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Workshop
[In-Person] Drug Metabolism Fundamentals and Metabolite Identification
Speakers:
Cyrus Khojasteh, PhD (Genentech), Bill Fitch, PhD (independent consultant), Shichang Miao, PhD (ex-Chemocentryx/Amgen), Raju Subramanian (Gilead); Shuguang Ma (Pliant Therapeutics); Bin Ma (Genentech); Lionel Cheruzel (Genentech)
Organizers:
Cyrus Khojasteh, PhD (Genentech), Bill Fitch, PhD (independent consultant), Shichang Miao, PhD (ex-Chemocentryx/Amgen)
Date:
2025-04-25
Time:
8:45-17:00 Pacific Time
Registration fee:
Regular attendees: $295; Academic/Students/Postdocs/Out-of-Pocket: $45; Major Sponsorship: $3000; Vendor Show: $750, Happy Hour Sponsorship: $1250; Lunch Sponsorship: $1500; On-site Registration: $500
Location:
Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor:
Vendor show vendors registered to date:
(10)BioDuro-Sundia; BioIVT; Hypha DIscovery Ltd; Labcorp; Meadowhawk Biolabs; Medicilon; Novabiosis, Inc; QPS; WuXi AppTec; Zinsser Analytic
Registration: http://www.PBSS.org
Registration deadline:2025-04-24
(it will close sooner if the seating cap is reached)
About the Topic
Drug Metabolism, a process by which the body converts a drug into metabolites generally favoring excretion, is a major clearance mechanism for drugs and plays a key role in a drug’s pharmacokinetic and pharmacodynamic profiles. Identification of the metabolites is a major component in drug metabolism studies and is critical for both drug discovery and drug development. At the discovery stage, when metabolic stability becomes an issue for the compound’s PK profiles, the medicinal chemists would demand the identification of the precise structural locations of the metabolic modifications, so that analog compounds can be designed to address the metabolic liability issue. For the development stage, it is critical to know the metabolites and the metabolic pathways of the drug as the metabolites can also play some biological and pharmacological roles such as efficacy, toxicity and drug-drug interaction. This workshop will discuss the fundamentals of drug metabolism, commonly used methods for studying drug metabolism, and techniques for identifying metabolites.
List of Topics:
- Fundamentals of drug metabolism and drug metabolizing enzymes (including phenotyping)
- Metabolite identification overview, metabolite isolation and separation techniques
- MS/MS interpretation
- NMR techniques for metabolite identification
- Metabolism and metabolite identification for new modalities (ADCs, PROTACs and Oligos)
- In vivo metabolite profiling and case studies
Time (PT) |
Topic |
Presenter(s) |
8:45 – 9:00 am |
PBSS Welcome and Overview |
Shichang Miao, PhD, President, PBSS |
9:00 - 10:00 am |
Biotransformation Science: Understanding Drug Metabolizing Enzymes and Reaction Mechanisms |
Cyrus Khojasteh, PhD, Senior Director, Genentech |
10:00 - 10:45 am |
Metabolite ID Overview |
Bill Fitch, PhD, Consulting Professor, Stanford University |
10:45 - 10:55 am |
Major Sponsor Presentation |
IQVIA Laboratories |
10:55 - 11:15 am |
Break and Vendor Show |
- |
11:15 am - 12:15 pm |
Metabolite Structure Identification Using MS/MS and Other Techniques |
Shichang Miao, PhD, ex-VP PreclinDev & ClinPharm, ChemoCentryx/Amgen |
12:15 - 1:15 pm |
Lunch |
Partially subsidized by WuXi AppTec |
1:15 - 1:45 pm |
Digital Tools for Metabolite Identification |
Lionel Cheruzel, PhD, Senior Principal Scientist - DMPK, Genentech |
1:45 - 2:45 pm |
Metabolite Identification in Drug Development and Case Studies |
Shuguang Ma, PhD, Senior Director, Head of DMPK, Pliant Therapeutics |
2:45 - 2:55 pm |
Major Sponsor Presentation |
Emery Pharma |
2:55 - 3:15 pm |
Break and Vendor Show |
- |
3:15 -4:15 pm |
Strategies and Tools to Address Challenges in Metabolism of New Drug Modalities |
Bin Ma, PhD, Senior Principal Scientist, DMPK, Genentech |
4:15 - 5:00 pm |
Drug Metabolite Generation and Identification by NMR |
Raju Subramanian, PhD, Executive Director, Gilead Sciences |
5:00 - 5:30 pm |
Panel discussion |
All presenters |
5:30 - 6:30 pm |
Happy Hour |
Sponsor by Labcorp |
About the SpeakersS. Cyrus Khojasteh is the Senior Director and Distinguished Scientist and heads the Biotransformation Function in DMPK department at Genentech, Inc. (South San Francisco). His biotransformation research focuses on the mechanisms of biotransformation in drug discovery and development, from small molecules, antibody drug conjugates, and macrocyclic peptides. Cyrus received his Ph.D. in Medicinal Chemistry from the University of Washington under the direction of the late Professor Sidney D. Nelson.
