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Workshop

[In-Person] Human Mass Balance and Metabolite Profiling Studies: Strategies, Technical Approaches, Regulatory Guidance, Applications and Case Studies


Speakers: Chandra Prakash, Agios; Zhixia Yan, FDA; Bernard Murray, Gilead; Ryan Takahashi, Denali Therapeutics; Shuai Wang, Genentech; Raman Sharma, Pfizer; Ronald Kong, PTC Therapeutics, Inc.
Organizers: Chandra Prakash (Agios)
Date: 2024-05-06
Time: 8:45-17:00 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs: $45; Out-of-Pocket: $45; Major Sponsorship: $3000; Vendor Show: $695, Happy Hour Sponsorship: $975; Lunch Sponsorship: $1250; On-site Registration: $500
Location: Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor: (2)Fortrea; Pharmaron
Vendor show vendors registered to date: (11)Celerion; Certara; Cyprotex; Discovery Life Sciences; Ellegaard BioResearch; Eurofins Selcia; Labcorp; MilliporeSigma [Sigma-Aldrich,Inc.]; Moravek, Inc.; Q Squared Solutions; Quotient Sciences
Registration: http://www.PBSS.org
Registration deadline:2024-05-02  (it will close sooner if the seating cap is reached)

About the Topic

Human absorption, distribution, metabolism, and excretion (ADME) study (also referred to as mass balance or radiolabel study) is a key study in the Clinical Pharmacology package of new drug application. The data gathered from this study provides a quantitative and comprehensive overall picture of the disposition of a drug, including excretion pattern and metabolite profiles in circulation and excreta and are highly informative for developing a cohesive strategy for clinical pharmacology studies, drug-drug interaction, organ impairment, monitoring of metabolite(s), and to obtain a waiver for the bioequivalence study.  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. Recently, US Food and Drug Administration (FDA) issued a guidance describing the recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies of investigational drug.  

The workshop is designed to provide detailed guidance on objectives, study designs, and data analysis of metabolism studies of small molecules. Speakers of this workshop bring a wealth of knowledge from the pharmaceutical industry/FDA in drug metabolism sciences. This workshop will describe the highlights of this regulatory guidance and various strategies and technical approaches for conducting the human radiolabeled ADME studies with examples of approved drugs.

The discussion will be centered around the following topics:

  • Overview of the recent FDA guidance
  • Radiolabeled human ADME studies-why, what and when
  • Human ADME studies: Design, data analysis, and interpretation
  • Approaches for safety assessments of human metabolites
  • IV tracer studies approach with case studies

 

Time (PST)  Topic Presenter
8:45-8:55 am  PBSS Welcome and Introduction  Shichang Miao, PhD, PBSS 
8:55-9:20 am Objectives and Overview of Various Approaches Used for hADME Studies: Pros and Cons  Chandra Prakash, Senior Research Fellow, Agios Pharmaceuticals
9:20-9:50 am  Importance of Preclinical Radiolabeled ADME Studies Chandra Prakash, Senior Research Fellow, Agios Pharmaceuticals 
9:50 -10:30 am Nonclinical QWBA Studies and their Application in Human Dosimetry Calculations Bernard Murray, PhD, Executive Director, Drug Metabolism, Gilead Sciences
10:30-10:40 am Major Sponsor Presentation Fortrea
10:40-11:00 am Break and Vendor Show  -
11:00-11:50 am A Deep Dive: FDA Draft Guidance on Human Radiolabeled Mass Balance Studies Zhixia (Grace) Yan Danielsen, PhD, Deputy Division Director, US Food and Drug Administration 
11:50 am-12:50 pm Lunch Sponsor, TBD
12:50-1:40 pm Human Mass Balance and Metabolite Profiling: Design, Data Analysis, and Interpretation  Shuai Wang, PhD, Principal Scientist, DMPK, Genentech
1:40-2:30 pm hADME Studies at Steady State: Design and Case Studies Ronald Kong, PhD, Vice President, Clinical Pharmacology and DMPK, PTC Therapeutics. 
2:30-2:40 pm Major Sponsor Presentation Pharmaron
2:40-3:00 pm Break and Vendor Show 
3:00-3:50 pm Approaches for the Determination of Absolute Bioavailability: Study Design, Data Analysis, and Interpretation  Raman Sharma, Senior Scientist, Pfizer
3:50-4:30 pm Approaches for Coverage Assessment of Human Metabolites in Safety Species (MIST) Ryan Takahashi, PhD, Head of Small Molecule DMPK, Denali Therapeutics
4:30-5:00 pm Panel Discussion All speakers
5:00-6:00 pm Happy Hour Sponsor, Labcorp 

 

 


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