Agenda

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10:00 - 12:15

Conference Welcome & Presidential Symposium

10:00 – 10:05 AM (EST)  Welcome to ASENT2022 Annual Meeting & Housekeeping

 Jessica Smith, Executive Director ASENT

10:05 – 10:10 AM (EST)  Welcome to ASENT2022 Annual Meeting 

 Thomas Sutula, MD, PhD, ASENT President / Professor Emeritus, University of Wisconsin-Madison

10:10 – 12:00 PM (EST)  PRESIDENTIAL SYMPOSIUM 

Rare Neurological Disorders – presented in partnership with the National Organization for Rare Disorders (NORD)

The Presidential Symposium, held in conjunction with the National Organization for Rare Disorders, will focus on the challenges of Rare Neurological Disorders, addressing approaches to diagnoses, development of therapeutic interventions, and regulatory issues including barriers and successes and innovative initiatives.

CHAIRS:

 Bennett Lavenstein, MD, Children’s National Hospital

 Thomas Sutula, MD, PhD, University of Wisconsin-Madison

10:10 – 10:20 AM (EST)  Introduction to Rare Disease Neurotherapeutic

 Peter Saltonstall, National Organization for Rare Disorders (NORD)

10:20 – 10:40 AM (EST)  Piloting Individualized Therapies for Orphan Neurogenetic Disease

 Timothy Yu, MD, PhD, Boston Children's Hospital and Harvard Medical School

10:40 – 11:00 AM (EST)  Accelerating the Development of Treatments for Rare Diseases: Gene-Targeted Therapies & the Bespoke Gene Therapy Consortium

 Edward Neilan, MD, PhD, National Organization for Rare Disorders (NORD)

11:00 – 11:20 AM (EST)   A voyage from Academia to Biotech

 Edward M. Kaye, MD, Stoke Therapeutics

11:20 – 11:40 AM (EST)   Issues in Orphan Products Development – especially in Neurodevelopmental Diseases

 Marlene Haffner, MD, MPH, Haffner Associates

11:40 – 12:00 AM (EST)  Live Faculty Panel Discussion – FULL PANEL

12:00 – 12:15 PM (EST)  BREAK

12:15 - 13:35

BREAKOUT SESSIONS (Hall A or B)

HALL A - Antisense Oligonucleotide Therapy in Rare Neurological Diseases

CHAIRS: 

 Bryan J. Traynor, MD, PhD, National Institutes of Health, National Institute on Aging

 C. Anthony Altar, PhD, Splice Therapeutics

HALL B - Emerging Brain Lipid Pharmacology for Neurodegenerative Disorder 

CHAIR: 

 Aditya Joshi, PhD, Penn Medicine - University of Pennsylvania

13:35 - 14:15

MAIN PLENARY: SynapCell Sponsored Symposium

1:35 – 2:15 PM (EST)  FORGING NEW FRONTIERS IN THE DISCOVERY OF NEUROTHERAPEUTICS 

Moderator:
 Thomas Sutula, MD, PhD, University of Wisconsin-Madison

Julien Volle, PhD, Head of Technology, SynapCell SAS (France)

Biomarkers are indispensable tools for drug discovery, as they are used extensively to assess the activity of novel neurotherapeutic compounds, investigate the mechanism of action, and predict therapeutic efficacy across a wide range of CNS disorders.

EEG is routinely used in the clinical practice and represents a direct window on brain function with high time resolution and great sensitivity. Our EEG-based Cue® technology platform measures neural activity in an objective and precise way, offering at the same time reproducibility of the results and countless paradigms. EEG is a versatile instrument which can be complemented by different approaches to create the most exhaustive profile when testing new neurotherapeutics and improve translation effectiveness from the preclinical to the clinical setting.

  • Introduction      
  • Addressing the challenges in discovering new Neurotherapeutics 
  • Supporting your drug discovery journey with a multimodal tech platform 
  • Fields of application: Case studies 
  • Future directions for improving the drug discovery process
  • Conclusion 
  • Q&A
14:15 - 15:15

POSTER DISCUSSION

2:15 – 3:15 pm (EST)  POSTER DISCUSSION 

Click here to join the POSTER DISCUSSION

We would like to acknowledge our YOUNG SCHOLARS: MABEL CHEN, Mounds View High School, and AARON TANG, The Bronx High School of Science.

