trial, and to pursue implementation of more rapid and comprehensive neonatal diagnostic testing in critically ill infants.

    Dr Jennifer L Cohen discloses: Advisory board/panel fees from Sanofi Genzyme (relationship terminated). Consultancy fees from Bayer Healthcare Pharmaceuticals (relationship terminated).
    Prof. Benedikt Schoser

    Ludwig Maximilians University, Munich, Germany

    Prof. Benedikt Schoser is professor of neurology, senior consultant neurologist and co-chair of the Friedrich-Baur-Institute, Department of Neurology, Ludwig Maximilians University, Munich, Germany. read more

    He is a trained neurologist, neurophysiologist, neurointensivist, palliative medicine doctor and muscle pathologist. He is the executive section editor of the journal Neuromuscular Disorders, and a member of the editorial boards of Current Opinions in Neurology and the European Journal of Neurology. He became a fellow of the European Academy of Neurology (EAN) in 2017 and serves as a board member of their educational, rare disease, and scientific muscle and neuromuscular panels.

    Prof. Schoser is co-chair of the joint educational board of the EAN/European Union of Medical Specialists (UEMS) and organizer of the European Neurology board exam. He is a long-term member of the World Muscle Society where he is a member of the executive board, and organizes their teaching course. Since 2015, he has chaired the European Pompe Consortium (EPOC). He has authored more than 350 peer-reviewed publications in the field myotonic dystrophies and glycogen storage diseases. Prof. Schoser’s special interests are multisystemic neuromuscular disorders, translational research and therapy.

    Prof. Benedikt Schoser discloses: Advisory board/panel fees from Alexion, Amicus, Astellas, Denali, Pepgen and Sanofi. Consultancy fees from Argenx, Avidity and Kedrion. Speaker’s bureau fees from Alexion, Astellas, Kedrion and Sanofi. Other financial or material support from Roche Diagnostics.
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    Tutorial

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    Poll

    <span style=”font-weight: 400″>How will new/emerging therapies impact Pompe disease management?</span>

    Submit your answer to see the results

    Potential for gene therapy
       
    More ERT options for tailored care
       
    Therapies reducing hospital burden
       
    Improved safety with reduced irAEs
       

    Tutorial

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    Poll

    What is the main challenge to ERT switching in your clinic?

    Submit your answer to see the results

    Lack of data to guide decisions
       
    Lack of availability of alternative ERT options
       
    No published guidelines on ERT switching
       
    No challenges in my current practice
       

    Tutorial

    These icons indicate there is something to be interacted with. Click it when you see it.

    Poll

    How do real-world data inform your management of Pompe disease?

    Submit your answer to see the results

    Guides my decisions on treatment switching
       
    Guides my patient discussions about their treatment needs
       
    Helps me better understand age-related disease burden
       
    Helps me optimize treatment (dosing and frequency)
       
     
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    Congenital Conditions CE/CME accredited

    touchCONGRESS
    Our faculty interpret key data from the congress, complimented by an expert panel discussing what has been presented. Close

    Expanding horizons for patients with Pompe disease: Using data to guide clinical practice

    Faculty Podcast Featured
    Learning Objectives

    After watching this activity, participants should be better able to:

    • Discuss long-term clinical data and real-world outcomes for current treatments for Pompe disease
    • Evaluate the outcomes associated with switching treatments for patients with Pompe disease and the potential impact on treatment practices
    • Analyse the latest clinical data for current and emerging therapies for patients with Pompe disease and how these may impact clinical practice
    Overview

    In this activity, three leading experts in Pompe disease come together in this engaging touchCONGRESS to explore the clinical implications of the latest data presented at key congresses: the 29th World Muscle Society Congress 2024 and the 21st Annual WORLDSymposiumTM 2025.

    This activity is jointly provided by USF Health and touchIME.
    touchIME is an EBAC®accredited provider. read more

    Target Audience

    This activity has been designed to meet the educational needs of neurologists, neuromuscular specialists (including lysosomal disease specialists), clinical geneticists, genetic counsellors, cardiologists, pulmonologists, paediatricians and nurse practitioners involved in the management of Pompe disease.

    Faculty

    Dr Tahseen Mozaffar discloses: Grants/research support from Amicus, Sanofi and Spark Therapeutics (relationships terminated). Consultancy fees from Amicus, Astellas Gene Therapy, Sanofi, Maze Therapeutics (relationship terminated) and Regeneron.

