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[Webcast from Boston-PBSS Free Workshop] Radio-labeled Mass Balance and Metabolite Profiling Studies: Fundamentals, Best Practices, Regulatory Requirements, Applications and Case Studies

Speakers: Chandra Prakash (Agios), Scott Obach (Pfizer), Douglas Spracklin (Pfizer), Xiaochun (Sean) Zhu (Takeda), Xiumin Liu (Alnylam), Prakash Bolleddula (EMD Serono)
Organizers: Chandra Prakash (Agios)
Date: 2021-10-14- 10/15/2021
Time: 13:00-17:00 Eastern Time
Registration fee: (USD): 0.0.
Location: Webcast from Boston-PBSS
Major Sponsor: (2)Hypha Discovery Limited; Sekisui XenoTech, LLC
Vendor show vendors registered to date:
Registration deadline:2021-10-13  (it will close sooner if the seating cap is reached)

About the Topic

Workshop Description:

Radio-labeled absorption, distribution, metabolism, and elimination (ADME) studies provide information related to rates and routes of elimination and major metabolic (excretory & circulatory) pathways of an investigational drug. The information generated with these studies is extremely valuable in predicting and explaining drug-drug interactions of parent/metabolites, as well as to understand the pharmacological and toxicological significance of metabolites. Regulatory guidelines (Metabolites in Safety Testing, MIST) warrant that human specific or disproportionate metabolites whose exposure is greater than 10% of total drug related material should be considered for safety assessment in preclinical species.

To establish quantitative metabolic pathways in laboratory animals and humans, a multitude of ADME studies are conducted at various stages of drug development utilizing radiolabeled compounds. Although radio-labeled ADME studies provide key information, there is limited regulatory guidance available on conducting these complex studies.  In addition, recently there has been an increased interest in understanding the importance of the metabolism/catabolism of new modalities such as siRNAs and biologics.

The workshop is designed to provide detailed guidance on objectives, study designs, and data analysis of metabolism studies of small molecules, siRNAs, and protein therapeutics. Speakers of this workshop bring a wealth of knowledge from the pharmaceutical industry in drug metabolism sciences. The discussion will be centered around the following topics:

  • Overview of drug metabolism and regulatory requirements for IND and NDA submission
  • Preclinical and human mass balance studies: Design, data analysis, and interpretation
  • New crossover human ADME study design using AMS
  • Approaches for safety assessments of human metabolites
  • Techniques (H/D exchange, derivatization, NMR and stable isotope) beyond mass spectrometry for metabolite identification
  • Human dosimetry calculations
  • Radio-labeled ADME studies of new modalities


Symposium Agenda and Speakers – Day 1 (Oct 14, 2021)
Times are PST (EST in brackets)

10:00am - 10:15am (1:00pm - 1:15pm)         Introduction - Chandra Prakash (Agios)

10:15am - 10:45am (1:15pm - 1:45pm)         Are Preclinical Mass Balance Studies Still Necessary?  - Chandra Prakash (Agios)

10:45am - 11:30am (1:45pm - 2:30pm)         Quantitative Whole-Body Autoradiography (QWBA) and human dosimetry - Michael (Potch) Potchoiba (Frontage)

11:30am - 12:15pm (2:30pm - 3:15pm)         Human Mass Balance Study: Design, Data analysis, and Interpretation - Prakash Bolleddula (EMD Serono)

12:15pm - 12:45pm (3:15pm - 3:45pm)         Break

12:45pm - 12:55pm (3:45pm - 3:55pm)         Major Sponsor Presentation - Sekisui XenoTech

12:55pm – 1:35pm (3:55pm - 4:35pm)          New AMS-enabled Human Absorption, Distribution, Metabolism & Excretion (hADME) Study: A Technological and Strategic Paradigm Shift - Douglas Spracklin (Pfizer)

1:35pm – 2:00pm (4:35pm - 5:00pm)            PANEL DISCUSSION - All speakers


Symposium Agenda and Speakers – Day 2 (Oct 15, 2021)
Times are PST (EST in brackets) 

10:00am - 10:05am (1:00pm - 1:05pm)         Welcome - Chandra Prakash (Agios)

10:05am - 10:45am (1:05pm - 1:45pm)         Approaches for Coverage Assessment of Human Metabolites in Safety Species - Scott Obach, Pfizer

10:45am - 11:45am (1:45pm - 2:45pm)         Techniques (H/D exchange, derivatization, NMR and stable isotope labeling) beyond mass spectrometry for metabolite identification  - Xiaochun (Sean) Zhu, Takeda

11:45am - 11:55am (2:45pm - 2:55pm)         Major Sponsor Presentation - Hypha

11:55am - 12:30pm (2:55pm - 3:30pm)         Break

12:30pm - 1:30pm (3:30pm - 4:30pm)           Opportunities and Challenges for Nonclinical Radiolabeled Mass Balance and QWBA Studies with siRNAs - Xiumin Liu, Alnylam

