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June 6th, 2022

Free Event

Basic tenets of ADC PK/PD and examples of how M&S can be used to support MIDD of ADCs

Dhaval Shah, PhD
University at Buffalo (Buffalo, New York, USA)

Formulating ADCs

Rajiv Nayar, PhD
HTD Biosystems
Over 11 antibody-drug conjugates (ADCs) are currently marketed and many more are in various stages of development.  These novel drug delivery systems combine the benefits of the selectivity of the antibody and the potency of the cytotoxic agent, referred to as a “war head”. The interplay of the antibody, linker and payload, however, calls for a stable and unique formulation that addresses the stability of the drug-antibody complex. 

​​​​​​​The first presentation will cover basic tenets of ADC PK/PD and examples of how M&S can be used to support MIDD of ADCs.

The second presentation will cover the formulations of the current ADCs and  address the general formulation considerations of the ADCs,  In addition,  the analytical toolbox for characterization the antibody, the warhead, and stability of the drug-antibody ratio (DAR) will be discussed.
Speaker Bios
Dr. Dhaval Shah
He is an Associate Professor at the University at Buffalo. He received his Ph.D. from the Department of Pharmaceutical Sciences at the University at Buffalo; and he was Principal Scientist at Pfizer Inc. before becoming a professor. His research focuses on understanding the determinants for the absorption, distribution, metabolism, and elimination (ADME) of protein therapeutics and novel biologics. His lab uses the principles of Pharmacokinetics-Pharmacodynamics (PK-PD) Modeling & Simulation to support the discovery, clinical translation, and late phase development of novel biologics like engineered antibodies, multi-specific proteins, immuno-oncology agents, engineered T cells, antibody-drug conjugates, and gene delivery vectors.

Dr. Rajiv Nayar
He is Founder and President of HTD Biosystems. Previously, Dr. Nayar was at Bayer where he established the formulation and drug delivery Group in the biotechnology division and was responsible for managing the formulation and drug delivery activities within the global Bayer network on protein/peptide based drugs.  He was a recipient of 3 consecutive Presidential Achievement Awards at Bayer for implementing Continuous Improvement Processes in pharmaceutical development.  He is the inventor the Bayer’s albumin-free Factor VIII formulation (Kogenate® FS, JiVI).  Prior to Bayer, he was at the Canadian Liposome Company and involved in the development of liposomal doxorubicin and vincristine (Caelyx®, Myocet®).
At HTD Biosystems, Rajiv has been involved in over 700 projects on protein formulation, liposomal and LNP drug delivery systems, vaccine development, and establishing novel high throughput technologies for rapid and efficient drug formulation using mg amounts of material and advanced DOE systems (iFormulate™).
He is an inventor on >20 patents and has authored >70 publications.  He is a recipient of a recently (Biochemistry) from University of British Columbia and was an MRC fellow at M.D Anderson Tumor Institute.

This is a Free Event


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