    Dr Jennifer L Cohen discloses: Advisory board/panel fees from Sanofi Genzyme (relationship terminated). Consultancy fees from Bayer Healthcare Pharmaceuticals (relationship terminated).

    Prof. Benedikt Schoser discloses: Advisory board/panel fees from Alexion, Amicus, Astellas, Denali, Pepgen and Sanofi. Consultancy fees from Argenx, Avidity and Kedrion. Speaker’s bureau fees from Alexion, Astellas, Kedrion and Sanofi. Other financial or material support from Roche Diagnostics.

    Content reviewer

    Danielle Walker, DNP, APRN, AGNP-C has no financial interests/relationships or affiliations in relation to this activity.

    Touch Medical Contributors

    Christina Mackins-Crabtree has no financial interests/relationships or affiliations in relation to this activity.

    USF Health Office of Continuing Professional Development and touchIME staff have no financial interests/relationships or affiliations in relation to this activity.

    Requirements for Successful Completion

    In order to receive credit for this activity, participants must review the content and complete the post-test and evaluation form. Statements of credit are awarded upon successful completion of the post-test and evaluation form.

    If you have questions regarding credit please contact cpdsupport@usf.edu.

    Accreditations

    Physicians

    This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through a joint providership of USF Health and touchIME. USF Health is accredited by the ACCME to provide continuing medical education for physicians.

    USF Health designates this enduring material for a maximum of 1.25 AMA PRA Category 1 CreditTM.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

    Advanced Practice Providers

    Physician Assistants may claim a maximum of 1.25 Category 1 credits for completing this activity. NCCPA accepts AMA PRA Category 1 CreditTM from organizations accredited by ACCME or a recognized state medical society.

    The AANPCP accepts certificates of participation for educational activities approved for AMA PRA Category 1 CreditTM by ACCME-accredited providers. APRNs who participate will receive a certificate of completion commensurate with the extent of their participation.

    Date of original release: 20 March 2025. Date credits expire: 20 March 2026.

    If you have any questions regarding credit please contact cpdsupport@usf.edu.

    EBAC® Accreditation

    touchIME is an EBAC® accredited provider since 2023.

    This programme is accredited by the European Board for Accreditation of Continuing Education for Health Professionals (EBAC®) for 1 hour 19 minutes of effective education time.

    EBAC® holds an agreement on mutual recognition of substantive equivalency with the US Accreditation Council for CME (ACCME) and the Royal College of Physicians and Surgeons of Canada, respectively.

    Through an agreement between the European Board for Accreditation of Continuing Education for Health Professionals (EBAC®) and the American Medical Association, physicians may convert EBAC® External CME credits to AMA PRA Category 1 Credits™. Information on the process to convert EBAC® credit to AMA credit can be found on the AMA website. Other health care professionals may obtain from the AMA a certificate of having participated in an activity eligible for conversion of credit to AMA PRA Category 1 Credit™.

    EBAC® is a member of the International Academy for CPD Accreditation (IACPDA) and a partner member of the International Association of Medical Regulatory Authorities (IAMRA).

    Faculty Disclosure Statement / Conflict of Interest Policy

    In compliance with EBAC® guidelines, all speakers/chairpersons participating in this programme have disclosed or indicated potential conflicts of interest which might cause a bias in the presentations. The Organizing Committee/Course Director is responsible for ensuring that all potential conflicts of interest relevant to the event have been mitigated and declared to the audience prior to the CME activities.

    Requirements for Successful Completion

    Certificates of Completion may be awarded upon successful completion of the post-test and evaluation form. If you have completed one hour or more of effective education through EBAC® accredited CE activities, please contact us at accreditation@touchime.org to receive your EBAC® CE credit certificate. EBAC® grants 1 CE credit for every hour of education completed.

    Date of original release: 20 March 2025. Date credits expire: 20 March 2027.

    Time to Complete: 1 hour 19 minutes

    If you have any questions regarding the EBAC® credits, please contact accreditation@touchime.org

    Course Modules

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    This activity is funded by:

    An independent medical education grant from Amicus Therapeutics.

    This activity is jointly provided by USF Health and touchIME.
    touchIME is an EBAC® accredited provider.

    USF Health

    The information provided by this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

    USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

    USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CME to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

    Date of original release: 20 March 2025. Date credits expire: 20 March 2026.

    EBAC®

    touchIME is an EBAC® accredited provider since 2023.