MODERATOR:
 Carolyn Tallon, PhD, Johns Hopkins University School of Medicine

The following posters presenters will be available for a live Q&A and discussion:

  1. The relevance of EEG biomarkers in evaluating the anti-dyskinetic effect of drugs in Parkinson’s disease
    Venceslas Duveau, PhD, Synapcell
     
  2. 40Hz-Auditory steady-state response in rodents, a new tool for drug discovery in schizophrenia?
    Julien Volle, PhD,     Synapcell
     
  3. Optimising the discovery and selection of new therapeutic strategies in epilepsy
    Corinne Roucard, PhD,     Synapcell
     
  4. Accelerating New Therapeutic Approaches for the treatment of Brain Disorders through NINDS/DTR Translational Research-BPN Funded Program
    Mohamed Hachicha, PhD,     National Institute of Neurological Disorders and Stroke (NINDS)
     
  5. Preclinical testing of drug mimics of the ketogenic diet in fragile X mice
    Cara Westmark, PhD,     University of Wisconsin-Madison
     
  6. Inhibiting elevated GCPII activity in aging mouse muscle reduces frailty
    Tawnjerae Joe, BS,     Johns Hopkins University School of Medicine
     
  7. Experimental substantiation of new target links in complex therapy of prenatal CNS damage. Pharmacological modulation of HSP70 – dependent mechanisms of endogenous neuroprotection
    Igor Belenichev, PhD, Zaporizhzhia State Medical University, Ukraine
     
  8. A Comprehensive Approach to Biomarker Discovery for Chemotherapy-Induced Peripheral Neuropathy (CIPN)
    Anukriti Sharma, PhD,     Cleveland Clinic
     
  9. The CURE Epilepsy Catalyst Award: Grant Opportunity For Translational Research in Epilepsy
    Priya Balasubramanian, PhD, CURE Epilepsy
     
  10. Digital Assessment of Patients with Glioblastoma in a Multicenter Trial
    Yasaman Damestani, PhD,     Karyopharm Therapeutics
     
  11. Evolution of EEG Spiking after Brain Injury
    Rehan Raiyyani, BS, Massachusetts General Hospital
     
  12. Niemann-Pick Disease Type C1 inhibition leads to loss of barrier integrity and altered metabolic phenotype in brain microvascular endothelial cells
    Bilal Abdul Moiz, BA, University of Maryland College Park
     
  13. Deep Brain Stimulation: Neural Tissue Response and Analysis of Adverse Events
    Mabel Chen,     Mounds View High School
     
  14. Analysis of Adverse Events Associated With Neurovascular Embolization Devices
    Aaron Tang,     The Bronx High School of Science
     
  15. Patient Profiles in Drug Resistant Epilepsy (DRE): Vagus Nerve Stimulation (VNS) vs. Responsive Neurostimulation (RNS)/Deep Brain Stimulation (DBS)
    Tom Vincent, MPA, MPH, Evidera
     
  16. Life After the Coronavirus Disease of 2019 Pandemic: Lessons Learned and Recommendations for Reducing Non-Compliance in Clinical Research
    Matthew Gooden, MS, National Institute of Health/National Institute of Neurological Disorders and Stroke (NINDS)
     
  17. Optical imaging for Brain MRI molecular contrast agent development 
    Shiran Su, BS, Washington University in St. Louis, National Institute of Health
     
  18. A Prescription Digital Therapeutic for Substance Use Disorder: Real World Engagement and Abstinence Patterns
    Xiaorui Xiong, PhD, Pear Therapeutics, Inc.
     
  19. Real-world use and clinical outcomes after 24 weeks of treatment with a prescription digital therapeutic for opium use disorder
    Yuri Maricich, PhD, Pear Therapeutics, Inc.
12:15 - 13:35

CONCURRENT SYMPOSIUM 1 - Antisense Oligonucleotide Therapy in Rare Neurological Diseases

12:15 – 1:30 PM (EST)  

FDA approval for an antisense oligonucleotide (ASO) that addresses a previously untreated disease, spinal muscular atrophy, has increased discovery and development efforts for this class of gene therapies. Three experts in ASO therapeutics will describe the application of ASO technology to the treatment of rare neurological diseases. The session will discuss recent advances in ASO delivery, toxicity, manufacturing, N=1 studies, and emphasize ASO applications to rare neurological diseases, including ALS and neuromuscular disease.

