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Session 9 Track 1: Advantages & Challenges of Early Phase Clinical Studies with Oligos
Session Chair(s)
Dan Swerdlow, MD, PhD
Senior Director, Early Clinical Development
GSK, United Kingdom
Sydney Stern, PhD, MS
Pharmacokineticist
FDA, United States
Phase 1 and 2 clinical trials of oligonucleotide therapeutics offer valuable opportunities as well as important challenges. In this session we will explore the unique features of the design and execution of early phase oligo trials, including: study duration and the operational challenges posed by long-acting drugs for rare diseases; gaining early clinical insights into potency and safety and the value of non-clinical data in informing study design; challenges of predicting and measuring drug accumulation; the importance of engagement with healthy participants and patients to support trial success.
Learning Objective : At the conclusion of this session, participants should be able to:- Recognize the opportunities and challenges of early phase clinical trials with oligonucleotides
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Formulate the designs of their own clinical programs to maximize those opportunities and address the challenges
- Interpret the findings of early phase oligonucleotide trials
- Identify the challenges associated with long oligo pharmacodynamic half-life and predicting optimal dose selection
Speaker(s)
Speaker
Representative Invited
Medpace, United States
Speaker
Representative Invited
FDA, United States
Speaker
Representative Invited
Hammersmith Medicines Research, United Kingdom
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