    In compliance with EBAC® guidelines, all speakers/chairpersons participating in this programme have disclosed or indicated potential conflicts of interest which might cause a bias in the presentations. The Organizing Committee/Course Director is responsible for ensuring that all potential conflicts of interest relevant to the event are declared to the audience prior to the CME activities.

    Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

    This content is intended for healthcare professionals.

    Date of original release: 20 March 2025. Date credits expire: 20 March 2027.

    Claim Credit
    touchCONGRESS
    Expanding horizons for patients with Pompe disease: Using data to guide clinical practice
    1.25 CE/CME credit
    Question 1/5
    Based on real-world data presented at WORLDSymposium 2025, which of the following statements best describes the predominant healthcare-related costs associated with Pompe disease for ERT-treated patients in the United States?

    ERT, enzyme replacement therapy.

    A retrospective cohort study conducted using a United States claims database over an 11-year period (1 January 2012 to 30 September 2022) provides insights into healthcare resource utilization and costs associated with Pompe disease in ERT-treated patients with IOPD (n=50) and LOPD (n=55) in the real-world. The study authors concluded Pompe disease incurs substantial economic burden for ERT-treated patients in the United States, predominantly due to the all-cause costs of outpatient visits (IOPD: 308,421;LOPD:778,190) and ERT prescription costs (IOPD: 211,536;LOPD:566,938). 

    Abbreviations

    ERT, enzyme replacement therapy; IOPD, infantile-onset Pompe disease; LOPD, late-onset Pompe disease.

    Reference

    Steiner RD, et al. Presented at 21st Annual WORLDSymposium 2025. San Diego, CA, USA. 3–7 February 2025. Abstr. 331.

    Question 2/5
    Your patient is a 32-year-old with LOPD who has been treated with alglucosidase alfa for the past 2 years. Together with the MDT involved in the care of this patient, you are discussing the possibility of switching therapy to avalglucosidase alfa, and its potential impact on motor function. Based on preliminary data on treatment switching presented at the World Muscle Society meeting 2024, which of the following statements would you consider making about switching to avalglucosidase alfa from prior ERT with alglucosidase alfa?

    ERT, enzyme replacement therapy; LOPD, late-onset Pompe disease; MDT, multidisciplinary team.

    Motor function outcomes data from patients with LOPD enrolled in the Pompe Registry (NCT00231400) who switched treatments from alglucosidase alfa to avalglucosidase alfa were reported at the World Muscle Society 2024 meeting. Preliminary results at 1-year post treatment switch showed motor function remained relatively stable, as demonstrated by a 6-minute walk test distance of ~400 metres maintained between last assessment pre-switch and first assessment post-switch in the overall population assessed and across patient subgroups stratified by duration of prior ERT with alglucosidase alfa (<5 years, and ≥5 years). The authors acknowledged the limitations of these data, as availability of post-switch data was limited and the duration on avalglucosidase alfa was short.

    Abbreviations

    ERT, enzyme replacement therapy; LOPD, late-onset Pompe disease. 

    Reference

    Schoser B, et al. Presented at: 29th Annual Congress of the World Muscle Society 2024, Prague, Czechia. 8–12 October 2024. P668.

    Question 3/5
    Your patient is a 49-year-old with LOPD who has been receiving ERT with ALG for 8 years. Monitoring in this patient has shown a steady deterioration in motor function and pulmonary outcomes over recent months. You are discussing with them the possibility of switching to CIPA + MIG, and your patient asks you what is known about this treatment. Based on recent data from a post hoc analysis of the PROPEL study (NCT03729362) presented at the WORLDSymposium 2025, how might you counsel this patient?

    6MWD, 6-minute walking distance; ALG, alglucosidase alfa; CIPA, cipalglucosidase alfa; ERT, enzyme replacement therapy; FVC, forced vital capacity; IAR, infusion-associated reaction; LOPD, late-onset Pompe disease; MIG, miglustat; PBO, placebo.

    Post hoc analyses of the PROPEL study (NCT03729362) presented at WORLDSymposium 2025 reported that among patients with LOPD who switched from alglucosidase alfa to cipalglucosidase alfa plus miglustat (n=65), 50.8% were classified as having a clinically relevant improvement in 6MWD and/or FVC after switching ERT; meanwhile, 13.3% of patients with LOPD receiving alglucosidase alfa plus placebo (n=30) showed a clinically relevant improvement in 6MWD and/or FVC. Safety profiles were comparable across both treatment arms.