CHAIRS:

 Bryan J. Traynor, MD, PhD, National Institutes of Health, National Institute on Aging

 C. Anthony Altar, PhD, Splice Therapeutics

12:15 – 12:35 PM (EST)  Progress in ASO Therapeutics for Rare Diseases

 Jonathan Watts, PhD, University of Massachusetts Medical School

12:35 – 12:55 PM (EST)  Bioconjugate and Nanotechnology for Oligonucleotide Delivery

 Matthew Wood, MD, DPhil, University of Oxford (UK)

12:55 – 1:15 PM (EST)  Computational Cellular and Chemical Approaches to Reduce ASO Neurotoxicity

 Peter Hagedorn, MSc, PhD, Roche Pharma, Research and Early Development

1:15 – 1:30 PM (EST)  Live Faculty Panel Discussion – FULL PANEL

12:15 - 13:35

CONCURRENT SYMPOSIUM 2 - Emerging Brain Lipid Pharmacology for Neurodegenerative Disorders

12:15 – 1:30 PM (EST)  

Lipids account for up to 50% of the brain’s dry weight and comprise thousands of distinct biochemical structures whose subcellular and intracellular expression regulates many levels of neurobiology including organelle homeostasis, synaptic function, stress responses, cell death, inflammation and repair. Not surprisingly, a key role for lipid biochemistry dysregulation has been emerging in neurological disorders involving myelin repair, neuroinflammation, and neurodegeneration. Indeed, the major genetic risk factors driving Alzheimer’s disease and Parkinson’s disease, the most common neurodegenerative disorders, participate in lipid homeostasis (APOE4 and GBA respectively). Advances in genomic, proteomic and lipidomic technologies as well as translational model systems are providing new opportunities for pharmacological approaches to regulate brain lipids. Several such approaches are currently in clinical development and are taking advantage of readily available peripheral lipid biomarkers.

CHAIRS:

 Aditya Joshi, PhD, Penn Medicine - University of Pennsylvania

12:15 – 12:30 PM (EST)  Development of a glucocerebrosidase activator for the GBA subtype of Parkinson's disease

 Peter Lansbury, PhD, Bial Biotech

12:30 – 12:45 PM (EST)  Fatty acid metabolism controls the reparative phenotype of phagocytes in the CNS

 Jeroen Bogie, PhD, Hasselt University (Belgium)

12:45 – 1:00 PM (EST)  Targeting APOE metabolism to reduce neurodegeneration and inflammation

 Jason Ulrich, PhD, Washington University at St. Louis

1:00 – 1:15 PM (EST)  Targeting a-Synuclein Lipidopathy in Parkinson’s Disease with YTX-7739, a Brain Penetrant Stearoyl CoA Desaturase Inhibitor

  Dan Tardiff, PhD, Yumanity Therapeutics Inc.

1:15 – 1:30 PM (EST)  Live Faculty Panel Discussion – FULL PANEL

10:00 - 11:30

PLENARY SESSION - Alzheimer’s Disease After Aducanumab

10:00 – 11:15 AM (EST)  

The goal of the symposium is to present the economic and healthcare industry implications of the controversial regulatory approval of Aducanamab, a fair-minded review of the evidence, the process, an overview of the implications for future Alzheimer’s and other neurologic drug development as well as other research areas in AD that are possible, such as Amyloid backups, Tau, and inflammation.

