The Biotechnology Specialty Section (BTSS) Executive Committee is excited to announce an upcoming webinar entitled, “Predictivity/Translatability of Toxicities Observed in Nonclinical Toxicology Studies to Clinical Safety Outcomes” with talks from four experts in the field (details below).
Date/Time: February 9, 1:00 pm–2:30 pm EST (10:00 am–11:30 am PST)
Registration for the webinar is required. Please register here.
Abstract: Nonclinical toxicology studies are conducted to characterize the potential toxicities and establish a safe starting dose for new drugs in clinical studies, but the question remains as to how predictable/translatable the nonclinical safety findings are to humans. In many cases, there is good concordance between nonclinical species and patients. However, there are cases when there is a lack of translatability/predictivity that lead to early termination of clinical studies due to unanticipated toxicities or early termination of programs before making it to the clinic due to unacceptable nonclinical toxicities assumed to be translatable. The objective of this session is to better understand safety findings that are translatable versus safety findings that are not and why. Case examples on anti-drug antibodies, drug-induced liver injury, bone marrow toxicity, and peripheral neuropathy will be highlighted. The desired outcome of this session is to better inform the future of nonclinical safety assessments for the field of pharmaceutical drug development.
Nonclinical to Clinical Translatability of Bone Marrow Toxicity and Peripheral Neuropathy with Microtubule Inhibitor Containing Antibody Drug Conjugates, Nicola Stagg, Genentech
Reliably Predicting the Toxicity in Humans Based on Nonclinical Studies: Anti-Drug Induced Anemia as a Case Example, Jane Sohn, US Food and Drug Administration
Predicting the Potential of Drug Candidates to Cause Idiosyncratic Liver Injury in Human Patients: Is There Hope?, Robert Roth, Michigan State University
Lack of Concordance between Nonclinical and Clinical Findings with Statin Class of Compounds, Kenneth Hastings, Hastings Toxicology Consulting LLC
Please join us and register here.