April 5, 2021 at 7:25 pm #18273
There’s been an explosion of online ALS-related seminars and webinars – – how do you keep track?
Let’s help forum members by posting in the comments section below the details of upcoming seminars and webinars. Then come back and tell us which ones you watched and, the high points or what you learned.
If this topic post proves useful, we do one for each month.
April 5, 2021 at 7:30 pm #18275
“ALS Drug Development Webinar Series Part 1: Scientific Considerations”
Wednesday, April 7, 2021
12:00 – 1:00 PM EDT
A new NEALS webinar series on ALS drug development moderated by Dr. Richard Bedlack from the Duke ALS Clinic. This series will include talks on the preclinical development of potential therapies, the regulatory pathway, the science of trials, the clinical trial site level overview, and the importance of patient engagement.
In this installment of the webinar series, Dr. Jeremy Shefner from the Barrow Neurological Institute will review the “therapeutic misconception,” the importance of distinguishing causality from correlation, the phases of clinical trials, design considerations (inclusion criteria, controls, outcomes, effect sizes, sample sizes, durations), and define open-label extensions and what we can learn from them.
April 5, 2021 at 7:32 pm #18276
“NU-9 and the Importance of Upper Motor Neuron Health in ALS.”
Join Dr. Ozdinler, Associate Professor of Neurology at Northwestern University for a webinar on “NU-9 and the Importance of Upper Motor Neuron Health in ALS.” The webinar is sponsored by Everything ALS
April 07th 2021 at 4:00 pm PT, 7:00pm ET, 6:00pm CT, 5:00 MT
RSVP below to join the event and receive the Zoom link:
Dr. Ozdinler is an Associate Professor of Neurology at Northwestern University, Feinberg School of Medicine. She is also a faculty member at the Chemistry of Life Processes Institute, Les Turner ALS Center, Mesulam Cognitive Neurology and Alzheimer’s Disease Center and the Robert H. Lurie Comprehensive Cancer Center.
The Ozdinler Lab is interested in understanding the molecular and cellular basis of neuronal vulnerability that is observed in distinct neuron populations in different diseases. They focus on the upper motor neurons that die in ALS, HSP and PLS. However, the lab has a broad interest in the common cellular mechanisms that lead to neuronal degeneration.
April 7, 2021 at 1:35 pm #18303
“ALS Drug Development Webinar Series Part 2: Regulatory Considerations”
Peter DiRoma and Holly Fernandez Lynch, JD, MBe
Friday, April 9, 2021
12:30 – 1:30 PM EDT
Join this second installment of the NEALS webinar series on ALS drug development moderated by Dr. Jinsy Andrews from Columbia University. This series will include talks on the preclinical development of potential therapies, the regulatory pathway, the science of trials, the clinical trial site level overview, and the importance of patient engagement.
In this webinar, Peter DiRoma will take us through the regulatory process and Holly Fernandez Lynch will discuss how the COVID-19 vaccines were developed and learnings that may apply to other disease areas. Some of the highlights will include:
1. Overview of FDA regulatory mechanisms to accelerate drug development for diseases with unmet medical needs like ALS
2. Review FDA data expectations of an ALS drug development program to support (a) Phase 3 clinical trial initiation and (b) New Drug Application (NDA) submission and approval
3. Importance of collecting long-term clinical data to support safety and efficacy determinations necessary for the FDA to approve an NDA
4. Other challenges and opportunities in ALS drug development
April 10, 2021 at 10:04 pm #18403AnonymousInactive
The NU-9 with Dr Ozdinler was a zoom meeting with over 400 participants. It was worth the 90 minutes. The talk covered a lot about the brain and how the corticospinal tract worked, and how NU-9 can help to prevent the death of motor neurons.
April 12, 2021 at 11:50 am #18446
Thank you John for your feedback on this webinar. I will post the link to the recorded version as soon as it is available – – so that interested members can also watch it.
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