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Workshop

[In-person] Distribution and Disposition Studies for Biotherapeutics: Multi-specific Antibodies, ADCs, Peptide Conjugates, Cell Therapies and Protein Degraders


Speakers: Victor Yip, Genentech; Andy Boswell, Genentech; Danielle Mandikian, Genentech; Greg Thurber, Univ. of Michigan; Huan-Chieh Chien, Amgen; Dale Miles, Genentech; Lisa O’Callaghan, Merck; Achala Punchi Hewage, Amgen; Mei Han, Merck
Organizers: Ben-Quan Shen, Genentech; Mei Han, Merck
Date: 2023-09-08
Time: 8:45-17:40 Pacific Time
Registration fee: Regular attendees: $295; Academic/Students/Postdocs/Between Jobs: $125; Major Sponsorship: $3000; Vendor Show: $695; Happy Hour Sponsorship: $995; Lunch Sponsorship: $1250; On-site Registration:$500
Location: Crowne Plaza, Foster City, CA (San Francisco Bay Area)
Major Sponsor: (1)Applied BioMath, LLC;(Major Sponsorship - afternoon session still open)
Vendor show vendors registered to date: (12)Agilent; Alturas Analytics; Aragen; BioTether Sciences; Celerion; Ellegaard BioResearch; IRBM; KCAS Bio; Meadowhawk Biolabs; Medicilon; NVIGEN Inc.; Olink Proteomics
Registration: http://www.PBSS.org
Registration deadline:2023-09-07  (it will close sooner if the seating cap is reached)

About the Topic

Advanced biologics and protein engineering enable the development of novel biotherapeutic modalities to treat critical disease-relevant targets. Distribution and disposition of small molecules is intensively investigated during drug discovery and development stages. In contrast, biotransformation of next generation modalities such as multispecifics, Antibody Drug Conjugates (ADCs), nucleotides, peptide conjugates, and protein degraders has not been extensively explored. This workshop will cover this diverse topic of next-generation novel biotherapeutics and provide an opportunity for the community to discuss the technical aspect, role and impact of distribution and disposition on the development of novel modalities.

Topics and Speakers: 

  1. Overview of Workshop on Distribution and Disposition of Larger Molecule Drugs 
    • Speaker:  Ben-Quan Shen and Mei Han
  2. Whole-body SPECT Imaging to Inform Biologic Disposition
    • Speaker: Andy Boswell, Genentech 
  3. Fundamentals of Effective Antibody Drug Conjugate Design: More Than Small Molecule, Linker, and Antibody Combinations
    • Speaker: Greg Thurber, Univ. of Michigan (Virtual Talk)
  4. Distribution and Disposition of Antibody-Drug Conjugates
    • Speaker: Victor Yip, Genentech
  5. Stability and Biotransformation of Biotherapeutic Peptides
    • Speaker: Lisa Anna O’Callaghan, Merck (Virtual talk)
  6. Preclinical Determination of Biotherapeutic Distribution
    • Speaker: Danielle Mandikian, Genentech
  7. Protein Degraders: Insights into Distribution and Disposition from a ADME Perspective
    • Speaker: Huan-Chieh Chien, Amgen
  8. Large Molecule Biotransformation in Support of Next Generation Biologics by Intact Mass Analysis Using Immunoaffinity Purification-Capillary Electrophoresis-Mass Spectrometry (IA-CE-MS) Workflow
    • Speaker: Mei Han* and Achala Punchi Hewage, Amgen
      *Current affiliation: Merck
  1. Disposition and Distribution of Adoptive T-cell Therapies: A Clinical Pharmacology Perspective
    • Speaker: Dale Miles, Genentech
  2. Panel Discussion/Wrap-up of Workshop

 

Time (PT)

Topic

Presenter

8:45-9:00 am

1. PBSS Welcome and Overview of Distribution and Disposition of Larger Molecule Drugs

Ben-Quan Shen (Genentech) and 
Mei Han (Merck) 

9:00-9:40 am

2. Distribution and Disposition of Antibody-Drug Conjugates

Victor Yip, Scientist 4, Genentech

9:40-10:20 am

3. Whole-body SPECT Imaging to Inform Biologic Disposition

Andy Boswell, PhD, Distinguished Scientist,Genentech

10:20-10:30 am

Major Sponsor’s Presentation 

Applied BioMath, LLC

10:30-10:50 am

Break Period & Vendor Show

 

