Pre-Conference Workshop Day
Tuesday, August 20

08:30 am – 11:00 am | WORKSHOP A

Exploring Novel Lipid-Delivery Systems for Next Generation Applications & Enhanced Therapeutic Outcomes

  • Diane Nelson Biomedical Engineer, National Institute of Standards & Technology

Synopsis

Bridging Traditional Lipid Systems with EV Innovation:

  • Limitations of traditional lipid delivery systems including liposomes, polymeric micelles, and PEGylated lipids.
  • Introduction to extracellular vesicles (EVs) as an innovative lipid-based delivery system in terms of delivery efficiency, biocompatibility, and therapeutic potential.

Advances in EV Characterization and Isolation for Therapeutic Delivery:

  • Discuss the latest methodologies and technologies for EV characterization and isolation.
  • The importance of purity and specificity in EV-based drug delivery systems.

Emerging Trends and Integration Strategies:

  • Challenges in scaling EV isolation and characterization for clinical applications.

12:00 pm – 2:30 pm | WORKSHOP B

Creating Seamless Synergy by Optimizing Device Integration With Lipid-Based Drug Delivery Formulations

  • James Leamon Medical Device & Combination Product Design & Development, Independent Expert, Formerly Jazz Pharmaceuticals

Synopsis

Understanding Interconnected Challenges:

  • Gain insights into the intricate balance required for harmonious device and lipid-based drug formulation development
  • Identify challenges in aligning design, functionality, and compatibility

Strategies for Effective Coordination:

  • Explore practical strategies for aligning device characteristics with specific formulation requirements
  • Address stability, bioavailability, and therapeutic efficacy in the development process

Incorporating Technological Advances:

  • Explore the impact of technological advancements on device and formulation coordination
  • Stay ahead by integrating cutting-edge technologies into your synchronized development approach

03:00 pm – 05:30 pm | WORKSHOP C

Navigating Clinical Immunogenicity of LNPs: Regulatory Guidelines & Clinical Management in Human Trials

Synopsis

  • Explore the regulatory framework surrounding the assessment of clinical immunogenicity of complex biologics, including those delivered via LNPs, ensuring compliance with guidelines and standards set forth by regulatory authorities
  • Discuss strategies for effective clinical monitoring of immunogenicity in human trials, including sample collection, and data interpretation to identify, manage, and mitigate potential risks and ensure patient safety
  • Discuss how the integrated immunogenicity data from clinical trials and the proposed management and mitigations may impact the label 
EVENT GUIDE
DAY ONE