    Abbreviations

    6MWD, 6-minute walk distance; ERT, enzyme replacement therapy; FVC, forced vital capacity; LOPD, late-onset Pompe disease.

    Reference

    Schoser B, et al. Presented at: WORLDSymposium 2025, San Diego, CA, USA. 3–7 February 2025. Abstr. 303.

    Question 4/5
    Based on data presented at WORLDSymposium 2025, which of the following statements best describes the role of miglustat in the ERT-based management of Pompe disease?

    ERT, enzyme replacement therapy; rhGAA, recombinant human acid alpha glucosidase.

    A review of pre-clinical and clinical data for the enzyme stabilizer miglustat, presented at WORLDSymposium 2025, reported that miglustat stabilizes ERT (cipalglucosidase alfa and alglucosidase alfa) at pH 7.4 in the blood.

    Abbreviations

    ERT, enzyme replacement therapy. 

    Reference

    Hopkin RJ, et al. Presented at 21st Annual WORLDSymposium 2025. San Diego, CA, USA. 3–7 February 2025. Abstr. 139.

    Question 5/5
    Your 36-year-old patient with LOPD is currently enrolled in a phase I/II, open-label, gene therapy trial in Pompe disease. Based on data from the FORTIS trial presented at WORLDSymposium 2025, which of the following would you consider a priority in terms of safety management in this patient?

    BNP, B-type natriuretic peptide; LOPD, late-onset Pompe disease.

    A safety update from the FORTIS phase I/II trial evaluating AT845 (a gene replacement therapy) in patients with LOPD (n=6) reported that patients who experienced liver events (e.g. elevation in ALT and AST levels) (n=5) responded to immunosuppressive treatment with glucocorticoid therapy.1 Immunomodulatary agents are available to manage outcomes to viral gene therapy;2 prophylactic immunosuppression has been used in gene therapy trials (for other monogenic diseases) to manage vector-related increases in liver aminotransferase levels.3 

    Abbreviations

    ALT, alanine aminotransferase; AST, aspartate aminotransferase; LOPD, late-onset Pompe disease. 

    References

    1. Mozaffar T, et al. Presented at 21st Annual WORLDSymposium 2025. San Diego, CA, USA. 3–7 February 2025. Abstr. 236. 
    2. McNally E. J Clin Invest. 2024;134:e177078.
    3. Chowdary P, et al. N Engl J Med. 2022;387:237–47
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    This activity is funded by:

    An independent medical education grant from Amicus Therapeutics.

    This activity is jointly provided by USF Health and touchIME.
    touchIME is an EBAC® accredited provider.

    USF Health

    The information provided by this CME activity is for continuing education purposes only and is not meant to substitute for the independent medical/clinical judgment of a healthcare provider relative to diagnostic and treatment options of a specific patient’s medical condition.

    USF is an Equal Opportunity / Affirmative Action / Equal Access Institution.

    USF Health is accredited by the Accreditation Council for Continuing Medical Education, the American Nurses Credentialing Center and the Accreditation Council for Pharmacy Education to provide continuing education to healthcare professionals. As an accredited provider, USF Health is required to disclose personal information to relevant accredited bodies that certify CME to process credits/contact hours, comply with reporting requirements, and for internal recordkeeping and regulatory purposes. USF Health does not share or sell any individual’s contact information or unique identifiers to any commercial supporter, advertiser, or third party without the specific permission of the individual.

    Date of original release: 20 March 2025. Date credits expire: 20 March 2026.

    EBAC®

    touchIME is an EBAC® accredited provider since 2023.

    In compliance with EBAC® guidelines, all speakers/chairpersons participating in this programme have disclosed or indicated potential conflicts of interest which might cause a bias in the presentations. The Organizing Committee/Course Director is responsible for ensuring that all potential conflicts of interest relevant to the event are declared to the audience prior to the CME activities.

    Unapproved products or unapproved uses of approved products may be discussed by the faculty; these situations may reflect the approval status in one or more jurisdictions. The presenting faculty have been advised by touchIME and USF Health to ensure that they disclose any such references made to unlabelled or unapproved use. No endorsement by touchIME or USF Health of any unapproved products or unapproved uses is either made or implied by mention of these products or uses in touchIME or USF Health activities. touchIME and USF Health accept no responsibility for errors or omissions.

    This content is intended for healthcare professionals.

    Date of original release: 20 March 2025. Date credits expire: 20 March 2027.

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