
Strategy for covalent drug discovery and development, and pharmacokinetics/pharmacodynamics (PK/PD) translation from pre-clinical and clinical data to inform future covalent drug design
Includes a Live Web Event on 07/08/2025 at 11:00 AM (EDT)
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This presentation will outline a general strategy for the discovery and development of TCIs. Additionally, pharmacokinetic/pharmacodynamic (PK/PD) and efficacy mechanistic models for covalent drugs will be discussed. These mechanistic PK/PD/efficacy models derived from pre-clinical and clinical experience will enhance our understanding of the pharmacokinetic and pharmacodynamic interplay and assist in designing next-generation covalent drugs.

Upendra Dhal
Upendra Dhal is currently a Scientific Director in Pharmacokinetic and Drug Metabolism (PKDM) Department at Amgen. He represents PKDM in multi-disciplinary teams from discovery to development, oversees small molecule projects and outsourcing of ADME studies, and supervises scientists and PTRs. Proficient in designing in vitro and in vivo studies to characterize/understand PKDM properties of the drug candidates, provides recommendations to the teams to design better compounds with minimal metabolic and DDI liabilities. Leading the biotransformation group for small molecule drugs, Upendra reviews data, monitors studies, and addresses PKDM challenges to mitigate risks. His role involves preparing as well as reviewing regulatory documents for IND and NDA submissions. Previously worked at Celgene and Pfizer, Upendra boasts diverse research interests, evidenced by a strong track record of peer-reviewed publications across various domains. Upendra received his PhD focusing on enzyme kinetics and drug metabolism from Washington State University under supervision of Prof. Jeff Jones.

Nashid Farhan
Nashid Farhan is a modeling and simulation expert working in the Pharmacokinetic and Drug Metabolism (PKDM) Department at Amgen. His specialization lies in small molecule pharmacokinetics/pharmacodynamics (PK/PD) and physiologically based pharmacokinetic (PBPK) modeling and simulation. As a subject matter expert (SME), he regularly develops models to predict human dose/dosing regimen, assess cardiac safety, and evaluate drug-drug interaction liabilities of small molecule drugs. In addition, Nashid is a Shiny App developer and has created multiple applications for PK/PD model fittings and simulations. Before joining Amgen, Nashid was a post-doctoral associate at the University of Florida's Center for Pharmacometrics and Systems Pharmacology, where he worked both on population PK/PD and PBPK models. He received his PhD in Pharmaceutics from the University of Houston, focusing on pharmacokinetics, drug metabolism, and PK/PD modeling.
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Li Di (Moderator)
Dr. Li Di has ~30 years of experience in the pharmaceutical industry including Pfizer, Wyeth, and Syntex. She is currently a DMPK fellow at Recursion Pharmaceuticals. Her research interests include the areas of drug metabolism, pharmacokinetics, PK/PD, drug-drug interactions, absorption, transporters, blood–brain barrier and PBPK modeling and simulation. She has 200 publications including two books and presented over 100 invited lectures. She is a recipient of the Thomas Alva Edison Patent Award, the New Jersey Association for Biomedical Research Outstanding Woman in Science Award, the Wyeth President’s Award, Peer Award for Excellence, Pfizer’s top 14 articles in 2023 and ISSX Distinguished Accomplishments in Drug Discovery and Development of Paxlovid Team Award (2023) and individual award (2024).
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