Navigating the Landscape of Service Providers for Critical Laboratory Assets Like LCMS

Wednesday, April 19, 2023, 11:15-11:45 am ET

Maintaining the performance, uptime, managing costs and overall sustainability of a busy LCMS lab today requires a well thought out plan and team of service providers. This presentation will discuss strategies to consider when selecting your partners including:

• Aligning stakeholder needs and requirements; scientists, facility/lab managers, finance
• Accessing service provider choices, differences, benefits for your operation
• Tailoring solutions for your lab with case study examples

Speaker: Kevork Kalaydjian, Zef Scientific

Methodology for Aerosol and Intranasal Aerosol Delivery and Characterization for Gene Therapy and Biologics

Wednesday, April 19, 2023, 1:15-1:45 pm ET

This e-chalk talk will detail the methodology for aerosol and intranasal delivery that is unique for gene therapy and biologics. The e-chalk will specifically highlight differences between a more standard approach used for small molecules compared with the fit for purpose approach(s) required for gene therapy. This will include details on the formulation, device, analytical methods, model selection, bioanalytical methods, biomarker methods and validations. The data presented will be based on the experience by the two primary presenters in supported over 6 open IND’s within the past three years in inhaled or intranasal delivery of gene therapy products. The audience will benefit from understanding the ability to design these as fit for purpose programs that allow streamlined regulatory approval.

Speakers:  
Ted Barrett, Ph.D., Lovelace
Philip Kuehl, Ph.D., Lovelace