Conference Day Two

8:00 am Check-In & Light Breakfast

8:55 am Chair’s Opening Remarks

Cultivating Academic, Biotech & Pharma Collaborations to Revolutionize Genome Editing Therapeutic Development

9:00 am Panel Discussion: Driving Collaborations to Unlock New Therapeutic Opportunities

  • Brad Ringeisen Executive Director, Innovative Genomics Initiative
  • Greg Newby Assistant Professor, Johns Hopkins University
  • Ralf Schmid Associate Director, Preclinical Research, Novartis AG

Synopsis

  • Evaluate partnerships between pharma and biotech companies and the impact academia can have on the development of genome editing therapies
  • Discuss the ideal criteria for company collaborations and investment to improve discovery efficiency
  • Highlight key strategies from successful collaborations to direct and refine future collaborative efforts

9:45 am Promoting How Gene Editing Has Fast-Tracked Novel Therapies for Complement-Driven Diseases

Synopsis

  • Explore the rationale behind developing gene therapy strategies including durability and convenience
  • Understand the strategies available to develop gene therapies ranging from AAVmediated gene editing, first to third generation CRISPR gene editing therapies and epigenetic editors
  • Emphasize how compared to these other available gene therapy strategies, why base editing technology is important and how base editing strategies have been guided through working in a collaboration with Beam Therapeutics

10:15 am Morning Refreshment Break & Networking

Optimizing CRISPR Technologies to Progress Epigenome Editors

11:15 am Highlighting How Designing Compact Epigenome Editors Can Facilitate Clearance for Clinical Trials

  • Dan Hart Head of Technology Development, Epic Bio

Synopsis

  • Focus in on the importance of designing gene editors with delivery in mind
  • Showcase strategies required to build a compact epigenetic gene editing platform
  • Highlight that AAVs are well-studied in clinical trials so provide a good way forward, but a condensed gene editing platform opens the opportunity to use alternative delivery methods

11:45 am Highlighting the Limited Immunogenicity Despite Sustained Cas-9 Expression

  • Yosuke Nakashima Vice President & Executive Officer - Operations & Business Development, Modalis Therapeutics

Synopsis

  • Explore how efficient and durable gene activation by Cas-9-mediated in vivo epigenome editing had limited immunogenicity
  • Understand the impact of using an AAV delivery system on targeting
  • Emphasize that despite sustained Cas-9 expression, good toxicology data shows therapeutic safety

12:15 pm Emphasizing how the TEMPO Platform Presents Several Benefits Over Nuclease-Based Editing Platforms

Synopsis

  • Conduct an overview of the mechanism of action of TEMPO
  • Showcase the importance of this platform in its ability to control gene function in a tunable and reversible way, and how this subsequently allows the bypassing of technical and clinical barriers
  • Highlight key safety and regulatory considerations needed to progress to the pre-clinic and beyond

12.45 pm Lunch Break & Networking

Evaluating Clinical & Commercial Approaches to Genome Editing

1:45 pm Fireside Chat: Enhancing Investment & Commercialization of Gene Editing Therapies

Synopsis

  • Reflect on the current genome editing therapeutics field and key successes and learnings
  • Discuss the need to make gene therapies more economical and accessible to a broader number of patients
  • Understand strategies and perspectives to increase investment

2:15 pm Applying CRISPR-based Therapeutic Technology to Treat Viral Infectious Diseases

Synopsis

  • Explore the advantages of applying gene editing therapies outside of rare disease
  • Define how Excision’s CRISPR approach allows for the excision of large sections of viral DNA to eliminate multiple viral genes
  • Understand the strategies and approaches which allow for the EBT-101 program to reach clinical trials

2:45 pm Identifying the Role of Clinical Biomarkers in Genome Editing Therapeutics for Sickle Cell Disease

  • Priya S. Chockalingam Vice President, Head, Clinical Bioanalytics & Translational Sciences, Beam Therapeutics Inc.

Synopsis

  • Biomarkers to support efficacy of gene editing therapies to treat sickle cell disease
  • Specialized biomarker discovery to assess disease pathophysiology
  • Importance and opportunity biomarkers bring to accelerate clinical development

3:15 pm Afternoon Break & Networking

Thinking Ahead: Reviewing Strategies to Streamline Translatability & Scalability

3:45 pm Innovating Manufacturing Processes to Enhance Quality, Quantity & Scalability

  • Anubhav Arora Director - Chemistry, Manufacturing, & Controls, Apellis Pharmaceuticals

Synopsis

  • Explore how the quality threshold needed for in vivo and ex vivo therapies differs and the subsequent early manufacturing considerations that this requires
  • Emphasize the importance of characterization of delivery vehicles when manufacturing, to demonstrate efficacy and safety
  • Promote the early evaluation of what aspects of the workflow of gene editing therapeutic development will be challenging to scale up to ensure a more time and cost-effective transition to the clinic

4:15 pm Roundtable: Limiting the Immunogenicity & Off-Target Effects of Editing Platforms to Enhance Therapeutic Safety & Efficacy

  • Dan Hart Head of Technology Development, Epic Bio

Synopsis

  • Discuss the immunogenicity risks of bacteria-derived genome editing proteins alongside the delivery capsid
  • Comprehend design strategies for building a genome editing platform to reduce immunogenicity and off-target effects
  • Reinstate how addressing immunogenicity is key to maintaining a platform that is safe and efficacious

4:45 pm Exploring How Novel Nucleases & Appropriate Animal Models Are Key to Clinical Success

  • TJ Cradick Chief Technology Officer, HuidaGene Therapeutics

Synopsis

  • Understand how engineering nucleases to improve on target efficacy and decrease off target effects was crucial to speeding up pre-clinical progression
  • Evaluate how selecting mouse models and NHPs provide appropriate models to showcase efficacy and safety
  • Reflect on how close collaboration between R&D and pre-clinic, as well as matching gene editing technology to appropriate indications, is essential to cut time and cost of therapeutic development

5:15 pm Close of Conference Day Two