8:50 am Chair’s Opening Remarks

Presenting Biomarker Efficacy & Advances in Clinical Validation of Biomarkers for Alzheimer’s Disease

9:00 am Biomarkers to Evaluate Therapies that Target the Immune System in Early-Stage Alzheimer’s Trials: Patient Selection, Target Engagement, & Promising Technologies

Synopsis

  • Biomarkers to select patients most likely to respond to treatment
  • Using Biomarkers to determine target engagement and demonstrate safety; inflammatory biomarkers are not enough
  • Non-invasive biomarkers to predict treatment response

9:20 am Mapping Alzheimer Biomarkers for Context of Use With the FDA BEST (Biomarkers, Endpoints, and other Tools) Guidance

  • Douglas Galasko Associate Director, UCSD Shiley-Marcos Alzheimer’s Disease Research Center

Synopsis

  • Applying biomarkers to Alzheimer’s Disease (AD) can be done in the context of the Amyloid, Tau, Neurodegeneration (ATN) framework, which can be used for diagnosis and staging, but has a complex relationship to cognition or clinical measures.
  • Biomarkers for prediction, prognosis and risk are increasingly being assessed in longitudinal studies, with the goals of facilitating early diagnosis and intervention.
  • Pharmacodynamic and surrogate markers are a challenge in the context of AD

9:40 am Presenter Led Audience Discussion

  • Douglas Galasko Associate Director, UCSD Shiley-Marcos Alzheimer’s Disease Research Center

Synopsis

For promising biomarker candidates, what types of clinical studies may be needed to support their use for:

1) diagnosis

2) prediction, prognosis and risk,

3) To assess drug effects in trials?

10:20 am Chair Led Q&A; Presenting Biomarker Efficacy & Advances in Clinical Validation of Biomarker’s for Alzheimer’s Disease

  • CJ Barnum Head of Neuroscience, INmune Bio
  • Douglas Galasko Associate Director, UCSD Shiley-Marcos Alzheimer’s Disease Research Center

10:30 am Virtual Networking Break

Precision Through Combination Biomarkers

11:00 am Presentation details to be confirmed

11:20 am What it Means to Demonstrate Target Engagement in Therapies that Target the Immune System: Role of Combination of Biomarkers.

Synopsis

  • Assessing target engagement of inflammatory treatments via multiple platforms and assays; why is it necessary?
  • “Anti-inflammatory” is not enough: Demonstrate downstream consequences of targeting inflammation
  • Integrating novel, non-invasive biomarkers, in early-stage trials – potential and limitations.

11:40 am Emerging Biomarker Combinations for Personalized Alzheimer’s Disease Diagnosis & Treatment

  • Nicole Bjorklund Assistant Director – Scientific Affairs, Alzheimer’s Drug Discover Foundation

Synopsis

  • Understanding heterogeneity in Alzheimer’s Disease; exploring AD subtypes
  • Emerging biomarkers of Alzheimer’s Disease pathways & pathology
  • Benefits of combination biomarkers in drug development & clinical trials
  • Potential pathways for the use of biomarker combinations to accurately diagnosis & measure AD progression

12:00 pm Chair Led Q&A; Precision Through Combination Biomarkers

  • CJ Barnum Head of Neuroscience, INmune Bio
  • Nicole Bjorklund Assistant Director – Scientific Affairs, Alzheimer’s Drug Discover Foundation
  • Maria Maccecchini Founder, President, CEO and Executive Board Member, Annovis Bio

12:20 pm Virtual Networking Lunch

Translating Biomarkers from Preclinical to Clinical Development

1:20 pm Leading the Vanguard – Early Clinical Assessment of Biomarkers to Drive Development of Alzheimer’s Disease Therapies

Synopsis

  • Building a translational strategy to identify robust preclinical signals
  • Interrogating biomarkers by applying a translational pharmacology approach in Phase 1
  • Capitalizing on objective assessments to guide clinical development in early patient studies

1:40 pm Chair Led Q&A; Translating Biomarkers from Preclinical to Clinical Development

Closing Discussion: Shaping the Future of Biomarkers for Neurodegeneration

1:50 pm Panel Discussion: How do we learn from the lessons of the past and implement those lessons learned going forward?

Synopsis

This closing panel and audience discussion will reflect over the industry sharing during the three days of the Biomarkers for Alzheimer’s Disease summit. This will be your opportunity to discuss with your colleagues the lessons learned from their own projects and the lessons learned over the course of the meeting.

2:30 pm Chair’s Closing Remarks

2:40 pm End of Conference