10:50-11:30am

4. Preclinical Determination of Biotherapeutic Distribution

Danielle Mandikian, PhD, Sr. Principal Scientist, Genentech

11:30-12:10pm

5. Fundamentals of Effective Antibody Drug Conjugate Design: More Than Small Molecule, Linker, and Antibody Combinations 

Greg Thurber, PhD, Associate Professor of Chemical Engineering, Biomedical Engineering & Associate Chair of Graduate Education, Univ. of Michigan

12:10-1:00pm

Lunch

Sponsor (TBD)

1:00-1:40pm

6. Stability and Biotransformation of Biotherapeutic Peptides

Lisa O’Callaghan, PhD, Principal Scientist, Merck

1:40-2:20pm

7. Protein Degraders: Insights into Distribution and Disposition from a ADME Perspective

Huan-Chieh Chien, PhD, Principal Scientist,Amgen, Inc. 

2:20-2:30pm

Major Sponsor’s Presentation

TBD

2:30-2:50pm

Break

-

2:50-3:30pm

8. Disposition and Distribution of Adoptive T-cell Therapies: A Clinical Pharmacology Perspective, 

Dale Miles, MS, PhD, Distinguished Scientist and Director,  Genentech

3:30-4:10pm

9. Large Molecule Biotransformation in Support of Next Generation Biologics by Intact Mass Analysis Using Immunoaffinity Purification-Capillary Electrophoresis-Mass Spectrometry (IA-CE-MS) Workflow

Mei Han* , Principal Scientist, and Achala PunchiHewage, PhD, Senior Scientist, Amgen, Inc.

*Current affiliation: Merck

4:10-4:40pm

Panel Discussion

All speakers

4:40-5:40pm

Happy Hour

Sponsor (TBD)

 


About the Speakers

Dr. Dale Miles is a Distinguished Scientist and Director at Genentech within the Clinical Pharmacology department, with over 25 years of drug development experience. His group includes 10 PhD scientists who provide clinical pharmacology expertise to guide a broad portfolio in oncology, including T-cell therapy, cancer immunotherapy, and signaling assets in both heme and solid tumors, and including large molecules, small molecules, and antibody-drug conjugates. Dale is a recognized external scientific leader with over 55 peer reviewed publications in the fields of clinical pharmacology, bioanalytical, and drug metabolism, and has been an invited speaker at external scientific conferences. He has a wide range of demonstrated drug development and regulatory experience, including leading the clinical pharmacology and nonclinical components of multiple successful BLA and NDA filings leading to approval.

Dr. Andy Boswell is a Distinguished Scientist and Postdoc Mentor in the Preclinical and Translational Pharmacokinetics Department with a joint appointment in the Department of Translational Imaging at Genentech. After completing a BS in Chemistry in his home state of Tennessee, Andy earned his PhD in Chemical Biology in 2004 at Washington University School of Medicine in Saint Louis, Missouri, where he specialized in synthesis and preclinical evaluation of radiotracers for nuclear medicine. He also completed a postdoc on novel targeted molecular imaging agents at the NCI in Bethesda, Maryland prior to joining Genentech. Andy has more than 20 years of expertise in radiopharmaceutical chemistry for labeling antibodies and other biologically targeted molecules. During his 14-year tenure at Genentech, he has gained additional expertise in pharmacokinetics within tissue sites of action and in the application of labeling and non-invasive imaging techniques to drug development across various therapeutic areas.

Victor Yip is a veteran of pharmaceutical research specialize in understanding ADME properties of drug products. He has over 20 years of experiences in various biotech and pharmaceutical companies. He joined Genentech in 2009 and has worked on multiple ADC projects over the years to understand their distribution and disposition. He has also contributed in agency filing of the Genentech’s ADCs, Kadcyla and Polivy.

Dr. Lisa O’Callaghan received her BS in Biochemistry from the University of Tulsa and her Ph.D. in Analytical Chemistry from the University of Texas-Austin under Dr. Jennifer Brodbelt. Upon graduation, Lisa was granted a postdoctoral fellowship at the Women’s Health Integrated Research Center where she applied LCMS to identify and quantify biomarkers of ovarian cancer. Dr. O’Callaghan joined Merck Research Laboratories in 2015 where she was the Scientific Lead for the Protein Bioanalysis group within Discovery Bioanalytics, responsible for the development and application of intact and bottom-up LCMS to support biopharmaceutical PK studies and biomarker analysis. In 2020, she transitioned her focus to improving metabolite identification of large biotherapeutics including monoclonal antibodies, antibody drug conjugates, siRNA and peptides. Outside of work Lisa serves on the ASMS Education committee, cheers on all Philadelphia sports teams and is mom to two amazing children, Conor and Lyla, who brighten her mood every day!

