Conference Day Two
Thursday April 25, 2024

7:00 am Coffee Room Networking

7:55 am Chair’s Opening Remarks

MEASURING NOVEL MODALITY AND DIAGNOSTIC SUCCESS IN NEURODEGNERATIVE RESEARCH

8:00 am Beyond Traditional Antibodies: Clinically Testing Novel Modalities of Targeting Neurodegenerative Diseases

Synopsis

  • Gaining insights into discovery and development of alternative approaches including small molecules, gene therapies and RNA based therapeutics, offering new avenues for potential Alzheimer’s treatments
  • Clinical strategies of novel modalities for Alzheimer’s to address challenges, opportunities and early results associated with these unconventional approaches
  • Understanding whether novel approaches may reshape the field, paving way to more diverse and effective treatment options in the fight against Alzheimer’s Disease

8:30 am Breaking Through the Biomarker Bottleneck: Alpha Synuclein Seed Amplification Assay (SAA)

  • Samantha Hutten Director, Discovery & Translational Research, The Michael J. Fox Foundation for Parkinson's Research

Synopsis

  • Historical perspective: How did we get here and what did it take?
  • Evaluating diagnostic performance of alpha synuclein SAA and use in early risk identification
  • On the horizon, what’s next? Enabling quantitation and exploring less invasive biomatrices

9:00 am Session Details to be Confirmed

Synopsis

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9:30 am Panel Discussion: How has the Recent Approval of Disease Modifying Drugs Impacted the Treatment Landscape for Alzheimer’s Disease?

  • Elena Dale Executive Director, Neuroscience, Bristol Myers Squibb
  • John Hey Chief Scientific Officer, Alzheon
  • Peter Heutink Chief Scientific Officer, Alector Pharmaceuticals LLC
  • Laura Cohen Associate Vice President, Alzheimer's Environment Shaping, Eli Lilly & Co.

Synopsis

  • Exploring the potential impact on novel target discovery and development strategies
  • Illuminating the impact on clinical development plans in demonstrating meaningful effect on patients
  • Reviewing how trial design might be impacted with Leqembi as a comparator or combination partner in future studies

10:00 am Morning Refreshment Break & Speed Networking

DISCOVERY

Reviewing Current Discovery Methodology & Modulating Inflammasome to Treat Neurodegeneration

10:30 am Inhibiting Caspase-1 & Inflammasome Activation: Preclinical Data & Clinical Observations

  • Paul Ashton President & Chief Executive Officer, Inflammasome Therapeutics

Synopsis

  • Inhibiting caspase-1 and inflammasome activation in vivo
  • Reversing cognitive decline in 5XFAD mice
  • Clinical use associated with reduced incidence of AD

11:00 am Session Details to be Confirmed

Synopsis

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11:30 am Roundtable Discussion: Splitting into Diverse, Cross- Disciplinary Groups, Dicuss and Review Varying Modality and Target Approaches in Neurodegenerative Drug Discovery

Synopsis

Exploring Novel Approaches to Drug Discovery to Target the Full Range of Alzheimer’s & Parkinson’s Pathology Beyond Protein Aggregate Approaches

• Reviewing alternative drug discovery approaches to target varied pathologies of AD beyond

• Exploring novel ways to target Alzheimer’s pathology beyond pathological proteins to include neuroinflammation, glia, oxidative stress, mitochondrial dysfunction

• Developing translational models to reflect the full range of Alzheimer’s pathology for more confident translation to the clinic

TRANSLATIONAL

Utilizing Brain-on-a-Chip Technology & Targeting Prion-like Spreading in Preclinical Research to Treat Neurodegeneration

10:30 am Targeting Prion-like Spreading Pathology in Proteopathic Diseases

Synopsis

  • Reviewing prion-like spreading as a root pathology underlying neurodegeneration
  • Exploring the preclinical development of UCB7853: an antibody designed to prevent spread in Parkinson’s Disease
  • Bepranemab as a novel paradigm for screening of anti-tau antibodies

11:00 am Session Details to be Confirmed

Synopsis

Session Details to be Confirmed

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11:30 am Roundtable Discussion: Splitting into Diverse, Cross- Disciplinary Groups to Explore Advancements in NHP Models of Neurodegeneration for More Confident Translation to the Clinic

Synopsis

Bridging the Gap: Reverse Translating Neurodegenerative Disease with NHPs for More Confident Translation to the Clinic

