Successfully advancing a drug candidate from discovery to IND requires a robust understanding of toxicology, regulatory documentation, and cardiac safety assessment. Join Medicilon for a free live webinar to explore key strategies for IND‑enabling toxicity studies, CTD preparation, and translational cardiac risk evaluation. Join Medicilon for a free live webinar！
Date:July 28th, 2026
Time:6:00-7:00 PM (PST) | 9:00-10:00 PM (EST)
What You Will Learn
Topic: Toxicity studies and CTD focusing on Module 2 and Module 4 for IND application
Abstract: The presentation highlights the toxicology strategy for IND application, dose selection strategies for toxicity studies, determination of starting dose for first in human clinical trials from NOAEL value of toxicity studies, and preparation of dossiers for eCTD Module 2.
Topic: Translational assessment of QT & arrhythmia liabilities by rabbit ventricular wedge assay with case studies
Abstract: The presentation highlights the robust translatability of an in vitro cardiac assay that predicts the arrhythmic risks of drugs causing torsades de pointes in the clinic, followed by case study demonstrating the utility of the assay in assessing cardiac liability in the early phase of nonclinical safety evaluations.
Meet Our Speakers
Moderator: Mingfeng Bai
SVP of Business Development, Medicilon
Dr. Bai earned his Ph.D. in Chemistry from Vanderbilt University and completed postdoctoral training at Washington University in St. Louis. He has over 10 years of faculty experience at US medical schools, specializing in targeted photodynamic therapy and surgical navigation agents. He has published more than 50 papers, holds 6 US patents, and previously served as CEO of a biotech company.
Speaker: Renzong Xie
VP of Toxicology, Medicilon
Dr. Xie holds a Ph.D. in Pharmacology and Toxicology from the University of Mississippi and is a DABT‑certified toxicologist. With over 30 years in the pharmaceutical industry, including 12 years at the CDE in Taiwan, he has reviewed more than 200 IND and 150 NDA applications. He also contributed to drafting nonclinical safety guidelines and held senior executive roles in several biotech companies.
Speaker: Haiming Tang
Senior Toxicologist, Medicilon
Mr. Tang holds a Master’s in Pharmacology from the University of Hawaii and a Bachelor’s from Fudan University. He has over 30 years of preclinical safety experience in the US, having worked at Roche, Novartis, and multiple biotech firms. His expertise spans toxicology, safety pharmacology, and regulatory requirements for IND submissions across various therapeutic areas.
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