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International Alliance of ALS/MND Associations

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  • What is ALS/MND
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  • Support for PALS & CALS
    • Fundamental Rights for People with ALS/MND and Caregivers
    • Research
      • Voice Preservation
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      • Expanded Access
      • Understanding ALS/MND Research
      • Improving Regulatory Pathways
      • Right to Try
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      • Advocacy Toolkit
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    • Drugs in Development
      • AB Science – Masitinib
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      • Collaborative Medicinal Development – CuATSM
      • ILB – Tikomed
      • Kadimastem – AstroRx
      • Mitsubishi Tanabe Pharma America – Oral Edaravone
      • Neuronata-R/Lenzumestrocel
      • NeuroSense – PrimeC
      • Neuvivo – NP001
      • Prilenia Therapeutics – Pridopidine
      • T Regulatory Cell Therapies
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    • Approved Drugs
      • Nuedexta
      • Radicava/Edaravone
      • Riluzole/Tiglutik
      • Rozebalamin/Methylcobalamin
      • Tofersen/Qalsody
    • Drugs No Longer in Development
      • Amylyx – AMX0035
      • Collaborative Medicinal Development – CuATSM
      • Cytokinetics – Reldesemtiv
      • Orphazyme – Arimoclomol
      • TUDCA Trial
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Improving Regulatory Pathways

The International ALS/MND Alliance seeks to encourage all international regulatory agencies to develop a framework for global alignment in evaluating potential new therapies for people living with ALS/MND. The Alliance believes that the ALS/MND community and all stakeholders will benefit from a more cooperative global approach to evaluation of risks and benefits of novel therapies, especially given the global nature of drug development and clinical trial conduct. People living with ALS/MND – regardless of where they reside – have extraordinary unmet need and seek the fastest and widest possible access to potentially beneficial therapies. Given the devastating nature of ALS/MND, this community cannot wait for excessive procedural delays caused by sequential reviews and hand-offs.

Pivotal clinical trials in ALS/MND are often conducted internationally and these global trials are increasingly important for investigating the safety and effectiveness of ALS/MND drugs for approval. Future drug development may benefit by establishing a greater uniformity of new global standards of treatment, leading to the optimal design of these important trials. There should be a cooperative, harmonized, pathway to approval which increases effectiveness and expediency for treatments of ALS/MND guided by the following principles.

Please download our full report on improving regulatory pathways.

