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Xtalks Webinar: ALS Biomarkers in Drug Development

Atlantic Research Group will be presenting a webinar via Xtalks on Tuesday, June 22, 2021 at 11am EST. Please register here.

Webinar Content Description:

Amyotrophic Lateral Sclerosis (ALS) is difficult to diagnose, because it requires ruling out other diseases, which may take months to years. Nerve cells break down and reduce functionality in the muscles they supply. ALS gradually prohibits muscle control and results in the loss of the capacity to speak, swallow, walk, move and breathe. There is a strong need for research, understanding and potential treatments in ALS. This webinar will focus on ALS biomarkers.

The first part of the webinar will provide an overview of ALS biomarkers, both fluid-based (blood, urine and cerebrospinal fluid) and non-fluid based (electrophysiology and PET/imaging). From there, the panel will focus on individual types of ALS biomarkers, discussing which are most helpful in terms of the science of the disease, including identification and diagnosis. In addition, the group will talk about the application of ALS biomarkers in drug development, addressing which are most useful and best translate in clinical research and in assessing a drug’s effect on the disease.

Specifically, the fluid-based ALS biomarkers and topics to be individually covered include genetic markers, cellular markers of neurodegeneration (markers of axon injury, neurofilaments), markers of inflammation and oxidative stress, and exploratory miRNA markers. The non-fluid-based ALS biomarkers will include electrophysiology and PET/imaging.

Biomarkers derived from blood, urine and cerebrospinal fluid provide the necessary biological information for the diagnosis and can be used as an indicator of disease progress and severity. Use of the most appropriate biomarker, in relation to a drug’s mode of action, may well be a very useful tool in better defining a study’s patient population and following the drug’s effectiveness.

It is important to note that some of the biomarkers are currently more established, understood and useful than others. The panel will touch on areas of struggle where there is lack of clarity and where researchers are not certain which biomarkers are the leads at this time. There are questions moving forward about what needs to be done and discovered, and where the gaps exist in terms of ALS biomarkers.

Finally, the panel will make specific and even controversial recommendations regarding ALS biomarkers in clinical trials. Areas to be addressed include which are must-haves in trials, which are most costly, and which are operator-dependent, as well as the ramifications in clinical research.

Register for this webinar to hear about why ALS research and biomarkers should be strongly considered in every trial moving forward.

Presenters:

  • Ignazio Di Giovanna, PhD, Vice-President, Europe, Atlantic Research Group
  • Toby Ferguson, MD, PhD, Vice-President, Head Neuromuscular Unit, Biogen
  • Angela Genge, MD, Executive Director, Clinical Research Unit (CRU), Montreal Neurological Institute

Key takeaways: 

  • Why the use of biomarkers in ALS trials should be a serious consideration
  • How some biomarkers in ALS research are more valuable than others at this time
  • How ALS biomarkers should be chosen based on the relevance to the MOA
  • How all ALS studies should be examining neurofilament biomarkers

Who Should Attend:

  • Asset Managers
  • Venture Capitalists
  • Fund Manager Scientists
  • Chief Medical/Scientific Officers
  • Investigators
  • Biomarkers Scientists
  • Clinical Scientists
  • Clinical Trialists
  • Clinical Operations Team
  • Project Management Team
  • Imaging Scientists