Speakers: Donglu Zhang (Genentech), Mark Cancilla (Merck), Aiming Yu (UC Davis), Jing Li (Alnylam Pharmaceuticals), Fang Xie (Amgen) , Mei Han (Amgen) , Srikanth Kotapat (Bristol-Myers Squibb), Dian Su (Genentech), Ben Shen (Genentech), Divya Samineni (Genentech)Donglu Zhang (Genentech), Mark Cancilla (Merck), Aiming Yu (UC Davis), Jing Li (Alnylam Pharmaceuticals), Fang Xie (Amgen) , Mei Han (Amgen) , Srikanth Kotapat (Bristol-Myers Squibb), Dian Su (Genentech), Ben Shen (Genentech), Divya Samineni (Genentech)
Organizers: Dian Su (Genentech)
Date: 2019-09-13
Time: 8:45-17:00 Pacific Time
Registration fee: (USD): Regular: $195; Academic: $125; For unemployed or students: $30; For major-sponsor rep (incl lunch): $0; For vendor-show rep: $35
Location: SF Bay Area: Foster City Crowne Plaza
Major Sponsor: (1)Almac;(Major Sponsorship - afternoon session still open)
Vendor show vendors registered to date: (10)Celerion; CMIC, Inc.; Intertek; Labcorp; MicroConstants; Pharmaron; PRIMERA ANALYTICAL SOLUTIONS CORP; Promethera Biosciences; QPS LLC; Waters Corporation
Registration: http://www.PBSS.org
Registration deadline:2019-09-11  (it will close sooner if the seating cap is reached)

About the Topic

​Biotransformation of small molecules is intensively investigated during drug discovery and development stages. In contrast, biotransformation of larger molecules such as antibodies, proteins, antibody-drug conjugates, peptides and nucleotides has been less emphasized. In the last decade, there have been increasing interests and expertise in understanding of larger molecule biotransformation and disposition. This workshop will cover this topic for diverse therapeutics and provide an opportunity for the community to discuss the technical aspect, role and impact of biotransformation for development of larger molecule therapeutics.

Key topics:

• Introduction to Disposition and Biotransformations of Larger Molecules 
• Biotransformation and Trafficking of Peptide Therapeutics
• Biotransforamtion and biodistribution of Oligonucleotide Therapeutics 
• Biotransformation of Antibody Therapeutics
• Biotransformation of Next-generation ADCs
• Tissue Disposition of Protein and Antibody Therapeutics

Agenda

8:45  Workshop welcome

8:45-9:30  Donglu Zhang (Genentech): Distribution and Disposition of Larger Molecule Drugs: Local Metabolism and Local Concentration

9:30-10:15  Mark Cancilla (Merck): Developing Peptide Therapeutics By Understanding Their Metabolism And Trafficking

10:15-10:30  Morning Break

10:30-11:15  Aiming Yu (UC Davis): Bioengineered RNAi Prodrug: Production, Biotransformation and Efficacy

11:15-11:50  Jing Li (Alnylam Pharmaceuticals): Understanding the Biotransformation of RNAi Therapeutics Using High Resolution Mass Spectrometry

11:50-12:25  Fang Xie (Amgen): Biotransformation of siRNA Therapeutics

12:25-1:20  Lunch

1:20-2:00  Mei Han (Amgen): Biotransformation Study for Protein and Antibody Therapeutics Using Immunoaffinity Purification Capillary Electrophoresis Mass Spectrometry (IA-CE-MS)

2:00-2:35  Srikanth Kotapat (Bristol-Myers Squibb): The Role of LC-MS in In Vivo Biotransformation Assessment of Therapeutic Proteins

2:35-3:10  Dian Su (Genentech): Advanced Strategies, Technologies and Applications in ADC Biotransformation

3:10-3:25 Afternoon Break

3:25-4:05  Ben Shen (Genentech): Considerations and Approaches in Determining Tissue Disposition of Biotherapeutics and Impact on Drug Development

4:05-4:45  Divya Samineni (Genentech): Impact of PBPK Modeling on Polatuzumab Vedotin Labeling – Waiver for Clinical DDI Studies

4:45-5:15 Panel discussion: all speakers/topics

Workshop ends by 5:15pm