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Advocacy

  • Advocacy Toolkit

  • Hans Dieter Olszewski, Diagnosed 2010 , DGM, Germany

    Hans Dieter Olszewski, Diagnosed 2010 , DGM, Germany

  • Phil Rossall, MND-Association, UK

    Phil Rossall, MND-Association, UK

  • Dorette Lüdi, Diagnosed 2014 , ALS Schweiz, Switzerland

    Dorette Lüdi, Diagnosed 2014 , ALS Schweiz, Switzerland

  • Jon Newsome, Les Turner ALS Foundation, USA

    Jon Newsome, Les Turner ALS Foundation, USA

  • Chih Ching Darren Wong, MND Malaysia

    Chih Ching Darren Wong, MND Malaysia

  • Bayley, Australia

    Bayley, Australia

  • Ali Var, Turkey

    Ali Var, Turkey

  • Conny van der Meijden, Diagnosed 2001,  ALS Netherlands

    Conny van der Meijden, Diagnosed 2001, ALS Netherlands

  • Zelina Brito, Diagnosed 2018, Brazil

    Zelina Brito, Diagnosed 2018, Brazil

  • Den Haag, Diagnosed 2016 , The Netherlands

    Den Haag, Diagnosed 2016 , The Netherlands

  • 727747090571358167

    727747090571358167

  • Fabio Correia

    Fabio Correia

  • Dad

    Dad

  • Ian Roberts

    Ian Roberts

  • Lombana, Spain

    Lombana, Spain

  • Josée Kolijn-de Man, Diagnosed 2015 , ALS Patients Connected, The Netherlands

    Josée Kolijn-de Man, Diagnosed 2015 , ALS Patients Connected, The Netherlands

  • Dawn Morton, Diagnosed 2014 , MND Scotland, UK

    Dawn Morton, Diagnosed 2014 , MND Scotland, UK

  • Yessenia Hernandez Mendoza, Apoyo Integral Gila A.C., Diagnosed 2018, Mexico

    Yessenia Hernandez Mendoza, Apoyo Integral Gila A.C., Diagnosed 2018, Mexico

  • John Dinon, MND Australia

    John Dinon, MND Australia

  • Anthony (Tony) Lynch, MND New South Wales, Diagnosed 2016, Australia

    Anthony (Tony) Lynch, MND New South Wales, Diagnosed 2016, Australia

  • Mark Miller

    Mark Miller

  • Glen Elison,  ALS Hope Foundation,  Diagnosed 2019,  USA

    Glen Elison, ALS Hope Foundation, Diagnosed 2019, USA

  • Joyce Rusinak, Forbes Norris ALS Center, USA

    Joyce Rusinak, Forbes Norris ALS Center, USA

  • Jon Newsome, USA

    Jon Newsome, USA

  • Tison, USA

    Tison, USA

  • Ian and Teresa Roberts

    Ian and Teresa Roberts

  • Natalya Rybakova, Russia

    Natalya Rybakova, Russia

  • Jean Waters, Diagnosed 2004, MND Association of England, Wales and N Ireland

    Jean Waters, Diagnosed 2004, MND Association of England, Wales and N Ireland

  • Ana María Zavala, FYADENMAC, Diagnosed 2019, Mexico

    Ana María Zavala, FYADENMAC, Diagnosed 2019, Mexico

  • 393647_2252248542053_984912751_n

    393647_2252248542053_984912751_n

  • Frank "Papa" Taylor

    Frank “Papa” Taylor

  • Steven Gallagher, Canada

    Steven Gallagher, Canada

  • Malcolm Buck, Australia

    Malcolm Buck, Australia

  • unnamed

    unnamed

  • João Marcos Andrietta, Diagnosed 2008 , ABrELA, Brazil

    João Marcos Andrietta, Diagnosed 2008 , ABrELA, Brazil

  • Dr Shelly Hoover

    Dr Shelly Hoover

  • Eric Von Schaumburg, USA

    Eric Von Schaumburg, USA

  • Roxana Canova, Diagnosed 2012 ,  Asociación ELA Argentina

    Roxana Canova, Diagnosed 2012 , Asociación ELA Argentina

  • Ismail Gokcek, Turkey

    Ismail Gokcek, Turkey
    ismail_gokcek_alsmnd_tr

  • IMG_2658

    IMG_2658

  • Steve Gallagher, ALS Society of Canada

    Steve Gallagher, ALS Society of Canada
    Picture1

  • Mike Small, Motor Neurone Disease (MND) Association, UK

    Mike Small, Motor Neurone Disease (MND) Association, UK

  • Horacio Fritzer, Argentina

    Horacio Fritzer, Argentina

  • Imelda Arenas, ACELA, Colombia

    Imelda Arenas, ACELA, Colombia

  • Claudia Cominetti, Associazione conSLAncio Onlus,  Italy

    Claudia Cominetti, Associazione conSLAncio Onlus, Italy

  • Ada Garrido Benavidez, Diagnosed 2016,  FYADENMAC, Mexico

    Ada Garrido Benavidez, Diagnosed 2016, FYADENMAC, Mexico

  • H. Todd Kelly, Diagnosed 2013 , ALS Hope Foundation, USA

    H. Todd Kelly, Diagnosed 2013 , ALS Hope Foundation, USA

  • Kris Van Reusel, Belgium

    Kris Van Reusel, Belgium

  • Hanne Stenmose, Muskelsvindfonden, Denmark

    Hanne Stenmose, Muskelsvindfonden, Denmark

  • Hollister

    Hollister
    hollister

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