Optimizing Early Clinical Research to Accelerate Drug Development Timelines: Value of Early Safety Assessments
April 28, 2011
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The primary focus of early phase studies is to assess the relative safety of new drug candidates in humans. However, the emphasis is not solely on identifying acute organ toxicity, but also to identify potential toxicity issues that may become a concern later in clinical development or when the drug is marketed. Early clinical safety assessment is being facilitated by the development of new safety biomarkers of organ-specific effects, changing study designs that incorporate learnings from prior experiences, and technologies that allow faster, better and efficient capture of more data.
In this webinar, Celerion’s experienced physicians described their approaches and experience in making the early assessments of safety and tolerability of new drug candidates. Through brief case studies, the speakers discussed changing tools, approaches and considerations for identifying hepatic, renal, pulmonary, neuropsychiatric and cardiovascular adverse effects as well as assessing risk for ocular toxicity in humans.
William Wheeler, MD, FACC, Therapeutic Area Lead-Cardiovascular
Value of Early Safety Assessments
William Wheeler, MD, FACC, Therapeutic Area Lead-Cardiovascular (Chair)
Sandra Connolly, MD, Principal Investigator, Neptune, NJ USA
Johnston Stewart, MB, MRCGP, MFPM, Principal Investigator, Belfast, Northern Ireland UK
Scott Rasmussen, MD, Principal Investigator, Lincoln, NE USA
Stephen P. Youngberg, MD, Principal Investigator, Lincoln, NE USA
Dennis Swearingen, MD, CPI, Principal Investigator, Phoenix, AZ USA