CHAIR: 

 Andrew Cole, MD, FRCP (C), Harvard Medical School

 Thomas Sutula, MD, PhD, ASENT President / Professor Emeritus, University of Wisconsin-Madison

 

10:00 – 10:25 AM (EST)  Regulatory Focus on Alzheimer’s after Aducanumab

 Jalayne Arias, JD, MA, Georgia State University

10:25 – 10:50 AM (EST)  Research Focus on Alzheimer’s after Aducanumab

 Karl Herrup, PhD, University of Pittsburgh School of Medicine

10:50 – 11:15 AM (EST)  Live Faculty Panel Discussion – FULL PANEL

11:15 – 11:30 AM (EST)  BREAK

11:30 - 12:45

BREAKOUT SESSIONS (Hall A or B)

HALL A - Devices and Software as Therapeutics for Substance Use Disorders (SUD)

CHAIRS:

 Stacie Gutowski, PhD, National Institutes of Health/ National Institute of Drug Abuse

 Cynthia Rothblum-Oviatt, PhD, Scientific Advisory Consultant/RO Scientific

HALL B - AI/Machine Learning in Repurposing Drugs for Alzheimer’s Disease

CHAIRS: 

 Jean Yuan, PhD, The National Institutes of Health/National Institute on Aging 

 Danilo Vitorovic, PhD, Loma Linda University Health

12:45 - 13:00

Break

13:00 - 15:05

PIPELINE PRESENTATIONS – Emerging Neurotherapeutics Pipeline

1:00 – 3:30 PM (EST)  PIPELINE PRESENTATIONS

CHAIRS:

 Stewart Factor, DO, Emory University 

 Carolyn Tallon, PhD, Johns Hopkins University School of Medicine

  1. The NIH HEAL Initiative/National Institute of Neurological Disorders and Stroke’s Early Phase Pain Investigation Clinical Network (EPPIC-Net): Year 2 Update
    Barbara Karp, MD, National Institute of Neurological Disorders and Stroke (NINDS)/NIH
     
  2. The NIH HEAL Initiative Preclinical Screening Platform for Pain (PSPP) efforts to accelerate development of non-opioid, non-addictive pain therapeutics: validation of the monoiodoacetate (MIA) model of osteoarthritis pain and chemotherapy-induced neuropathy in the rat
    Smriti Iyengar, PhD, National Institute of Neurological Disorders and Stroke (NINDS)/NIH
     
  3. Brain Penetrant scFv Antibody Block of P2X4 Receptor for Treatment of Chronic Pain
    Karin N Westlund High, PhD, University of New Mexico Health Sciences Center
     
  4. Prescription Digital Therapeutics: reSet and reSet-O from the clinical to the real world
    Yuri Maricich, MD, MBA, Pear Therapeutics 
     
  5. Inhibition of EV biogenesis reduces tau propagation in seeded tau model of Alzheimer’s Disease
    Carolyn Tallon, PhD, Johns Hopkins University School of Medicine
     
  6. Non-Addictive Analgesic Small Antibody Therapeutic Development Targeting CCKBR
    Adinarayana Kunamneni, PhD, Mayo Clinic, Jacksonville, Florida
     
  7. Alzheimer’s Disease Preclinical Efficacy Database: Improving the scientific rigor, reproducibility, and predictive value of preclinical research for Alzheimer’s disease
    Shreaya Chakraborty, PhD, National Institute on Aging | National Institutes of Health
     
  8. Novel, non-opioid, non-addictive intrathecal therapy for the treatment of chronic pain
    James Campbell, MD    , Centrexion Therapeutics
11:30 - 13:00

CONCURRENT SYMPOSIUM 3 - Devices and Software as Therapeutics for Substance Use Disorders (SUD)

11:30 – 12:45 PM (EST)  

Exacerbated by COVID-19, the opioid epidemic continues to ravage the United States. In addition to canonical pharmacologic and psychological approaches to SUD treatment, innovative device-based therapeutic solutions, including software as medical device, have recently emerged. During this symposium, the executives from some of the most disruptive and innovative device startups in today’s healthcare ecosystem will discuss the opportunities and challenges of this new field.