  • Advancing NHP model development and characterization to incorporate genetic, environmental and age-related factors for disease modelling
  • Utilizing advanced imaging and biomarker technologies to assess disease progression
  • Addressing the challenges and limitations in current NHP models

CLINICAL & COMMERCIAL

Clinical Breakthroughs in Targeting Neuroinflammation through Modulating Astrocytes & Microglia to Slow Cognitive Decline

10:30 am Targeting the Microglia Brain Immune system with TREM2 Agonism as a Broad Therapy for Alzheimer’s Disease

  • Peter Heutink Chief Scientific Officer, Alector Pharmaceuticals LLC

Synopsis

  • Trem2 is a damage sensing microglia receptor. Partial loss of TREM2 increases AD risk while high levels appear protective
  • AL002, Alector Trem2 activating biologics was shown to be well tolerated, engage microglia and is associated with incidences of ARIA-like events in AD
  • Clinical, imaging, and biomarkers data from a double-blind, placebo-controlled, 4-dose arm, Phase 2 study in early AD patients is expected in Q4 2024

11:00 am Session Details to be Confirmed

Synopsis

Session Details to be Confirmed

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11:30 am Targeting Neuroinflammation to Modulate Reactive Astrocytes for Treatment of Neurodegenerative Disease

Synopsis

  • Understanding the impact of astrocyte activation and the role of SEMA4D
  • Exploring plasma GFAP as a biomarker of neuroinflammation
  • The effect of blocking the upregulation of SEMA4D, preventing neuronal stress and cognitive decline

12:00 pm Lunch Refreshment Break & Networking

DISCOVERY

Targeting Microglia & Mitochondrial Dysfunction to Reduce Neuroinflammation and Treat Neurodegeneration

1:00 pm The Next Generation of Alzheimer’s Treatment: Harnessing Microglia with TREM2 Agonism

  • David Gray Chief Science Officer, Vigil Neuroscience

Synopsis

  • Harnessing neuroprotective microglial states for the next generation of AD treatment
  • Potent small molecule TREM2 agonists that act as molecular glues to stabilize a multimeric signalling complex
  • Genetic and biomarker strategies to aid early development and how a small molecule TREM2 agonist may address unmet needs in AD

1:30 pm Reversing Mitochondrial Dysfunction & Energy Metabolism as a Novel Target for Neurodegeneration

  • Enchi Liu Senior Vice President Translational Sciences, Tranquis Therapeutics Inc.

Synopsis

  • Switching microglia from a neuroinflammatory state to homeostatic state
  • Regulating mitochondrial energy metabolism to slow cognitive decline in Alzheimer’s Disease, & Diabetic CI
  • Potential Utility of targeting energy metabolism in aging

2:00 pm Unlocking Brain-on-Chip Technology’s Potential for Advancing Neurodegenerative Drug Clinical Translation

Synopsis

  • Utilizing Brain-on-a-Chip technology to recreate complex pathophysiological characteristics of CNS diseases, including Blood-Brain Barrier dysfunction
  • Focusing on astrocyte-microglia cell interactions within Brain-Chip models to study neuroinflammation
  • Exploring ways to refine Brain-on-a-Chip technology for more precise simulation of disease pathologies and their potential clinical applications

TRANSLATIONAL

Harnessing Cell Therapy & Senescence to Reduce Alzheimer’s Pathology in Preclinical Research

1:00 pm Thinking Outside the Brain: Targeting the Peripheral Immune System to Treat Alzheimer’s Disease

  • Kuti Baruch Vice President Research & Development, Immunobrain

Synopsis

  • Utilizing immune checkpoint blockade for treating neurodegeneration: the advantage of targeting the peripheral immune system
  • Drug development and translational work of IBC-Ab002, a novel anti-PD-L1 antibody tailored for treating Alzheimer's disease
  • Early insights from IBC-01-01, a Phase I clinical study in persons with early Alzheimer's disease

1:30 pm Session Reserved for Sapient

Synopsis

Session Reserved for Sapient

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2:00 pm Evaluating Adoptive Cellular Immunotherapy for Neurodegeneration with Autologous SNK01

