Kristin Luther

Company: AGS Therapeutics

Job title: VP of CMC

Bio:

Dr. Kristin Luther is the VP of CMC & Analytics at AGS Therapeutics and brings a wealth of first-hand experience, extensive expertise, and a proven track record in the field of extracellular vesicles. With over eight years of focused experience in biopharmaceutical CMC development, she offers in-depth knowledge of downstream processes, analytics, regulatory filings, and tech transfer to CDMOs for extracellular vesicle-based therapeutics. Dr. Luther has held key roles at leading companies, including Vesigen Therapeutics (USA), Nanoview Biosciences (USA), and Capricor Therapeutics (USA). Her contributions have played a critical role in the successful filing of Investigational New Drug (IND) applications with the FDA for extracellular vesicle-based product candidates.

Seminars:

MEVs (Microalgae Extracellular Vesicles) – A Universal Delivery System for RNA Therapeutics, Vaccines & Gene Therapies 4:20 pm

Introducing MEVs and MEV technology Showcasing the uniqueness of MEVs compared with mammalian EVs Demonstrating MEV potential through data-driven case studies NEW COMPANY!Read more

day: Conference Day One

Roundtable Discussion: Utilizing the Most Optimal Analytical Assays to Support Your Exosome Drug Product Release Strategies 2:30 pm

Evaluating conventional and novel instruments to analyze exosomes across ELISA, acoustic Imaging, flow cytometry, and more to confidently select your technology Ensuring analytical methods are validating, qualifying, and reproducible to ensure safety and sterility of the exosome product One vs multiple potency assays – How to address complex mechanisms of action within the production phaseRead more

day: Pre-Conference Focus Day