CHAIR: 

 Stacie Gutowski, PhD, National Institutes of Health/ National Institute of Drug Abuse

 Cynthia Rothblum-Oviatt, PhD, Scientific Advisory Consultant/RO Scientific

11:30 – 11:50 AM (EST)  Woebot for Substance Use Disorders

 Athena Robinson, PhD, Woebot Health

         Maddie Pirner, MS, Woebot Health

11:50 – 12:10 PM (EST)  Software-based therapeutics: longitudinal data on impact of disease as an emerging standard of treatment

 Yuri Maricich, MD, MBA, Pear Therapeutics

12:10 – 12:30 PM (EST)  Clinical applications of transcutaneous auricular neurostimulation for opioid use disorder

 Navid Khodaparast, PhD, Spark Biomedical

12:30 – 12:45 PM (EST)  Live Faculty Panel Discussion – FULL PANEL

12:45 – 1:00 PM (EST)  BREAK

11:30 - 13:00

CONCURRENT SYMPOSIUM 4 - AI/Machine Learning in Repurposing Drugs for Alzheimer’s Disease

11:30 – 12:45 PM (EST)  

The emergence of biomedical big data and advances in computational technology have created unprecedented opportunities for drug repositioning and combination therapy development, particularly for CNS diseases including Alzheimer’s Disease (AD). In this symposium, you will have the opportunity to hear the most recent progress made from academic investigators, and to learn from biopharma senior scientists in sharing their drug repurposing effort from industry. The opportunities and challenges will also be discussed to help realize the full potential of drug repurposing for AD and CNS diseases.

CHAIRS:

 Jean Yuan, PhD, The National Institutes of Health/National Institute on Aging 

 Danilo Vitorovic, PhD, Loma Linda University Health

11:30 – 11:50 AM (EST)  Computational Methods and Practical Considerations in Repurposing Drugs for Neurosciences

 Pankaj Agarwal, PhD, BioInfi

11:50 – 12:10 PM (EST)  From Machine Learning to Basket Clinical Trial: Testing the JAK inhibitor baricitinib in Alzheimer’s disease and ALS

 Mark W. Albers, MD, PhD,  Massachusetts General Hospital, Harvard Medical School 

12:10 – 12:30 PM (EST)  Precision Medicine and Computational Drug Repurposing for Alzheimer’s Disease

 Yadong Huang, MD, PhD, University of California, San Diego (UCSD) 

12:30 – 12:45 PM (EST)  Live Faculty Panel Discussion – FULL PANEL

12:45 – 1:00 PM (EST)  BREAK

10:00 - 11:30

PLENARY SESSION -  Emerging Science of the Exposome and its Significance to Neurotherapeutics

10:00 – 11:15 AM (EST)   

The exposome is defined as all exposures a person receives during the lifespan including internal (e.g., microbiome) and external (e.g., physical-chemical, social) sources. Major progress is being made in data collection, curation, and analysis. This session will discuss the exposome concept, significance of the exposome within the neurological disease community, and scientific approaches to advance the field of exposome research and how these could be used in experimental neurotherapeutics.

CHAIR: 

 David Jett, PhD, National Institute of Neurological Disorders and Stroke (NINDS)

 Cynthia Rothblum-Oviatt, PhD, Scientific Advisory Consultant/RO Scientific

10:00 – 10:20 AM (EST)  The Exposome: A Tool For Discovery

 Yuxia Cui, PhD, National Institute of Environmental Health Sciences

10:20 – 10:40 AM (EST) ALS and the Exposome

 Eva L. Feldman, MD, PhD, University of Michigan, Department of Neurology

10:40 – 11:00 AM (EST)  Exposomics: Environmental Insights for Neurotherapeutics

 Gary W. Miller, PhD, Columbia University 

11:00 – 11:15 AM (EST)  Live Faculty Panel Discussion – FULL PANEL

11:15 – 11:30 AM (EST)  BREAK

11:30 - 13:00

BREAKOUT SESSIONS (Hall A or B)

HALL A - Innovative Treatments for Rare Neurodevelopmental Diseases

CHAIRS:

 Joseph Sullivan, MD, University of California, San Francisco (UCSF)  

 Elizabeth Berry-Kravis, MD, PhD, Rush University Medical Center

HALL B - The Use of Digital Monitoring Devices in Neurological Clinical Studies

CHAIRS:

 Sharon Tamir, Karyopharm Therapeutics Inc.  

