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Announcing the 2023 Biologics Summit!

This Biologics Summit, jointly hosted by the Controlled Release Society and IPEC-Americas, will address the current state and prospects for future advancements related to formulation and characterization technologies, functional excipients, predictive bioavailability, and device technologies to enable the SC delivery of high dose/volume biologics.

PART II: CRS 2023 Annual Meeting & Expo

July 24, 2023
Paris Hotel
Las Vegas, NV

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About Biologic Therapeutics

Subcutaneous (SC) delivery of biologic therapeutics as an alternative to IV infusion is of increasing interest to expand the patient-centric opportunities for self-or caregiver-assisted administration at home or in an office setting. The normally high dose and volumes associated with IV administration of therapeutic proteins present significant challenges to achieving SC delivery, such as, high concentration viscosities, stability/protein aggregation, unpredictable bioavailability, potential immunogenicity, manufacturability and injection device compatibility.

Agenda

8:30 AM & 8:35 AM
 Welcome, Logistics, Intro & Overview of administration of biologics: past, present, future
Simon Matoori, Université de Montréal


8:50 AM
Biologics Summit Part 1 review and key learnings
Nigel Langley, Gaylord Chemical & IPEC-Americas


9:05 AM
 Introduction to high dose/high volume SC administration of biologics and the SC Delivery Consortium
Beate Bittner, F. Hoffmann - La Roche Ltd


9:30 AM
 Crash Course on High Dose/High Volume Subcutaneous Delivery with Recombinant Human Hyaluronidase (rHuPH20)
Marie Printz, Halozyme


10:00 am - BREAK


10:20 AM
 Microglassification™ suspensions of biologics for SC delivery of high concentration formulations
Deborah Bitterfield, Lindy Biosciences


10:50 AM
 An injectable hydrogel particle platform enabling high concentration delivery of amorphous solid and crystalline biologics
Patrick Doyle, MIT


11:20 AM
 XERIJECT formulation technology for SC delivery of ultra-high concentration biologics
Rick Fitch, Xeris Pharmaceuticals


11:50 AM - LUNCH BREAK


1:00 PM
 Prediction of clinical SC bioavailability: relevance of in vivo models
Beate Bittner, F. Hoffman - La Roche


1:30 PM
 How Aggregated Clinical Data Can Provide Greater Utility than Animal Models for Predicting Antibody Subcutaneous PK
Ryan Nolan, Halozyme


2:00 PM
 Uncloaking In-vitro Subcutaneous Bioavailability Tools
Manuel Sanchez-Felix, Novartis


2:30 PM
 Predicting Subcutaneous Drug Absorption via Machine Learning Attempts and A Custom In Vitro Device
Hao Lou, University of Kansas


3:15 PM
 Panel Discussion
Simon Matoori, Université de Montréal


4:00 PM - CONCLUSION