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Final Program


CRS Abstract Guide

Workshop: Debunking the Myths of Subcutaneous Drug Delivery

Monday, July 8, 2024
1:00 PM - 5:00 PM CET
Location: Magenta A

Sponsored By 
The subcutaneous (SC) route of drug administration has increasingly gained regulatory acceptance and patient/HCP preference, particularly for delivery of biological therapeutics. In this educational workshop, we aim to debunk some myths surrounding subcutaneous drug delivery, and to provide guidance for scientists from both Industry and Academia who are in the field of SC drug development and delivery. Topics include the misperceptions with SC (1) pain associated with delivery of large doses and volumes, (2) immunogenicity, (3) low and unpredictable bioavailability, and (4) need for extensive clinical trials.

Agenda


1:00 pm to 1:05 pm                              Introductions
                                                               David Kang, Halozyme Therapeutics
                                                               Beate Bittner, F. Hoffmann-La Roche Ltd.


1:05 pm to 1:45 pm                              Myth 1: SC Delivery is Painful and Limited to Small Volumes
                                                               Sylvain Huille, Sanofi
                                                               Hannie Shih, Eli Lilly & Co.
                                                               David Kang, Halozyme Therapeutics


1:45 pm to 2:25 pm                              Myth 2: SC Delivery Increases Immunogenicity
                                                               Marie Printz, Halozyme Therapeutics
                                                               Nicole Buist, Merck Sharpe & Dohme LLC


2:25 pm to 2:55 pm                              Coffee/Tea Break


2:55 pm to 3:35 pm                              Myth 3: SC Delivery is Challenging Due to Low and/or Unpredictable                                                                                        Bioavailability
                                                               Nicole Buist, Merck Sharpe & Dohme LLC
                                                               Manuel Sanchez-Felix, Halozyme Therapeutics
                                                               Kate Harris, AstraZeneca
                                                               Marta Venczel, Sanofi


3:35 pm to 4:15 pm                              Myth 4: SC Delivery Requires Extensive Clinical Trials When Bridging                                                                                       Devices or From IV
                                                               Beate Bittner, F. Hoffmann-La Roche Ltd.
                                                               Gerard Bruin, Novartis


4:15 pm to 4:20 pm                               Mini-Break


4:20 pm to 5:00 pm                               Round Table Discussion
                                                                All Speakers

Learning Objectives:

At the completion of this activity, participants will know
  • We will discuss some misconceptions surrounding subcutaneous drug delivery and how to navigate the SC drug development and delivery process.
  • SC drug delivery is not limited to small volumes. We will discuss options and key parameters for large volume delivery.
  • SC drug delivery is not prohibited by immunogenicity. We will provide the current understanding of SC immunogenicity and key factors affecting risk.
  • SC bioavailability is not limiting. We will discuss unvalidated views that SC delivery results in low or unpredictable bioavailability and share strategies and methods for optimizing and characterizing it.
  • The clinical development path for SC drugs does not have to be long and complicated. We will discuss strategies for a streamlined approach from early to registrational trials.