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Workshop
[In-Person] Current State of Bioanalysis for Biologics and Cell/Gene Therapy Products: Refining Established Approaches for New Complex Therapies
Speakers:
Stephanie Pasas-Farmer, BioData Solutions; Kelly Colletti, Beam Therapeutics; Jintang He, Genentech; Suk Hyung, Genentech; Sebastian Guelman, Genentech; Bob Liu, Genentech
Organizers:
Sebastian Guelman, Genentech; Jintang He, Genentech; Stephanie Pasas-Farmer, BioData Solutions Consulting; Kelly Colletti, Beam Therapeutics; Surinder Kaur, Genentech
Date:
2024-11-15
Time:
8:45-17:20 Pacific Time
Registration fee:
Regular attendees: $295; Academic/Students/Postdocs/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:
Vendor show vendors registered to date:
(19)Agilex Biolabs Pty Ltd; Aliri Bioanalysis; Altasciences; B2S Life Sciences; BioAgilytix; Celerion.; Curia; ICON Clinical Research; IDEXX BioAnalytics; KBI Biopharma, Inc.; Labcorp; Meadowhawk Biolabs; MilliporeSigma [Sigma-Aldrich,Inc.]; Newomics Inc.; PPD, Part of Thermo Fisher Scientific; QPS LLC; Quantall LLC; SCIEX; Unchained Labs
Registration: http://www.PBSS.org
Registration deadline:2024-11-14
(it will close sooner if the seating cap is reached)
About the Topic
This bioanalytical workshop will explore the impact of different modalities and platforms on bioanalysis, and the varying degrees of regulatory guidance available. This includes the difficulties in applying conventional bioanalytical methods (e.g. LBAs and LC-MS) to new therapeutic agents, and how these challenges affect development. Speakers will discuss the current state of pharmacokinetic (PK) and immunogenicity assessments, existing regulatory frameworks and areas where guidance is still in development, the challenges associated with applying traditional bioanalytical techniques to novel therapies, and the implications for drug development. In-depth analysis of case studies will provide practical insights, troubleshooting strategies, and innovative approaches to overcome the challenges in complex-modality bioanalysis.
Time (PT) |
Topic |
Speaker(s) |
8:45 - 9:00 am |
PBSS Welcome |
Shichang Miao, PhD, President, PBSS |
9:00 - 9:30 am |
Current industry status and trends – biologics, oligonucleotides, cell & gene therapies |
Stephanie Pasas-Farmer, PhD, President and Founder, BioData Solutions |
9:30 - 10:15 am |
Overview of conventional bioanalytical methods - platforms and regulatory guidance |
Kelly Colletti, PhD, MBA, Director, Preclinical Bioanalytics, Beam Therapeutics |
10:15 - 10:45 am |
Bioanalysis of oligonucleotides |
Stephanie Pasas-Farmer, PhD, President and Founder, BioData Solutions |
10:45 - 10:55 am |
Major Sponsor Presentation |
KCAS Bio |
10:55 - 11:15 am |
Break and Vendor Show |
- |
11:15 am - 12:15 pm |
Bioanalysis of monoclonal antibodies and antibody-drug conjugates (ADCs) |
Stephanie Pasas-Farmer, PhD, President and Founder, BioData Solutions; Jintang He, PhD, Sr. Principal Scientist, Genentech; Suk Hyung, PhD, Sr. Principal Scientist, Genentech |
12:15 - 1:15 pm |
Lunch |
Subsidized by PPD, Part of Thermo Fisher Scientific |
1:15 - 2:00 pm |
The complexities of mRNA PK in advanced modalities |
Sebastian Guelman, PhD, Sr. Principal Scientist, Genentech |
2:00 - 3:00 pm |
Allogeneic CAR-T and challenges: what about immunogenicity? |
Bob Liu, PhD, Principal Scientist, Genentech |
3:00 - 3:10 pm |
Major Sponsor Presentation |
CMIC, Inc. |
3:10 - 3:30 pm |
Break and Vendor Show |
- |
3:30 - 4:30 pm |
Advances in next-generation sequencing (NGS) technologies and applications in pharmacodynamic (PD) bioanalysis |
Kelly Colletti, PhD, Director, Preclinical Bioanalytics, Beam Therapeutics |
4:30 - 5:00 pm |
Panel Discussion |
All speakers |
5:00 - 6:00 pm |
Happy Hour |
Sponsored by B2S Life Sciences |
About the Speakers
Dr. Stephanie Pasas-Farmer is a bioanalytical expert with over 20 years of experience in pharmaceutical, biologics, and hybrid technologies. She founded BioData Solutions® in 2015 to support bioanalytical drug development through specialized consulting and software offerings. Previously, she established. Stephanie has advanced early-stage molecules into potential new drug candidates with bioanalysis support and regulatory compliance planning as well as led teams in global bioanalytical labs, focusing on large molecule and antibody-drug conjugate programs. She holds a PhD and MSc in pharmaceutical chemistry from the University of Kansas and a BS in chemistry from St. Mary’s College of Notre Dame.