Bill Fitch is a consultant in the fields of drug metabolite identification and mass spectrometry. He worked in environmental, agricultural chemical and pharmaceutical research at Bay Area firms Acurex, Zoecon, Affymax and Roche. His current clients include Stanford Medical School and a number of small or virtual pharmaceutical companies. He received his Ph.D. in organic chemistry at Stanford under Professor Carl Djerassi.
Shichang Miao, PhD, is a seasoned DMPK/ClinPharm scientist and drug developer and biotech investor. During his career, he worked at several biotech companies in the San Francisco Bay Area, including Tularik, ChemoCentryx and Amgen. At ChemoCentryx, as Vice President of Preclinical Development & Clinical Pharmacology, he led a team to conduct the preclinical assessment and clinical pharmacology studies for the development of Tavneos® (avacopan), which was approved in 2021 by the FDA for the treatment of ANCA-associated vasculitis, leading to the acquisition of ChemoCentryx by Amgen in 2022. He received his PhD in organic chemistry and post-doctoral training in biochemistry at the University of British Columbia (Vancouver, Canada).
Lionel Cheruzel, Ph.D. is a Senior Principal Scientist leading the Discovery Biotransformation Group at Genentech, Inc. (South San Francisco). Previously, he was a Professor in the Department of Chemistry at San Jose State University where he pioneered the development of light-driven P450 biocatalysis leveraging an inorganic photosensitizer as light-harvesting unit. He received his Ph.D. from the University of Louisville, KY and a post-doctoral training in bioinorganic chemistry at the California Institute of Technology (Pasadena, CA).
Shuguang Ma is currently a Senior Director and head of DMPK at Pliant Therapeutics Inc. Previously he was a Director at Amgen Inc., a Senior Principal Scientist at Genentech Inc. and Schering-Plough (now Merck & Co., Inc.). He received his Ph.D. in Analytical Chemistry from Purdue University, followed by a postdoctoral training in biological mass spectrometry at Vanderbilt University School of Medicine. He has authored 70 research articles in peer-reviewed journals and contributed eight book chapters and one recent book (as co-editor). His research interests include the development of novel LC/MS-based techniques for metabolite detection and investigation of biotransformation and bioactivation of xenobiotics.
Bin Ma is a Senior Principal Scientist in the DMPK department at Genentech, focusing on the metabolism of novel drug modalities including macrocyclic peptides, disulfide constrained peptides, protein degraders, and oligonucleotides. He earned his PhD in Pharmacology from The Chinese University of Hong Kong and completed postdoctoral research at the University of Minnesota. Before joining Genentech, he worked as a Staff Scientist at the Masonic Cancer Research Center and later at Gilead Sciences. Dr. Ma’s research has been featured as cover stories in several scientific journals, including J. Med. Chem., Carcinogenesis, Mutagenesis, and Chem. Res. Toxicol.
Raju Subramanian, Executive Director in Drug Metabolism and Pharmacokinetics (DMPK), holds a Ph.D. in Physical Chemistry from SUNY Stony Brook (1994). He completed postdoctoral research at William and Mary and UIUC. With 25+ years in the pharmaceutical industry, he worked at Merck, Amgen, and Gilead since 2016. As a nonclinical sciences team leader, he mentors and supports discovery and development teams across multiple therapeutic areas, including cardiovascular, virology, inflammation, and oncology. A (co)author of 85+ publications, he has contributed to four drug approvals: Parsabiv, Biktarvy, Veklury, and Sunlenca, making significant impacts on patient treatments and pharmaceutical advancements.
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