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Description
3:00 PM – 5:00 PM (EST) Part 2: Trial Designs and Regulatory Considerations
for SC Development
Paths
3:00 PM – 3:05 PM
Introduction
and Welcome
Ryan
Nolan, Ph.D., Halozyme
3:05 PM – 3:35
PM
Ultralong
Acting Injectables for HIV Treatment and Prevention: Clinical Pharmacology
Consideration for Developing the Next Generation of Therapeutics
Andrew Webber, MS, ViiV Healthcare
Recent progress in the HIV therapeutic field has led to injectable products supporting monthly dosing intervals, with next generation therapeutics in development targeting 3-6 months or longer. This talk will introduce and summarize the progress in the field as well as the modalities which may support these medicines. The development paths and challenges of long-acting regimens will be discussed, followed by an overview of several tools which enable the next generation of therapeutics and can be used to more efficiently support clinical development and regulatory pathways. Strategies to be discussed include the use of recombinant human hyaluronidase (rHuPH20) to support large volume injections, oral bridging strategies, concentration-QT (C-QT) and drug-drug interaction (DDI) analysis, and in vitro-in vivo correlation.
3:35 PM – 4:00
PM
Developing
Subcutaneous Dosing Alternatives to High-Dose
Intravenous Infusions for Monoclonal Antibodies - Clinical Bridging Approach
Beate Bittner, Ph.D., F. Hoffmann - La Roche
The presentation describes the pharmacokinetic-based clinical bridging approach from intravenous to subcutaneous administration for high-dose monoclonal antibodies. Different intravenous versus subcutaneous launch scenarios are discussed future focus areas are introduced.
4:00 PM –
4:55 PM
Moderated
Panel: Trial Designs and Regulatory Considerations for SC Development Paths
including Role of Virtual Data in Successful Bridging Studies
Kaoutar Abbou Oucherif, Ph.D., Eli Lilly
Beate Bittner, Ph.D., F. Hoffmann - La Roche
Ramesh Kashi, Ph.D., Bristol-Myers Squibb
Yow-Ming Wang, Ph.D., US Food and Drug Administration (FDA)
Andrew Weber, MS, ViiV Healthcare
4:55 PM - 5:00 PM
Closing Remarks
Ryan Nolan, Ph.D., Halozyme