Dr. Huan-Chieh Chien received his PhD. degree in Genomic Sciences in Taiwan. His research focused on comparing evolutionary rates of brain-expressed genes to identify and characterize novel fast-evolving genes during brain development. He joined Dr. Kathleen Giacomini’s laboratory at UCSF in 2013 as a postdoctoral scholar and served as one of the team leads in a joint-effort project between UCSF and Pfizer, aiming to develop a therapeutic antibody for the treatment of NASH by targeting OCT1. He was also a co-Principal Investigator on two SBIR grants during 2016-19 in Apricity Therapeutics Inc. In 2019, he joined AbbVie, where he was a sub-functional lead, coordinating transporter-related assays. He then moved to Amgen PKDM in 2020, where he collaborates with multi-functional groups both internally and externally. Dr. Chien has a total 24 co-author papers, with 19 of them being from Dr. Giacomini’s lab. His publications have accumulated more than 1,500 citations since 2017.

Mei Han is currently a Principal Scientist at Merck, PDMB, working on new technology implementation and novel workflow development for biotransformation analysis of next-gen biologics and targeted therapies. Prior to joining Merck, Mei was a Principal Scientist in PKDM department at Amgen South San Francisco, she led the large molecule biotransformation team within PKDM and serve as a PKDM project team representative in project team for multiple projects. Mei has 20+ years’ of biopharma experience in drug discovery and development specialized in analytical sciences, biologics optimization, pharmacokinetics and drug metabolism. As a subject matter expert of protein therapeutics purification and characterization, in vitro (pre-dose) and in vivo (post-dose), her expertise ranging from chromatographic, electrophoresis and mass spectrometry analytical method development, inter- and intra- departmental method transfer, method qualification per ICH guidelines and experience with regulatory filings. She also served as a CE Pharm Committee member and Associate Director for CASSS.

Dr. Achala Punchi Hewage completed her BSc at the University of Kelaniya, Sri Lanka and she completed her PhD at the University of Kansas. She did research on bacterial iron homeostasis as a novel target for antibiotic development and her findings resulted in impactful publications and presentations. Achala joined Amgen in June 2021 after completing her postdoctoral research at the University of Kansas on the involvement of nuclear hormone receptors in axon myelination. Capillary electrophoresis (CE) based techniques such as CE-MS, CE-SDS and icIEF are routinely used in her research at Amgen. Achala will be discussing a summary of her results on the analysis of large molecule drugs using CE-MS, CE-SDS and icIEF.

Dr. Danielle Mandikian holds a PhD in Biochemistry and Molecular Biology from UC Davis. Her graduate work focused on identifying a novel functional association of a voltage gated potassium channel and a calcium release receptor in the mammalian brain that results in regulation of circuit specific excitability. Following her graduate studies, Danielle joined the Investigational Pharmacokinetics group, currently as a Senior Principal Scientist, in the Preclinical and Translational Pharmacokinetics Department at Genentech. Her current research focus is on development of therapeutics for oncology, neurology and ophthalmology; specializing in how certain design features impact in vivo target engagement and biodistribution.


Dr. Greg M. Thurber is Associate Professor of Chemical Engineering and Biomedical Engineering at the University of Michigan and Associate Chair of Graduate Education in ChE. His work focuses on applying fundamental biotransport principles to design novel therapeutics and molecular imaging agents including antibody drug conjugates. Prof. Thurber received his PhD training in protein therapeutics at MIT and postdoctoral training in molecular imaging at Mass General Hospital and Harvard Medical School. Prof. Thurber has authored over 65 papers and book chapters and delivered 85 invited talks at major pharmaceutical companies, conferences, and seminars. His work has been featured in popular news outlets including NPR’s “All Things Considered” and Smithsonian Magazine, and he has received several awards including an NIH K01 award, the National Science Foundation CAREER award, and the World ADC George R. Pettit Award.

 


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