Workshop: Development Pathways and Considerations for Subcutaneous Biologic Formulations

Sponsored By 

Sponsored by: Subcutaneous Drug Delivery And Development Consortium (Charles River Associates)

The workshop aims to provide an overview of the clinical development and regulatory pathways for subcutaneous (SC) administration of biologics. The content covers the overall SC clinical development program, clinical design choices, and endpoints. It addresses the industry perspective on bridging approaches from intravenous (IV) to SC administration and associated endpoints, the impact of targeted therapy on the selection of the study population, changes between clinical phases, and the use of high- volume devices. Case study presentations will be delivered by different pharmaceutical companies. The event concludes with a panel discussion, inviting audience participation and questions.

Presentations:

• 1:00 PM - 1:45 PM EDT

  Clinical Development and Regulatory Strategies for SC Drug and Device Development
  

  Speaker: Charles Theuer, MD, PhD (he/him/his) – Halozyme Therapeutics
• 1:45 PM - 2:30 PM EDT

  Speaker Presentation II
  

  Speaker: Dany Doucet
• 2:30 PM - 3:15 PM EDT

  Device Considerations for Combination Product Development …is it all about the dose delivery?
  

  Speaker: Ron J. Pettis, MS, PhD – RJPettis Ventures
• 3:15 PM - 4:00 PM EDT

  Speaker Presentation IV
  

  Speaker: Peter Skutnik
• 4:00 PM - 5:00 PM EDT

  Speaker Panel
  

  Panelist: Charles Theuer, MD, PhD (he/him/his) – Halozyme Therapeutics

  Panelist: Dany Doucet

  Panelist: Ron J. Pettis, MS, PhD – RJPettis Ventures

  Panelist: Peter Skutnik