Conference Day Two | Thursday, October 30

8:45 am Check- In & Morning Coffee

9:20 am Chair’s Opening Remarks

OPTIMIZING TRANSLATIONAL DEVELOPMENT TO GAIN REGULATORY APPROVAL & SUCCESSFULLY MOVE INTO CLINICAL TRIALS

9:30 am Selecting Human-Translatable BBB-Crossing Capsids Using Humanized Mice

Synopsis

  • Providing an overview of current strategies for engineering BBB-crossing capsids that target human receptors
  • Highlighting recent advancements in differential directed evolution for identifying and optimizing capsids
  • Exploring ongoing challenges in the field, including issues of cross-species reactivity and translational barriers

10:00 am Roundtable Discussion: Identifying Biomarkers & Endpoints in Slowly Progressing Neurodegenerative Diseases to Predict Disease Progression & Improve Patient Targeting

Synopsis

  • Exploring emerging fluid and imaging biomarkers to get a better understanding of progressing neurodegenerative diseases
  • Discussing what endpoints are important to better understand disease progression
  • Analyzing the difficulty in understanding disease progression and its effects on clinical and preclinical trials

10:30 am Preclinical Studies for Gene Therapies in Common NDDs: From Human-Based Cellular Through Mouse Models

Synopsis

  • Neurodegenerative diseases (NDDs) in aging, on the spectrum of Alzheimer’s and Parkinson’s diseases, have unmet clinical need with no effective and safe disease modifying therapy (DMT)
  • Gene-targeted therapies will move the field foward towards precision medicine
  • Epigenome editing platform delivered by AAV offers the opportunity for the development of innovative therapeutics for NDDs caused by dysregulation of targeted gene expression 

11:00 am Morning Break & Networking

TRANSLATING LEARNINGS TO ALZHEIMER’S, PARKINSON’S, & OTHER DISEASES TO WIDEN THE TARGET PATIENT POPULATION

12:00 pm Roundtable Discussion: Diving into the Intricacies of Alzheimer’s & Parkinsons to Open Up New Disease Options for Gene Therapy Modalities

  • James Warren Senior Vice President - Global Chemistry, Manufacturing & Controls Development, Ultragenyx Pharmaceutical Inc.

Synopsis

  • Comparing the differences between diseases affecting paediatric populations and older patients to understand how it affects gene therapy development
  • Unpacking the unique pathophysiological mechanisms of Alzheimer’s and Parkinson’s to identify gene therapy targets
  • Assessing the challenge with delivery, targeting, and timings of administering the gene therapy

1:00 pm Strategies for Developing Therapies for Rare CNS Disorders

  • TJ Cradick Chief Scientific Officer, Principal Consultant, Gene Editing Frontiers

Synopsis

  • Building on previous preclinical and clinical data
  • Establishing a collaborative network to gain market intelligence
  • Overcoming regulatory and financial hurdles to streamline development

1:30 pm Lunch & Networking

2:30 pm Bridging the Gap: Applying Learnings from Gene Therapies Targeting Other CNS Diseases to the Giants of Neurodegenerative Disorders to Widen the Target Patient Pool

Synopsis

  • Utilizing learnings from SMA, Huntington’s, and other diseases to understand how to target other neurodegenerative diseases
  • Identifying if there are shared biological pathways that can be easily targeted Learn from clinical and preclinical data to inform discovery development for these diseases

UNDERSTANDING THE IMPACT OF EARLY-STAGE DEVELOPMENT ON DOWNSTREAM MANUFACTURING PROCESS TO STREAMLINE THEM & REDUCE OVERALL COSTS

3:00 pm Understanding the Hurdles with Scaling Up & How Vector Technologies Affect it to Prevent Manufacturing Setbacks

  • Patrick Hossler Executive Director - Global Chemistry, Manufacturing & Controls Development, Ultragenyx Pharmaceutical Inc.

Synopsis

  • Identifying common scale up challenges associated with vector manufacturing
  • Analyzing the influence of vector technologies on manufacturing processes
  • Developing strategies in vector development to mitigate manufacturing errors

3:30 pm Chair’s Closing Remarks

3:40 pm End of 7th Gene Therapy for CNS Summit