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Symposium

[Free Online Symposium] Cardiac Safety from Preclinical to the Clinic: Industry and Regulatory Trends in T-QT and Concentration-QT Studies for Assessing QT Prolongation Risks


Speakers: Borje Darpo (ERT), Jay Mason (Spaulding Clinical), Anne Bonneville (Terns Pharmaceuticals), Lauren Lohmer (Nuventra), Yehong Wang (Genentech)
Organizers: Peter Staehr (ChemoCentryx), Snow Ge (Nektar), Kelly Gelinne (Nuventra) and Ginny Schmith (Nuventra)
Date: 2021-03-23- 03/24/2021
Time: 8:30-12:30 Pacific Time
Registration fee: (USD):
Location: Online via Zoom
Major Sponsor: (1)Altasciences;(Major Sponsorship - Day 2 still open)
Vendor show vendors registered to date:
Registration: http://www.PBSS.org
Registration deadline:2021-03-20  (it will close sooner if the seating cap is reached)

About the Topic

In an effort to reduce risk to patients, regulatory agencies now require rigorous analysis of QT intervals in clinical trials as a measure of drug safety. This seminar will discuss the various ways to evaluate cardiac safety using a variety of methods - as early as preclinical and throughout your clinical trials.

Symposium Agenda – Day 1: March 23, 2021 (Times listed for Pacific Time (PT) and Eastern Time (ET))

8:30-8:45 PT / 11:30-11:45 ET: PBSS Welcome and Introductions – Shichang Miao, PBSS President

8:45-9:30 PT / 11:45-12:30 ET: State-of-the-Art: TQT studies (QT and C-QT Analyses, Challenges & Examples) - Borje Darpo (ERT)

9:30-10:15 PT / 12:30-1:15 ET: Non-clinical aspects related to the ICH Q&A - Anne Bonneville (Terns Pharmaceuticals) 

10:15-10:25 PT / 1:15-1:25 ET: AltaSciences – Major Sponsor Presentation

10:25-10:40 PT / 1:25-1:40 ET: Break

10:40-11:25 PT / 1:40-2:25 ET: Case Study - Biologics C-QT project supporting a major readout - Yehong Wang (Genentech)

11:25 -12:10 PT / 2:25-3:10 ET: Panel Discussion Day 1 (All speakers, moderated by Ginny Schmith)

 

Symposium Agenda – Day 2: March 24, 2021 (Times listed for Pacific Time (PT) and Eastern Time (ET))

8:30-8:45 PT / 11:30-11:45 ET: Introductions

8:45-9:30 PT / 11:45-12:30 ET: Cardiac safety and TQT waivers (Waiver pathways, ECG acquisition requirements) - Jay Mason (Spaulding)

9:30-10:15 PT / 12:30-1:15 ET: Wide Confidence Intervals with a Non-Positive Concentration-Related Slope: Implications from the White Paper - Lauren Lohmer (Nuventra)

10:15-10:30 PT / 1:15-1:30 ET: Break

10:30-11:15 PT / 1:30-2:15 ET: Evaluating QT Changes in the Presence of HR Changes - Lars Johannesen (FDA)

11:15 -12:00 PT / 2:15-3:00 ET: Panel Discussion Day 2 (All speakers except Yehong Wang, moderated by Ginny Schmith)


About the Speakers

Click to Enter Answer Explanations.


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©Pharmaceutical & BioScience Society, International; Last Modified: 9/18/2021; Admin Logon
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