 Suhayl Dbib-Jalbut, PhD, Rutgers-Robert Wood Johnson (RWJ) Medical School

13:00 - 13:15

Break

13:15 - 15:15

PIPELINE PRESENTATIONS – Emerging Neurotherapeutics Pipeline

01:15 - 3:15 PM (EST)  PIPELINE PRESENTATIONS

CHAIRS: 

 Stewart Factor, DO, Emory University 

 Carolyn Tallon, PhD, Johns Hopkins University School of Medicine 

  1. Fenfluramine (Fintepla®) Treatment Improves Everyday Executive Functioning in Preschool Children With Dravet Syndrome: Analyses From 2 Pooled Phase 3 Trials
    Kim Bishop, PhD, Global Pharma Consultancy 
     
  2. Interim Safety, Pharmacokinetics (PK), and Cerebral Spinal Fluid (CSF) Exposure Data from the Phase 1/2a MONARCH Study of STK-001, an Antisense Oligonucleotide (ASO), in Children and Adolescents with Dravet Syndrome (DS) 
    Linda Laux, MD, Ann & Robert H. Lurie Children's Hospital of Chicago
     
  3. Phase 2b Efficacy and safety of XEN1101, a novel potassium channel opener, in adults with focal onset seizures (X-TOLE)
    Jacqueline French, MD, NYU Comprehensive Epilepsy Center
     
  4. The Impact of Disease Severity on Efficacy from a Phase 2b Study of XEN1101, a novel potassium channel opener, in adults with focal epilepsy (X-TOLE)
    Christopher Kenney, MD, Xenon Pharmaceuticals
     
  5. GM6 attenuates activated cofilin and beta-arrestin2 impact on pathological tau and decreasing tau aggregates in Alzheimer’s disease (AD) and frontotemporal lobar degeneration (FTLD)
    Mark Kindy, PhD, University of South Florida, Tampa
     
  6. Treatment with Selective Inhibitors of Nuclear Export (SINE) compounds attenuates dystrophic symptoms in zebrafish and mouse models of Duchenne muscular dystrophy
    Matthew S. Alexander, PhD, University of Alabama at Birmingham
     
  7. Oral small molecule hepatocyte growth factor/MET positive modulator ATH-1020 reduces depression-like behaviors and normalizes pathological EEG mismatch negativity in preclinical models
    Andrée-Anne Berthiaume, PhD, Athira Pharma
     
  8. Positive modulation of hepatocyte growth factor/MET by a novel small molecule induces neurotrophic and procognitive effects
    Jewel Johnston, PhD, Athira Pharma
     
  9. Pharmacologically Targeting Inducible Prostaglandin E Synthase to Counteract Neuroinflammation-associated Cognitive Impairments
    Lexiao Li, PhD, The University of Tennessee Health Science Center
     
  10. Preclinical Development of NRTX-1001, an Inhibitory Interneuron Cellular Therapeutic for the Treatment of Chronic Focal Epilepsy    
    Mansi Parekh, PhD, Neurona Therapeutics
15:15 - 16:00

AAN Meeting of the Asent Board

3:15 – 4:00 PM (EST)  Joint Interest Group meeting of the AAN Neurotherapeutics Section and ASENT members

Click here to join the AAN Meeting

11:30 - 13:15

CONCURRENT SYMPOSIUM 5 - Innovative Treatments for Rare Neurodevelopmental Diseases

11:30 AM – 1:00 PM (EST)  

Neurodevelopmental disease-modifying drug discovery is increasing enormously, however, high unmet needs remain. This is notably true for more rare monogenetic disorders, such as Angelman, Rett, and Dravet syndromes, and across modalities (eg. small molecule, gene therapy and antisense oligonucleotides). This symposium will discuss scientific advances, hurdles in drug development and delivery, and a fair-balanced review of advantages and disadvantages from bench to bedside. 

CHAIRS: 

 Joseph Sullivan, MD, University of California, San Francisco (UCSF)  

 Elizabeth Berry-Kravis, MD, PhD, Rush University Medical Center

11:30 – 11:50 AM (EST)  

Wearing MANY hats: From Impossible to Possible: A parent’s journey through drug development

 Allyson Berent, DVM, DACVIM, GeneTx Biotherapeutics, Foundation for Angelman Syndrome Therapeutics 

Therapeutic Antisense Oligonucleotide (ASO) Interventions for Neurodevelopmental Disorders: Lessons from Angelman Syndrome

 Elizabeth Berry-Kravis, MD, PhD, Rush University Medical Center

11:50 AM – 12:10 PM (EST)  