Dr. Kelly Colletti is the Director, Preclinical Bioanalytics at Beam Therapeutics. She oversees the development and validation of bioanalytical assays supporting nonclinical development for all therapeutic areas. She has over 15 years experience designing and troubleshooting ligand binding assays in bioanalysis and has more recently contributed to the validation principles for qPCR and NGS assays. Kelly has been highly engaged in the bioanalytical community with a passion for mentoring students and scientists. She received her PhD in cellular and molecular biology in 2005 from the University of Nevada Reno, where she also completed an MBA.
Dr. Jintang He is currently a Senior Principal Scientist in the BioAnalytical Sciences department at Genentech. He received his Ph.D. in Biochemistry from Peking University. He then completed his postdoctoral training in proteomics at University of Michigan – Ann Arbor, and pursued further training in mass spectrometry at Pacific Northwest National laboratory. Dr. Jintang He joined Genentech in 2014 and his research interests include developing novel mass spectrometry technologies and implementing these technologies to support PK, biomarker and biotransformation assessment.
Dr. Suk Hyung is a Senior Principal Scientist at BioAnalytical Sciences department, Genentech. He is experienced in planning, developing and execution of bioanalytical strategies including pharmacokinetic, immunogenicity and biotransformation assessments of peptide therapeutics, monoclonal antibodies, and antibody-drug conjugates, in support of both early and late-stage pharmaceutical drug development programs. With a Ph.D. in Chemistry from the University of Cambridge, Suk has extensive experience in the characterization of protein complexes and peptides using LC-MS based methods.
Dr. Sebastian Guelman is a Senior Principal Scientist in the BioAnalytical Sciences Department at Genentech. He currently leads the development of bioanalytical strategies to support cancer immunotherapy programs in Genentech’s pipeline, including advanced modalities such as T cell therapy and the mRNA-based Individualized Neoantigen-specific Therapy. Prior to joining Genentech, Sebastian acquired experience in the development of pharmacokinetic, immunogenicity, biomarker and cell-based potency assays, as well as the development of immunoassays for clinical diagnostics using a variety of platforms. Sebastian received his PhD degree in Biochemistry and Molecular Biology from the Pennsylvania State University and was a post-doctoral fellow in the Department of Pathology at Genentech.
Dr. Bob Liu is a Sr. Principal Scientist in the Department of Bioanalytical Sciences in Genentech/Roche, where he has been for the past two years. His primary focus is the development and implementation of clinical assays to monitor immunogenicity for allogeneic CAR-T therapies. With 13 years of experience supporting drug development across various companies, including Cytomx, Amunix, Cellerant, and Stemcentrx, he led and contributed to oncology programs utilizing diverse therapeutic modalities, such as CAR-T, T-cell bispecifics (TCB), and antibody-drug conjugates (ADC). His passion lies in advancing drug development across all stages, from early discovery to late clinical trials.
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