  • Paul Song Chief Scientific Officer, Genequantum Healthcare

Synopsis

  • Enhancing natural killer cells to maximize the body’s ability to destroy diseased and abnormal cells
  • Reviewing NK cell therapy as an alternative modality of treatment to resolve neurodegeneration with the body’s natural immune system
  • Exploring phase 1 clinical safety and efficacy data of autologous SNK01 in treating neurodegenerative disease

2:30 pm CNS Delivery of Biotherapeutics for the Treatment of Neurodegenerative Diseases

Synopsis

  • Exploring methods of delivery of biotherapeutics into the CNS to enhance therapeutics efficacy of antineurodegenerative assets
  • Reviewing the safety aspects in developing platform technologies for long term use in older populations
  • Identifying typical scientific dogmas that need to be challenged in order to successfully develop CNS targeted biotherapeutics
  • Childhood dementia and the role of the lysosome

CLINICAL & COMMERCIAL

Exploring Patient Access to Disease Modifying Therapeutics from a Regulatory & Commercial Perspective

1:00 pm US Coverage Dynamics for Alzheimer’s Diagnostics & Therapeutics: Lessons from the Field

  • Laura Cohen Associate Vice President, Alzheimer's Environment Shaping, Eli Lilly & Co.

Synopsis

  • US Medicare coverage landscape to explore coverage discretion and policies for Alzheimer’s diagnostics and therapeutics
  • Overviewing program for coverage with evidence development with the Medicare registry
  • Access and reimbursement considerations when bringing a product to the US market: coverage, policy and reimbursement dynamics

1:30 pm Developing a Model to Optimize Clinical Trial Design & Site Selection, Integrating Randomized Control Data & Real World Data

  • Asma Kasuba Senior Director, Global Development, R&D Data Science & Digital Health, Janssen

Synopsis

  •  Harmonizing cross-industry past clinical trial performance data to secure insights
  • Leveraging AI & ML modeling for site tiering and stratification
  • Identifying research-naïve sites for untapped clinical opportunity

2:00 pm Narrowing the Gap in Neurodegenerative Drug Development to Meet Regulatory Needs

Synopsis

  • Identifying and generating evidence to support safety biomarkers (including fluid and imaging) as clinical endpoints
  • Discussing data sharing and generating regulatory-grade data
  • Regulatory successes of drug development tools (biomarkers, trial simulation tools, patient enrichment tools) and impact on clinical trials

UNDERSTANDING PATIENT PERSPECTIVES & PRECISION MEDICINE APPROACHES FOR HOLISTIC CARE & PROGRESS

3:00 pm Afternoon Refreshment Break & Networking

3:30 pm Precision Medicine Approaches as the Next Step to Account for Alzheimer’s & Parkinson’s Disease Heterogeneity & Patient Specificity

  • Rouba Kozak Global Biomarker & Diagnostics Leader of Neuroscience, Novartis AG

Synopsis

  • Harnessing multi-omic and GWAS data to identify the range of genetic markers and risk factors contributing to the heterogeneity of Alzheimer’s and Parkinson’s disease
  • Strategizing on how personalized treatment plans targeting specific disease subtypes and characteristics can optimize effectiveness of interventions and slow disease progression
  • Highlighting the potential of precision medicine to bridge the gap between research and clinical practice by offering insights into how genetic and molecular profiling can guide treatment decisions, improving patient outcomes and enhancing drug development efforts

4:00 pm Applying the Principles of Precision Medicine to Alzheimer’s Disease Drug Development

  • Fiona Elwood Vice President & Disease Area Stronghold Lead, Neurodegeneration, Janssen

Synopsis

  • The principles of precision medicine – targeting the right drug to the right patient at the right time, have transformed oncology drug development and clinical practice, and are poised to do the same for neuroscience
  • In Alzheimer’s disease (AD) we can now identify people with Alzheimer’s pathologic changes, decades before the onset of clinical symptoms, and target specific therapeutics to the stage of disease where they are most likely to give the greatest benefit to patients
  • We will present data and strategies using digital, blood based, and imaging biomarkers applied to the clinical development of two tau-targeting therapeutics: Posdinemab, a monoclonal antibody targeting p217+ tau and JNJ-64042056 (ACI-35.030), an active immunotherapy targeting phosphorylated tau
  • Data from the Global Neurodegeneration Proteomics Consortium (GNPC) supports the hypothesis that there are specific subtypes of Alzheimer’s disease that may benefit from different therapeutic interventions

4:30 pm Closing Remarks & Close of Conference