Utility of EEG as a biomarker in clinical development: Angelman Syndrome

 Rob Komorowski, PhD, Ionis Pharmaceuticals 

Dravet syndrome: Unmet need for seizures and non-seizure co-morbidities

 Joseph Sullivan, MD, University of California, San Francisco (UCSF)  

12:10 – 12:30 PM (EST)  

Developing STK-001: An Antisense Oligonucleotide (ASO) Treatment for Dravet Syndrome

 Kimberly A. Parkerson, MD, Stoke Therapeutics 

Disease Modifying Therapies in Neurodevelopmental Disorders (NDDs) Becoming a Reality 

 Elizabeth Berry-Kravis, MD, PhD, Rush University Medical Center

12:30 – 1:00 PM (EST)  Live Faculty Panel Discussion – FULL PANEL

11:30 - 13:15

CONCURRENT SYMPOSIUM 6 - The Use of Digital Monitoring Devices in Neurological Clinical Studies

11:30 AM – 1:00 PM (EST)  

In many neurodegenerative diseases, we see the measures of quality of life, mobility, quality of sleep etc., as measurements that may reflect the stage of the disease. While QoL questionnaires rely on subjective reporting of patients, digital monitoring devices can bridge this gap by allowing for quantitative, frequent, reliable and clinically meaningful measurements of the state of patients in their daily lives. This rich dataset can help us monitor the treatment response and disease progression.

CHAIRS: 

 Sharon Tamir, Karyopharm Therapeutics Inc.  

 Suhayl Dbib-Jalbut, PhD, Rutgers-Robert Wood Johnson (RWJ) Medical School 

11:30 – 11:50 AM (EST)  Deep Phenotyping Using Digital Health Technology in Parkinson’s Disease

 Jamie Lynn Adams, MD, University of Rochester Medical Center

11:50 – 12:10 PM (EST)  Remote Digital Monitoring Technology and AI-driven Analytics in Neurodegenerative Diseases

 Amir Lahav, ScD, Redenlab

12:10 – 12:30 PM (EST)  

Regulatory Considerations When Using Digital Health Technologies in Clinical Investigations

 Christina Webber, PhD, CDRH/FDA

Digital Monitoring Devices in Neurological Device Studies – an FDA Device Reviewer’s Perspective

 Patrick Antkowiak, PhD, Center for Devices and Radiological Health, FDA

12:30 – 1:00 PM (EST)  Live Faculty Panel Discussion – FULL PANEL

10:00 - 11:45

MAIN PLENARY

10:00 – 10:05 AM (EST)  Remarks - ASENT President

 Thomas Sutula, MD, PhD, ASENT President / Professor Emeritus, University of Wisconsin-Madison

10:00 – 11:30 AM (EST)  PLENARY SESSION 

Covid-19 and The Brain: Update 2022 

This plenary session covers how the virus creates CNS damage and compromises functions, as evidenced by sensory, cognitive, and behavioral impairments that last beyond the typical symptoms of COVID-19.

  • Avindra Nath, MD, will address the neurological involvement and potential therapeutic targets of COVID-19 toxicity in the CNS.
  • Ming Lim, MD, PhD, will describe long-term CNS consequences of COVID-19 infection in children.
  • Clinton B. Wright, MD, MS, will emphasize neurological characterization of the post-acute features of COVID-19 and the NIH initiative RECOVER designed to understand causes and preventive measures against long COVID.

This session will update us with new information since the first ASENT symposium on this topic was held in 2021.   

CHAIR:

 C. Anthony Altar, MD, PhD, Splice Therapeutics

 Thomas Sutula, MD, PhD, University of Wisconsin-Madison

10:00 – 10:25 AM (EST)  Pathophysiology and therapeutic targets for Neuro-COVID 

 Avindra Nath, MD, PhD, National Institutes of Health 

10:25 – 10:50 AM (EST)  Clinical features and outcome following Neuro-COVID in children

 Ming Lim, MD, Evelina London Children’s Hospital

10:50 – 11:10 AM (EST)  Characterizing Post-acute Sequelae of Covid-19 (PASC): Overview and the NIH RECOVER Initiative

 Clinton B. Wright, MD, MS, National Institutes of Health

11:10 – 11:30 AM (EST)  Live Faculty Panel Discussion – FULL PANEL

11:30 – 11:45 AM (EST)  BREAK

11:45 - 13:30

BREAKOUT SESSIONS (Hall A or B)

HALL A - Not a One-Trick Pony: Repurposing Established Drugs for New Neurological Indications 

CHAIRS: 

 Sharon Tamir, Karyopharm Therapeutics, Inc.