1:30pm – 2:00pm (4:30pm - 5:00pm)            PANEL DISCUSSION - All speakers

About the Speakers

Jayaprakasam Bolleddula is currently a Clinical Pharmacology Expert Team Lead (CPET) at EMD Serono in Billerica, MA. Prior to joining EMD, Dr. Bolleddula led drug metabolism groups at Agios Pharmaceuticals in Cambridge MA, Takeda-Boston and at Theravance Biopharma in South San Francisco. He has published over 50 peer reviewed research articles and also a co-inventor of numerous patents. Dr. Bolleddula has been involved in conducting many human mass balance studies and supporting several regulatory filings. He obtained a PhD in Natural Products Chemistry/Pharmacognosy from Sri Venkateswara University in Tirupati, India and held a Junior faculty position at Mount Sinai School of Medicine, NY.  His current research interests are various aspects of clinical pharmacology including drug-drug interactions, PBPK, and PK/PD modeling.

Xiumin Liu is currently a Senior Scientist in DMPK group at Alnylam. After earned Ph.D. in Analytical Chemistry at the University of Akron, in 2014 she joined Covance DMPK department at Madison site, mainly conducting metabolite profiling and identification for radiolabeled studies. She has been with Alnylam for about four years, using DMPK and analytical approaches to support drug development of RNAi therapeutics. A key part of her role at Alnylam is to support radiolabeled studies for pre-clinical development.

Scott Obach is currently a Vice President of Scientific Research in the Pharmacokinetics, Dynamics, and Drug Metabolism Department at Pfizer in Groton, CT.  He joined the company ion 1992.  His main role in Pfizer’s early research is to aid medicinal chemists in designing new drugs that will have good exposure in the body, and his role in the later phase of drug development is to characterize how the body metabolizes and excretes individual drug candidates.  His research interests include application of in vitro approaches to study drug metabolism, prediction of human pharmacokinetics and drug interactions, mechanisms of chemical reactions of drug metabolism, and late stage lead diversification using enzymatic and chemical approaches.  Scott earned his Ph.D. in biochemistry from Brandeis University in 1990, followed by a post-doctoral fellowship in 1990-1992 at the New York State Department of Health Research Laboratories.  He is an author or coauthor on over 200 research publications (H-index = 63) and on the editorial boards of Drug Metabolism and Disposition and Xenobiotica.

Michael Potchoiba (Potch) is currently a DMPK Senior Director at Frontage Laboratories, Inc.  Potch established a World-Class QWBA COE at Frontage, managing QWBA tissue distribution studies with radiation dosimetry in support of hAME.  Prior to joining Frontage, Potch left Pfizer as a Senior Principal Scientist after 18 years and was a Senior Study Director at Covance for 11 years primarily conducting radiolabeled QWBA and ADME studies in small and large animals.  Potch also provided radiation dosimetry and radioanalysis support for hAME studies at both Pfizer and Covance.  Potch’s major role at Frontage is to provide leadership and management for the QWBA COE while collaborating with Clients on their pre‑clinical development and discovery in‑life projects and providing hAME radiation dosimetry for their hAME studies.

Chandra Prakash is a Senior Research Fellow in Drug Metabolism, Pharmacokinetics and Clinical Pharmacology Department at Agios, Cambridge, MA. Prior to joining Agios, he worked at Vanderbilt University (Nashville, TN), Pfizer Global Research and Development (Groton, CT) and Biogen (Cambridge, MA). For the last 30 years, Dr. Prakash has been involved in the drug metabolism and clinical pharmacology studies to support drug discovery, development and registration. His research is primarily focused on the development and utilization of novel approaches and techniques which include in vitro methods using human and animal hepatic cellular and subcellular systems, recombinant human drug metabolizing enzymes, sensitive analytical technologies and in silico computational models to assess the metabolism and toxicological aspects of the new chemical entities. He is the author of more than 285 manuscripts, book chapters, presentations and patents. He also coedited five volumes of Handbook of Metabolic Pathways of Xenobiotics. He served as the editor-in-chief of the Journals “Current Drug Metabolism” and "Drug Metabolism Letters" (2000-2015) and editorial board member of several journals.

Douglas K. Spracklin is the Director of the Biotransformation & Environmental Sciences group within Medicine Design at Pfizer. He received his Ph.D. degree in Chemistry from the University of British Columbia and carried out postdoctoral research at the University of Washington. He spent two years at Abbott Laboratories before joining the Neuroscience Drug Metabolism group at Pfizer. In that role, he supported programs spanning early discovery through clinical development for almost 10 years before assuming his current position.

Xiaochun (Sean) Zhu is an associate director of DMPK at Takeda Pharmaceutical Company Ltd in Cambridge, Massachusetts where he leads the met ID function to support new chemical entities and biologics from discovery to development stages. He has extensive industry experience in small molecule metabolism and also has broad knowledge and experience in the peptide and large molecule biotransformation/catabolism using IC-LC/MS. Prior to Takeda, Dr. Zhu led the biotransformation function at Q2 Solutions in Indianapolis, Indiana after he served as a senior biotransformation scientist at Amgen Inc. in Thousand Oaks, California. Dr. Zhu obtained his Ph.D. in Analytical and Bioorganic Chemistry from Case Western Reserve University.

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