 Aditya Joshi, MD, Penn Medicine - University of Pennsylvania

HALL B - New Approaches to Pain Therapeutics R&D: Models and Results from Academic and Industry Sectors 

CHAIRS: 

 Mary Ann Pelleymounter, PhD, National Institutes of Health/National Institute of Neurological Disorders and Stroke (NINDS)

 Debra Ehrlich, MD, MS, National Institutes of Health/National Institute of Neurological Disorders and Stroke (NINDS)

11:45 - 13:00

CONCURRENT SYMPOSIUM 7 - Not a One-Trick Pony: Repurposing Established Drugs for New Neurological Indications

11:45 – 1:00 PM (EST)  

Many diseases have multifactorial pathophysiology, creating an opportunity to treat them with therapies originally developed for different indications. Here, we will discuss the development of products that utilize already established drugs from other fields of medicine for novel neurological indications. 

CHAIRS: 

 Sharon Tamir, Karyopharm Therapeutics, Inc.

 Aditya Joshi, MD, Penn Medicine - University of Pennsylvania

11:45 – 12:05 PM (EST)  Targeting multiple neuron death pathways in neurodegenerative diseases: clinical trial experience with sodium phenylbutyrate and taurursodiol

 Machelle Manuel, PhD, Amylyx

12:05 – 12:25 PM (EST)  Breaking the Paradigm – PrimeC as a Novel Approach to ALS therapy

 Shiran Salomon-Zimri, PhD, Neurosense

12:25 – 12:45 PM (EST)  Repurposing anti-IL-6R antibody from RA to NMOSD: Challenge and success

 Takashi Yamamura, MD, PhD, National Institute of Neuroscience in Tokyo (Japan)

12:45 – 1:00 AM (EST)  Live Faculty Panel Discussion – FULL PANEL

11:45 - 13:00

CONCURRENT SYMPOSIUM 8 - New Approaches to Pain Therapeutics R&D: Models and Results from Academic and Industry Sectors 

11:45 – 1:00 PM (EST)  

Development of novel pain therapeutics continues to present significant challenges, demonstrated by data showing only a 2% probability of drug approval for Phase I candidate pain therapeutics, compared to an overall 10% probability in other disease areas. Challenges include unknown neurobiological mechanisms of pain, translation of preclinical data, large placebo effects and disease population heterogeneity. Recently, much more emphasis has been placed on the urgent need to develop successful non-addictive therapeutics for pain as a result of efforts to address the opioid crisis. This symposium will include an overview of new models for pain therapeutics that address the challenge of pain therapeutics development from several perspectives including those representing the scientific, process management and financial challenges. 

CHAIRS: 

 Mary Ann Pelleymounter, PhD, National Institutes of Health/National Institute of Neurological Disorders and Stroke (NINDS)

 Debra Ehrlich, MD, MS, National Institutes of Health/National Institute of Neurological Disorders and Stroke (NINDS)

11:45 – 12:05 PM (EST)  Dual Ion channel Modulation, a Novel Mechanism for Treatment of Sensory Hyperexcitability

 Haim Belinson, PhD, Bsense Bio Therapeutics Ltd

12:05 – 12:25 PM (EST)  Leveraging A Single-Sponsor Master Protocol to Address the Challenges Inherent in Pain Therapeutic Development

 Kelly L. Knopp, PhD, Lilly Research Laboratories, Eli Lilly and Company

12:25 – 12:45 PM (EST)  HEAL Initiative Pain Therapeutics Development: A flexible approach for academics and small businesses 

 Michael Oshinsky, PhD, National Institutes of Health/National Institute of Neurological Disorders and Stroke

12:45 – 1:00 AM (EST)  Live Faculty Panel Discussion – FULL PANEL